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Stryker Instruments Div. of Stryker Corporation

413 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutt recall (Z-0431-2021)Stryker Instruments Div. of Stryker Corporation2020-11-06
SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The product is a Bov recall (Z-1097-2020)Stryker Instruments Div. of Stryker Corporation2020-01-28
Telescopic Smoke Evac Pencil, PB, Coated, Product No. SHKTSPCL. The product is a Bovie pen recall (Z-1098-2020)Stryker Instruments Div. of Stryker Corporation2020-01-28
Telescopic Uncoated (Push Button), Product No. SHK TSPL. The product is a Bovie pencil tha recall (Z-1099-2020)Stryker Instruments Div. of Stryker Corporation2020-01-28
Stryker PROFESS Registration Kit. The Stryker PROFESS Registration Kit is a member of the recall (Z-2071-2017)Stryker Instruments Div. of Stryker Corporation2017-04-19
8450-107-530 3.0MM Precision Match Head, 13CM, single use, Sterile The Stryker MIS (Minima recall (Z-0868-2017)Stryker Instruments Div. of Stryker Corporation2016-12-21
8450-107-525 2.5MM Precision Match Head, 13CM, single use, Sterile The Stryker MIS (Minima recall (Z-0869-2017)Stryker Instruments Div. of Stryker Corporation2016-12-21
8470-009-030 3.0MM Precision Round, 16CM, single use, Sterile The Stryker MIS (Minimally I recall (Z-0870-2017)Stryker Instruments Div. of Stryker Corporation2016-12-21
8470-009-040 4.0MM Precision Round, 16CM, single use, Sterile The Stryker MIS (Minimally I recall (Z-0871-2017)Stryker Instruments Div. of Stryker Corporation2016-12-21
8450-010-040 4.0MM Round, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Su recall (Z-0872-2017)Stryker Instruments Div. of Stryker Corporation2016-12-21
8450-009-030 3.0MM Precision Round, 13CM, single use, Sterile The Stryker MIS (Minimally I recall (Z-0873-2017)Stryker Instruments Div. of Stryker Corporation2016-12-21
8450-009-040 4.0MM Precision Round, 13CM, single use, Sterile The Stryker MIS (Minimally I recall (Z-0874-2017)Stryker Instruments Div. of Stryker Corporation2016-12-21
RF MultiGen, 0406-900-000; Refurb RF MultiGen, 0406-900-000U recall (Z-0584-2017)Stryker Instruments Div. of Stryker Corporation2016-11-16
Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090 Product Usage: Heavy duty Sagitt recall (Z-0112-2017)Stryker Instruments Div. of Stryker Corporation2016-10-18
120 V Neptune 3 Rover, Model Number: 0703-001-000 recall (Z-2630-2016)Stryker Instruments Div. of Stryker Corporation2016-08-23
Stryker AutoPlex System. Model Numbers 0607-687-000, 0605-887-000, 0605-687-000, and 0605- recall (Z-2536-2016)Stryker Instruments Div. of Stryker Corporation2016-08-15
2.3MM Tapered Router, Product Number 5407-FA2-023 A router is a cutting accessory used in recall (Z-2238-2016)Stryker Instruments Div. of Stryker Corporation2016-07-19
5.0mm Round Fluted Bur, Super Long recall (Z-2204-2016)Stryker Instruments Div. of Stryker Corporation2016-07-14
6.0mm Round Fluted Bur, Super Long recall (Z-2205-2016)Stryker Instruments Div. of Stryker Corporation2016-07-14
Maestro Air Motor Pneumatic cranial drill motor. The Maestro Air Pneumatic System is a pne recall (Z-1939-2016)Stryker Instruments Div. of Stryker Corporation2016-06-09
Spetzler Claw Tip, Universal - 5450-800-311 Spetzler Open Angle Micro Claw Tip, Universal recall (Z-1378-2016)Stryker Instruments Div. of Stryker Corporation2016-04-13
SurgiCounter scanner, part of the SurgiCount Safety-Sponge System. Model numbers 0694-097- recall (Z-1379-2016)Stryker Instruments Div. of Stryker Corporation2016-04-13
(Stryker) AccuPlace Straight Level Needle Guide; Assists the user with inserting a needle recall (Z-1037-2016)Stryker Instruments Div. of Stryker Corporation2016-03-03
(Stryker) AccuPlace Round Level Needle Guide; Assists the user with inserting a needle at recall (Z-1038-2016)Stryker Instruments Div. of Stryker Corporation2016-03-03
50000 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a recall (Z-1039-2016)Stryker Instruments Div. of Stryker Corporation2016-03-03
50001 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a recall (Z-1040-2016)Stryker Instruments Div. of Stryker Corporation2016-03-03
Cournand Modified 2-PC 19G, 5.4cm or (Guidewire Introducer Needle) 20 units per case The S recall (Z-0417-2016)Stryker Instruments Div. of Stryker Corporation2015-12-14
Neptune 2 Waste Management System Docking Station (120V and 230V), New and Refurbished Pro recall (Z-2524-2015)Stryker Instruments Div. of Stryker Corporation2015-09-01
Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM Product Usage: The Stryker Sele recall (Z-2102-2015)Stryker Instruments Div. of Stryker Corporation2015-07-18
0702-001-350Q, Diverter Valve Assembly 0702-001-000, Neptune 2 Rover Ultra (120V) 0702-001 recall (Z-2099-2015)Stryker Instruments Div. of Stryker Corporation2015-07-17
0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare Replacement recall (Z-2062-2015)Stryker Instruments Div. of Stryker Corporation2015-07-13
Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103-001 and Arti recall (Z-1810-2015)Stryker Instruments Div. of Stryker Corporation2015-06-16
EliteCore Full Core Biopsy Device. EliteCore 18G, 20cm with and without HiLiter tip, 15 cm recall (Z-1671-2015)Stryker Instruments Div. of Stryker Corporation2015-05-26
Universal Charger Product Usage: The Stryker Universal Battery Charger is designed to be u recall (Z-1587-2015)Stryker Instruments Div. of Stryker Corporation2015-05-07
3/16 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound recall (Z-1562-2015)Stryker Instruments Div. of Stryker Corporation2015-05-01
3/16 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with recall (Z-1563-2015)Stryker Instruments Div. of Stryker Corporation2015-05-01
1/8 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound D recall (Z-1564-2015)Stryker Instruments Div. of Stryker Corporation2015-05-01
1/8 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with W recall (Z-1565-2015)Stryker Instruments Div. of Stryker Corporation2015-05-01
1/4 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound D recall (Z-1566-2015)Stryker Instruments Div. of Stryker Corporation2015-05-01
1/4 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with W recall (Z-1567-2015)Stryker Instruments Div. of Stryker Corporation2015-05-01
3/16 in. Round Drain with Trocar Curved Trocar with Wound Drain/Double Trocar with Wound D recall (Z-1568-2015)Stryker Instruments Div. of Stryker Corporation2015-05-01
1/4 in. Round Drain with Trocar Curved Trocar with Wound Drain/Double Trocar with Wound Dr recall (Z-1569-2015)Stryker Instruments Div. of Stryker Corporation2015-05-01
3/16 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with recall (Z-1570-2015)Stryker Instruments Div. of Stryker Corporation2015-05-01
1/8 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with W recall (Z-1571-2015)Stryker Instruments Div. of Stryker Corporation2015-05-01
1/4 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with W recall (Z-1572-2015)Stryker Instruments Div. of Stryker Corporation2015-05-01
Ambulating Bulb Ambulating Bulb: The Ambulating Bulb comprises four main components: the s recall (Z-1573-2015)Stryker Instruments Div. of Stryker Corporation2015-05-01
Flyte Togas are components of the Stryker Flyte System and are intended to be worn over an recall (Z-1077-2015)Stryker Instruments Div. of Stryker Corporation2015-02-10
System 6 Aseptic Housing. The Stryker System 6 Aseptic Housings provide a sterile enclosur recall (Z-1066-2015)Stryker Instruments Div. of Stryker Corporation2015-02-09
The SurgiCounter Charging Cradle Product Usage: SurgiCounter Charging Cradles are designed recall (Z-0986-2015)Stryker Instruments Div. of Stryker Corporation2015-01-15
Stryker SmartLife Large Aseptic Housing REF 7126-120-000 Rx Only The SmartLife" Aseptic Ho recall (Z-0172-2015)Stryker Instruments Div. of Stryker Corporation2014-11-05
Stryker SmartLife Small Aseptic Housing REF 7222-120-000 Rx Only The SmartLife" Aseptic Ho recall (Z-0173-2015)Stryker Instruments Div. of Stryker Corporation2014-11-05
Sonopet Ultrasonic Surgical System Console, Ultrasonic Aspirator, Stryker Medtech. recall (Z-2156-2014)Stryker Instruments Div. of Stryker Corporation2014-08-07
Stryker 0.5mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used recall (Z-1749-2014)Stryker Instruments Div. of Stryker Corporation2014-06-11
Stryker 1.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used recall (Z-1750-2014)Stryker Instruments Div. of Stryker Corporation2014-06-11
Stryker 2.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used recall (Z-1751-2014)Stryker Instruments Div. of Stryker Corporation2014-06-11
Stryker 4.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used recall (Z-1752-2014)Stryker Instruments Div. of Stryker Corporation2014-06-11
Stryker 6.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used recall (Z-1753-2014)Stryker Instruments Div. of Stryker Corporation2014-06-11
Stryker 3.0mm Round Fluted Bur Soft Touch Sterile Product Usage: The devices are intended recall (Z-1754-2014)Stryker Instruments Div. of Stryker Corporation2014-06-11
Stryker 5.5mm Round Fluted Bur Soft Touch Sterile Product Usage: The devices are intended recall (Z-1755-2014)Stryker Instruments Div. of Stryker Corporation2014-06-11
Stryker 3.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended recall (Z-1756-2014)Stryker Instruments Div. of Stryker Corporation2014-06-11
Stryker 4.5mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended recall (Z-1757-2014)Stryker Instruments Div. of Stryker Corporation2014-06-11
Stryker 5.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended recall (Z-1758-2014)Stryker Instruments Div. of Stryker Corporation2014-06-11
Stryker 5.5mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended recall (Z-1759-2014)Stryker Instruments Div. of Stryker Corporation2014-06-11
Stryker 6.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended recall (Z-1760-2014)Stryker Instruments Div. of Stryker Corporation2014-06-11
Stryker 2.0mm Tapered Round Elite Bur Sterile Product Usage: The devices are intended to b recall (Z-1761-2014)Stryker Instruments Div. of Stryker Corporation2014-06-11
Stryker 3.5mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended recall (Z-1762-2014)Stryker Instruments Div. of Stryker Corporation2014-06-11
Stryker 5.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended recall (Z-1763-2014)Stryker Instruments Div. of Stryker Corporation2014-06-11
Stryker 6.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended recall (Z-1764-2014)Stryker Instruments Div. of Stryker Corporation2014-06-11
Stryker 2.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended recall (Z-1765-2014)Stryker Instruments Div. of Stryker Corporation2014-06-11
Stryker 5.0mm Egg Bur Sterile Product Usage: The devices are intended to be used to cut bo recall (Z-1766-2014)Stryker Instruments Div. of Stryker Corporation2014-06-11
Stryker 6.0mm Egg Bur Sterile Product Usage: The devices are intended to be used to cut bo recall (Z-1767-2014)Stryker Instruments Div. of Stryker Corporation2014-06-11
Stryker 5.0mm Barrel Bur Sterile recall (Z-1768-2014)Stryker Instruments Div. of Stryker Corporation2014-06-11
Stryker 5.0mm Acorn Bur Sterile Product Usage: The devices are intended to be used to cut recall (Z-1769-2014)Stryker Instruments Div. of Stryker Corporation2014-06-11
Stryker 6.0mm Acorn Bur Sterile Product Usage: The devices are intended to be used to cut recall (Z-1770-2014)Stryker Instruments Div. of Stryker Corporation2014-06-11
Lindemann Drill Short, 1.6mm Sterile Product Usage: The devices are intended to be used to recall (Z-1771-2014)Stryker Instruments Div. of Stryker Corporation2014-06-11
Stryker 1.3mm Wire Pass Drill Sterile Product Usage: The devices are intended to be used t recall (Z-1772-2014)Stryker Instruments Div. of Stryker Corporation2014-06-11
Stryker 1.5mm Wire Pass Drill Sterile Product Usage: The devices are intended to be used t recall (Z-1773-2014)Stryker Instruments Div. of Stryker Corporation2014-06-11
Stryker 2.5mm x 3.6mm Neuro Drill Soft Touch Sterile Product Usage: The devices are intend recall (Z-1774-2014)Stryker Instruments Div. of Stryker Corporation2014-06-11
Stryker 3.0mm x 3.8mm Neuro Drill Soft Touch Sterile Product Usage: The devices are intend recall (Z-1775-2014)Stryker Instruments Div. of Stryker Corporation2014-06-11
Stryker 4.0mm x 5.1mm Neuro Drill Soft Touch Sterile Product Usage: The devices are intend recall (Z-1776-2014)Stryker Instruments Div. of Stryker Corporation2014-06-11
Stryker 3.0mm x 3.8mm Neuro Drill Sterile Product Usage: The devices are intended to be us recall (Z-1777-2014)Stryker Instruments Div. of Stryker Corporation2014-06-11
Stryker 3.0mm x 3.8mm Precision Neuro Drill Sterile Product Usage: The devices are intende recall (Z-1778-2014)Stryker Instruments Div. of Stryker Corporation2014-06-11
Stryker 5.0mm Barrel Bur Sterile Product Usage: The devices are intended to be used to cut recall (Z-1779-2014)Stryker Instruments Div. of Stryker Corporation2014-06-11
Stryker 3.0mm x 3.8mm Neuro Drill Less Aggressive Sterile Product Usage: The devices are i recall (Z-1780-2014)Stryker Instruments Div. of Stryker Corporation2014-06-11
The Stryker NAV3i Platform is a mobile cart platform consisting of the sub-components Stry recall (Z-1715-2014)Stryker Instruments Div. of Stryker Corporation2014-06-04
The NAV3i Platform Power Box supplies the electrical components with power (e.g. Stryker N recall (Z-1716-2014)Stryker Instruments Div. of Stryker Corporation2014-06-04
Stryker PenAdapt"; Rx Only, Sterile. This device is an accessory to an electrosurgical uni recall (Z-1493-2014)Stryker Instruments Div. of Stryker Corporation2014-04-24
2.5MM Aggressive Blade Known as a Sinuscopic Shaver Blade, this device is composed of a me recall (Z-1247-2014)Stryker Instruments Div. of Stryker Corporation2014-03-20
Neptune 2 Rover Ultra Waste Management System. recall (Z-0902-2014)Stryker Instruments Div. of Stryker Corporation2014-01-31
Neptune 2 Rover Ultra Waste Management System recall (Z-0903-2014)Stryker Instruments Div. of Stryker Corporation2014-01-31
Stryker Color Cuff, REF 5921-034-135 Disposable Tourniquet Cuffs 34 in x 4 in (86 cm x 10 recall (Z-0630-2014)Stryker Instruments Div. of Stryker Corporation2014-01-06
Acetabular Pressurizer; single use and six units per box. The Acetabular Pressurizer 0206- recall (Z-0280-2014)Stryker Instruments Div. of Stryker Corporation2013-11-14
Dekompressor Percutaneous Discectomy Probe. The Dekompressor is a single use disposable di recall (Z-0127-2014)Stryker Instruments Div. of Stryker Corporation2013-11-01
REF 5100-088, TPS Micro Driver, For Use with Stryker Total Performance System Caution Fede recall (Z-0092-2014)Stryker Instruments Div. of Stryker Corporation2013-10-28
Sonopet Ultrasonic Aspirator Console (Console 110V with Pedal & Pole) Product Usage: The S recall (Z-1878-2013)Stryker Instruments Div. of Stryker Corporation2013-08-06
Sonopet Ultrasonic Aspirator Console 5450-851-000(Console 100V) Product Usage: The Sonopet recall (Z-1879-2013)Stryker Instruments Div. of Stryker Corporation2013-08-06
Sonopet Ultrasonic Aspirator Console 5450-852-000 (Console 230V) Product Usage: The Sonope recall (Z-1880-2013)Stryker Instruments Div. of Stryker Corporation2013-08-06
Stryker TPS Universal Driver REF 5100- 99 Rx , The Stryker Total Performance System (TPS) recall (Z-1740-2013)Stryker Instruments Div. of Stryker Corporation2013-07-16
CORE Universal Driver REF 5400- 99 Rx Only This drill may also be used with theTotal Perfo recall (Z-1741-2013)Stryker Instruments Div. of Stryker Corporation2013-07-16
RemB Electric Universal Driver REF 6400-099-000 For use with the CORE and TPS System sRx O recall (Z-1742-2013)Stryker Instruments Div. of Stryker Corporation2013-07-16
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Every clearance here is in the API, with alerts when new ones post.