Atlas FDA

2015

3,020 FDA 510(k) clearances · Clearance year

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RecordFirmDate
OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System (K142451)Merete Medical GmbH2015-02-09
Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach (K143085)Stryker Orthopaedics2015-02-09
POWDER FREE NITRILE EXAMINATION GLOVE, WHITE (colored) (K142858)Careplus (M) Sdn Bhd2015-02-09
ENROUTE Transcarotid Neuroprotection System (K143072)Silk Road Medical, Inc.2015-02-09
ACUSON P500 Diagnostic Ultrasound System (K150050)Siemens Medical Solutions USA, Inc.2015-02-09
ULTICARE SAFETY SYRINGE WITH REMOVABLE NEEDLE (K140949)Ultimed Incorporated2015-02-09
Heated Eye Pad (K142228)Digital Heat Corporation2015-02-09
ENDOCAPSULE SOFTWARE 10; ENDOCAPSULE SOFTWARE 10 LIGHT (K142680)Olympus Medical Systems Corp.2015-02-08
ADVANCED MEMBRANCE GAS EXCHANGE PMP STERILE (A.M.G PMP STERILE) (K141492)Eurosets S.R.L2015-02-06
Zimmer Segmental System XT Components (K150028)Zimmer, Inc.2015-02-06
NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory (K143678)Ninepoint Medical, Inc.2015-02-06
MD322C8 31.5 Diagnostic Imaging LCD Monitor (K150145)Nec Display Solutions , Ltd.2015-02-06
VERTEX Reconstruction System (K143471)Medtronic Sofamor Danek USA, Inc.2015-02-06
ULTRASONIC POCKET DOPPLER (K140579)Edan Instruments, Inc.2015-02-06
Unimed Disposable and Reusable SPO2 Sensors (K142832)Unimed Medical Supplies, Inc.2015-02-06
CAAS A-Valve (K143044)Pie Medical Imaging BV2015-02-06
KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic System (K143257)Medicatech USA2015-02-06
Renovis S141 Lumbar Interbody Cage System (K143126)Renovis Surgical Technologies2015-02-06
Nexis osteosynthesis snap-off screws (K143146)Novastep2015-02-06
Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set (K143500)Immunalysis Corporation2015-02-06
Kirschner Wires, Steinmann Pins (K143618)Zimmer, Inc.2015-02-06
CLEO PATIENT MONITOR (K142244)Infinium Medical2015-02-06
Nexis osteosynthesis compressive screws (K143229)Novastep2015-02-06
12SL ECG ANALYSIS PROGRAM (K141963)Ge Medical Systems Information Technologies, Inc.2015-02-05
SonicFill 2 (K143209)Sybron Dental Specialties2015-02-05
CO2 monitoring line with and without in-line filter (K143150)Besmed Health Business Corp2015-02-05
DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (K141982)Wrp Asia Pacific Sdn. Bhd.2015-02-05
Acumed Small Bone IM Nail System (K143276)Acumed, LLC2015-02-05
MINDFRAME CAPTURE LP REVASCULARIZATION DEVICE (K141516)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2015-02-05
DMRC Light Cure Orthodontic Adhesive System (K142880)Daville Materials, LLC2015-02-04
Extremity Medical Calcaneal Osteotomy Device (K143402)Extremity Medical, LLC2015-02-04
Laparoscopic Handles with peek Insulation (K150127)Stryker Endoscopy2015-02-04
Digital Diagnostic X-ray System (GC80) (K143029)Samsung Electronics Co., Ltd.2015-02-04
SIGNA Creator, SIGNA Explorer (K143251)Ge Healthcare (Ge Medical Systems, LLC)2015-02-04
ACL SMART System (K143172)Smith & Nephew, Inc.2015-02-04
NEUROREADER MEDICAL IMAGE PROCESSING SOFTWARE (K140828)Brainreader Aps2015-02-04
BWMINI EEG, BWMINIHST, BWMINI PSG (K131335)Neurovirtual USA, Inc.2015-02-03
TCS Blend (K142894)Thermoplastic Comfort Systems, Inc.2015-02-03
ENGSTROM CARESTATION, ENGSTROM PRO (K140575)Datex-Ohmeda, Inc.2015-02-03
MIS Z-Pedicle Screw System (K143200)Z-Medical GmbH & Co. KG2015-02-03
Infusion Aspiration Catheter System (K143563)Inari Medical, Inc.2015-02-03
extriCARE 3600 Negative Pressure Wound Therapy System 1000cc canister (K143362)Devon Medical Products2015-02-03
ECHOSTAR COMFORT 1.5T MRI (K141945)Alltech Medical Systems America, Inc.2015-02-03
Ebony PTA 0.014 RX Peripheral Dilatation Catheter (K142459)Natec Medical , Ltd.2015-02-03
FERTILIGENT SLOW RELEASE IUI CATHETER KIT (K141666)Fertiligent, Ltd.2015-02-03
ThinkMed Intermittent Catheter with/without Hydrophilic Coating (K142767)Thinkmed Medical Technology Co., Ltd.2015-02-03
PREMIUM, SHELTA Implant Systems (K142242)Sweden & Martina S.P.A.2015-02-02
EmboGuide (K142273)Philips Medical Systems Nederland B.V.2015-01-30
FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0 (K143171)Biofire Diagnostics, LLC2015-01-30
ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008, ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI BLACK, ASAHI NEUROVASCULAR (K141751)Asahi Intecc Co., Ltd.2015-01-30
FilmArray 2.0 System (K143178)Biofire Diagnostics, LLC2015-01-30
Ideal pedicle screw spinal system (K142957)Jiangsu Ideal Medical Science & Technology Co., Ltd.2015-01-30
HIGH TIBIAL OSTEOTOMY SYSTEM (K141548)Newclip Technics2015-01-30
The LINK® Endo-Model® Knee System (K143179)Waldemar Link GmbH & Co. KG2015-01-30
CREO Stabilization System (K143633)Globus Medical, Inc.2015-01-30
VECTRAPLEX CMS (K140852)Vectracor, Inc.2015-01-30
NAVAJO PTA BALLOON DILATATION CATHETER (K141354)Curative Medical, Inc.2015-01-30
SOMNOTOUCH RESP (K140861)Somnomedics GmbH2015-01-30
ELUX 810 LASER (K141986)Equipmed North America, Inc.2015-01-30
MULTIPULSE TM+1470 (K133891)Asclepion Laser Technologies GmbH2015-01-30
NANOBONE / GRANULATE (K141189)Artoss GmbH2015-01-30
Universal Digital Interface 2W, UDI 2W (K143232)Meridian Medical Systems, LLC2015-01-30
Prelude PF Patellae (K143543)Biomet, Inc.2015-01-30
Ultimax-i (K143281)Toshibamedical Systems Corporation2015-01-29
LightStim for Acne/ LightStim for Acne Mini (K142246)Led Intellectual Properties, LLC2015-01-29
One Way Soft Valve (K142500)Terumo Cardiovascular Systems Corporation2015-01-29
Surgical Gut Suture (K142656)Covidien2015-01-29
easyEndo Linear Cutting Stapler and Loading Unit for Single Use(Stapler;Loading Unit) (K143129)Ezisurg Medical Co., Ltd.2015-01-29
TRANSONIC ELSA SYSTEM (K134051)Transonic Systems, Inc.2015-01-29
S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System (K142714)Sonoscape Company Limited2015-01-29
Capillus 272 Pro (K143199)Capillus, LLC2015-01-29
LOGIQ P9, LOGIQ P7 (K143452)GE Healthcare2015-01-29
Mini ONE Enteral Extension Set (K142989)Applied Medical Technology, Inc.2015-01-29
HEINE SIGMA 250 & HEINE SIGMA 250 M2 (K142837)Heine Optotechnik GmbH & Co. KG2015-01-29
LISTERINE Sensitivity Defense Mouthrinse (K143155)Johnson & Johnson Healthcare Products, Division of Mcneil-Pp2015-01-29
QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS (K141210)Inova Diagnostics, Inc.2015-01-29
WINSIX Implant System (K133733)Biosaf IN S.R.L.2015-01-28
Endoskeleton TCS System (K142940)Titan Spine, LLC2015-01-28
QK-SYSTEMIC THERAPEUTIC APPARATUS (K141892)Harbin Quanke Medi-Technical Development Co., Ltd.2015-01-28
LDLC3 LDL-Cholesterol Gen.3 (K143691)Roche Diagnostics Operations (Rdo)2015-01-28
DCCERAM SYSTEM (K141400)Ceramay GmbH & Co.Kg2015-01-28
S22 Digital Color Doppler Ultrasound System (K142815)Sonoscape Company Limited2015-01-28
Klassic BiPolar System (K143113)Total Joint Orthopedics2015-01-28
Wound Matrix TF (K143426)Miromatrix Medical, Inc.2015-01-27
MasterSL femoral stem (K143509)Lima Corporate S.P.A.2015-01-27
PANAVIA SA Cement Plus Automix; (Universal(A2), White, Translucent); Value Pack (Universal(A2), Translucent); Automix Trial (Universal(A2), White, Translucent); Mixing tip; Endo tip (SS) (K142625)Kuraray Noritake Dental, Inc.2015-01-27
Ligasure Blunt Tip Sealer/Divider (K142929)Covidien2015-01-27
Celerity PICC Tip Confirmation System (K142889)AngioDynamics, Inc.2015-01-27
NAUTILUS DELTA (K141634)Romedex International Srl2015-01-27
ADVIA Centaur IgE Master Curve Material (K143680)Siemens Healthcare Diagnostics, Inc.2015-01-27
SCHOELLY SINUSCOPE (K142249)Schoelly Fiberoptic GmbH2015-01-27
Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card) (K143187)Healgen Scientific,, LLC2015-01-27
Stryker SonicPin System, Stryker SonicAnchor System (K143063)Stryker Trauma GmbH2015-01-27
AliveCor Heart Monitor (K142743)AliveCor, Inc.2015-01-27
CROC (K141685)Combat Medical Systems, LLC2015-01-26
TAMTEC-HANA TENS / EMS (Sport Muscle Stimulator) (K143059)Tone-A-Matic International, Inc.2015-01-26
Activ Ankle Locking Plating System (K143061)Newclip Technics2015-01-26
LEVA (TM) SPACER SYSTEM (K141980)Spine Wave, Inc.2015-01-26
VERTA Corpectomy Cage (K143490)Camber Spine2015-01-26
AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System (K143163)Stryker Corporation2015-01-26
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