Atlas FDA

2021

3,023 FDA 510(k) clearances · Clearance year

Sort:Newest firstOldest first

Download CSV table Client report (share link) ◉ Watch

Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.

RecordFirmDate
Clue Birth Control (K193330)Biowink GmbH2021-02-18
LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus (K202574)DiaSorin, Inc.2021-02-18
iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizing (PS) Knee Replacement System (K210252)Conformis, Inc.2021-02-17
Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein (K202401)Eco Medi Glove Sdn. Bhd.2021-02-17
s-Clean SQ-SL Implant System Regular (K210132)Dentis Co., Ltd.2021-02-17
VIOLA (K203307)Vascular Graft Solutions, Ltd.2021-02-17
FITBONE(R) TAA (K203399)Wittenstein Intens GmbH2021-02-17
SpaceFlex Shoulder (K202338)G21, S.R.L.2021-02-17
VesselIQ Xpress (K200626)GE Medical Systems SCS2021-02-16
Relivion (K203419)Neurolief , Ltd.2021-02-16
cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System (K210234)Roche Molecular Systems, Inc.2021-02-16
Rebar Micro Catheter (K210114)Micro Therapeuatics, Inc. D/B/A Ev3 Neurovascular2021-02-16
Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On (K201732)Dukal Corporation2021-02-16
EZ-Injec LDV Sterile Safety Needle (K210444)Poonglim Pharmatech, Inc.2021-02-16
Vitrea Software Package, VSTP-001A (K203312)Canon Medical Systems Corporation2021-02-16
Easytech® Anatomical Shoulder System (K201391)Fx Shoulder USA, Inc.2021-02-16
Extra Large Check-Flo Introducer (K203670)Cook Incorporated2021-02-16
PLPT LDV (Low Dead Volume) Sterile Syringe (K210443)Poonglim Pharmatech, Inc.2021-02-16
ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System (K210035)Aegis Spine2021-02-16
740 SafeSAT (K200160)Zoe Medical, Inc.2021-02-15
gammaCore Sapphire (K203546)Electrocore, Inc.2021-02-12
Infrared Thermometer (K202368)Shandong Bittel Intelligent Technology Co., Ltd.2021-02-12
Disposable Surgical Mask (K202341)Shanghai Jianzhong Medical Packaging Co., Ltd.2021-02-12
Surgical Face Mask (K201545)Amphastar Nanjing Pharmaceuticals, Inc.2021-02-12
JuggerKnot Soft Anchor (K203740)Riverpoint Medical2021-02-12
Plastic LOR Syringe (K201356)Jiangsu Caina Medical Co.,Ltd2021-02-12
Vinyl Examination Gloves (Yellow) (K203702)Xinying Trading Co., Ltd.2021-02-12
Straumann Variobase C (K192742)Institut Straumann AG2021-02-12
LYDUS Nitrile Examination Gloves, Powder Free (K203191)Nathan Trading Co., Ltd.2021-02-12
MedCAD® AccuPlate® Patient-Specific Plate (K193280)Medcad2021-02-12
CleaniCal (K201799)Maruchi2021-02-12
4D Integrated Treatment Console (K203766)Varian Medical Systems, Inc.2021-02-12
Electro Flo 6 Airway Clearance System (K201490)Med Systems, Inc.2021-02-12
NOA Sleep Apnea and Snoring Device (K202651)Orthoapnea S.L.2021-02-12
Catalyst OrthoScience R1 Reverse Shoulder System (K202611)Catalyst Orthoscience, Inc.2021-02-12
MucoLock Oral Gel (K203091)Pcca, Inc.2021-02-12
Straumann TLX Novaloc and Cementable Abutments (K203355)Institut Straumann AG2021-02-12
EDS Bioceramic Sealer (Bioseal) (K202281)Essential Dental Systems2021-02-12
Panda iRes Warmer, Giraffe Warmer (K201628)GE Healthcare2021-02-12
MectaLIF Transforaminal TiPEEK (K200551)Medacta Inernational SA2021-02-12
DSP Implant System (K192839)D.S.P Industrial Eireli2021-02-11
CATSmart, Automated Blood Processing Autotransfusion System (K210089)Fresenius Kabi AG2021-02-11
TRAUS SIP20 (K201292)Saeshin Precision Co., Ltd.2021-02-11
Ezlymph, Ezlymph M (K193662)Eezcare Medical Corp2021-02-11
Bio-C Repair Ion+ (K201222)Angelus Industria DE Produtos Odontologicos S/A2021-02-11
TenoTac Soft Tissue Fixation System (K203385)Paragon 28, Inc.2021-02-11
VORTRAN GO2VENT with PEEP Valve (K202219)Vortran Medical Technology 1, Inc.2021-02-11
da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments (K203632)Intuitive Surgical, Inc.2021-02-10
Hi bebe super (Models BT-150S and BT-150L) (K200675)Bistos Co., Ltd.2021-02-10
Meditech ABPM-06 (BP6) (K201332)Meditech , Ltd.2021-02-10
DSG Connect Technology (K201454)Spineguard S.A.2021-02-10
EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing (K203557)Encore Medical L.P.2021-02-10
FORE-SIGHT ELITE Absolute Tissue Oximeter (K203490)Edwards Lifesciences, LLC2021-02-10
Infrared Forehead Thermometer (K201536)Hangzhou Qingyuan Medical Equipment Technology Co., Ltd.2021-02-10
SLENDERTONE Evolve Abs, Type 735 (K203513)Bio-Medical Research, Ltd.2021-02-10
Digital NeuroPort Biopotential Signal Processing System (K202174)Blackrock Microsystems2021-02-10
Solax Electric Scooter (Models: S3023, S3024, S3025, S3026) (K191897)Dongguan Prestige Sporting Goods Co., Ltd.2021-02-10
Standard Procedure Mask, Standard Surgical Mask (K202605)Jiangsu Medplus Non-Woven Manufacturer Co., Ltd.2021-02-10
Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7 (K210083)Penumbra, Inc.2021-02-09
Synapse 3D, Synapse 3D Base Tools v6.1 (K203103)Fujifilm Corporation2021-02-09
MR Conditional Sticky Pad Electrode (K203079)Rhythmlink International, LLC2021-02-09
LIAISON Anti-HAV (K210272)DiaSorin, Inc.2021-02-09
SmartCT R1.0 (K201583)Philips Medical Systems Nederland B.V.2021-02-09
Concerto Versa, Detachable Coil (K202850)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2021-02-09
nPro Surgical Mask (K203265)Np Medical, Inc.2021-02-09
Stryker PEEK Customized Cranial Implant Kit (K203055)Stryker2021-02-09
Straumann 4 mm Short Implants (K202942)Straumann USA, LLC2021-02-08
HydroMID (K203069)Access Vascular, Inc.2021-02-08
MouthLab Vital Signs Monitoring System (K201635)Multisensor Diagnostics (Dba Aidar Health)2021-02-06
SPEAC System (K200276)Brain Sentinel, Inc.2021-02-06
LINK Embrace Shoulder System - Reverse Configuration (K200368)Waldemar Link GmbH & Co. KG2021-02-05
GentleWave X (K203302)Sonendo, Inc.2021-02-05
Cios Spin (K210054)Siemens Medical Systems USA, Inc.2021-02-05
Cios Alpha (K210055)Siemens Medical Solutions USA, Inc.2021-02-05
LimaCorporate Kirschner Wire (K203475)Lima Corporate S.P.A.2021-02-05
Carnation Ambulatory Monitor (CAM) (K210036)Bardy Diagnostics, Inc.2021-02-05
HAMILTON-C3 (K201306)Hamilton Medical AG2021-02-05
Bonelogic (K203290)Disior, Ltd.2021-02-05
The Citrefix Knotless Suture Anchor (K203334)Acuitive Technologies, Inc.2021-02-05
Freudenberg Surgical Mask (K210063)Freudenberg Performance Materials LP2021-02-05
Sphincterotome (K201121)Hangzhou AGS MedTech Co., Ltd.2021-02-05
X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology) (K203374)De Götzen S.R.L.2021-02-05
ELEOS™ Limb Salvage System (K203588)Onkos Surgical2021-02-05
LVivo Software Application (K210053)Dia Imaging Analysis, Ltd.2021-02-05
Patient Monitoring Cables (K203635)Jkh USA, LLC2021-02-05
eXciteOSA with remote and eXciteOSA without remote (DEN200018)Signifier Medical Technologies2021-02-05
Antibacterial Bandage (K201324)Jiangsu Excellence Medical Supplies Co., Ltd.2021-02-05
Shofu Block HC Hard (K200470)Shofu Dental Corporation2021-02-05
Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload (K200320)M/s. Meril Endo Surgery Private Limited.2021-02-05
SYMPHONY™ OCT System (K203319)Medos International SARL2021-02-05
Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield; Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons (K201421)Dukal Corporation2021-02-05
Medical Face Mask (K202493)Gemtier Medical (Shanghai), Inc.2021-02-04
QUIBIM Precision Prostate (qp-Prostate) (K203582)Quibim S.L.2021-02-04
BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set (K210174)Bemer Int AG2021-02-04
Prase PEEK Anterior Cervical Interbody Spacer (K202872)Gbs Commonwealth Co., Ltd.2021-02-04
RESPONSE Navigation Instruments (K203573)OrthoPediatrics Corp.2021-02-04
EcoFit® Hip System (K203420)Implantcast GmbH2021-02-03
Balex bone Expander System (K202027)Taeyeon Medical Co., Ltd.2021-02-03
Omnichroma Flow Bulk (K203598)Tokuyama Dental Corporation2021-02-03
Jiajian Self-Adhesive Electrode (K192568)Wuxi Jiajian Medical Instrument Co., Ltd.2021-02-03
← Previous Next →

Track 2021 automatically

Every clearance here is in the API, with alerts when new ones post.