Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
31849–31872 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 17, 2016
EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit...
K161003 · PIF
Boston Scientific Corporation
Gastroenterology & Urology · 67d
Cleared Jun 17, 2016
NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and...
K161039 · PNR
Neomed, Inc.
Gastroenterology & Urology · 65d
Cleared Jun 17, 2016
Monoject
K161045 · PNR
Covidien
Gastroenterology & Urology · 65d
Cleared Jun 17, 2016
Cervical Stand Alone System
K161280 · OVE
Orthofix, Inc.
Orthopedic · 42d
Cleared Jun 17, 2016
BinaxNOW G6PD Test
K161364 · JBF
Alere Scarborough, Inc.
Hematology · 31d
Cleared Jun 16, 2016
silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX...
K153076 · GAT
Teleflexmedical, Inc.
General & Plastic Surgery · 237d
Cleared Jun 16, 2016
Sophono Bone Conduction Systems (S) Configuration and (M) Configuration
K153391 · LXB
Sophono, Inc.
Ear, Nose, Throat · 205d
Cleared Jun 16, 2016
Endoform Reconstructive Template
K153632 · FTL
Aroa Biosurgery Limited (Formerly...
General & Plastic Surgery · 181d
Cleared Jun 16, 2016
StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis
K160071 · MBB
Biomet, Inc.
Orthopedic · 155d
Cleared Jun 16, 2016
ECG CT Gating Device
K160350 · JAK
Neocoil, LLC
Radiology · 129d
Cleared Jun 16, 2016
PreSep Oligon Oximetry Catheter
K160645 · DQE
Edwards Lifesciences, LLC
Cardiovascular · 101d
Cleared Jun 16, 2016
United Urologics Intermittent Catheter
K160795 · GBM
Robling Medical
Gastroenterology & Urology · 85d
Cleared Jun 16, 2016
Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit
K160819 · OPX
The Binding Site Group , Ltd.
Immunology · 84d
Cleared Jun 15, 2016
LightLas Multi-Wavelength Medical Laser System
K152688 · HQF
Lightmed Corporation
Ophthalmic · 271d
Cleared Jun 15, 2016
Disposable Surgical Face Mask
K153496 · FXX
Xiantao Rayxin Medical Products Co.,...
General Hospital · 191d
Cleared Jun 15, 2016
ROMA Calculation Tool Using Elecsys Assays
K153607 · ONX
Roche Diagnostics
Immunology · 181d
Cleared Jun 15, 2016
ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT...
K153730 · LIP
Abbott Laboratories
Microbiology · 170d
Cleared Jun 15, 2016
Dentivera Milling Disc
K160498 · EBI
Dental Solutions, LLC
Dental · 113d
Cleared Jun 15, 2016
BiZact Open Sealer/Divider
K160539 · GEI
Covidien
General & Plastic Surgery · 110d
Cleared Jun 15, 2016
ZUK Select Knee System
K160738 · HSX
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Jun 15, 2016
Tria Sapphire
K160821 · OLP
Tria Beauty, Inc.
General & Plastic Surgery · 83d
Cleared Jun 15, 2016
Sonic Window
K161342 · IYO
Analogic Corporation
Radiology · 33d
Cleared Jun 15, 2016
NormaTec PCD-T and PCD-B
K161346 · JOW
NormaTec Industries, LP
Cardiovascular · 30d
Cleared Jun 14, 2016
PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter
K151985 · LJS
C.R. Bard, Inc.
General Hospital · 333d