FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
77017–77040 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 08, 2001
IQUANTIFY, VERSION 1.0
K011196 · LLZ
Insightful Corporation
Radiology · 203d
Cleared Nov 08, 2001
UNI-GOLD STREP A TEST KIT
K011709 · GTZ
Trinity Biotech, Plc
Microbiology · 157d
Cleared Nov 08, 2001
SPECTRUM VENTRICULAR CATHETER
K011812 · NHC
Cook, Inc.
Neurology · 150d
Cleared Nov 08, 2001
ACRYDERM SILVER ANTTIMICROBIAL WOUND GEL MODEL# A-002101
K011994 · MGQ
Acrymed, Inc.
General & Plastic Surgery · 135d
Cleared Nov 08, 2001
WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001
K012326 · JGJ
Wiener Laboratories Saic
Chemistry · 108d
Cleared Nov 08, 2001
REPROCESSED PHACO TIPS
K012579 · NKX
Sterilmed, Inc.
Ophthalmic · 91d
Cleared Nov 08, 2001
REPROCESSED ARTHROSCOPIC BLADES, ARTHROSCOPIC SHAVERS, SHAVER BLADE, BLADE,...
K012624 · HRX
Medical Instruments Technology, Inc.
Orthopedic · 87d
Cleared Nov 08, 2001
REPROCESSED DYONICS ARTHROSCOPIC BURS
K012652 · HRX
Alliance Medical Corp.
Orthopedic · 87d
Cleared Nov 08, 2001
REPROCESSED RF ARTHROSCOPY PROBES
K012679 · GEI
Sterilmed, Inc.
General & Plastic Surgery · 86d
Cleared Nov 08, 2001
REPROCESSED LASER PROBE
K012682 · GEX
Sterilmed, Inc.
General & Plastic Surgery · 86d
Cleared Nov 08, 2001
TULSA CONTRA ANGLES
K012720 · EFB
Dentsply Intl.
Dental · 85d
Cleared Nov 08, 2001
SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273
K012724 · LYK
Smith & Nephew, Inc.
Cardiovascular · 86d
Cleared Nov 08, 2001
TISSUE GRASPING FORCEPS, SCISSORS, CLAMPS AND DISSECTORS FOR LAPAROSCOPIC...
K012725 · GEI
Endo-Therapeutics, Inc.
General & Plastic Surgery · 85d
Cleared Nov 08, 2001
MAROSIS PACS
K012844 · LLZ
Marotech, Inc.
Radiology · 77d
Cleared Nov 08, 2001
NEUROMOVE NM900
K012885 · IPF
Dan Med, Inc.
Physical Medicine · 72d
Cleared Nov 08, 2001
INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO,...
K013073 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 55d
Cleared Nov 08, 2001
PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS
K013339 · DTB
Oscor, Inc.
Cardiovascular · 30d
Cleared Nov 08, 2001
EBI XFIX DFS SYSTEM
K013378 · KTT
Ebi, L.P.
Orthopedic · 27d
Cleared Nov 08, 2001
LIFTLOC SAFETY INFUSION SET
K013394 · FPA
Specialized Health Products, Inc.
General Hospital · 24d
Cleared Nov 08, 2001
LIGHTSPEED 4.0 CT SCANNER SYSTEM
K013561 · JAK
GE Medical Systems
Radiology · 13d
Cleared Nov 07, 2001
TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL, MODEL 8119, 8120,...
K010989 · MQP
Interpore Cross Intl.
Orthopedic · 218d
Cleared Nov 07, 2001
DRT4 LASER DOPPLER PERFUSION AND TEMPERATURE MONITOR
K011070 · GEX
Moor Instruments, Ltd.
General & Plastic Surgery · 212d
Cleared Nov 07, 2001
PARADIGM-FONTONA PEROVSKITE ND: YAP LASER SYSTEM AND ACCESSORIES
K011174 · GEX
Fotona D.D.
General & Plastic Surgery · 204d
Cleared Nov 07, 2001
BODY FAT ANALYZER, MODEL HBF-306
K011652 · MNW
Omron Healthcare, Inc.
Gastroenterology & Urology · 162d