FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
77521–77544 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 09, 2001
BCS SYSTEM
K013114 · JPA
Dade Behring, Inc.
Hematology · 52d
Cleared Nov 09, 2001
N LP(A) STANDARD SY
K013126 · JIS
Dade Behring, Inc.
Chemistry · 51d
Cleared Nov 09, 2001
ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS
K013152 · LBS
Elan Holdings, Inc.
Chemistry · 50d
Cleared Nov 09, 2001
CLEARBLUE EASY EARLY RESULT PREGNANCY TEST
K013372 · LCX
Unipath , Ltd.
Chemistry · 29d
Cleared Nov 09, 2001
HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM
K013393 · KFM
A-Med Systems, Inc.
Cardiovascular · 25d
Cleared Nov 09, 2001
FAS SET #4551
K013497 · MQE
Gynetics Medical Products NV
Obstetrics & Gynecology · 18d
Cleared Nov 09, 2001
STANDARD IMAGING IVB 1000 WELL CHAMBER
K013548 · KPT
Standard Imaging, Inc.
Radiology · 16d
Cleared Nov 09, 2001
CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257
K013573 · ETB
Heinz Kurz GmbH Medizintechnik
Ear, Nose, Throat · 11d
Cleared Nov 08, 2001
3CC NMT SAFETY SYRINGE
K010819 · MEG
New Medical Technology , Ltd.
General Hospital · 234d
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