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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
162001–162024 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 05, 1981
TECHNICATOR
K812702 · GEI
Cameron-Miller, Inc.
General & Plastic Surgery · 43d
Cleared Nov 05, 1981
DRAWER TEST
K812713 · FTY
Medmetric Corp.
General & Plastic Surgery · 41d
Cleared Nov 05, 1981
BODAI PATIENT COMMUNICATOR
K812720 · ILQ
Sontek Industries, Inc.
Physical Medicine · 41d
Cleared Nov 05, 1981
SAFE GUARD
K812722 · GEI
Concept, Inc.
General & Plastic Surgery · 38d
Cleared Nov 05, 1981
KERMATH THERAPY SIMULATOR
K812726 · KPQ
Kermath Mfg. Corp.
Radiology · 38d
Cleared Nov 05, 1981
GASTRIN 1-17 BY RADIOIMMUNOASSAY KIT
K812727 · CGC
Immuno Nuclear Corp.
Chemistry · 38d
Cleared Nov 05, 1981
MODEL 325C UNIPOLAR CARDIAC PULSE GEN.
K812832 · DXY
Cook Pacemaker Corp.
Cardiovascular · 27d
Cleared Nov 04, 1981
DIGITRON
K812721 · IZI
Siemens Corp.
Radiology · 37d
Cleared Nov 02, 1981
FE-CULT PLUS
K811752 · KHE
Gamma Biologicals, Inc.
Toxicology · 133d
Cleared Nov 02, 1981
KENZ-GELECT
K812263 · GYB
Suzuken Co., Ltd.
Neurology · 81d
Cleared Nov 02, 1981
SPHYGMOMANOMETER
K812409 · DXN
Somatronix Research Corp.
Cardiovascular · 73d
Cleared Nov 02, 1981
450/800 DRILL
K812436 · HBC
Black & Decker(Tm)
Neurology · 68d
Cleared Nov 02, 1981
150 DRIVER REAMER
K812437 · GEY
Black & Decker(Tm)
General & Plastic Surgery · 68d
Cleared Nov 02, 1981
SAGITTAL SAW
K812438 · GEY
Black & Decker(Tm)
General & Plastic Surgery · 68d
Cleared Nov 02, 1981
DUAL MPC CHARGER
K812439
Black & Decker(Tm)
Orthopedic · 68d
Cleared Nov 02, 1981
POWER PACK
K812440
Black & Decker(Tm)
Orthopedic · 68d
Cleared Nov 02, 1981
DADE IMMU-TRACE TRI-RAC R TRI-LEVEL R.C
K812556 · JJY
American Dade
Immunology · 55d
Cleared Nov 02, 1981
GAUZE SPONGES
K812572 · EFQ
Worldwide Surgical Gauze
General & Plastic Surgery · 54d
Cleared Nov 02, 1981
CLEANING SOLUTION FOR RADIOMETER OSM2
K812623 · CHL
Fisher Scientific Co., LLC
Chemistry · 48d
Cleared Nov 02, 1981
STERILE DISSECTOR SPONGES-X-RAY DETECT
K812707 · GDY
Medspec Corp.
General & Plastic Surgery · 39d
Cleared Nov 02, 1981
STERILE LAPAROTOMY SPONGES-X-RAY DETECT
K812710 · GDY
Medspec Corp.
General & Plastic Surgery · 39d
Cleared Nov 02, 1981
STERILE GAUZE PADS 12PLY
K812711 · NAB
Medspec Corp.
General & Plastic Surgery · 39d
Cleared Nov 02, 1981
SHILEY ARTERIAL FILTER W/40 MICRON SCREE
K812742 · DTM
Shiley, Inc.
Cardiovascular · 34d
Cleared Nov 02, 1981
WARMING LISTHTS #96H & 96HT
K812745 · FMT
J. H. Emerson Co.
General Hospital · 34d