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
139705–139728 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 12, 1987
CREATINE KINASE FOR CONTINUOUS FLOW INSTRUMENTS
K871677 · JHY
Catachem, Inc.
Chemistry · 14d
Cleared May 11, 1987
RAPIDEX BIOLOGICAL SURFACTANT
K862282 · FLG
Rapidex of London
General Hospital · 329d
Cleared May 11, 1987
APPLICARD SYSTEM (ECG ELECTRODE SYSTEM)
K864260 · DRX
Grandcor Medical Systems
Cardiovascular · 194d
Cleared May 11, 1987
CARDIAC PERFORMANCE MONITOR
K864583 · DQK
Vascular Technology Incorporated
Cardiovascular · 172d
Cleared May 11, 1987
3MHZ ANNULAR ARRAY
K864980 · JOP
Philips Ultrasound, Inc.
Cardiovascular · 140d
Cleared May 11, 1987
RECORD KEEPING/DATA MANAGEMENT SYSTEM
K865035 · DQK
Critical Care Systems, Inc.
Cardiovascular · 139d
Cleared May 11, 1987
SINGLE LUMEN ACUTE CATHETER
K870328 · LFJ
Quinton, Inc.
Gastroenterology & Urology · 103d
Cleared May 11, 1987
IVR-SP CUSTOM ANGIOGRAPHY TRAY
K870419 · DQO
North Coast Medi-Tek
Cardiovascular · 97d
Cleared May 11, 1987
GASTROINTESTINAL TUBE
K870508 · KNT
Penn Medical Devices, Inc.
Gastroenterology & Urology · 95d
Cleared May 11, 1987
OMEGA SILICONE CHIN IMPLANT
K871070 · FWP
Omega Silicone, Inc.
General & Plastic Surgery · 54d
Cleared May 11, 1987
OMEGA BIVALVE NASAL SPLINTS
K871073 · FYI
Omega Silicone, Inc.
General & Plastic Surgery · 54d
Cleared May 11, 1987
BARD EMS SYSTEM 6000 E.S.U.
K871435 · HAM
C.R. Bard, Inc.
General & Plastic Surgery · 28d
Cleared May 11, 1987
THERMOMETER SHEATHS
K871465 · FLL
Abco Dealers, Inc.
General Hospital · 27d
Cleared May 11, 1987
SOLOLIFT - PATIENT TRANSFER STRETCHER
K871475 · FMR
Adel Medical , Ltd.
General Hospital · 27d
Cleared May 08, 1987
EUROMEDICAL, ENDOSOFT ENDOTRACHEAL TUBE
K870387 · BTR
American Pharmaseal Div. Ahsc
Anesthesiology · 98d
Cleared May 08, 1987
A1-A2 AMBULATORY EEG CASSETTE RECORDER
K870432 · GWQ
Grass-Telefactor Product Group
Neurology · 94d
Cleared May 08, 1987
TRACH MATE TRACHEAL TUBE
K870470 · BTR
Mccormick Laboratories, Inc.
Anesthesiology · 94d
Cleared May 08, 1987
CSI/3D
K870513 · JAK
Columbia Scientific, Inc.
Radiology · 92d
Cleared May 08, 1987
IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST
K870602 · GQN
Boots-Celltech Diagnostics, Inc.
Microbiology · 86d
Cleared May 08, 1987
FNA THYROID BIOPSY KIT
K870863 · FMI
Flint Laboratories Div. Travenol
General Hospital · 66d
Cleared May 08, 1987
KM-4(TM) METAL-BACKED ACETABULAR CUP
K870867 · JDL
Kirschner Medical Corp.
Orthopedic · 66d
Cleared May 08, 1987
COMPASS STEREOTACTIC POSITIONING SYSTEM
K871046 · HAW
Stereotactic Medical Systems, Inc.
Neurology · 52d
Cleared May 08, 1987
SUNBEAM DURA-VAP WARM STEAM VAPORIZER MODEL 1380
K871189 · KFZ
Sunbeam Appliance Service Co.
Anesthesiology · 45d
Cleared May 08, 1987
GRATICULE
K871214 · IYE
Mick Radio-Nuclear Instruments, Inc.
Radiology · 43d