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
110713–110736 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 03, 1994
KIDNEY AFRICAN GREEN MONKEY CELLS-CV-1
K934239 · KIR
Advanced Clinical Diagnostics
Pathology · 130d
Cleared Jan 03, 1994
KIDNEY AFRICIAN GREEN MONKEY CELLS-VERO
K934240 · KIR
Advanced Clinical Diagnostics
Pathology · 130d
Cleared Jan 03, 1994
MCCOY CULTURE CELLS-MCCOY
K934241 · KIR
Advanced Clinical Diagnostics
Pathology · 130d
Cleared Jan 03, 1994
BUFFALO GREEN MONKEY KIDNEY CELLS-B.G.M.K.
K934242 · KIR
Advanced Clinical Diagnostics
Pathology · 130d
Cleared Jan 03, 1994
HUMAN EPIDERMAL CARCINOMA LARYNX CELLS-HEP-2
K934243 · KIR
Advanced Clinical Diagnostics
Pathology · 130d
Cleared Jan 03, 1994
HUMAN LUNG DIPLOID CELLS-MRC-5
K934244 · KIR
Advanced Clinical Diagnostics
Pathology · 130d
Cleared Jan 03, 1994
HUMAN FORESKIN FIBROBLAST CELLS-H.F.F.
K934245 · KIR
Advanced Clinical Diagnostics
Pathology · 130d
Cleared Jan 03, 1994
LUNG DIPLOID HUMAN CELLS-WI-38
K934246 · KIR
Advanced Clinical Diagnostics
Pathology · 130d
Cleared Jan 03, 1994
860 MEASURMENT SYSTEM
K934907 · CHL
Ciba Corning Diagnostics Corp.
Chemistry · 80d
Cleared Jan 03, 1994
ENDOPATH ENDOSCOPIC LINEAR CUTTER MODIFICATION
K935064 · OCW
Ethicon, Inc.
Gastroenterology & Urology · 75d
Cleared Jan 03, 1994
EMIT IIC NEGATIVE CONTROL, CONTROL I AND II
K935230 · DIF
Syva Co.
Toxicology · 63d
Cleared Jan 03, 1994
IRON -II (FE-II) METHOD/TECH CHEM 1(R) 1+TM SYSTEM
K935287 · JIY
Miles, Inc.
Chemistry · 61d
Cleared Jan 03, 1994
CYNOMOLOGUS MONKEY KIDNEY CELLS
K935336 · KIR
Advanced Clinical Diagnostics
Pathology · 59d
Cleared Jan 03, 1994
RHABDOMYOSARCOMA CELLS
K935337 · KIR
Advanced Clinical Diagnostics
Pathology · 59d
Cleared Jan 03, 1994
LUNG CACINOMA, HUMAN CELLS
K935338 · KIR
Advanced Clinical Diagnostics
Pathology · 59d
Cleared Jan 03, 1994
HELA HELA EPITHELOID CARCINOMA
K935339 · KIR
Advanced Clinical Diagnostics
Pathology · 59d
Cleared Jan 03, 1994
NICKEL-TITANIUM K-TYPE FILE
K935542 · EKS
Union Broach, Div. Moyco Industries,...
Dental · 48d
Cleared Jan 03, 1994
ABUSCREEN ONLINE NEGATIVE CAL/CONTROL CAL PACK AND MIL CALIBRATION PACK
K935550 · DKB
Roche Diagnostic Systems, Inc.
Toxicology · 47d
Cleared Dec 30, 1993
LAKE OSTOMY CARE SET
K922730 · EXB
Lake Medical Products, Inc.
Gastroenterology & Urology · 573d
Cleared Dec 30, 1993
PHOENIX BONE SCREWS PBS-TYPE SERIES
K930125 · HXA
Phoenix Bioengineering, Inc.
Orthopedic · 352d
Cleared Dec 30, 1993
CARAPACE CATARACT TRAYS
K931673 · LRO
Carapace, Inc.
General & Plastic Surgery · 268d
Cleared Dec 30, 1993
VACVENT
K931873 · CBT
Steven Frank Mercereau
Anesthesiology · 260d
Cleared Dec 30, 1993
STRATO MEDICAL LIFEPORT LPS 7255 LOW PROFILE DUAL LUMEN VASCULAR ACCESS SYSTEM
K933884 · LJS
Strato Medical Corp.
General Hospital · 142d
Cleared Dec 30, 1993
ARGYLE TURKEL SAFETY PNEUMOTHORAX PROCEDURE TRAY
K934428 · LRO
Sherwood Medical Co.
General & Plastic Surgery · 111d