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
122521–122544 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 22, 1991
ACCENT DG(TM) BALLOON ANGIOPLASTY CATHETER
K900677 · LIT
Cook, Inc.
Cardiovascular · 375d
Cleared Feb 22, 1991
CK-MB IMMUNOASSAY CONTROL
K905623 · JJT
Seradyn, Inc.
Chemistry · 70d
Cleared Feb 22, 1991
ECLIPSE ICA TSH
K910256 · JLW
Biotope, Inc.
Chemistry · 31d
Cleared Feb 22, 1991
ECLIPSE ICA ANALYZER
K910302 · JJQ
Biotope, Inc.
Chemistry · 29d
Cleared Feb 22, 1991
EMIT II BENZODIAZEPINE ASSAY
K910376 · JXM
Syva Co.
Toxicology · 24d
Cleared Feb 21, 1991
TITANIUM MESH
K903485 · GWO
Ruggles Corp.
Neurology · 205d
Cleared Feb 21, 1991
TROCAR DISPOSABLE
K904638 · FBQ
L.A.S.E.R., Inc.
General & Plastic Surgery · 133d
Cleared Feb 21, 1991
STERILE AND NON-STERILE TEXTILE PACKS
K904957 · KKX
Surgical Pack Services, Inc.
General Hospital · 108d
Cleared Feb 21, 1991
EXTERNAL FIXATION
K904973 · KTT
Dynasplint Systems, Inc.
Orthopedic · 115d
Cleared Feb 21, 1991
BIO-GUARD O.R. SCRUB PREP TRAY
K905004 · LRO
Network Medical Systems, Inc.
General & Plastic Surgery · 106d
Cleared Feb 21, 1991
SURGILASE SL 150 SURGICAL LASER SYSTEM
K905006 · GEX
Surgilase, Inc.
General & Plastic Surgery · 107d
Cleared Feb 21, 1991
SURGICAL MASK
K905209 · FXX
Lancaster County Blind Assoc.
General Hospital · 93d
Cleared Feb 21, 1991
CODMAN DISPOSABLE SCALP CLIP APPLIER
K905433 · HBO
Codman & Shurtleff, Inc.
Neurology · 79d
Cleared Feb 21, 1991
VALLEYLAB E1554 REDUCED ESCHAR ELECTRODE
K905529 · GEI
Valleylab, Inc.
General & Plastic Surgery · 73d
Cleared Feb 21, 1991
PREP AND OPERATING STAND
K905564 · FWZ
Mcconnell Orthopedic
General & Plastic Surgery · 71d
Cleared Feb 21, 1991
LATERAL BUTTRESS SUPPORT
K905565 · FWZ
Mcconnell Orthopedic
General & Plastic Surgery · 71d
Cleared Feb 21, 1991
VENTREX COATED TUBE IGE RADIOIMMUNOASSAY
K905612 · DGC
Ventrex Laboratories, Inc.
Immunology · 69d
Cleared Feb 21, 1991
CVIS INSIGHT IMAGING CATHETER
K905625 · DQO
Cardiovascular Imaging Systems, Inc.
Cardiovascular · 69d
Cleared Feb 21, 1991
PHARMACIA DELFIA NEONATAL HTSH KIT
K905710 · JLW
Pharmacia, Inc.
Chemistry · 62d
Cleared Feb 21, 1991
OPUS GENTAMICIN
K905721 · LCQ
Pb Diagnostic Systems, Inc.
Toxicology · 62d
Cleared Feb 21, 1991
TOTAL PROTEIN REAGENT SET
K905790 · CEK
Biochemical Trade, Inc.
Chemistry · 56d
Cleared Feb 21, 1991
EBV IGM ELISA TEST
K910042 · LJN
Gull Laboratories, Inc.
Microbiology · 48d
Cleared Feb 21, 1991
STRYKER LAPAROSCOPE
K910132 · GCJ
Stryker Corp.
General & Plastic Surgery · 43d
Cleared Feb 21, 1991
PLP LAPAROSCOPIC CHOLECYSTECTOMY DIS. ELEC. PROBES
K910184 · GEI
Precision Laser Products, Inc.
General & Plastic Surgery · 37d