FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
122785–122808 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 19, 1991
ENDOSCOPIC ACCESSORY TO THE LIGHT SOURCE
K905282 · GCT
Frantz Medical Development, Ltd.
Gastroenterology & Urology · 116d
Cleared Mar 19, 1991
CHEMTRAK ACCUMETER CHOLESTEROL TEST
K905405 · CHH
Chemtrak, Inc.
Chemistry · 106d
Cleared Mar 19, 1991
SURGICAL DRAPE
K910084 · KKX
Biocor Medical, Inc.
General Hospital · 70d
Cleared Mar 19, 1991
REDDICK IRRIGATION/ASPIRATION SYSTEM
K910117 · GAA
Ideal Medical, Inc.
General & Plastic Surgery · 67d
Cleared Mar 19, 1991
TARGET COCAINE METABOLITE-R
K910122 · KLN
V-Tech, Inc.
Immunology · 67d
Cleared Mar 19, 1991
TARGET COCAINE METABOLITE-V
K910123 · KLN
V-Tech, Inc.
Toxicology · 67d
Cleared Mar 19, 1991
CPI MODEL 2215/SEAMED MODEL 3400
K910223 · DTC
Seamed Corp.
Cardiovascular · 60d
Cleared Mar 19, 1991
PLATELET AGGREGATION REAGENTS
K910286 · GHR
Medical Diagnostic Technologies, Inc.
Hematology · 56d
Cleared Mar 19, 1991
FLEXIFLO SACKS-VINE GASTROSTOMY KITS
K910332 · KNT
Abbott Laboratories
Gastroenterology & Urology · 53d
Cleared Mar 19, 1991
ELASTIC ADHESIVE BANDAGE
K910436 · KGX
Byron Medical
General & Plastic Surgery · 47d
Cleared Mar 19, 1991
MODEL 3150-64 QUADRATURE SPINE COIL IN POSITIONER
K910513 · LNH
Medical Advances, Inc.
Radiology · 42d
Cleared Mar 19, 1991
MODEL 3150-21 QUADRATURE SPINE COIL IN POSITIONER
K910514 · LNH
Medical Advances, Inc.
Radiology · 42d
Cleared Mar 19, 1991
IPAZYME (TM) CHLAMYDIA IGG-IGA
K910644 · LKH
Savyon Diagnostics , Ltd.
Microbiology · 33d
Cleared Mar 19, 1991
ORTHO* CHLAMYDIA ANTIGEN ELISA TEST/MODIFICATION
K910668 · LJC
Ortho Diagnostic Systems, Inc.
Microbiology · 34d
Cleared Mar 19, 1991
RHEUMAJET CRP
K910686 · DCN
Biokit USA, Inc.
Immunology · 28d
Cleared Mar 19, 1991
PANTEX IRMA LH 1251 KIT
K910717 · CEP
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 27d
Cleared Mar 19, 1991
TARGET AMPHETAMINE/METHAMPHETAMINE-V (VISUAL METH)
K910738 · DKZ
V-Tech, Inc.
Toxicology · 26d
Cleared Mar 19, 1991
SURGITEK(R) 420 CM G.I. INFUSION GUIDEWIRE
K910768 · FGE
Surgitek Medical Engineering Corp.
Gastroenterology & Urology · 25d
Cleared Mar 19, 1991
ENDOPATH DISPOSABLE PNEUMOPERITONEUM NEEDLE
K910875 · FDP
Ethicon, Inc.
General & Plastic Surgery · 18d
Cleared Mar 18, 1991
DEFIBRILLATOR ANALYZER MODEL QED-5
K904159 · DRL
Bio-Tek Instruments, Inc.
Cardiovascular · 188d
Cleared Mar 18, 1991
ZOEX ANTISHOCK TROUSERS
K904267 · JOW
Zoex Corp.
Cardiovascular · 181d
Cleared Mar 18, 1991
PALCO LABS MODEL 400 OXYGEN/PULSE MONITOR
K904988 · DQA
Palco Laboratories, Inc.
Anesthesiology · 131d
Cleared Mar 18, 1991
PTI ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFT
K905067 · DSY
Pioneering Technologies, Inc.
Cardiovascular · 129d
Cleared Mar 18, 1991
ELECTROSURGICAL UNIT WITH ACCESSORIES
K905654 · GEI
Aspen Labs
General & Plastic Surgery · 90d