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
150481–150504 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 20, 1984
EMG/NCV & EVOKED RESPONSE, DESIGN W/
K843253 · GWF
Neurodiagnostics, Inc.
Neurology · 92d
Cleared Nov 20, 1984
FLOW-DIRECTED PEDIATRIC THERMODIL- CATH
K843410 · KRB
Andover Medical, Inc.
Cardiovascular · 81d
Cleared Nov 20, 1984
FLOW DIRECTED THERMODILUTION CATH W/VEN
K843412 · KRB
Andover Medical, Inc.
Cardiovascular · 81d
Cleared Nov 20, 1984
SIEGEN NEUROSCOPE
K843464 · GWF
Siegen Corp.
Neurology · 76d
Cleared Nov 20, 1984
LIQUID CHROMATOGRAPH 400
K843568 · KZR
The Perkin-Elmer Corp.
Toxicology · 71d
Cleared Nov 20, 1984
MODEL {M-102 I-CHANNEL ELECTRO CARDIOGRAPH UNIT
K843934 · DPS
Future Impex Corp.
Cardiovascular · 42d
Cleared Nov 20, 1984
9 FRENCH 42LONG POLYURETHANE GRADUATED ENTERIC FE
K843975 · KNT
Superior Plastic Products Corp.
Gastroenterology & Urology · 40d
Cleared Nov 20, 1984
TURBOAIRE CHALLANGER ENVIRONMENTAL AIR CONTROLLER
K843996 · BZG
Equilibrated Bio Systems, Inc.
Anesthesiology · 40d
Cleared Nov 20, 1984
ELECATH VENTRICULAR PACING THERMAL DILUTION CATH
K844022 · DXG
Electro-Catheter Corp.
Cardiovascular · 36d
Cleared Nov 20, 1984
ACCUMETER ELECTRONIC URINEMETER SYSTEM
K844030 · FFG
Travenol Laboratories, S.A.
Gastroenterology & Urology · 36d
Cleared Nov 20, 1984
GENERAL SURGICAL FILES
K844145 · GEO
Med-Tool, Inc.
General & Plastic Surgery · 28d
Cleared Nov 20, 1984
TOGGLE LOCKING PLIERS-STRAIGHT JAW, CURVED JAW
K844146 · HTC
Med-Tool, Inc.
General & Plastic Surgery · 28d
Cleared Nov 20, 1984
WIRE TWISTERS
K844147
Med-Tool, Inc.
General & Plastic Surgery · 28d
Cleared Nov 20, 1984
PIN CUTTER
K844148
Med-Tool, Inc.
General & Plastic Surgery · 28d
Cleared Nov 20, 1984
AMYLASE REAGENT CS-726
K844168 · CJA
Fisher Scientific Co., LLC
Chemistry · 26d
Cleared Nov 20, 1984
B-1000
K844226 · BZG
Biotrine Corp.
Anesthesiology · 19d
Cleared Nov 20, 1984
CHLORIDE STANDARD
K844235 · JIS
Shaban Mfg. Co.
Chemistry · 19d
Cleared Nov 20, 1984
ALKALINE PHOSPHATASE REAGENT SET
K844237 · CIO
Livonia Diagnostics, Inc.
Chemistry · 19d
Cleared Nov 20, 1984
SPIROMETRICS 2451 & SMI I
K844333 · BZG
Spirometrics, Inc.
Anesthesiology · 13d
Cleared Nov 19, 1984
MEDO MEDOMER MBF-100 II
K841235 · JOW
Medo U.S.A., Inc.
Cardiovascular · 242d
Cleared Nov 19, 1984
BAILEY LENS SHOOTER
K841730 · KYB
Intermedics Intraocular, Inc.
Ophthalmic · 208d
Cleared Nov 19, 1984
J4 MYO-MONITOR
K842223 · NUW
Myo-Tronics Research, Inc.
Dental · 167d
Cleared Nov 19, 1984
BNS 40
K842224 · NUW
Myo-Tronics Research, Inc.
Dental · 167d
Cleared Nov 19, 1984
UNILOC
K842465 · KWL
American Ortomed Corp.
Orthopedic · 147d