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
151945–151968 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 19, 1984
PROXIMA 1 PH MONITOR
K841384 · FFT
American Endoscopy, Inc.
Gastroenterology & Urology · 121d
Cleared Jul 19, 1984
HEART - AID ALS, 95
K841556 · LDO
Cardiac Resucitator Corp.
Toxicology · 94d
Cleared Jul 19, 1984
STERILE, FOLEY CATHETERS W/PTFE COAT
K841678 · KOD
Abco Dealers, Inc.
Gastroenterology & Urology · 87d
Cleared Jul 19, 1984
MELOY IMMUNOSTAT MONOCLONAL FACTOR VIII
K841708 · GGP
Meloy Laboratories, Inc.
Hematology · 87d
Cleared Jul 19, 1984
CORPAK FOLEY CATH TRAY W/16FR. TEFLON
K841819 · KOD
Corpak Co.
Gastroenterology & Urology · 78d
Cleared Jul 19, 1984
EEG ELECTRODE PAD
K841877 · GXY
Neurologics, Inc.
Neurology · 73d
Cleared Jul 19, 1984
SEGURA BASKET
K841942 · FFL
Van-Tec, Inc.
Gastroenterology & Urology · 69d
Cleared Jul 19, 1984
ULTRA SHIELD BRIEFS
K841953 · EYQ
Ipco Corp.
Gastroenterology & Urology · 66d
Cleared Jul 19, 1984
BOVINE THROMBIN, HUMAN THROMBIN
K841956 · GJA
Haemachem, Inc.
Hematology · 66d
Cleared Jul 19, 1984
BOVINE FACTOR XA-HUMAN FACTOR XA
K841957 · GGP
Haemachem, Inc.
Hematology · 66d
Cleared Jul 19, 1984
GLUCOSE-TRINDER-ADDAY KIT
K842506 · CGA
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 23d
Cleared Jul 18, 1984
STEAM STERILIZER
K831356 · FLE
Ars Enterprises, Inc.
General Hospital · 449d
Cleared Jul 18, 1984
WATER FLOATION BED 800/TC/H
K840881 · IOQ
Western Medical, Ltd.
Physical Medicine · 142d
Cleared Jul 18, 1984
HOME CARE WATER FLOTATION BED HC4/TC/H
K840882 · IOQ
Western Medical, Ltd.
Physical Medicine · 142d
Cleared Jul 18, 1984
A.S.A.P.
K841318 · LDR
Trimedyne, Inc.
General Hospital · 107d
Cleared Jul 18, 1984
OPTIMIST SIZED PARTICLE AEROSOL NEBULIZ
K841322 · FLL
Airmed Corp.
General Hospital · 107d
Cleared Jul 18, 1984
ELEVATOR
K841356 · KAD
Treace Medical, Inc.
Ear, Nose, Throat · 107d
Cleared Jul 18, 1984
FENESTRA HOOK
K841359 · IYL
Treace Medical, Inc.
Radiology · 107d
Cleared Jul 18, 1984
BRONCHOSCOPE SUCTION UNIT
K841399 · BTA
Keymed, Inc.
General & Plastic Surgery · 106d
Cleared Jul 18, 1984
IMPEDANCE/PURE TONE AUDIOMETER MA620
K841568 · ETY
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 92d
Cleared Jul 18, 1984
TERUMO DIGITAL CLINICAL THERMOMETER
K841740 · FLL
Terumo Medical Corp.
General Hospital · 82d
Cleared Jul 18, 1984
GLOTTAL FREQUENCY ANALYSER
K841832 · KLX
Teltec Electronic Equipment AB
Ear, Nose, Throat · 76d
Cleared Jul 18, 1984
IVAC 3080 ENTERAL FEEDING PUMP
K842027 · FRN
Y
General Hospital · 61d
Cleared Jul 18, 1984
ABBOTT LIFECARE 1050 CONTROLLER
K842080 · LDR
Abbott Laboratories
General Hospital · 56d