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
170401–170424 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 26, 1978
MEDIASTINAL DRAINAGE TUBE SET MDT-36TC2
K781553 · CAC
Sorensen Research
Anesthesiology · 44d
Cleared Oct 26, 1978
FILTER, ARTERIAL BLOOD W/TUBING BYPASS
K781707 · DTM
Surgikos, Inc.
Cardiovascular · 16d
Cleared Oct 25, 1978
INTRA-ALERT
K781297 · FLN
Pan-Tech Research, Inc.
General Hospital · 90d
Cleared Oct 24, 1978
MUELLER HINTON AGAR WITH 5% SHEEP BLOOD
K780958 · JTZ
Pittsburgh Micro-Media, Inc.
Microbiology · 134d
Cleared Oct 24, 1978
MUELLER HINTON AGAR WITH THYMIDINE
K780959 · JTZ
Pittsburgh Micro-Media, Inc.
Microbiology · 134d
Cleared Oct 24, 1978
DIALYSIS SYS., PDS 400 & RO 400
K781156 · DJC
Physio-Control Corp.
Toxicology · 105d
Cleared Oct 24, 1978
CENTRAL CATHETER TRAY
K781333 · KGC
Argon Medical Corp.
Gastroenterology & Urology · 83d
Cleared Oct 24, 1978
CYTOMEGILISH TEST KIT
K781392 · GOK
Microbiological Assoc.
Microbiology · 75d
Cleared Oct 24, 1978
BAYLOW VISUAL ACUITY TESTER
K781452 · HOX
Codman & Shurtleff, Inc.
Ophthalmic · 62d
Cleared Oct 24, 1978
MODEL 770 ARGON LASER
K781453 · GEX
Spectra-Physics, Inc.
General & Plastic Surgery · 63d
Cleared Oct 24, 1978
MONOJECT SCALE MAGNIFIER
K781459 · HJY
Sherwood Medical Industries
Ophthalmic · 62d
Cleared Oct 24, 1978
DISPOSABLE LECTROSWITCH, MODEL E2503
K781510 · GEI
Valleylab, Inc.
General & Plastic Surgery · 53d
Cleared Oct 24, 1978
LECTROSWITCH MODEL E2502B
K781511 · GEI
Valleylab, Inc.
General & Plastic Surgery · 53d
Cleared Oct 24, 1978
SURG-O-PAK PREP PAD
K781534 · KKX
Convertors
General Hospital · 48d
Cleared Oct 24, 1978
ORBIOGRAPH
K781543 · HLT
Sonometrics Systems, Inc.
Ophthalmic · 46d
Cleared Oct 24, 1978
MICROSURGURY VISIBILITY BACKGROUND
K781547
Ethicon, Inc.
General & Plastic Surgery · 41d
Cleared Oct 24, 1978
ALKALINE PHOSPHATASE IN SERUM
K781609 · CJE
Fisher Scientific Co., LLC
Hematology · 35d
Cleared Oct 24, 1978
BILIRUBIN DETERMINTAITON IN SERUM
K781610 · CIG
Fisher Scientific Co., LLC
Chemistry · 35d
Cleared Oct 24, 1978
CHOLESTEROL DET. IN SERUM
K781611 · CGO
Fisher Scientific Co., LLC
Chemistry · 35d
Cleared Oct 24, 1978
SHILEY CRICOTHYROTOMY TUBE
K781639 · EQN
Shiley, Inc.
Ear, Nose, Throat · 33d
Cleared Oct 24, 1978
ASSAY SYSTEM, GAMMAFLO, AUTOMATED
K781659
E. R. Squibb & Sons, Inc.
Toxicology · 26d
Cleared Oct 24, 1978
RIA, DIGOXIN
K781660 · DON
E. R. Squibb & Sons, Inc.
Toxicology · 26d
Cleared Oct 24, 1978
STERILIZER, EAGLE 2000
K781684 · FLE
American Sterilizer Co.
General Hospital · 22d
Cleared Oct 24, 1978
EAGLE PAC/VISIBLE SEAL
K781699 · KCT
American Sterilizer Co.
General Hospital · 13d