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
163777–163800 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 17, 1981
BARNES-HIND ROSE BENGAL OPHTHALMIC STR.
K810285 · KYC
Barnes-Hind, Inc.
Ophthalmic · 74d
Cleared Apr 17, 1981
STERI-VERS
K810311 · LDS
The Hilrad Co.
General Hospital · 71d
Cleared Apr 17, 1981
SHILEY S-100A (ADULT) BLOOD OXYGENATOR
K810470 · DTZ
Shiley, Inc.
Cardiovascular · 53d
Cleared Apr 17, 1981
SONTEK ANGIOGRAPHIC CATHETER
K810508 · DQO
Sontek Corp.
Cardiovascular · 52d
Cleared Apr 17, 1981
DISPOSABLE 22MM. FLEXIBLE ADAPTOR
K810621 · BZA
Intec Medical, Inc.
Anesthesiology · 39d
Cleared Apr 17, 1981
POLARISED LIGHT GRONIOMETER
K810640 · KQX
Cairco , Ltd.
Neurology · 38d
Cleared Apr 17, 1981
GILUCOCHEK REFLECTANCE METER
K810665 · JJQ
Lifescan, Inc.
Chemistry · 37d
Cleared Apr 17, 1981
MS-303-OXYGEN REGULATOR SHIELD
K810679 · CAN
Instrumentation Industries, Inc.
Anesthesiology · 35d
Cleared Apr 17, 1981
ENDOTRACHEAL TUBE HOLDER
K810737 · CBH
Aircare Systems
Anesthesiology · 30d
Cleared Apr 17, 1981
5 MHZ TRANSDUCER
K810749 · ITX
General Electric Co.
Radiology · 28d
Cleared Apr 17, 1981
SURGICAL TUBE HOLDER
K810788 · FZX
The Urology Group
General & Plastic Surgery · 25d
Cleared Apr 17, 1981
AMICON ULTRAFILTRATION MEMBRANES CMII
K810810 · DHX
Amicon, Inc.
Chemistry · 24d
Cleared Apr 17, 1981
DRAINING-WOUND MGMT. SYSTEM
K810812 · EXB
Johnson & Johnson Professionals, Inc.
Chemistry · 24d
Cleared Apr 17, 1981
ERIKA EXTENSION SETS
K810823 · FJK
Erika, Inc.
Gastroenterology & Urology · 24d
Cleared Apr 17, 1981
ERIKA HEPARIN INFUSION ADAPTOR
K810824 · FJK
Erika, Inc.
Gastroenterology & Urology · 24d
Cleared Apr 17, 1981
SWEEN UNIVERSAL BED RAIL PADS
K810846 · FNJ
Sween Corp.
General Hospital · 21d
Cleared Apr 17, 1981
CORDIS BIOPSY FORCEPS
K810849 · DWZ
Cordis Corp.
Cardiovascular · 18d
Cleared Apr 17, 1981
KANGAROO NASOGASTRIC FEEDING TUBE
K810854 · KNT
Chesebrough-Pond'S U.S.A. Co.
Gastroenterology & Urology · 18d
Cleared Apr 17, 1981
ORTHOSIS BANDAGES
K810877 · ITG
Ortho-Cast, Inc.
Physical Medicine · 17d
Cleared Apr 17, 1981
ELECTRO-SUCTION UNIT
K810892 · KDQ
Jedmed Instrument Co.
General Hospital · 15d
Cleared Apr 17, 1981
VENTI-GARD JR.
K810896 · KGX
Con Med Equipment, Inc.
General & Plastic Surgery · 14d
Cleared Apr 17, 1981
MICRO CAUTERY
K810909 · HAM
Key Medical, Inc.
General & Plastic Surgery · 14d
Cleared Apr 17, 1981
MEDRAD HIGH PRESSURE CONECTING TUBE
K810924 · DWE
Medrad, Inc.
Cardiovascular · 11d
Cleared Apr 17, 1981
CHORIO-SHURE
K810936 · JHI
Nuclear Medical Laboratories, Inc.
Chemistry · 10d