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
163153–163176 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 26, 1981
ETHIX FEEDING TUBES POLYURETHANE/RADIOP.
K811639 · KNT
Ethox Corp.
Gastroenterology & Urology · 16d
Cleared Jun 26, 1981
ANIS LENS IMPLANT FORCEPS #2
K811658 · HNR
American V. Mueller
Ophthalmic · 14d
Cleared Jun 26, 1981
CREATININE REAGENT
K811659 · CGX
Gilford Diagnostics
Chemistry · 14d
Cleared Jun 26, 1981
NORELCO ELECTRONIC DIGITAL THERMOMETER
K811672 · FLL
North American Philips Corp.
General Hospital · 11d
Cleared Jun 26, 1981
FORDER RETRACTOR
K811693 · KOA
Dacomed Corp.
Gastroenterology & Urology · 11d
Cleared Jun 25, 1981
ACTH RADIOIMMUNOASSAY KIT
K811565 · CKG
Immuno Nuclear Corp.
Chemistry · 21d
Cleared Jun 25, 1981
C-TERMINAL PTH BY RADIOIMMUNOASSAY KIT
K811566 · CEW
Immuno Nuclear Corp.
Chemistry · 21d
Cleared Jun 25, 1981
CARDIOZYME PLUS CK-MB ITEM #65045
K811573 · JHW
Harleco
Chemistry · 21d
Cleared Jun 25, 1981
CARDIOZYME PLUS CK-TOTAL ITEM #65046
K811574 · CGS
Harleco
Chemistry · 21d
Cleared Jun 25, 1981
CARDIOZYME PLUS CK-MB ITEM #65045 (G)
K811575 · JHW
Harleco
Chemistry · 21d
Cleared Jun 25, 1981
CARDIOZYME PLUS CK-TOTAL ITEM #65046 (A)
K811576 · CGS
Harleco
Chemistry · 21d
Cleared Jun 25, 1981
HELENA FETAL-TEK 200 METHOD
K811588 · JHG
Helena Laboratories
Chemistry · 17d
Cleared Jun 25, 1981
ZIMMER ARTHROSCOPY SYSTEM
K811596 · HRX
Zimmer, Inc.
Orthopedic · 17d
Cleared Jun 25, 1981
UREA AGAR SLANT
K811597 · JSH
Micro Media Laboratories
Microbiology · 17d
Cleared Jun 25, 1981
DNASE AGAR MEDIA
K811598 · JSI
Micro Media Laboratories
Microbiology · 17d
Cleared Jun 25, 1981
EOSIN METHYLENE BLUE AGAR
K811599 · JSI
Micro Media Laboratories
Microbiology · 17d
Cleared Jun 25, 1981
BILE ESCULIN MEDIA
K811600 · JSI
Micro Media Laboratories
Microbiology · 17d
Cleared Jun 25, 1981
PHENYETHYL ALCOHOL AGAR
K811601 · JSJ
Micro Media Laboratories
Microbiology · 17d
Cleared Jun 25, 1981
TRYPTIC SOY BROTH
K811602 · JSC
Micro Media Laboratories
Microbiology · 17d
Cleared Jun 25, 1981
SALMONELLA SHIGELLA AGAR
K811603 · JSI
Micro Media Laboratories
Microbiology · 17d
Cleared Jun 25, 1981
XYLOSE LYSINE DEOXYCHOLATE AGAR
K811604 · JSI
Micro Media Laboratories
Microbiology · 17d
Cleared Jun 25, 1981
HEKTOEN ENTERIC AGAR
K811605 · JSI
Micro Media Laboratories
Microbiology · 17d
Cleared Jun 25, 1981
FLUID THIOCLYCOLLATE MEDIUM
K811606 · JSG
Micro Media Laboratories
Microbiology · 17d
Cleared Jun 25, 1981
COLUMBIA AGAR CNA W/5% SHEEP BLOOD
K811607 · JSJ
Micro Media Laboratories
Microbiology · 17d