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
163057–163080 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 02, 1981
RESIDENT BEDSIDE MONITOR
K811216 · DRT
Abbott Laboratories
Cardiovascular · 59d
Cleared Jul 02, 1981
TRISCAN, MODELS 38,40,41,43 & 45
K811316 · IYO
Visidyne Corp.
Radiology · 51d
Cleared Jul 02, 1981
ECA
K811397 · FOA
Gillco, Inc.
General Hospital · 45d
Cleared Jul 02, 1981
ALUMINUM FILTRATION SYSTEM
K811450 · KPW
Wedge Filtration System
Radiology · 41d
Cleared Jul 02, 1981
GRAYLINE IMAGING SYSTEM
K811520 · HEM
Sonics Research Corp.
Radiology · 34d
Cleared Jul 02, 1981
BARNES-HIND SPECTACLE LENS CLEANER
K811554 · HQG
Barnes-Hind, Inc.
Ophthalmic · 30d
Cleared Jul 02, 1981
SMR PARAGON CHAIR TABLE
K811623 · LGX
Smr
General Hospital · 23d
Cleared Jul 02, 1981
MEDICASE SOY AGAR
K811640 · JSG
Hardy Media
Microbiology · 23d
Cleared Jul 02, 1981
COLUMBIA AGAR BASE
K811641 · JSG
Hardy Media
Microbiology · 23d
Cleared Jul 02, 1981
EOSIN METHYLENE BLUE AGAR (LEVINE)
K811642 · JSI
Hardy Media
Microbiology · 23d
Cleared Jul 02, 1981
MACCONKEY AGAR
K811643 · JSI
Hardy Media
Microbiology · 23d
Cleared Jul 02, 1981
HEKTOEN ENTERIC AGAR
K811644 · JSI
Hardy Media
Microbiology · 23d
Cleared Jul 02, 1981
THAYER-MARTIN, GC AGAR BASE
K811645 · JTY
Hardy Media
Microbiology · 23d
Cleared Jul 02, 1981
MUELLER HINTON AGAR
K811646 · JTZ
Hardy Media
Microbiology · 23d
Cleared Jul 02, 1981
SALMONELLA-SHIGELLA AGAR
K811647 · JSI
Hardy Media
Microbiology · 23d
Cleared Jul 02, 1981
ENDO AGAR
K811648 · JSI
Acumedia Manufacturers, Inc.
Microbiology · 22d
Cleared Jul 02, 1981
GELYSATE
K811649 · JSK
Acumedia Manufacturers, Inc.
Microbiology · 22d
Cleared Jul 02, 1981
MACCONKEY BROTH
K811650 · JSJ
Acumedia Manufacturers, Inc.
Microbiology · 22d
Cleared Jul 02, 1981
TRYPTICASE
K811651 · JSG
Acumedia Manufacturers, Inc.
Microbiology · 22d
Cleared Jul 02, 1981
POLYPEPTONE PEPTONE
K811652 · JSK
Acumedia Manufacturers, Inc.
Microbiology · 22d
Cleared Jul 02, 1981
PHYTONE
K811653 · JSK
Acumedia Manufacturers, Inc.
Microbiology · 22d
Cleared Jul 02, 1981
BRAIN HEART INFUSION AGAR
K811654 · JSG
Acumedia Manufacturers, Inc.
Microbiology · 22d
Cleared Jul 02, 1981
MAXI CAMERA/D
K811676 · IYX
General Electric Co.
Radiology · 17d
Cleared Jul 02, 1981
KRYPTON CART
K811677 · KPY
Medi-Physics Inc. Dba Nycomed...
Radiology · 17d