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
122353–122376 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 06, 1991
CONVATEC ABSORBENT BANDAGE
K904233 · EXE
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 182d
Cleared Mar 06, 1991
INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER
K904265 · FZW
Inamed Development Co.
General & Plastic Surgery · 169d
Cleared Mar 06, 1991
OMIBAND
K904445 · KGX
Omikron Scientific, Ltd.
General & Plastic Surgery · 159d
Cleared Mar 06, 1991
CRI CYNOSAR CATHETER
K904785 · DRA
Catheter Research C/O Burditt, Bowles...
Cardiovascular · 135d
Cleared Mar 06, 1991
ELLIPSE PUNCH
K904869 · LRY
Kramer Const
General & Plastic Surgery · 128d
Cleared Mar 06, 1991
DISPOSABLE YANKAUER SUCTION TUBE
K904881 · GEA
Pilling Medical S.A.
General & Plastic Surgery · 133d
Cleared Mar 06, 1991
LAPAROTOMY SPONGES
K905135 · GDY
American Healthcare Corp.
General & Plastic Surgery · 111d
Cleared Mar 06, 1991
GAUZE SPONGES, INTERNAL AND EXTERNAL
K905136 · EFQ
American Healthcare Corp.
General & Plastic Surgery · 111d
Cleared Mar 06, 1991
NO PROFILE OLBERT CATHETER SYSTEM FOR UROLOGY
K905181 · EZN
Meadox Surgimed, Inc.
Gastroenterology & Urology · 107d
Cleared Mar 06, 1991
E-20 RAPID CUFF INFLATOR
K905367 · DXN
D. E. Hokanson, Inc.
Cardiovascular · 99d
Cleared Mar 06, 1991
MONTROSE DRESSING APPLICATORS
K905519 · NAD
Olemunda Pty , Ltd.
General & Plastic Surgery · 89d
Cleared Mar 06, 1991
CRP LIPID REAGENT TEST PACK
K905648 · CHH
Cirrus Diagnostics, Inc.
Chemistry · 79d
Cleared Mar 06, 1991
MICRO-X 80HF
K905695 · IZO
Fischer Imaging Corp.
Radiology · 77d
Cleared Mar 06, 1991
HASSON STABILIZING ACCESS CANNULA FOR OPEN LAPAROS
K905759 · HET
Marlo Surgical Technology
Obstetrics & Gynecology · 69d
Cleared Mar 06, 1991
DRAINAGE TUBE RESTRAINT/WOUND COVER
K905766 · GBX
M. Imonti and Associates Inc.,
General & Plastic Surgery · 69d
Cleared Mar 06, 1991
ORTHOVISION TABLE
K905816 · JEB
American Sterilizer Co.
General & Plastic Surgery · 68d
Cleared Mar 06, 1991
ANTI-FOR SURGICAL FACE MASK
K905865 · FXX
Anago, Inc.
General Hospital · 72d
Cleared Mar 06, 1991
MILENIA BETA-2 MICROGLOBULIN
K910052 · JZG
Diagnostic Products Corp.
Immunology · 58d
Cleared Mar 06, 1991
HEMAGEN ENA SCREENING KIT
K910232 · LLL
Hemagen Diagnostics, Inc.
Immunology · 47d
Cleared Mar 06, 1991
X-RAY TUBE HOUSING ASSEMBLY SOREDEX DC/CIR 51
K910276 · ITY
Inmark Corp.
Radiology · 42d
Cleared Mar 06, 1991
KEY COMFORT GRIPS
K910328 · FSM
Key Surgical, Inc.
General & Plastic Surgery · 40d
Cleared Mar 06, 1991
CIBA CORNING ACS VITAMIN B12 IMMUNOASSAY
K910343 · CDD
Ciba Corning Diagnostics Corp.
Chemistry · 36d
Cleared Mar 06, 1991
CLINAK(TM) ISE SUBSYSTEM
K910554 · JGS
Baxter Healthcare Corp
Chemistry · 34d
Cleared Mar 06, 1991
DI2000/HS-45-150 X-RAY TUBE INSERT
K910842 · ITY
Comet Ltd. C/O Radiology Resources, Inc.
Radiology · 7d