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
165913–165936 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 13, 1980
TRIMETHOPRIM 5MCG. SENSITIVITY DISCS
K801474 · JTN
Difco Laboratories, Inc.
Microbiology · 50d
Cleared Aug 13, 1980
MRI HCG-BETA RIA KIT CAT. #MR-10100
K801491 · JHI
Microanalytic Research, Inc.
Immunology · 48d
Cleared Aug 13, 1980
PORPHYRIN (ALA) DISK
K801492 · JTO
Remel Co.
Microbiology · 48d
Cleared Aug 13, 1980
ALA SWAB
K801493 · JTO
Remel Co.
Microbiology · 48d
Cleared Aug 13, 1980
AGA UV PHOTOMETER
K801499 · JJQ
Syva Co.
Chemistry · 47d
Cleared Aug 13, 1980
HOLLISTER KARAYA SEAL RING
K801503 · EXB
Hollister, Inc.
Gastroenterology & Urology · 47d
Cleared Aug 13, 1980
VENTREX/SEP TSH TEST SET
K801560 · JLW
Ventrex Laboratories, Inc.
Immunology · 36d
Cleared Aug 13, 1980
FERRITIN RIA KIT
K801580 · DBF
Diagnostic Products Corp.
Immunology · 34d
Cleared Aug 13, 1980
MADDOX LENS SPATULA CAT. #7245
K801609 · HND
Edward Weck, Inc.
Ophthalmic · 29d
Cleared Aug 13, 1980
MODEL 40-30-2 AIR ELIMINATING FILTER SET
K801614 · FPB
Y
General Hospital · 29d
Cleared Aug 13, 1980
ARGYLE A-V MEDI-WING HEMODIALYSIS SET
K801618 · FIE
Sherwood Medical Co.
Gastroenterology & Urology · 29d
Cleared Aug 13, 1980
A O CUSTOM II CHAIR AND STAND
K801638 · HME
American Optical Corp.
Ophthalmic · 27d
Cleared Aug 13, 1980
TRIMETHROPRIM 5MCG. SENSI DISC.
K801648 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 26d
Cleared Aug 13, 1980
CUTTER JET
K801651 · EFB
Cutter Laboratories, Inc.
Dental · 26d
Cleared Aug 13, 1980
PROXIMATE * PSD PURSE-STRING DEVICE
K801660 · GDJ
Ethicon, Inc.
General & Plastic Surgery · 23d
Cleared Aug 13, 1980
QUICK CEPT
K801668 · JHS
Laboratory Diagnostics Co., Inc.
Chemistry · 23d
Cleared Aug 13, 1980
SPOR-TEST-STRIP
K801678 · FRC
Sterilization Technical Services, Inc.
General Hospital · 22d
Cleared Aug 13, 1980
VALIANT
K801690 · EJJ
L.D. Caulk Co.
Dental · 21d
Cleared Aug 13, 1980
OPEN-LOOP INSULIN DELIVERY SYSTEM
K801704 · FRN
Delta Medical Industries
General Hospital · 20d
Cleared Aug 13, 1980
BK-6010 CATHETER TUBE HOLDER
K801711 · KNX
Fred Sammons, Inc.
Gastroenterology & Urology · 20d
Cleared Aug 13, 1980
UR 150-UR 150T
K801723 · KQS
Siemens Corp.
Radiology · 20d
Cleared Aug 13, 1980
KANGAROO ENTERAL FEEDING PUMP
K801725 · FRN
Chesebrough-Pond'S U.S.A. Co.
General Hospital · 20d
Cleared Aug 13, 1980
KRYMED SYSTEM 4001 TILT SCOPE
K801730 · HEX
Cryomedics, Inc.
Obstetrics & Gynecology · 19d
Cleared Aug 13, 1980
C-DAK DUO-FLUX ARTIFICIAL KIDNEY
K801731 · KDI
Cordis Corp.
Gastroenterology & Urology · 19d