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
161689–161712 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 09, 1981
ACKRAD INCISION & DRAIN SET
K813103 · KDD
Ackrad Laboratories
General & Plastic Surgery · 36d
Cleared Dec 09, 1981
PEDIATRIC VENTILATOR CIRCUIT 2C7131
K813155 · BZO
Travenol Laboratories, S.A.
Anesthesiology · 33d
Cleared Dec 09, 1981
FLO TEM II (BLOOD/FLUID WARMER
K813161 · LGZ
Datachem, Inc.
General Hospital · 29d
Cleared Dec 09, 1981
INFANT PHOTOTHERAPY LIGHT
K813188 · LBI
Montrose Phototherapy Supply
General Hospital · 23d
Cleared Dec 09, 1981
TRACHEOBRONCHIAL SUCTION CATHETER
K813209 · BSY
Hydromer, Inc.
Anesthesiology · 33d
Cleared Dec 09, 1981
INFANT PHOTOTHERAPY MASK
K813214 · FOK
Montrose Phototherapy Supply
General Hospital · 30d
Cleared Dec 09, 1981
IC-5 VENTILATOR
K813253 · CBK
Bio-Med Devices, Inc.
Anesthesiology · 20d
Cleared Dec 08, 1981
UROPAPER EIKEN UHAG
K811816 · JIL
Syn-Kit, Inc.
Microbiology · 165d
Cleared Dec 08, 1981
VIDICAM 200
K812613 · IZJ
Diversified P.A.
Radiology · 84d
Cleared Dec 08, 1981
THE TELOS EQUIPMENT
K812778 · KQW
The Telos Co.
Radiology · 64d
Cleared Dec 08, 1981
D-3260 SORBENT CARTRIDGE
K812869 · FKT
Organon Teknika Corp.
Gastroenterology & Urology · 55d
Cleared Dec 08, 1981
SUPERFLAB
K812893 · IYP
Mick Radio-Nuclear Instruments, Inc.
Radiology · 54d
Cleared Dec 08, 1981
ARGYLE ACC-U-THERM W/TEMPERATURE PROBE
K812976 · BZT
Sherwood Medical Co.
Anesthesiology · 46d
Cleared Dec 08, 1981
B.D.A.S.
K813065 · KPT
General Electric Co.
Radiology · 39d
Cleared Dec 08, 1981
OMEGA 500 RECTANGULAR FIELD CAMERA W/SC
K813073 · IYX
Technicare Corp.
Radiology · 36d
Cleared Dec 08, 1981
ETHICON* SKIN CLOSURE TAPE
K813124 · KGX
Ethicon, Inc.
General & Plastic Surgery · 34d
Cleared Dec 08, 1981
KODAK INTENSIFYING SCREEN SO-168
K813139 · EAM
Eastman Kodak Company
Radiology · 32d
Cleared Dec 08, 1981
VACUSHIELD TM
K813159 · JRL
Gelman Sciences, Inc.
Chemistry · 22d
Cleared Dec 08, 1981
RESPIRATOR MONITOR
K813198 · CCL
Florida Medical Equipment Repair, Inc.
Anesthesiology · 25d
Cleared Dec 08, 1981
HEARING AID CUSTOM ITE
K813206 · ESD
Duvan Acoustics, Inc.
Ear, Nose, Throat · 25d
Cleared Dec 08, 1981
Y-GLUTAMYLTRANSFERASE
K813215
American Monitor Corp.
Chemistry · 29d
Cleared Dec 08, 1981
TDX VANCOMYCIN
K813218 · LEH
Abbott Laboratories
Toxicology · 29d
Cleared Dec 08, 1981
HEARING AID MODEL UE9-R
K813229 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 28d
Cleared Dec 08, 1981
OHIO AIR ADAPTOR
K813234 · BYX
Timeter Instrument Corp.
Anesthesiology · 21d