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
170113–170136 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 20, 1978
APPLICATOR, LEE IMPRESSION
K781977 · EID
Lee Pharmaceuticals
Dental · 23d
Cleared Dec 20, 1978
SURGAIRTOME TWO
K781979 · HSZ
American Sterilizer Co.
Orthopedic · 23d
Cleared Dec 20, 1978
RADIATION ONCOLOGY SYSTEM
K782005 · KPQ
Adac Laboratories
Radiology · 16d
Cleared Dec 20, 1978
HYSTERECTOMY T DRAIN
K782027 · JOL
Davol, Inc.
General Hospital · 15d
Cleared Dec 20, 1978
ROUND SILICONE DRAIN
K782028 · GCY
Davol, Inc.
General & Plastic Surgery · 15d
Cleared Dec 20, 1978
PROCESSING SYSTEM, A2 IMAGE
K782047 · IYX
Medtronic Vascular
Radiology · 12d
Cleared Dec 20, 1978
MULTIFORMAT FILM CASSETTE TRANSPORT
K782060 · IYO
Mediscan, Inc.
Radiology · 12d
Cleared Dec 20, 1978
CATHETER, DIGITAL POSITRAL II
K782082 · DQO
C.R. Bard, Inc.
Cardiovascular · 6d
Cleared Dec 20, 1978
CLAMP, DISPOSABLE
K782090 · HXD
Concord Laboratories, Inc.
General & Plastic Surgery · 6d
Cleared Dec 19, 1978
ADAPTER KIT
K781864 · DTD
Daig Corp.
Cardiovascular · 43d
Cleared Dec 19, 1978
ELECTRODES, OFFSET AND DX
K781963 · DRX
Graphic Controls Corp.
Cardiovascular · 27d
Cleared Dec 18, 1978
ALARM UNIT, BATTERY OPERATED
K781158 · BZQ
Thompson Respiration Products, Inc.
Anesthesiology · 166d
Cleared Dec 15, 1978
SUPER-SORBER
K780938 · EYQ
Home Healthcare Products, Inc.
Gastroenterology & Urology · 190d
Cleared Dec 15, 1978
AQUA-GEL
K781032 · EXQ
Murray, Salk, Inc.
Gastroenterology & Urology · 179d
Cleared Dec 15, 1978
TUBE, LEATHERMAN/IMBRUCE
K781665 · GBA
National Catheter Co. Div. Mallinckrodt
General & Plastic Surgery · 78d
Cleared Dec 15, 1978
DIALYZER, PARALLEL FLOW DISPOSABLE
K781795 · FJG
Medical, Inc.
Gastroenterology & Urology · 51d
Cleared Dec 15, 1978
SPIROMETER, INCENTIVE CATALOG # 1750
K781831 · BWF
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 46d
Cleared Dec 15, 1978
UNDERPADS, HIGH ABSORBANT POLYMER
K781877 · KMF
Bridgewater Mfg. Corp.
General & Plastic Surgery · 39d
Cleared Dec 15, 1978
OMNIPREP
K781989 · GYB
Weaver & Co.
Neurology · 18d
Cleared Dec 15, 1978
TRACH-COLLAR
K782002 · EQN
Kinetic Concepts, Inc.
Ear, Nose, Throat · 11d
Cleared Dec 15, 1978
LEAD, TIMED PACING, IMPLANTABLE
K782004 · DTB
Daig Corp.
Cardiovascular · 11d
Cleared Dec 15, 1978
MEDGENERAL SINGLE-USE BULLDOG
K782006 · GDJ
Med General
General & Plastic Surgery · 14d
Cleared Dec 15, 1978
CARDIAC CARE Q/C TEST KIT
K782033 · DRL
Instrumentation Laboratory CO
Cardiovascular · 9d
Cleared Dec 15, 1978
HEARING AID, POST-AURICULAR
K782053 · ESD
Hc Electronics
Ear, Nose, Throat · 8d