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
138289–138312 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 18, 1987
BRAIN HEART INFUSION AGAR W/GENTAMICIN - #P3704
K873231 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 35d
Cleared Sep 18, 1987
BRAIN HEART INFUSION AGAR - BHIA PRODUCT #P3302
K873232 · JSG
Lakewood Biochemical Co., Inc.
Microbiology · 35d
Cleared Sep 18, 1987
CSF-FLOW CONTROL VALVE, ULTRA SMALL
K873247 · JXG
Pudenz-Schulte Medical Research Corp.
Neurology · 35d
Cleared Sep 18, 1987
OMNIFIT BONE SCREW
K873251 · HWC
Osteonics Corp.
Orthopedic · 32d
Cleared Sep 17, 1987
RESTORE
K872164 · LPN
Anderson Research, Inc.
Ophthalmic · 104d
Cleared Sep 17, 1987
SPS SUSPENSION ENEMA KIT
K872992 · FCE
Carolina Medical Products Co.
Gastroenterology & Urology · 48d
Cleared Sep 17, 1987
ORTHOPAEDIC TABLE 1420
K873273 · JEB
Stierlen-Maquet AG
General & Plastic Surgery · 31d
Cleared Sep 17, 1987
PLASTER TABLE 1418
K873274 · JEB
Stierlen-Maquet AG
General & Plastic Surgery · 31d
Cleared Sep 17, 1987
EXTENSION TABLE 1417
K873275 · JEB
Stierlen-Maquet AG
General & Plastic Surgery · 31d
Cleared Sep 17, 1987
EXTENSION DEVICE 1416
K873276 · JEB
Stierlen-Maquet AG
General & Plastic Surgery · 31d
Cleared Sep 17, 1987
MITRAFLEX(TM) WOUND DRESSING
K873277 · NAD
Matrix Medica, Inc.
General & Plastic Surgery · 31d
Cleared Sep 16, 1987
WAKO(TM) ZN TEST
K863920
Wako Chemicals USA, Inc.
Chemistry · 343d
Cleared Sep 16, 1987
CENTRAL VENOUS MULTI-LUMEN CATHETERS AND KITS
K871573 · DQY
Spectramed, Inc.
Cardiovascular · 147d
Cleared Sep 16, 1987
GLUCOCHEK S.C. WITH AUDIO OPTION
K871586 · CGA
Larken Industries, Inc.
Chemistry · 146d
Cleared Sep 16, 1987
NASOGASTRIC VOICETUBE
K871632 · BTR
American Omni Medical, Inc.
Anesthesiology · 142d
Cleared Sep 16, 1987
COULTER DART CK-MB ISOENZYME REAGENT SYSTEM
K872041 · JHT
Coulter Electronics, Inc.
Chemistry · 112d
Cleared Sep 16, 1987
RVT-50 ROTARY CHAIR FOR VESTIBULAR TESTING
K872093 · LXV
Ics Medical Corp.
Ear, Nose, Throat · 107d
Cleared Sep 16, 1987
SURGITEK INFUSION STENT SYSTEM*
K872353 · FAD
Surgitek
Gastroenterology & Urology · 90d
Cleared Sep 16, 1987
LARKEL DEVICE W/ATTACHMENTS A-H
K872486 · BTO
Seidel Medizin GmbH
Anesthesiology · 85d
Cleared Sep 16, 1987
HEWSON A.C.L. GUIDE SET
K872608 · KGS
Concept, Inc.
General & Plastic Surgery · 72d
Cleared Sep 16, 1987
MASTER-FIT HEARING EVALUA. & RECOM. (HEAR) SYSTEM
K872633 · ETW
Hearing Health Care Program
Ear, Nose, Throat · 72d
Cleared Sep 16, 1987
SPECTROPHOTOMETERS MODELS:ABC+,ABC,S 500, S 1000
K872749 · JJQ
Secomam Co.
Chemistry · 65d
Cleared Sep 16, 1987
LACTATE DEHYDROGENASE ISOENZYME 1
K872891 · CEX
Data Medical Associates, Inc.
Chemistry · 55d
Cleared Sep 16, 1987
IN THE EAR HEARING AID
K872922 · ESD
Audio Hearing Aid Service
Ear, Nose, Throat · 51d