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
123793–123816 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 26, 1990
ZIMMON ENDOSCOPIC PANCREATIC STENT
K900923 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 241d
Cleared Oct 26, 1990
ETUDE, URODYNAMIC INVESTIGATION SYSTEM
K901494 · FAP
Dantec Medical, Inc.
Gastroenterology & Urology · 211d
Cleared Oct 26, 1990
SAFTE ORIONE HERNIA BELT ITEMS NO. 316, 515, 536
K901922 · EXN
Safte S.P.A.
Gastroenterology & Urology · 179d
Cleared Oct 26, 1990
VITALOGRAPH - BREATHCO MONITOR
K902113 · CCJ
Mcneill Intl., Inc.
Anesthesiology · 168d
Cleared Oct 26, 1990
CPR VALVE (NON-REBREATHING) MODEL #9030
K902299 · CBP
Rondex Products, Inc.
Anesthesiology · 157d
Cleared Oct 26, 1990
CLINICAL THERMOMETER
K902625 · FLK
Liaoning-Usa Corp.
General Hospital · 134d
Cleared Oct 26, 1990
G.E. AMX 110, AMX II AND AMX 3 X-RAY UNITS
K902984 · IZL
Electromek Diagnostic Systems, Inc.
Radiology · 122d
Cleared Oct 26, 1990
MEGA-TENS DUAL CHANNEL T.E.N.S.
K903017 · GZJ
Futuremed Div. of Future Impex Corp.
Neurology · 108d
Cleared Oct 26, 1990
LATEX EXAMINATION GLOVES
K903111 · LYY
Kaen Yang Industry Co., Ltd.
General Hospital · 107d
Cleared Oct 26, 1990
AUKUFLEX(TM) RADIATION RESISTANT GLOVES
K903142 · LZC
Aukland Mfg., Inc.
General Hospital · 101d
Cleared Oct 26, 1990
PRECISION OPTICS ENDOSCOPE ADAPTER
K903459 · FET
Precise Optics
Gastroenterology & Urology · 86d
Cleared Oct 26, 1990
DSL ERYTHROPOIETIN (DSL # 1100)
K903492 · GGT
Diagnostic Systems Laboratories, Inc.
Hematology · 84d
Cleared Oct 26, 1990
ILC LEG BAG HOLDER
K903611 · FAQ
Inman Liebelt Corp.
Gastroenterology & Urology · 78d
Cleared Oct 26, 1990
SURGIMEDICS, SLP LAPAROSCOPIC CHOLANGIOGRAM CATH
K903709 · GBZ
Lifestream Int'L, Inc.
General & Plastic Surgery · 71d
Cleared Oct 26, 1990
EZ-BEAD TSH ENZYME IMMUNOASSAY KIT
K903725 · JLW
Immunotech Corp.
Chemistry · 71d
Cleared Oct 26, 1990
CAT. #6000-21 VOLUME NECK COIL, MODIFIED
K903753 · LNH
Medical Advances, Inc.
Radiology · 94d
Cleared Oct 26, 1990
CAT. #4050-64 & 4065-64 SHOULDER COILS, MODIFIED
K903754 · LNH
Medical Advances, Inc.
Radiology · 94d
Cleared Oct 26, 1990
CAT/ #4100-21 SHOULDER COIL PACKAGE, MODIFIED
K903755 · LNH
Medical Advances, Inc.
Radiology · 94d
Cleared Oct 26, 1990
IRRICLEAR EAR IRRIGATION SYRINGE
K903759 · KYZ
Nortech Laboratories, Inc.
General Hospital · 67d
Cleared Oct 26, 1990
SUNGLASSES
K903902 · HQY
K & P Trading Co., Inc.
Ophthalmic · 64d
Cleared Oct 26, 1990
REPAK SURGICAL PACKS
K903908 · KKX
Repack Surgical Enterprises, Inc.
General Hospital · 64d
Cleared Oct 26, 1990
BLIND CONTROLS FOR DRUGS OF ABUSE TESTING
K903909 · DIF
Rapid Diagnostic Laboratories, Inc.
Toxicology · 65d
Cleared Oct 26, 1990
LUBRICATING JELLY
K903910 · KMJ
Lake Pharmaceutical, Inc.
General Hospital · 64d
Cleared Oct 26, 1990
SLT CONTACT LASER SYSTEM ND:YAG MEDICAL LASER SYST
K903936 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 60d