FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
126985–127008 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 13, 1990
EUP-F124 5.0 MHZ CONVEX ARRAY FINGER TOP PROBE
K890531 · ITX
Hitachi Medical Corp. of America
Radiology · 435d
Cleared Apr 13, 1990
EUP-C321 5.0MHZ CONVEX TYPE PROBE
K890532 · ITX
Hitachi Medical Corp. of America
Radiology · 435d
Cleared Apr 13, 1990
UNION BROACH BLEACHING LIGHT
K895174 · EEG
Union Broach, Div. Moyco Industries,...
Dental · 249d
Cleared Apr 13, 1990
MYOTRACE 10 BIOFEEDBACK DEVICE
K895633 · HCC
Noraxon USA, Inc.
Neurology · 206d
Cleared Apr 13, 1990
INNOVATIONS NASAL TAMPON
K896248 · EMX
Innovations by Necessity, Inc.
Ear, Nose, Throat · 165d
Cleared Apr 13, 1990
NOVADERM
K896531 · KMF
Syncare Corp.
General & Plastic Surgery · 148d
Cleared Apr 13, 1990
MIDIMATE 622
K896710 · EWO
Madsen North America, Inc.
Ear, Nose, Throat · 136d
Cleared Apr 13, 1990
SPERM SELECT SYSTEM
K900308 · HDR
Pharmacia, Inc.
Obstetrics & Gynecology · 81d
Cleared Apr 13, 1990
DUODERM* ADHESIVE COMPRESSION BANDAGE
K900447 · KGX
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 73d
Cleared Apr 13, 1990
CLEARFIL VENEER BOND KIT
K900690 · EBF
Kuraray Co.
Dental · 59d
Cleared Apr 13, 1990
ENEMA KIT 'Y' DESIGN
K900847 · FCE
Custom Medical Products, Ltd.
Gastroenterology & Urology · 50d
Cleared Apr 13, 1990
ENEMA KIT 'STRAIGHT' DESIGN
K900848 · FCE
Custom Medical Products, Ltd.
Gastroenterology & Urology · 50d
Cleared Apr 13, 1990
DAHLBERG MODEL JM IN-THE-EAR HEARING INSTRUMENT
K900862 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 49d
Cleared Apr 13, 1990
F300 SERIES CONTACT FIBER HANDPIECES
K901021 · GEX
Hgm Medical Laser Systems, Inc.
General & Plastic Surgery · 39d
Cleared Apr 13, 1990
SEARS MODEL LS9093 IN-THE-EAR HEARING INSTRUMENT
K901386 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 18d
Cleared Apr 13, 1990
LASER LAPAROSCOPIC CHOLECYSTECTOMY
K901541 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 10d
Cleared Apr 12, 1990
GRIESHABER RETINAL TACK AND SUTHERLAND TACK FORCEP
K897119 · HQW
Grieshaber & Co.
Ophthalmic · 107d
Cleared Apr 12, 1990
CONNECT
K900303 · EMA
Parkell
Dental · 80d
Cleared Apr 12, 1990
MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA
K900702 · LGI
Innotron of Oregon, Inc.
Toxicology · 59d
Cleared Apr 12, 1990
MODIFIED ACCUFLUOR GENTAMICIN REAGENT & CALIBRATOR
K900703 · LCD
Innotron of Oregon, Inc.
Toxicology · 59d
Cleared Apr 12, 1990
MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRA
K900704 · LGQ
Innotron of Oregon, Inc.
Toxicology · 59d
Cleared Apr 12, 1990
MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATOR
K900705 · LBZ
Innotron of Oregon, Inc.
Toxicology · 59d
Cleared Apr 12, 1990
MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA
K900706 · LGS
Innotron of Oregon, Inc.
Toxicology · 59d
Cleared Apr 12, 1990
CHEM 1 CLINICAL ANALYZER (URINE INORGANIC PHOSPHO)
K901137 · CEO
Technicon Instruments Corp.
Chemistry · 31d