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
126385–126408 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 16, 1990
ES 300 IMMUNOASSAY SYSTEM
K901346 · JJE
Boehringer Mannheim Corp.
Chemistry · 24d
Cleared Apr 16, 1990
SUPERARM 2000 LIFT
K901381 · ING
Handicaps, Inc.
Physical Medicine · 25d
Cleared Apr 16, 1990
SEARS MODEL LI9097 IN-THE-EAR HEARING INSTRUMENT
K901387 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 21d
Cleared Apr 16, 1990
SEARS MODEL LM9091 IN-THE-EAR HEARING INSTRUMENT
K901388 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 21d
Cleared Apr 16, 1990
SEARS MODEL LC9092 IN-THE-EAR HEARING INSTRUMENT
K901389 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 21d
Cleared Apr 16, 1990
DMAC INDOLE REAGENT
K901390 · JTO
Analytical Products, Inc.
Microbiology · 21d
Cleared Apr 16, 1990
SEARS MODEL LF9096 IN-THE-EAR HEARING INSTRUMENT
K901469 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 20d
Cleared Apr 16, 1990
SEARS MODEL JCS IN-THE-EAR HEARING INSTRUMENT
K901470 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 20d
Cleared Apr 16, 1990
TRI-ROLLS REAR WHEEL DRIVE POWERED SCOOTER
K901586 · INI
Invacare Corp.
Physical Medicine · 12d
Cleared Apr 13, 1990
ADDIT. TRANS. EUP-B31/033J/V33/U33/032T/L33/U322
K884644 · IYO
Hitachi Medical Corp. of America
Radiology · 522d
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