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
146497–146520 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 04, 1985
ACA FIBRIN DEGRADATION PROD ANALYTICAL TEST PACK
K852520 · GHH
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 109d
Cleared Oct 04, 1985
DISPOSABLE, STERILE BIOPSY PUNCH
K853104 · FCI
August C. Stiefel Research Institute,...
Gastroenterology & Urology · 73d
Cleared Oct 04, 1985
URODYN 1000
K853119 · FFO
Dantec Electronics, Inc.
Gastroenterology & Urology · 71d
Cleared Oct 04, 1985
INTERNATIONAL MODEL SC CUSTOM IN THE EAR HEARG AID
K853170 · ESD
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 66d
Cleared Oct 04, 1985
ADDITIONAL HEMOTEC ACT COAGULATION CARTRIDGES
K853198 · JPA
Medical Device Consultants, Inc.
Hematology · 66d
Cleared Oct 04, 1985
MYREADER 7
K853284 · JJQ
Scientific Sales Intl., Inc.
Microbiology · 60d
Cleared Oct 04, 1985
MYWASHER 5
K853285 · LIB
Scientific Sales Intl., Inc.
Microbiology · 60d
Cleared Oct 04, 1985
FEEDING UNITS & TUBES
K853288 · KNT
I M, Inc.
Gastroenterology & Urology · 38d
Cleared Oct 04, 1985
KEATES IRRIGATION/ASPIRATION/VITREOUS CUTTER 5000
K853308 · HQE
Frigitronics of Connecticut, Inc.
Ophthalmic · 58d
Cleared Oct 04, 1985
RELIANCE PENDULUM OPHTHALMIC DELIVERY SYSTEM
K853358 · HMF
Dentsply Intl.
Ophthalmic · 53d
Cleared Oct 04, 1985
MAID MENTOR ASPIRATION/IRRIGATION DEVRO
K853382 · HQE
Mentor O & O, Inc.
Ophthalmic · 53d
Cleared Oct 04, 1985
RIGID ENDOSCOPE
K853514 · GCM
American Edwards Laboratories
Gastroenterology & Urology · 43d
Cleared Oct 04, 1985
ENDO DYNAMICS GASTROINTESTINAL CYTOLOGY BRUSH
K853530 · FDX
E-Z-Em, Inc.
Gastroenterology & Urology · 42d
Cleared Oct 04, 1985
TRAVENOL CAPD Y SET 5C4354
K853550 · KDJ
Travenol Laboratories, S.A.
Gastroenterology & Urology · 39d
Cleared Oct 04, 1985
VENTREZYME T3 IMMUNOASSAY T3
K853703 · CDP
Vxr, Inc.
Chemistry · 30d
Cleared Oct 04, 1985
COLORADO MEDICAL MODEL CTM-3000
K853735 · FIZ
Colorado Medical, Inc.
Gastroenterology & Urology · 28d
Cleared Oct 04, 1985
C-TERMINAL PTH RIA KIT
K853784 · CEW
Diagnostic Systems Laboratories, Inc.
Chemistry · 25d
Cleared Oct 04, 1985
ADDITIONAL HEMOTEC HEPCON/SYS B-10 COAGULATION CAR
K853789 · JPA
Hemotec, Inc.
Hematology · 24d
Cleared Oct 04, 1985
BABE SHADE-INFANT AMBIENT LIGHT INTENSITY REDUCER
K853790 · HQY
Rocky Mountain Medical Corp.
Ophthalmic · 24d
Cleared Oct 04, 1985
LYTENING 1
K853832 · JGS
Amdev, Inc.
Chemistry · 21d
Cleared Oct 04, 1985
PANTEX DIRECT DHEA-S COATED TUBE RADIOIMMUNOASSAY
K853867 · JKC
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 17d
Cleared Oct 04, 1985
QCA ENZYMATIC CHOLESTEROL
K853871 · CHH
Bd Becton Dickinson Vacutainer...
Chemistry · 17d
Cleared Oct 04, 1985
INDIRECT OPHTHALMOSCOPE
K853891 · HLJ
Carl Zeiss, Inc.
Ophthalmic · 15d
Cleared Oct 04, 1985
LIQUI-SERA CHEMISTRY CONTROLS (COMPREHENSIVE)
K853906 · JJY
Biodiagnostic Intl
Chemistry · 14d