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
123289–123312 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 13, 1990
MINNOW PENILE IMPLANT PROTECTOR
K904262 · FAE
Ruja-Med Medical Marketing
Gastroenterology & Urology · 90d
Cleared Dec 13, 1990
CO2 LASERS AND INFRAGUIDE DELIVERY SYSTEM
K904423 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 77d
Cleared Dec 13, 1990
MODELS 4000,4900,6000,8000,8900, LUXUS 6&100/1700
K904444 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 76d
Cleared Dec 13, 1990
ACTIVE ADAPTER
K904506 · GEI
Beacon Laboratories, Inc.
General & Plastic Surgery · 72d
Cleared Dec 13, 1990
ABL510 BLOOD GAS SYSTEM
K904513 · CHL
Radiometer America, Inc.
Chemistry · 72d
Cleared Dec 13, 1990
QUALTEX SKIN MARKER
K904559 · FZZ
Qualtex, Inc.
General & Plastic Surgery · 69d
Cleared Dec 13, 1990
DSL CK-MB (DSL #3200)
K904721 · JHT
Diagnostic Systems Laboratories, Inc.
Toxicology · 56d
Cleared Dec 13, 1990
CARDIOFAX ECG-8830A
K904758 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 55d
Cleared Dec 13, 1990
ABUSCREEN ONTRAK FOR THC
K904856 · LDJ
Roche Diagnostic Systems, Inc.
Toxicology · 45d
Cleared Dec 13, 1990
COULTER CK-MB ISOENZYME REAGENT
K904866 · JHT
Coulter Electronics, Inc.
Chemistry · 45d
Cleared Dec 13, 1990
QUALTEX SURGICAL DRAPE
K904960 · KKX
Deroyal Industries, Inc.
General Hospital · 38d
Cleared Dec 13, 1990
POSITIVE CONTROL PAD ALLERGEN/FOOD ALLERGEN SCREEN
K905176 · DHB
Quidel Corp.
Immunology · 24d
Cleared Dec 13, 1990
DIASTAT ANTI-LA (SS-B)
K905193 · LKO
Shield Diagnostics, Ltd.
Immunology · 24d
Cleared Dec 13, 1990
DIASTAT ANTI-RO (SS-A)
K905194 · LKO
Shield Diagnostics, Ltd.
Immunology · 24d
Cleared Dec 13, 1990
TURBIQUANT MYOGLOBIN
K905202 · DDR
Behring Diagnostics, Inc.
Immunology · 23d
Cleared Dec 13, 1990
1-CUT ACL GRAFT KNIFE
K905380 · GDX
Depuy, Inc.
General & Plastic Surgery · 13d
Cleared Dec 13, 1990
DISTAT ANTI-DSDNA KIT
K905386 · KTL
Shield Diagnostics, Ltd.
Immunology · 13d
Cleared Dec 12, 1990
PEEWEE REPLACEMENT GASTROSTOMY TUBE
K903662 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 121d
Cleared Dec 12, 1990
MULTILASE 45
K904227 · GEX
Laser Photonics, Inc.
General & Plastic Surgery · 90d
Cleared Dec 12, 1990
MULTILASE 60
K904229 · GEX
Laser Photonics, Inc.
General & Plastic Surgery · 90d
Cleared Dec 12, 1990
KALTOSTAT WOUND DRESSING
K904488 · QSY
Calgon Vestal Div.
General & Plastic Surgery · 71d
Cleared Dec 12, 1990
NEW COBE CENTRYSYSTEM(TM) 100 HG DIALYZER
K904566 · FJI
Cobe Laboratories, Inc.
Gastroenterology & Urology · 64d
Cleared Dec 12, 1990
NA NEEDLES
K904667 · GDM
Olympus Corp.
General & Plastic Surgery · 58d
Cleared Dec 12, 1990
HOOD, OPERATING, SURGICAL
K904969 · FXY
Chicago Assoc. For Retarded Citizens
General Hospital · 37d