FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
41137–41160 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 21, 2013
ACUSON S1000 DIAGNOSTIC ULTRASOUND SYSTEM
K130619 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 14d
Cleared Mar 20, 2013
INTERVENTIONAL HEMOSTATIC BANDAGE
K120782 · QSY
Z-Medica Corporation
General & Plastic Surgery · 370d
Cleared Mar 20, 2013
BD ALCOHOL SWAB
K121655 · LKB
Becton, Dickinson & CO
General Hospital · 288d
Cleared Mar 20, 2013
VANGUARD XP KNEE SYSTEM
K122160 · MBH
Biomet Manufacturing Corp
Orthopedic · 243d
Cleared Mar 20, 2013
LIDCORAPID V2 MONITOR
K122247 · DXG
Lidco, Ltd.
Cardiovascular · 236d
Cleared Mar 20, 2013
AXSOS PROXIMAL LATERAL TIBIA LONG PLATES
K123403 · HRS
Stryker Trauma AG
Orthopedic · 135d
Cleared Mar 20, 2013
DEMI ULTRA
K123468 · EBZ
Kerr Corporation
Dental · 131d
Cleared Mar 20, 2013
TX1 TISSUE REMOVAL SYSTEM
K123640 · LFL
Tenex Health
General & Plastic Surgery · 114d
Cleared Mar 20, 2013
OPTETRAK LOGIC POROUS FEMORAL COMPONENT
K123687 · JWH
Exactech, Inc.
Orthopedic · 107d
Cleared Mar 20, 2013
E-Z CHEK BLOOD LEAK TEST STRIPS
K123805 · FJD
Reprocessing Products Corp
Gastroenterology & Urology · 99d
Cleared Mar 20, 2013
OIC DISTAL RADIUS PLATING SYSTEM, OIC PROXIMAL HUMERUS PLATING SYSTEM, OIC...
K123832 · HRS
The Orthopaedic Implant Company (Oic)
Orthopedic · 97d
Cleared Mar 20, 2013
CEREC BLOCS C IN
K123952 · EIH
Sirona Dental Systems GmbH
Dental · 89d
Cleared Mar 20, 2013
PENTAX EG-3670URK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS
K130206 · ODG
Pentax of America, Inc.
Radiology · 51d
Cleared Mar 20, 2013
SUITEHEART
K130228 · LLZ
Neosoft, LLC
Radiology · 50d
Cleared Mar 20, 2013
PALM BLADDER SCANNER
K130229 · IYO
Mianyang Meike Electronic Equipment...
Radiology · 50d
Cleared Mar 20, 2013
PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS
K130247 · ODG
Pentax of America, Inc.
Radiology · 47d
Cleared Mar 20, 2013
CPS AIM UNIVERSAL SLITTABLE INNER CATHETER
K130252 · DQY
St Jude Medical
Cardiovascular · 47d
Cleared Mar 20, 2013
CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER
K130257 · DQY
St Jude Medical
Cardiovascular · 47d
Cleared Mar 20, 2013
MIRADA RTX
K130393 · LLZ
Mirada Medical, Ltd.
Radiology · 33d
Cleared Mar 20, 2013
INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR,...
K130433 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 27d
Cleared Mar 19, 2013
ENI-EYE SH SOFT K SEMI SCLERAL (EFROFILCON A) SOFT (HYDROPHILIC) KERATOCONUS...
K122220 · LPL
Soflex Limited
Ophthalmic · 237d
Cleared Mar 19, 2013
DENTOETCH QUICKBOND BOND ACTIVATOR
K122522 · KLE
Itena Clinical
Dental · 211d
Cleared Mar 19, 2013
ADVANCE MICRO 14 ULTRA LOW PROFILE BALLOON DILATATION CATHETER MODEL PTA3
K122940 · DQY
Cook, Inc.
Cardiovascular · 176d
Cleared Mar 19, 2013
DIGITAL RETINAL CAMERA
K123208 · HKI
Canon Inc. -Medical Equipment Group
Ophthalmic · 158d