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
40009–40032 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 08, 2013
PEDIGUARD NERVE DETECTOR SYSTEM
K123390 · PDQ
Spineguard S.A.
Neurology · 279d
Cleared Aug 08, 2013
MP VIAL ADAPTER 13MM
K130179 · LHI
Medimop Medical Projects, Ltd.
General Hospital · 195d
Cleared Aug 08, 2013
PANPAC VAGINAL DILATORS
K130273 · HDX
Panpac Medical Corporation
Obstetrics & Gynecology · 185d
Cleared Aug 08, 2013
EXPANDABLE LUMBAR INTERBODY SYSTEM
K130820 · MAX
Nu Vasive, Incorporated
Orthopedic · 136d
Cleared Aug 08, 2013
MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN
K130846 · LZA
Industrial Clothings, Ltd.
General Hospital · 134d
Cleared Aug 08, 2013
CAPLOX II PEDICLE SCREW SYSTEM/TOWERLOX PEDICLE SCREW SYSTEM
K131538 · MNH
Captiva Spine
Orthopedic · 71d
Cleared Aug 08, 2013
PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING
K131674 · JEY
Biomet Microfixation
Dental · 62d
Cleared Aug 08, 2013
NMI PORT II CATHETER
K131694 · LJT
Navilyst Medical, Inc.
General Hospital · 59d
Cleared Aug 08, 2013
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE CONNECTOR,...
K131744 · LKN
Terumobct, Inc.
Gastroenterology & Urology · 56d
Cleared Aug 08, 2013
METALLIC LOCKING COMPRESSION BONE PLATES AND SCREWS SYSTEM
K131759 · HRS
Tianjin Walkman Biomaterial Co., Ltd.
Orthopedic · 52d
Cleared Aug 08, 2013
OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM
K131810 · MNH
Osseus Fusion Systems, LLC
Orthopedic · 50d
Cleared Aug 08, 2013
PTS-X SIZING BALLOON CATHETER
K131869 · MJN
NuMED, Inc.
Cardiovascular · 45d
Cleared Aug 08, 2013
GE DATEX-OHMEDA AVANCE CS2
K131945 · BSZ
Datex-Ohmeda
Anesthesiology · 42d
Cleared Aug 08, 2013
BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND...
K132090 · DLJ
Randox Laboratories, Ltd.
Toxicology · 27d
Cleared Aug 07, 2013
PROTHELIAL
K123904 · FRO
Mueller Medical International, LLC
General & Plastic Surgery · 231d
Cleared Aug 07, 2013
FOREIGN BODY HOOD
K130148 · FDS
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 197d
Cleared Aug 07, 2013
QUADCUT
K130608 · HAW
Medtronic Navigation, Inc.
Neurology · 153d
Cleared Aug 07, 2013
FIREBIRD SPINAL FIXATION SYSTEM
K130932 · NKB
Orthofix, Inc.
Orthopedic · 125d
Cleared Aug 07, 2013
ACTIVE BREATHING COORDINATOR
K131313 · IYE
Aktina Medical Corp.
Radiology · 92d
Cleared Aug 07, 2013
TIARRAY DENTAL IMPLANT SYSTEM
K131345 · DZE
Nasseo, Inc.
Dental · 90d
Cleared Aug 07, 2013
INTEGRA TITANIUM BONE WEDGE
K131360 · HRS
Ascension Orthopedic
Orthopedic · 86d
Cleared Aug 07, 2013
KATIA SYSTEM
K131512 · KWQ
Shanghai Sanyou Medical Co, Ltd.
Orthopedic · 71d
Cleared Aug 07, 2013
RSH BILIARY STONE REMOVAL DEVICE
K131642 · LQR
Rsh, LLC
Gastroenterology & Urology · 64d
Cleared Aug 07, 2013
I.T.S. EXTREMITY FIXATION SYSTEMS
K131722 · HRS
I.T.S. GmbH
Orthopedic · 56d