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
37417–37440 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 05, 2014
HET SYSTEMS, LLC, HET BIPOLAR LIGATOR SYSTEM
K140422 · GEI
Het Systems, LLC
General & Plastic Surgery · 107d
Cleared Jun 05, 2014
MEDICAD CLASSIC
K140434 · LLZ
Hectec GmbH
Radiology · 105d
Cleared Jun 05, 2014
COLGATE DESENSITIZING MOUTHRINSE, COLGATE SENSITIVE PRO-RELIEF MOUTHWASH
K140481 · LBH
Colgate-Palmolive Company
Dental · 99d
Cleared Jun 05, 2014
BN LUMBAR CAGE SYSTEM
K140564 · MAX
Medyssey USA, Inc.
Orthopedic · 92d
Cleared Jun 05, 2014
FLASH PENTA MB QUICK, FLASH MB QUICK
K140602 · ELW
3M Espe AG
Dental · 87d
Cleared Jun 05, 2014
STRYKER KWIC NEEDLE
K140868 · HAW
Orthovita, Inc.
Neurology · 63d
Cleared Jun 05, 2014
STARCERAM
K140924 · EIH
H.C. Starck Ceramics GmbH
Dental · 55d
Cleared Jun 05, 2014
RSP HUMERAL SOCKET INSERT
K141006 · PHX
Djo Global
Orthopedic · 48d
Cleared Jun 05, 2014
LOGIQ S7 EXPERT, LOGIQ S7 PRO
K141261 · IYN
Ge Healthcare
Radiology · 21d
Cleared Jun 04, 2014
MOTEX POLYISOPRENE POWDER-FREE SURGICAL GLOVES MODEL # 6412(6432) AND #...
K123126 · KGO
Shanghai Motex Healthcare Co., Ltd.
General Hospital · 608d
Cleared Jun 04, 2014
EXHALATION VALVE
K132143 · CBP
Intersurgical Incorporated
Anesthesiology · 328d
Cleared Jun 04, 2014
ZIBONE CERAMIC DENTAL IMPLANT SYSTEM
K132585 · DZE
Coho Technology Co., Ltd.
Dental · 292d
Cleared Jun 04, 2014
PANPAC INFLATABLE DOCUT PESSARY
K132670 · HHW
Panpac Medical Corporation
Obstetrics & Gynecology · 281d
Cleared Jun 04, 2014
SOFTECH PLUS ETC02 CANNULA
K132946 · CCK
Teleflexmedical, Inc.
Anesthesiology · 258d
Cleared Jun 04, 2014
CAMOUFLAGE NANOHYBRID COMPOSITE (UNIVERSAL & FLOWABLE)
K133850 · EBF
Prismatik Dentalcraft, Inc.
Dental · 167d
Cleared Jun 04, 2014
ASTRAL VENTILATOR
K133868 · CBK
Resmed, Ltd.
Anesthesiology · 166d
Cleared Jun 04, 2014
STERISPINE PS
K140802 · NKB
Safe Orthopaedics
Orthopedic · 65d
Cleared Jun 04, 2014
VTI SUCTION IRRIGATION SYSTEM
K141323 · GCJ
Regulatory Technology Services, LLC
General & Plastic Surgery · 15d
Cleared Jun 03, 2014
AXON-BUS PROSTHETIC SYSTEM
K123795 · GXY
Otto Bock Austria
Neurology · 540d
Cleared Jun 03, 2014
MED-RX ORAL/ENTERAL SYRINGE
K131183 · KNT
Benlan, Inc.
Gastroenterology & Urology · 403d
Cleared Jun 03, 2014
EWNL SAFETY SYRINGE WITH NEEDLE
K132557 · FMI
Jiamei-Un Co., Ltd.
General Hospital · 293d
Cleared Jun 03, 2014
SMR TT METAL BACK GLENOID
K133349 · KWS
Lima Corporate S.P.A.
Orthopedic · 216d
Cleared Jun 03, 2014
COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST
K140026 · LZU
Lacrimedics, Inc.
Ophthalmic · 148d
Cleared Jun 03, 2014
OTIS-C-PLUS, NEOTIS PLATE, SCREW 06.5
K140226 · HRS
Science For Biomaterials
Orthopedic · 125d