Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
37441–37464 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 06, 2014
NORAS OR HEAD HOLDER FLEXIBILITY
K133506 · MOS
Noras Mri Products GmbH
Radiology · 265d
Cleared Aug 06, 2014
STARLITE-OM, LIGHT EFFECTS, THIBIANT
K133546 · OHS
Ps Advanced Engineering
General & Plastic Surgery · 260d
Cleared Aug 06, 2014
DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT
K133803 · LCP
Diazyme Laboratories
Chemistry · 233d
Cleared Aug 06, 2014
ISY
K133991 · DZE
Altatec GmbH
Dental · 223d
Cleared Aug 06, 2014
AEQUALIS REVERSED SHOULDER PROSTHESIS
K140478 · PHX
Tornier S.A.S.
Orthopedic · 161d
Cleared Aug 06, 2014
HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS
K140686 · PDE
The Binding Site Group , Ltd.
Immunology · 140d
Cleared Aug 06, 2014
TANDEMHEART VENO-VENOUS CANNULA
K140999 · DWF
Cardiacassist, Inc.
Cardiovascular · 110d
Cleared Aug 06, 2014
MINIMA S SYSTEM
K141327 · LZO
Lima Corporate S.P.A.
Orthopedic · 77d
Cleared Aug 06, 2014
SOURCE GUIDE TUBE WITH LOCKING MECHANISM FOR 113 MM NEEDLES, GAMMAMEDPLUS
K141336 · JAQ
Varian Medical Systems, Inc.
Radiology · 77d
Cleared Aug 06, 2014
X-REPAIR
K141394 · FTL
Synthasome
General & Plastic Surgery · 70d
Cleared Aug 06, 2014
CD HORIZON SPINAL SYSTEM
K141494 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 61d
Cleared Aug 06, 2014
ASTROGLIDE NATURAL
K141581 · NUC
Biofilm, Inc.
Obstetrics & Gynecology · 54d
Cleared Aug 05, 2014
CAPNOSTREAM20P WITH HIFI C02 MONITORING
K123690 · CCK
Oridion Medical 1987 , Ltd.
Anesthesiology · 610d
Cleared Aug 05, 2014
ORTOMED
K131348 · LLZ
Infomed Servicios Informaticos S.L.
Radiology · 452d
Cleared Aug 05, 2014
FIT BELT
K133108 · NGX
Hong Qiangxing (Shenzhen) Electronics...
Physical Medicine · 309d
Cleared Aug 05, 2014
VITEK 2 AST - YEAST FLUCONAZOLE
K133817 · NGZ
bioMerieux, Inc.
Microbiology · 232d
Cleared Aug 05, 2014
INTRAVASCULAR ADMINISTRATION SET
K140175 · FPA
Delta Med Spa
General Hospital · 194d
Cleared Aug 05, 2014
Terumo Pen Injector Needle 34
K140516 · FMI
Kofu Factory of Terumo Corp.
General Hospital · 158d
Cleared Aug 05, 2014
VAPR ARCTIC SUCTION ELECTRODE
K140896 · GEI
Depuy Mitek, A Johnson & Johnson Company
General & Plastic Surgery · 119d
Cleared Aug 05, 2014
TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS
K141056 · MBH
Stryker Orthopaedics
Orthopedic · 103d
Cleared Aug 05, 2014
RHYTHMSTAR SYSTEM
K141813 · DXH
RhythMedix, LLC
Cardiovascular · 29d
Cleared Aug 05, 2014
TURBO-JECT PICC SETS
K141818 · LJS
Cook Corporated
General Hospital · 29d
Cleared Aug 05, 2014
SENSEI X ROBOTIC CATHETER SYSTEM
K141822 · DXX
Hanson Medical, Inc.
Cardiovascular · 29d
Cleared Aug 05, 2014
SAPPHIRE ADMINISTRATION SET
K141834 · FPA
Q Core Medical , Ltd.
General Hospital · 29d