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
36841–36864 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 07, 2014
HI-TORQUE VERSATURN GUIDE WIRE
K141782 · DQX
Abbott Vascular
Cardiovascular · 36d
Cleared Aug 07, 2014
SAGITTILT
K141787 · IYE
Orfit Industries NV
Radiology · 36d
Cleared Aug 07, 2014
AAP LOQTEC CLAVICLE PLATES 2.7/3.5
K141823 · HRS
Aap Implantate AG
Orthopedic · 31d
Cleared Aug 07, 2014
ACUSON X700 ULTRASOUND SYSTEM, ACUSON X600 ULTRASOUND SYSTEM
K141846 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Aug 07, 2014
BREAST VOLUME NAVIGATOR
K141870 · IYN
Metritrack, LLC
Radiology · 27d
Cleared Aug 07, 2014
Straumann Bone Level NC Angled Screw Retained Abutments
K141871 · NHA
Straumann USA, LLC
Dental · 27d
Cleared Aug 07, 2014
PATHASSIST LED LIGHT FIBER
K141916 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 23d
Cleared Aug 07, 2014
VARIAX 2 SYSTEM
K141992 · HRS
Stryker Trauma AG
Orthopedic · 16d
Cleared Aug 06, 2014
IQ TECHNOLOGIES
K131290 · NUH
Iq Technologies, Inc.
Neurology · 457d
Cleared Aug 06, 2014
SAAD PATIENT MONITOR (SPM)
K133222 · MHX
Hanin Medical Services Co., Ltd.
Cardiovascular · 292d
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