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
40249–40272 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 17, 2013
CREODENT SOLIDEX CUSTOM ABUTMENT
K113738 · NHA
Creodent Prosthetics, Ltd.
Dental · 637d
Cleared Sep 17, 2013
VCARE A
K121817 · OMP
IVT Medical, Ltd.
General & Plastic Surgery · 454d
Cleared Sep 17, 2013
FACIAL SPA
K122711 · NFO
Nuskin
Neurology · 378d
Cleared Sep 17, 2013
ANSWATCH WRIST MONITOR MODEL TS-0411
K123130 · DXN
Taiwan Scientific Corporation
Cardiovascular · 348d
Cleared Sep 17, 2013
ELECTRONIC BLOOD PRESSURE MONITOR FOR UPPER ARM
K130232 · DXN
Jinxinbao Electronic Co.,Ltd
Cardiovascular · 231d
Cleared Sep 17, 2013
ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL AND STAINLESS STEEL TIBIAL NAIL
K130595 · HSB
Zimmer, Inc.
Orthopedic · 194d
Cleared Sep 17, 2013
DIGITAL FLAT PANEL X-RAY DETECTOR
K131114 · MQB
Rayence Co., Ltd.
Radiology · 148d
Cleared Sep 17, 2013
EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER
K131161 · ITX
CIVCO Medical Instruments Co., Inc.
Radiology · 146d
Cleared Sep 17, 2013
BLOM-SINGER SEPTAL PERFORATION PROSTHESIS
K131745 · LFB
Helix Medical, LLC
Ear, Nose, Throat · 96d
Cleared Sep 17, 2013
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K131830 · IYO
Edan Instruments, Inc.
Radiology · 89d
Cleared Sep 17, 2013
CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENT
K131977 · LLZ
Ge Healthcare
Radiology · 81d
Cleared Sep 17, 2013
ABL90 FLEX ANALYZER
K131988 · CHL
Radiometer Medical Aps
Chemistry · 81d
Cleared Sep 17, 2013
HEARTSPAN STEERABLE INTRODUCER KIT
K132164 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 67d
Cleared Sep 17, 2013
5.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, 6.5MM MULTIFIX S KNOTLESS FIXATION...
K132590 · MBI
ArthroCare Corporation
Orthopedic · 29d
Cleared Sep 17, 2013
MAXLOCK EXTREME SYSTEM
K132591 · HRS
Orthohelix Surgical Designs, Inc.
Orthopedic · 29d
Cleared Sep 17, 2013
CRYSTALSERT DELIVERY SYSTEM
K132593 · MSS
Bausch & Lomb
Ophthalmic · 29d
Cleared Sep 16, 2013
PNEUPAC PARAPAC PLUS
K123957 · BTL
Smiths Medical International , Ltd.
Anesthesiology · 269d
Cleared Sep 16, 2013
DEPUY CORAIL AMT HIP PROSTHESIS
K123991 · KWY
Depuy France S.A.S.
Orthopedic · 264d
Cleared Sep 16, 2013
ELECTROSURGICAL GENERATOR
K130760 · GEI
Beijing Jinhengwei Technology...
General & Plastic Surgery · 180d
Cleared Sep 16, 2013
OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060)
K130802 · NUH
Shenzhen Dongdixin Technology Co., Ltd.
Neurology · 178d
Cleared Sep 16, 2013
ERCHONIA EMERGE
K130996 · NHN
Erchonia Medical, Inc.
Physical Medicine · 159d
Cleared Sep 16, 2013
NOVOKNEE TOTAL KNEE SYSTEM
K131398 · JWH
Novosource, Inc.
Orthopedic · 124d
Cleared Sep 16, 2013
HEART SYNC
K131494 · MKJ
Heart Sync, Inc.
Cardiovascular · 116d
Cleared Sep 16, 2013
RAMPART-O, RAMPART-T
K132053 · MAX
Spineology, Inc.
Orthopedic · 75d