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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
63745–63768 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 26, 2006
RADIANCY SKINSTATION WITH PSORIASIS LIGHT UNIT ASSEMBLY
K052442 · GEX
Radiancy (Israel) , Ltd.
General & Plastic Surgery · 142d
Cleared Jan 26, 2006
MBATH 1000 (60)
K052479 · ILJ
Enneking Medical, Inc.
Physical Medicine · 139d
Cleared Jan 26, 2006
ESTECH CLEARVIEW MV ATRIAL DEPRESSOR
K053021 · DTS
Estech, Inc.
Cardiovascular · 92d
Cleared Jan 26, 2006
SIMPLEX P SPEEDSET BONE CEMENT
K053198 · LOD
Howmedica Osteonics Corp.
Orthopedic · 71d
Cleared Jan 26, 2006
OXICOM CONTROL
K053327 · JJX
Bionostics, Inc.
Chemistry · 56d
Cleared Jan 26, 2006
ARTHREX TITANIUM AND BIO-DEGRADABLE (POLYMER) IMPLANTS
K053338 · HWC
Arthrex, Inc.
Orthopedic · 56d
Cleared Jan 26, 2006
TRIATHLON TOTAL KNEE SYSTEM
K053514 · JWH
Stryker Orthopaedics
Orthopedic · 41d
Cleared Jan 26, 2006
MUCOHARD
K053516 · EBI
Parkell, Inc.
Dental · 41d
Cleared Jan 26, 2006
INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR
K053518 · NEU
Medical Device Technologies, Inc.
General & Plastic Surgery · 38d
Cleared Jan 26, 2006
LEVITRONIX CENTRIMAG PRIMARY CONSOLE
K053630 · DWA
Levitronix, LLC
Cardiovascular · 28d
Cleared Jan 26, 2006
OSTEOSET DBM PELLETS
K053642 · MBP
Wrightmedicaltechnologyinc
Orthopedic · 27d
Cleared Jan 26, 2006
KOBY SURGICAL INTERNAL FIXATION SYSTEM
K060026 · HWC
Koby Surgical
Orthopedic · 22d
Cleared Jan 26, 2006
ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH)
K060027 · JJX
Biokit, S.A.
Chemistry · 22d
Cleared Jan 26, 2006
NEXA COMPRESSION SCREW
K060071 · HWC
Nexa Orthopedics, Inc.
Orthopedic · 17d
Cleared Jan 25, 2006
NON-STERILE POWDER FREE NATURAL/GREEN LANO-E LATEX EXAM GLOVES, WITH OR...
K052666 · LYY
Ascend Eagle, Inc.
General Hospital · 120d
Cleared Jan 25, 2006
OSSIMEND (TM) BONE GRAFT MATERIAL
K052812 · MQV
Collagen Matrix, Inc.
Orthopedic · 113d
Cleared Jan 25, 2006
FD TENS 2030, MODEL DFJ24T
K052813 · GZJ
Fuji Dynamics Limited
Neurology · 113d
Cleared Jan 25, 2006
PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS
K053180 · NDN
Arthrocare Corp.
Orthopedic · 72d
Cleared Jan 25, 2006
ANATOMICAL SHOULDER INVERSE/REVERSE
K053274 · PHX
Zimmer GmbH
Orthopedic · 63d
Cleared Jan 25, 2006
BIOSPLINT SPLINTING RIBBON
K053328 · EBI
Satelec
Dental · 55d
Cleared Jan 25, 2006
RELI-ON ONE STEP, ORTHODONTIC ADHESIVE
K053379 · DYH
Classone Orthodontics, Inc.
Dental · 51d
Cleared Jan 25, 2006
ENCOMPASS.NET
K053455 · LLZ
Empiric Systems, LLC
Radiology · 47d
Cleared Jan 25, 2006
MEDLINE PEDIATRIC WHEELCHAIRS
K053574 · IOR
Medline Industries, Inc.
Physical Medicine · 34d
Cleared Jan 24, 2006
IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM
K052577 · JOY
Ikonisys, Inc.
Hematology · 127d