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

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175,820 results
45145–45168 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 16, 2012
ARENA-C CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
K113518 · ODP
Spinefrontier, Inc.
Orthopedic · 79d
Cleared Feb 16, 2012
CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM
K113526 · JXG
Medos International SARL
Neurology · 78d
Cleared Feb 16, 2012
VISIA NEURO
K113701 · LLZ
Mevis Medical Solutions AG
Radiology · 62d
Cleared Feb 16, 2012
COMPREHENSIVE REVERSE SHOULDER-MINI BASEPLATE
K120121 · PHX
Biomet, Inc.
Orthopedic · 30d
Cleared Feb 16, 2012
ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL
K120143 · ODP
Apollo Spine
Orthopedic · 29d
Cleared Feb 16, 2012
I-PORT ADVANCE INJECTION PORT
K120337 · FOZ
Unomedical A/S
General Hospital · 13d
Cleared Feb 16, 2012
CHROMOPHARE F 628 AND F 528
K120392 · FSY
Berchtold GmbH & Co. KG
General & Plastic Surgery · 8d
Cleared Feb 15, 2012
CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900
K110278 · EKX
Nakanishi, Inc.
Dental · 380d
Cleared Feb 15, 2012
OLYMPUS INSTRUMENT TRAY
K110748 · KCT
Olympus Winter & Ibe GmbH
General Hospital · 335d
Cleared Feb 15, 2012
CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
K113378 · JWH
Conformis, Inc.
Orthopedic · 91d
Cleared Feb 15, 2012
S2 FEMORAL A/R NAIL S2 FEMORAL COMRESSION NAIL S2 TIBIAL NAIL S2 TIBIAL...
K113409 · HSB
Howmedica Osteonics Corp.
Orthopedic · 89d
Cleared Feb 15, 2012
TEPHAFLEX LIGHT MESH
K113721 · OOD
Tepha, Inc.
General & Plastic Surgery · 58d
Cleared Feb 15, 2012
TEPHAFLEX MESH
K113723 · OOD
Tepha, Inc.
General & Plastic Surgery · 58d
Cleared Feb 15, 2012
ELECTROPULSE-COSMETIC
K113724 · NFO
Pain Relief Technologies
Neurology · 58d
Cleared Feb 15, 2012
FOCUS SPINAL SYSTEM
K120140 · NKB
L & K Biomed Co., Ltd.
Orthopedic · 28d
Cleared Feb 14, 2012
POLYFUSE - NEUROBONE
K111018 · MQV
Atpac Medical, LLC
Orthopedic · 308d
Cleared Feb 14, 2012
CADENS (TM) COLON
K111758 · LLZ
Dog Microsystems, Inc.
Radiology · 237d
Cleared Feb 14, 2012
IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION...
K111938 · JJX
Immunodiagnostic Systems , Ltd.
Chemistry · 221d
Cleared Feb 14, 2012
LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500)
K113390 · GEX
Meridian AG
General & Plastic Surgery · 90d
Cleared Feb 14, 2012
GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM
K113403 · OWB
GE Medical Systems SCS
Radiology · 89d
Cleared Feb 14, 2012
VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT
K113496 · OTM
Coloplast A/S
Gastroenterology & Urology · 81d
Cleared Feb 14, 2012
ESOPHAGEAL TTS STENT
K113551 · ESW
Taewoong Medical Co., Ltd.
Gastroenterology & Urology · 75d
Cleared Feb 14, 2012
INJEKT CYSTO FLEXIBLE INJECTION NEEDLE
K113634 · FBK
Cook Ireland, Ltd.
Gastroenterology & Urology · 67d
Cleared Feb 14, 2012
DISPOSABLE POWDER FREE VINYL EXAM GLOVE, YELLOW COLOR
K113710 · LYZ
Full Synergy Medical Products, Inc.
General Hospital · 57d