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

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176,076 results
59857–59880 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 16, 2007
POLARCUP DUAL MOBILITY SYSTEM
K070278 · LPH
Plus Orthopedics AG
Orthopedic · 77d
Cleared Apr 16, 2007
SIMPLEX CERVICAL FIXATION SYSTEM
K070335 · KWQ
Pisharodi Surgicals, Inc.
Orthopedic · 70d
Cleared Apr 16, 2007
NANO COMPOSITE
K070583 · EBF
Cosmedent, Inc.
Dental · 46d
Cleared Apr 16, 2007
EXPRESS SERIES
K070858 · BZL
Medical Graphics Corp.
Anesthesiology · 19d
Cleared Apr 16, 2007
LIFT CHAIR, MODEL C5
K070950 · INO
Pride Mobility Products Corp.
Physical Medicine · 12d
Cleared Apr 13, 2007
RS-4I MUSCLE STIMULATOR FAMILY
K062325 · NYN
Rs Medical
Neurology · 247d
Cleared Apr 13, 2007
SINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO-RECTAL MANOMETRY...
K062362 · KLA
Sarmed Srl
Gastroenterology & Urology · 242d
Cleared Apr 13, 2007
EMPOWERMR INJECTOR SYSTEM, MODEL 9730
K062449 · IZQ
E-Z-Em, Inc.
Cardiovascular · 234d
Cleared Apr 13, 2007
BLUE POWDERED LATEX EXAMINATION GLOVES, NON-STERILE
K062526 · LYY
Multisafe Sdn. Bhd.
General Hospital · 228d
Cleared Apr 13, 2007
DISCYPHOR CATHETER SYSTEM, MODEL D01A
K063071 · BSP
Kyphon, Inc.
Anesthesiology · 189d
Cleared Apr 13, 2007
FILTERFLO HEPA
K063125 · CAH
Arc Medical, Inc.
General Hospital · 182d
Cleared Apr 13, 2007
MODIFICATION TO STAXX FX SYSTEM
K063606 · OBL
Spine Wave, Inc.
Orthopedic · 133d
Cleared Apr 13, 2007
VAPOTHERM MODEL# 2000I AND 2000H
K070056 · BTT
Vapotherm, Inc.
Anesthesiology · 98d
Cleared Apr 13, 2007
AUDICOR 200 SYSTEM, MODELS 200D AND 200S
K070136 · DPS
Inovise Medical, Inc.
Cardiovascular · 87d
Cleared Apr 13, 2007
MULTI-ANALYTE CHEMISTRY CALIBRATOR
K070207 · JIX
Pointe Scientific, Inc.,
Chemistry · 81d
Cleared Apr 13, 2007
DGSCOPE, RELEASE 1.0
K070397 · LLZ
Segami Corporation
Radiology · 60d
Cleared Apr 13, 2007
FLEXITRON
K070574 · JAQ
Isodose Control B.V.
Radiology · 44d
Cleared Apr 13, 2007
MODIFICATION TO: BODYGUARD INFUSION SYSTEM
K070718 · FRN
Caesarea Medical Electronics , Ltd.
General Hospital · 30d
Cleared Apr 13, 2007
MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC...
K070745 · HIL
Playtex Products, Inc.
Obstetrics & Gynecology · 25d
Cleared Apr 13, 2007
LERADOTECH, MODEL SC
K070802 · INI
Lerado China Limited
Physical Medicine · 21d
Cleared Apr 13, 2007
LERADOTECH SCOOTER, MODEL SB
K070817 · INI
Lerado China Limited
Physical Medicine · 18d
Cleared Apr 13, 2007
ARTHROCARE SPINEWANDS
K070851 · GEI
Arthrocare Corp.
General & Plastic Surgery · 16d
Cleared Apr 13, 2007
STARION UNIVERSAL POWER SUPPLY
K070871 · HQO
Starion Instruments
Ophthalmic · 15d
Cleared Apr 13, 2007
TEPHAFLEX SURGICAL MESH
K070894 · OOD
Tepha, Inc.
General & Plastic Surgery · 14d