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
59017–59040 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 02, 2007
ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE
K071903 · EOX
Vision-Sciences, Inc.
Ear, Nose, Throat · 23d
Cleared Aug 01, 2007
BARD INTRA-ABDOMINAL PRESSURE MONITORING DEVICE, MODEL IAP-001
K070201 · PHU
C.R. Bard, Inc.
General & Plastic Surgery · 191d
Cleared Aug 01, 2007
PALMTOP VENTILATOR, MODELS PTV-8, PTV-10
K070594 · CBK
Pulmonetic Systems, Inc.
Anesthesiology · 152d
Cleared Aug 01, 2007
PELVIMESH / HERMESH 7
K070625 · FTL
Marketing Solutions, Inc.
General & Plastic Surgery · 148d
Cleared Aug 01, 2007
ARCHITECT TACROLIMUS: MODEL 1L77
K070820 · MLM
Fujirebio Diagnostics,Inc.
Toxicology · 128d
Cleared Aug 01, 2007
CERAMIC BALL HEADS, 28, 32 AND 36 MM
K070928 · LZO
Plus Orthopedics AG
Orthopedic · 120d
Cleared Aug 01, 2007
SONICATOR PLUS 940, MODEL ME940
K071137 · IMG
Mettler Electronics Corp.
Physical Medicine · 99d
Cleared Aug 01, 2007
HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM
K071269 · CBT
Smiths Medical Asd, Inc.
Anesthesiology · 86d
Cleared Aug 01, 2007
TATTOOSTAR Y
K071451 · GEX
Asclepion Laser Technologies GmbH
General & Plastic Surgery · 69d
Cleared Aug 01, 2007
MODIFICATION TO: VIPER SPINE SYSTEM
K071860 · NKB
Depuy Spine, Inc.
Orthopedic · 27d
Cleared Aug 01, 2007
VICTORY, 4 WHEEL SCOOTER / MODEL, # SC1740
K071949 · INI
Pride Mobility Products Corp.
Physical Medicine · 19d
Cleared Aug 01, 2007
ANGIODYNAMICS, INC.NEVERTOUCH 600UM FIBER AND VENACURE PROCEDURE KIT
K071959 · GEX
AngioDynamics, Inc.
General & Plastic Surgery · 16d
Cleared Jul 31, 2007
GRAFT CONTAINMENT DEVICE
K070148 · KWQ
Nuvasive, Inc.
Orthopedic · 196d
Cleared Jul 31, 2007
ABLE CENTRAL VENOUS CATHETER
K070451 · FOZ
Foshan Nanhai Bai HE Medical...
General Hospital · 166d
Cleared Jul 31, 2007
PIGALILEO TOTAL HIP REPLACEMENT (THR) SYSTEM
K070731 · HAW
Plus Orthopedics AG
Neurology · 138d
Cleared Jul 31, 2007
ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY RING
K071214 · KRH
Genesee Biomedical, Inc.
Cardiovascular · 91d
Cleared Jul 31, 2007
ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040, 105042, 106552,...
K071342 · QEZ
Possis Medical, Inc.
Cardiovascular · 78d
Cleared Jul 31, 2007
SUBTALAR IMPLANT
K071498 · HWC
Biomet Sports Medicine, Inc.
Orthopedic · 61d
Cleared Jul 31, 2007
ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307
K071514 · QEZ
Possis Medical, Inc.
Cardiovascular · 57d
Cleared Jul 31, 2007
THERMA-CURE
K071590 · DYH
Reliance Orthodontic Products, Inc.
Dental · 50d
Cleared Jul 30, 2007
SIS SINUS IMPLANT STABILIZER
K062436 · JEY
Mondeal Medical Systems GmbH
Dental · 343d
Cleared Jul 30, 2007
MBCP+
K063527 · MQV
Biomatlante
Orthopedic · 250d
Cleared Jul 30, 2007
COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET...
K070062 · LIO
Diesse Diagnostica Senese S.P.A.
Microbiology · 206d
Cleared Jul 30, 2007
MAXINSIGHT
K070358 · OLX
Eemagine Medical Imaging Solutions GmbH
Neurology · 173d