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
57385–57408 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 14, 2008
ATLANTIS ABUTMENT FOR BIOHORIZON IMPLANTS, ATLANTIS GEMINI ABUTMENT FOR...
K073258 · NHA
Atlantis Components, Inc.
Dental · 86d
Cleared Feb 14, 2008
PRO-V
K073263 · EBG
Bisco, Inc.
Dental · 86d
Cleared Feb 14, 2008
V-RASER DIODE LASER SYSTEM
K073332 · GEX
Hoya Conbio, Inc.
General & Plastic Surgery · 79d
Cleared Feb 14, 2008
PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA...
K073419 · HCG
Rj Medical, Inc.
Neurology · 71d
Cleared Feb 14, 2008
BLACKSTONE ASCENT MULTIAXIAL SCREWS
K073420 · KWP
Blackstone Medical, Inc.
Orthopedic · 71d
Cleared Feb 14, 2008
VARIAX ELBOW SYSTEM
K073527 · KTT
Howmedica Osteonics Corp.
Orthopedic · 59d
Cleared Feb 14, 2008
CYCLETRAC CT-5000
K073542 · ITH
Pt Products, LLC
Physical Medicine · 59d
Cleared Feb 14, 2008
MODIFICATION TO: APEX KNEE SYSTEM
K073602 · JWH
Omnlife Science
Orthopedic · 55d
Cleared Feb 14, 2008
ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX
K080074 · DZE
Ace Surgical Supply Co., Inc.
Dental · 34d
Cleared Feb 14, 2008
MODIFICATION TO STRYKER SPINE OASYS SYSTEM
K080143 · MNI
Stryker Spine
Orthopedic · 23d
Cleared Feb 14, 2008
TERASON ECHO T/3000 ULTRASOUND SYSTEM WITH STRESS ECHO
K080234 · IYO
Teratech Corp.
Radiology · 15d
Cleared Feb 13, 2008
FAST1 INTRAOSSEOUS INFUSION SYSTEM
K072487 · FMI
Pyng Medical Corp.
General Hospital · 162d
Cleared Feb 13, 2008
CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE-ADMINISTRATOR (21-6275), POINT OF...
K072955 · MRZ
Smiths Medical MD, Inc.
General Hospital · 117d
Cleared Feb 13, 2008
MECTACER BIOLOX FORTE-FEMORAL HEADS
K073337 · LZO
Medacta International S.A.
Orthopedic · 77d
Cleared Feb 13, 2008
RELIANCE BUTTRESS WASHER SYSTEM
K073349 · KWQ
Reliance Medical Systems, LLC
Orthopedic · 76d
Cleared Feb 13, 2008
THOR ANTERIOR PLATING SYSTEM
K073437 · KWQ
Stryker Spine
Orthopedic · 69d
Cleared Feb 13, 2008
ORIA NATURA SPACER
K073669 · MAX
Choicespine, LP
Orthopedic · 49d
Cleared Feb 13, 2008
DIMERTEST
K080069 · DAP
American Diagnostica, Inc.
Hematology · 34d
Cleared Feb 13, 2008
CLAVE STOPCOCK
K080077 · FMG
Icu Medical, Inc.
General Hospital · 33d
Cleared Feb 13, 2008
ARTHREX COMPRESSION STAPLE
K080111 · JDR
Arthrex, Inc.
Orthopedic · 28d
Cleared Feb 12, 2008
INVIROLINK AND INVIRO TIP BLUNT CANNULAS, MODEL 130001, 130501, 140001,...
K071307 · FMI
Inviro Medical Devices, Inc.
General Hospital · 279d
Cleared Feb 12, 2008
WATERLASE AND WATERLASE MD
K071363 · GEX
Biolase Technology, Inc.
General & Plastic Surgery · 273d
Cleared Feb 12, 2008
SILVERHAWK-R PERIPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE
K071432 · MCW
Fox Hollow Technologies
Cardiovascular · 265d
Cleared Feb 12, 2008
AFINION ACR AND ACR CONTROL
K072409 · JFY
Axis-Shield Poc AS
Chemistry · 169d