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
65449–65472 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 13, 2005
TRIATHLON KNEE SYSTEM
K051146 · JWH
Howmedica Osteonics Corp.
Orthopedic · 70d
Cleared Jul 13, 2005
CANDELA FAMILY OF PULSED DYE LASER SYSTEMS: PIGMENTED LESION HANDPIECE ACCESSORY
K051359 · GEX
Candela Corp.
General & Plastic Surgery · 50d
Cleared Jul 13, 2005
CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM
K051549 · KPS
Digirad Corp.
Radiology · 30d
Cleared Jul 13, 2005
SEMIAL SPINAL IMPLANT
K051659 · MQP
Signus Medizintechnik GmbH
Orthopedic · 21d
Cleared Jul 13, 2005
T-PLATE ANTERIOR FIXATION SYSTEM
K051764 · KWQ
Esm Technologies
Orthopedic · 13d
Cleared Jul 13, 2005
PROTEGE ULTRASONIC INSERT
K051776 · ELC
Discus Dental, Inc.
Dental · 12d
Cleared Jul 12, 2005
RAPID READER
K041696 · DKZ
American Bio Medica Corp.
Chemistry · 385d
Cleared Jul 12, 2005
RELIADENT DENTAL IMPLANT SYSTEM
K043428 · NHA
Bioinfera, Inc.
Dental · 211d
Cleared Jul 12, 2005
CS MEDICAL ADULT TTCF CATHETER
K050379 · BTO
Cs Medical, Inc.
Anesthesiology · 147d
Cleared Jul 12, 2005
SOMNOMED MAS RXA
K050592 · LRK
Somnomed, Ltd.
Dental · 126d
Cleared Jul 12, 2005
POWDERFREE POLYCHLOROPRENE STERILE EXAMINATION GLOVES
K050968 · LZA
Pt. Medisafe Technologies
General Hospital · 85d
Cleared Jul 12, 2005
HUBER CLEAR SAFETY INFUSION SET
K051009 · FPA
Now Medical Distribution, Inc.
General Hospital · 82d
Cleared Jul 12, 2005
ENDOSSEOUS DENTAL IMPLANT ABUTMENT
K051011 · NHA
Atlantis Components, Inc.
Dental · 82d
Cleared Jul 12, 2005
ZILVER 635 BILIARY STENT
K051124 · FGE
Cook, Inc.
Gastroenterology & Urology · 70d
Cleared Jul 12, 2005
SIDEKICK BLOOD GLUCOSE TEST SYSTEM
K051147 · NBW
Home Diagnostics, Inc.
Chemistry · 69d
Cleared Jul 12, 2005
MODIFICATION TO LNCS OXIMETRY SENSORS
K051212 · DQA
Masimo Corporation
Anesthesiology · 62d
Cleared Jul 12, 2005
EVITAXL WITH OPTION SMARTCARE
K051263 · CBK
Drager Medical AG & Co. Kgaa
Anesthesiology · 57d
Cleared Jul 12, 2005
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MINIMUM INHIBITORY CONCENTRATION/COMBO...
K051311 · LON
Dade Behring, Inc.
Microbiology · 54d
Cleared Jul 12, 2005
R&D CBC-4K PLUS RETICS HEMATOLOGY CONTROL
K051339 · JPK
R&D Systems, Inc.
Hematology · 50d
Cleared Jul 12, 2005
XENO ADHESIVE WITH ACTIVATOR
K051463 · KLE
Dentsply Intl.
Dental · 39d
Cleared Jul 12, 2005
POWDERED LATEX PATIENT EXAMINATION GLOVES
K051465 · LYY
P.T. Anlis Abadi Internasional
General Hospital · 39d
Cleared Jul 12, 2005
INSPIRATION VENTILATOR SYSTEM
K051550 · CBK
eVent Medical, Ltd.
Anesthesiology · 29d
Cleared Jul 12, 2005
BIOLOX DELTA CERAMIC FEMORAL HEADS
K051588 · LZO
Howmedica Osteonics Corp.
Orthopedic · 27d
Cleared Jul 12, 2005
MALIBU SPINAL SYSTEM
K051663 · NKB
Seaspine, Inc.
Orthopedic · 20d