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
45769–45792 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 07, 2011
EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER
K113182 · DXC
Edwards Lifesciences, LLC
Cardiovascular · 40d
Cleared Dec 06, 2011
ASCENSION ATLAS HUMERAL PLATING SYSTEM
K110700 · HRS
Ascension Orthopedics, Inc.
Orthopedic · 267d
Cleared Dec 06, 2011
PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL
K111363 · JXN
Medica Corp.
Chemistry · 204d
Cleared Dec 06, 2011
INFRARED EAR THERMOMETER
K111637 · FLL
Radiant Innovation, Inc.
General Hospital · 176d
Cleared Dec 06, 2011
DISCO SUBTALAR IMPLANT
K111834 · HWC
Trilliant Surgical, Ltd.
Orthopedic · 160d
Cleared Dec 06, 2011
ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT
K111889 · DZE
Zimmer Dental, Inc.
Dental · 158d
Cleared Dec 06, 2011
H-WAVE
K112485 · GZJ
Electronic Waveform Lab, Inc.
Neurology · 99d
Cleared Dec 06, 2011
NOVAPORT ONE VASCULAR ACCESS CANNULA
K112565 · DWF
Novalung GmbH
Cardiovascular · 95d
Cleared Dec 06, 2011
SPARTAN S3 FACET SYSTEM
K113011 · MRW
Amendia, Inc.
Orthopedic · 56d
Cleared Dec 06, 2011
DENTAL 3D PLANNING SOFTWARE
K113404 · LLZ
Symbyo Dental, LLC
Radiology · 18d
Cleared Dec 05, 2011
SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS
K111667 · JDS
Synthes (Usa)
Orthopedic · 174d
Cleared Dec 05, 2011
AQUAMANTYS SBS 5.0 SHEATED BIOPOLAR SEALER
K111732 · GEI
Salient Surgical Technologies, Inc.
General & Plastic Surgery · 168d
Cleared Dec 05, 2011
BENDINI(TM) SPINAL ROD BENDING SYSTEM
K111811 · OLO
Nuvasive, Inc.
Orthopedic · 161d
Cleared Dec 05, 2011
ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT
K112125 · NJR
Meridian Bioscience, Inc.
Microbiology · 133d
Cleared Dec 05, 2011
SYNTHES CORTICAL SCREWS
K112583 · HWC
Synthes USA Products, LLC
Orthopedic · 90d
Cleared Dec 05, 2011
AXLE PEEK INTERSPINOUS FUSION SYSTEM
K112592 · KWP
X-Spine Systems, Inc.
Orthopedic · 89d
Cleared Dec 05, 2011
SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS)
K112610 · LYZ
Inpro Technology Device Factory
General Hospital · 89d
Cleared Dec 05, 2011
EYE CARE CURE CONTACT LENS CASE
K112832 · LRX
Eye Care and Cure
Ophthalmic · 67d
Cleared Dec 05, 2011
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
K112845 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 67d
Cleared Dec 05, 2011
LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM...
K113213 · DRF
Biosense Webster, Inc.
Cardiovascular · 34d
Cleared Dec 05, 2011
BRIVO NM 615
K113350 · KPS
Ge Healthcare
Radiology · 21d
Cleared Dec 05, 2011
AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP)
K113501 · DIO
Ameditech, Inc.
Toxicology · 10d
Cleared Dec 02, 2011
WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE
K110615 · KKO
Bebe Toys Manufactory , Ltd.
Dental · 274d
Cleared Dec 02, 2011
ORAGENE-DX OGD-500
K110701 · OYJ
DNA Genotek, Inc.
Chemistry · 263d