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
44665–44688 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 13, 2012
ALPHAPOINT IMAGING SOFTWARE
K120161 · LLZ
Radlogics, Inc.
Radiology · 85d
Cleared Apr 13, 2012
CAPLOX II PEDICLE SCREW SYSTEM
K120292 · MNI
Captiva Spine, Inc.
Orthopedic · 73d
Cleared CT Apr 13, 2012
CT-GUIDE NEEDLE GUIDANCE SYSTEM
K120300 · JAK
Activiews, Ltd.
Radiology · 73d
Cleared Apr 13, 2012
SYNGO.MR SPECTRO ENGINE, SYNGO.MR SPECTRO SVS, SYNGO.MR SPECTRO CSI, SYNGO.MR...
K120315 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 72d
Cleared Apr 13, 2012
SYNGO CT DYNAMIC ANGIO
K120331 · JAK
Siemens AG Medical Solutions
Radiology · 71d
Cleared Apr 13, 2012
ZONARE ZS3 DIAGNOSTIC UNLTRASOUND SYSTEM
K120703 · IYN
Zonare Medical Systems, Inc.
Radiology · 36d
Cleared Apr 13, 2012
ASCEND SHOULDER SYSTEM
K120794 · KWS
Tornier, Inc.
Orthopedic · 29d
Cleared Apr 13, 2012
PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE
K120805 · LIT
Angioslide, Ltd.
Cardiovascular · 28d
Cleared Apr 13, 2012
FLEXITOUCH SYSTEM
K120972 · JOW
Tactile Systems Technology, Inc.
Cardiovascular · 11d
Cleared Apr 12, 2012
NATURALASE CO2 LASER SYSTEM
K110333 · ONG
Focus Medical, LLC
General & Plastic Surgery · 434d
Cleared Apr 12, 2012
ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH...
K111050 · BZT
Starboard Medical, LLC
Anesthesiology · 363d
Cleared Apr 12, 2012
BILI-THERAPY PAD TYPE
K111547 · LBI
Atom Medical Corporation
General Hospital · 314d
Cleared Apr 12, 2012
HEMCON HEMOSTATIC GEL
K112215 · QSY
Hemcon Medical Technologies Europe, Ltd.
General & Plastic Surgery · 254d
Cleared Apr 12, 2012
TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH...
K112398 · DYB
Galt Medical
Cardiovascular · 237d
Cleared Apr 12, 2012
STERILE INSULIN PEN NEEDLE
K113186 · FMI
Shina Corp.
General Hospital · 167d
Cleared Apr 12, 2012
CURAD ANTIBACTERIAL BANDAGE
K113583 · FRO
Medline Industries, Inc.
General & Plastic Surgery · 129d
Cleared Apr 12, 2012
U-RIGHT TD-4280 BLOOD GLUCOSE MONITORING SYSTEM
K113768 · LFR
Taidoc Technology Corporation
Chemistry · 113d
Cleared Apr 12, 2012
RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE
K113839 · MVL
Parkell, Inc.
Dental · 106d
Cleared Apr 12, 2012
PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLE
K120209 · MRZ
American I.V. Products, Inc.
General Hospital · 79d
Cleared Apr 11, 2012
ORATECT ORAL FLUID DRUG SCREEN DEVICES
K103227 · DIO
Branan Medical Corporation
Toxicology · 527d
Cleared Apr 11, 2012
INFUSITE NEEDLELESS ACCES DEVICE (STERILE, BULK NON-STERILE) AND INFUSITE...
K112073 · FPA
Rx Devices, LLC
General Hospital · 266d
Cleared Apr 11, 2012
TITAN MODULAR TOTAL SHOULDER SYSTEM
K112438 · KWS
Ascension Orthopedic
Orthopedic · 231d
Cleared Apr 11, 2012
NEURO CHECK DEVICE WITH IO-FLEX WIRE
K113533 · HAE
Baxano, Inc.
Neurology · 133d
Cleared Apr 11, 2012
BORRELIA BURGDORFERI IGG BLOT TEST
K113847 · LSR
Gold Standard Diagnostics
Microbiology · 104d