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
45193–45216 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 09, 2012
HAMILTON-TC1
K112006 · CBK
Hamilton Medical AG
Anesthesiology · 211d
Cleared Feb 09, 2012
SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS
K112407 · DYB
Smiths Medical MD, Inc.
Cardiovascular · 171d
Cleared Feb 09, 2012
STIMULATION/DISSECTION INSTRUMENTS
K112709 · ETN
Nu Vasive, Incorporated
Ear, Nose, Throat · 143d
Cleared Feb 09, 2012
INTEGRA WOUND MATRIX (THIN)
K113104 · KGN
Integra LifeSciences Corporation
General & Plastic Surgery · 112d
Cleared Feb 09, 2012
PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500
K113183 · MWI
Shanghai 3f Electronics Co, Ltd.
Cardiovascular · 104d
Cleared Feb 09, 2012
DYNATRON TRI-WAVE LIGHT PAD DYNATRON TRI-WAVE LIGHT PROBE
K113250 · ILY
Dynatronics Corp.
Physical Medicine · 98d
Cleared Feb 09, 2012
CD HORIZON VOYAGER SPINAL SYSTEM
K113529 · NKB
Medtronic Sofamor Danek
Orthopedic · 71d
Cleared Feb 09, 2012
HPR EMOLLIENT FOAM
K113772 · FRO
Prugen IP Holdings, Inc.
General & Plastic Surgery · 49d
Cleared Feb 09, 2012
HPR PLUS EMOLLIENT FOAM
K113774 · FRO
Prugen IP Holdings, Inc.
General & Plastic Surgery · 49d
Cleared Feb 09, 2012
AFX INTRODUCER SYSTEM
K120212 · DYB
Endologix, Inc.
Cardiovascular · 16d
Cleared Feb 08, 2012
JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS
K103726 · KNF
Integra LifeSciences Corporation
Obstetrics & Gynecology · 413d
Cleared Feb 08, 2012
ORTHOSLENDERIZER
K111249 · EFB
Orthomatics, Inc.
Dental · 281d
Cleared Feb 08, 2012
CLEARFLASH AC2100 COSMETIC SYSTEM
K111937 · OLP
Clearflash Technologies, Inc.
General & Plastic Surgery · 215d
Cleared Feb 08, 2012
YOMURA SAFETY I.V. CATHETER
K112542 · FOZ
Yomura Technologies, Inc.
General Hospital · 160d
Cleared Feb 08, 2012
EPIGRAY
K112723 · MUJ
Dosisoft SA
Radiology · 142d
Cleared Feb 08, 2012
DIACHECK SMART/SUPERIOR BLOOD GLUCOSE MONITORING SYSTEM
K113343 · NBW
Delbio Incorporation
Chemistry · 86d
Cleared Feb 08, 2012
DEPUY PULSE THORACOLUMBAR SCREW SYSTEM
K113396 · NKB
Medos International SARL
Orthopedic · 93d
Cleared Feb 08, 2012
VERACIA SA
K113426 · ELM
Shofu Dental Corporation
Dental · 82d
Cleared Feb 08, 2012
IM BAND
K113600 · DXC
Synexmed(Shenzhen)Company Limited
Cardiovascular · 65d
Cleared Feb 08, 2012
SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)
K120083 · HSB
Synthes (Usa)
Orthopedic · 28d
Cleared Feb 08, 2012
PUREIMAGE ULTRASOUND TRANSMISSION GEL
K120156 · ITX
Medline
Radiology · 21d
Cleared Feb 08, 2012
WINGMAN EXTENDABLE TIP SUPPORT CATHETER
K120178 · DQY
Reflow Medical
Cardiovascular · 19d
Cleared Feb 07, 2012
ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS
K111678 · HRS
Ortho Solutions Limited
Orthopedic · 237d
Cleared Feb 07, 2012
CALLOS PROMODEL BONE VOID FILLER, SKAFFOLD MP (MACRO POROUS) BONE VOID FILLER
K112383 · MQV
Skeletal Kinetics, LLC
Orthopedic · 173d