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
58777–58800 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 30, 2007
150W CERALAS D 980NM DIODE LASER
K072106 · GEX
Biolitec, Inc.
General & Plastic Surgery · 30d
Cleared Aug 30, 2007
LDR SPINE ROI-T SYSTEM
K072132 · MQP
Ldr Spine USA
Orthopedic · 28d
Cleared Aug 30, 2007
DEN TEK COMFORT FIT NIGHTGUARD
K072147 · OBR
Den Tek Oral Care, Inc.
Dental · 27d
Cleared Aug 30, 2007
ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M
K072217 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 21d
Cleared Aug 30, 2007
ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEM
K072285 · ITX
Aloka Co., Ltd.
Radiology · 14d
Cleared Aug 30, 2007
PORTABLE ECSCOPE
K072353 · DPS
Dyansys Corp
Cardiovascular · 8d
Cleared Aug 29, 2007
SBI FOREFOOT SET
K063635 · HWC
Small Bone Innovations, Inc.
Orthopedic · 266d
Cleared Aug 29, 2007
VITALCOR FEATHERWEIGHT VASCULAR CLAMPS
K070661 · DXC
Vitalcor, Inc.
Cardiovascular · 173d
Cleared Aug 29, 2007
FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05
K071367 · MJN
LeMaitre Vascular, Inc.
Cardiovascular · 105d
Cleared Aug 29, 2007
AAP APS SYSTEM
K071852 · KTT
Aap Implantate AG
Orthopedic · 55d
Cleared Aug 29, 2007
MHI-TM2000 LINEAR ACCELERATOR SYSTEM
K072047 · IYE
Mitsubishi Heavy Industries, Ltd.
Radiology · 35d
Cleared Aug 29, 2007
VISION-SCIENCES ENT-5000 AND ENT-5100 VIDEO ENT SCOPE WITH ENDOSHEATH SYSTEM,...
K072073 · EOB
Vision-Sciences, Inc.
Ear, Nose, Throat · 30d
Cleared Aug 29, 2007
MODIFICATION TO GE LOGIQ A3
K072075 · IYN
General Electric Co.
Radiology · 30d
Cleared Aug 29, 2007
FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROCESSOR AND...
K072088 · EOX
Vision-Sciences, Inc.
Ear, Nose, Throat · 30d
Cleared Aug 29, 2007
VISAGE PACS/CS, RELEASE VERSION 5.0
K072205 · LLZ
Mercury Computer Systems, Inc.
Radiology · 21d
Cleared Aug 29, 2007
ACUSON P50 DIAGNOSTIC ULTRASOUND SYSTEM
K072266 · ITX
Siemens Medical Solutions USA, Inc.
Radiology · 14d
Cleared Aug 28, 2007
RAINBOW, RAINBOW LIGHT,RAINBOW BLUE, RAINBOW PLUS
K070338 · ILY
Rainbow Communications, Inc.
Physical Medicine · 204d
Cleared Aug 28, 2007
TPC ADVANCECAM INTRA ORAL CAMERA SYSTEM, MODEL AIC 888
K071485 · EIA
Tpc Advanced Technology, Inc.
Dental · 90d
Cleared Aug 28, 2007
FIRSTVIEW
K071492 · LLZ
Riverain Medical Group,Llc
Radiology · 90d
Cleared Aug 28, 2007
ECLOS COMPUTED TOMOGRAPHY X-RAY SYSTEM
K071806 · JAK
Hitachi Medical Systems America, Inc.
Radiology · 57d
Cleared Aug 27, 2007
STRYKER SPINE XIA III SPINAL SYSTEM
K071373 · NKB
Stryker Spine
Orthopedic · 103d
Cleared Aug 27, 2007
SBI ARTFIX
K071656 · HWC
Small Bone Innovations, Inc.
Orthopedic · 90d
Cleared Aug 27, 2007
LIFESYNC ADAPTER, MODEL LS-302
K071751 · DSA
Lifesync Corporation
Cardiovascular · 60d
Cleared Aug 27, 2007
MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE...
K072157 · FMT
Ohmeda Medical
General Hospital · 24d