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
39049–39072 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 07, 2014
FDES106 MINI TENS&EMS DEVICE,FDES106 MULTI-FUNCTION MINI TENS&EMS...
K130723 · NGX
Famidoc Technology Co., Ltd.
Physical Medicine · 326d
Cleared Feb 07, 2014
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K130807 · LYZ
Hope Plastic Co., Ltd.
General Hospital · 319d
Cleared Feb 07, 2014
TWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION...
K131966 · LXC
Twin Star Medical, Inc.
Orthopedic · 224d
Cleared Feb 07, 2014
NB3D BONE VOID FILLER
K132050 · MQV
Pioneer Surgical Technology, Inc.
Orthopedic · 220d
Cleared Feb 07, 2014
RING-LOK MODULAR BIPOLAR SYSTEM
K132539 · KWY
Implants International, Ltd.
Orthopedic · 178d
Cleared Feb 07, 2014
SONICAID FREEDOM WIRELESS FETAL MONITORING SYSTEM
K132650 · HGM
Huntleigh Healthcare Limited
Obstetrics & Gynecology · 165d
Cleared Feb 07, 2014
ECLIPSE TREATMENT PLANNING SYSTEM
K133247 · MUJ
Varian Medical Systems, Inc.
Radiology · 108d
Cleared Feb 07, 2014
PROTEUS PATCH, PROTEUS INGESTIBLE SENSOR (ACCESSORY)
K133263 · OZW
Proteus Digital Health, Inc.
Gastroenterology & Urology · 107d
Cleared Feb 07, 2014
DUOCENTRIC REVERSED SHOULDER PROSTHESIS
K133462 · KWS
Aston Medical
Orthopedic · 87d
Cleared Feb 07, 2014
MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN ROBOTIC CATHETER...
K133552 · DRA
Hansen Medical
Cardiovascular · 80d
Cleared Feb 06, 2014
INTEGRITY SPINAL CARE SYSTEM 3.0
K130249 · ITH
Integrity Life Sciences
Physical Medicine · 370d
Cleared Feb 06, 2014
C-MAX+ (PLUS)
K130864 · ILK
Aat Alber Antriebstechnik GmbH
Physical Medicine · 315d
Cleared Feb 06, 2014
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K130890 · LYZ
Air Plastic Co., Ltd.
General Hospital · 311d
Cleared Feb 06, 2014
ALIVECOR HEART MONITOR OTC
K130921 · DPS
AliveCor, Inc.
Cardiovascular · 309d
Cleared Feb 06, 2014
POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
K131341 · LYZ
Shijiazhuang Winful Plastic Co., Ltd.
General Hospital · 273d
Cleared Feb 06, 2014
DUAL ENERGY SYSTEM PACKAGE
K132813 · JAK
Toshibamedical Systems Corporation
Radiology · 150d
Cleared Feb 06, 2014
CARESTREAM VUE PACS VERSION 11.4 CARESTREAM VUE MOTION APPLICATION
K132824 · LLZ
Carestream Health, Inc.
Radiology · 150d
Cleared Feb 06, 2014
FUSE 1C COLONOSCOPY SYSTEM
K132839 · FDF
Endochoice, Inc.
Gastroenterology & Urology · 149d
Cleared Feb 06, 2014
AIRSTRIP REMOTE PATIENT MONITORING
K133394 · MWI
Airstrip Technologies, LP
Cardiovascular · 93d
Cleared Feb 06, 2014
VDRIVE WITH V-SONO
K133396 · DQX
Stereotaxis, Inc.
Cardiovascular · 92d
Cleared Feb 06, 2014
STAPIX SUPERELASTIC IMPLANT BONE STAPLES
K133523 · JDR
Instratek, Inc.
Orthopedic · 83d
Cleared Feb 06, 2014
NUVANT MCT SYSTEM
K133701 · QYX
Corventis, Inc.
Cardiovascular · 65d
Cleared Feb 06, 2014
APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH
K140036 · OTD
Aptus Endosystems, Inc.
Cardiovascular · 30d
Cleared Feb 05, 2014
SONILASE LIGHT THERAPY DEVICE
K132613 · OHS
Biorenew Labs, LLC
General & Plastic Surgery · 168d