FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
38449–38472 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 10, 2014
NEXXZR(TM)T AND NEXXZR(TM)S
K130991 · EIH
Sagemax Bioceramics, Inc.
Dental · 306d
Cleared Feb 10, 2014
ARTASSIST AND VENASSIST
K131146 · JOW
Aci Medical, LLC
Cardiovascular · 293d
Cleared Feb 10, 2014
TOEGRIP, IMPLANT FOR PROXIMAL INTER-PHALANGEAL ARTHRODESIS
K133477 · HTY
Synchro Medical
Orthopedic · 90d
Cleared Feb 10, 2014
AQUILION ONE VISION
K133497 · JAK
Toshibamedical Systems Corporation
Radiology · 88d
Cleared Feb 10, 2014
OPTICAGE INTERBODY FUSION DEVICE, MODEL SERIES 9070
K133583 · MAX
Interventional Spine, Inc.
Orthopedic · 81d
Cleared Feb 10, 2014
C-PLUS
K133623 · ODP
Pioneer Surgical Technology, Inc.
Orthopedic · 76d
Cleared Feb 10, 2014
IMRI 1.5T AND IMRI 3T S
K133692 · LNH
Imris, Inc.
Radiology · 70d
Cleared Feb 07, 2014
QUANTA FLASH CENTROMERE
K123880 · LJM
Inova Diagnostics, Inc.
Immunology · 417d
Cleared Feb 07, 2014
ALERTWATCH: OR
K130401 · MHX
Alertwatch, LLC
Cardiovascular · 353d
Cleared Feb 07, 2014
MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES,...
K130616 · KNW
Biopsybell S.R.L.
Gastroenterology & Urology · 337d
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