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

Filters: Cleared only ×
175,820 results
39145–39168 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 27, 2014
DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE
K132638 · CGX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 157d
Cleared Jan 27, 2014
AVERSION PEDICLE SCREW SYSTEM
K133103 · MNI
K7, LLC
Orthopedic · 119d
Cleared Jan 27, 2014
4D INTEGRATED TREATMENT CONSOLE
K133331 · MUJ
Varian Medical Systems, Inc.
Radiology · 90d
Cleared Jan 27, 2014
PERI-PROSTHETIC CABLE SYSTEM
K133354 · JDQ
Biomet, Inc.
Orthopedic · 88d
Cleared Jan 27, 2014
TRITIUM STERNAL CABLE PLATE SYSTEM
K133785 · JDQ
Pioneer Surgical Technology, Inc.
Orthopedic · 46d
Cleared Jan 27, 2014
1.5T ORBIT AND MANDIBLE ARRAY, 3.0T ORBIT AND MANDIBLE ARRAY
K133986 · MOS
Resonance Innovations, LLC
Radiology · 32d
Cleared Jan 24, 2014
ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR
K131307 · LCP
Siemens Healthcare Diagnostics, Inc.
Chemistry · 262d
Cleared Jan 24, 2014
FETAL ULTRASONIC MONITOR AND ACCESSORIES
K131457 · KNG
Shenzhen Jumper Medical Equipment...
Obstetrics & Gynecology · 249d
Cleared Jan 24, 2014
YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS
K131500 · HCH
Aesculap, Inc.
Neurology · 245d
Cleared Jan 24, 2014
MPP
K131910 · NUH
Marc Pro
Neurology · 212d
Cleared Jan 24, 2014
DYNATRON PELTIER THERMOSTIM PROBE
K132057 · GXY
Dynatronics Corp.
Neurology · 205d
Cleared Jan 24, 2014
EPIX ELECTROSURGICAL PROBE SPATULA TIP, EPIX ELECTROSURGICAL PROBE L-HOOK...
K132300 · GEI
Applied Medical Resources Corp.
General & Plastic Surgery · 184d
Cleared Jan 24, 2014
EPAD
K132616 · GWF
Safeop Surgical, Inc.
Neurology · 156d
Cleared CT Jan 24, 2014
CARTO3 EP NAVIGATION SYSTEM, VERSION 3.2
K132782 · DQK
Biosense Webster, Inc.
Cardiovascular · 140d
Cleared Jan 24, 2014
PUREGRAFT 50 SYSTEM
K132815 · MUU
Cytori Therapeutics, Inc.
General & Plastic Surgery · 137d
Cleared CT Jan 24, 2014
KIVA VCF TREATMENT SYSTEM
K132817 · NDN
Benvenue Medical, Inc.
Orthopedic · 137d
Cleared Jan 24, 2014
INVENTIS MIDDLE EAR ANALYZER, FLUTE BASIC, INVENTIS MIDDLE EAR ANALYZER,...
K133013 · ETY
Inventis S.R.L.
Ear, Nose, Throat · 121d
Cleared Jan 24, 2014
YSIO MAX
K133259 · KPR
Siemens Medical Solutions USA, Inc.
Radiology · 93d
Cleared Jan 24, 2014
ADD-VANTAGE ADDAPTOR
K133602 · LHI
Hospira, Inc.
General Hospital · 60d
Cleared Jan 24, 2014
RAPIDFRET ORAL FLUID ASSAY FOR OPIATES
K133642 · DJG
Biophor Diagnostics, Inc.
Toxicology · 58d
Cleared Jan 24, 2014
MEGA SOFT UNIVERSAL PATIENT RETURN ELECTRODE
K133726 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 49d
Cleared Jan 24, 2014
DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE
K133728 · CGX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 49d
Cleared Jan 24, 2014
MACY CATHETER
K133881 · KNT
Hospi Corporation
Gastroenterology & Urology · 35d
Cleared Jan 24, 2014
CAPTIVATOR II,SINGLE-USE POLYPECTOMY SNARES
K133987 · FDI
Boston Scientific Corporation
Gastroenterology & Urology · 29d