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
38569–38592 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 24, 2014
PUREGRAFT 50 SYSTEM
K132815 · MUU
Cytori Therapeutics, Inc.
General & Plastic Surgery · 137d
Cleared 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
Cleared Jan 24, 2014
ATRICURE CRYO MODULE SYSTEM
K140058 · GEH
AtriCure, Inc.
General & Plastic Surgery · 14d
Cleared Jan 23, 2014
KHAN KINETIC TREATMENT (KKT-M2)
K130666 · LXM
Optima Health Solutions International...
Physical Medicine · 317d
Cleared Jan 23, 2014
ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
K131490 · HSB
Ellipse Technologies, Inc.
Orthopedic · 245d
Cleared Jan 23, 2014
AUTOMATED GYLCOHEMOGLOBIN ANALYZER HLC-723G8
K131580 · PDJ
Tosoh Bioscience, Inc.
Chemistry · 237d
Cleared Jan 23, 2014
JUVORA DENTQAL DISC
K132725 · EBI
Juvora
Dental · 146d
Cleared Jan 23, 2014
ZYNO MEDICAL ADMINISTRATION SET
K132841 · FPA
Zyno Medical, LLC
General Hospital · 135d
Cleared Jan 23, 2014
MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE
K132928 · DXT
Medrad, Inc. / Bayer Medical Care, Inc.
Cardiovascular · 127d
Cleared Jan 23, 2014
SPEED 808 DIODE LASER SYSTEM
K132989 · GEX
Beijing Toplaser Technology Co., Ltd.
General & Plastic Surgery · 121d
Cleared Jan 23, 2014
GRINDGUARD
K133037 · OBR
Grind Guard Technologies, LLC
Dental · 119d
Cleared Jan 23, 2014
CAREFINE PEN NEEDLE
K133100 · FMI
Facet Technologies
General Hospital · 115d
Cleared Jan 23, 2014
MAC 2000 ECG ANALYSIS SYSTEM
K133622 · DPS
Wipro GE Healthcare
Cardiovascular · 62d
Cleared Jan 23, 2014
AAP LOQTEQ DISTAL ANTEROLATERAL TIBIA PLATE 3.5
K133675 · HRS
Aap Implantate AG
Orthopedic · 55d
Cleared Jan 22, 2014
CANNULATED SCREW AND KIRSCHNER (KWIRE) SYSTEM
K130613 · HWC
Laura Cattabriga
Orthopedic · 321d
Cleared Jan 22, 2014
BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER...
K131135 · MBB
Biomet Manufacturing Corp
Orthopedic · 275d