17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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U-MOTION II ACETABULAR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ZrLiquid HT A2-S 100ml
FDA UDI
ARGEN CORPORATION, THE·D818122185·Dental porcelain/ceramic restoration kit
SCOTT'S SELECT K-FILES 6/pk 21mm # 15-40 ASST
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D77811221851·ENDODONTIC K-FILES (6/pack) Length: 21mm, Size:...
UNIVERSAL CMF SYSTEM
FDA 510(k)
FDA Class 2
·Dental
FOURSNARE VASCULAR RETRIEVAL SNARE
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 22, 2024
IN00087 CLERMONT FERRAND PH
FDA Adverse Event
Death
·SORIN GROUP ITALIA·Product code DWF·March 7, 2014
INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·January 7, 2016
COLLAMER UV-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE IOL
FDA Adverse Event
Injury
·STAAR SURGICAL CO.·Product code HQL·May 17, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 13, 2011
INTRO-FLEX PERCUTANEOUS SHEATH INTRODUCER KIT
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code DYB·August 15, 2008
ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)
FDA Adverse Event
Injury
·ANGIOSCORE, INC·Product code LIT·March 29, 2016
ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)
FDA Adverse Event
Malfunction
·ANGIOSCORE, INC·Product code LIT·November 26, 2015
INSPIRE 6F HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·April 21, 2022
INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL
FDA Adverse Event
Injury
·SORIN GROUP ITALIA·Product code DTZ·June 8, 2016
SOMATOM Edge Plus-Computed tomography system Model 1026700
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·January 19, 2022
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023