16 results · 28ms · Sources: EU EUDAMED, US FDA

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ANGIOSCULPT PTA SCORING BALLOON CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

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

ArgenZ HT+ 95x12 C1

FDA UDI
ARGEN CORPORATION, THE·D818122685·Dental porcelain/ceramic restoration kit

Hu Capsular Polisher

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896112193·HU Capsular Polisher E0645 Single End Angled Wi...

SOPROCARE

FDA 510(k)
FDA Class 2 ·Dental

ZYNO MEDICAL ADMINISTRATION SET

FDA 510(k)
FDA Class 2 ·General Hospital

VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAM·August 1, 2018

PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code NEW·August 1, 2018

GYNECARE UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code OTO·August 3, 2018

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·March 30, 2026

CAPSUREFIX NOVUS

FDA Adverse Event
Death ·MPRI·Product code DTB·May 21, 2013

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 18, 2014

GLOBAL CAP CTA DUOFIX 52X21

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code HSD·June 3, 2011

EAGLE EYE PLATINUM ST CATHETER

FDA Adverse Event
Malfunction ·PHILIPS VOLCANO·Product code OBJ·February 27, 2020

Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018