19 results · 31ms · Sources: EU EUDAMED, US FDA

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KITTYCAT CATHETER, KITTYCAT 2 CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

ArgenZ HT+ 95x25

FDA UDI
ARGEN CORPORATION, THE·D818120273·Dental porcelain/ceramic restoration kit

JOBST soSoft

FDA UDI
BSN MEDICAL, INC.·00035664007379·SOSOFT 8-15 MM HG KNEE HIGH BROCADE EXTRA LARGE...

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450254615·

INSTAFLO BOWEL CATHETER SYSTEM KIT

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

MERIT BIPOLAR COAGULATION PROBE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code OZO·October 7, 2022

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·March 26, 2026

COBAS 8000 E 602 MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·December 13, 2024

ASR ACETABULAR CUPS 56

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·May 20, 2013

ANIMAS INSULIN CARTRIDGE

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·September 26, 2014

PRECISION XTRA

FDA Adverse Event
Malfunction ·Product code NBW·June 10, 2011

CORAIL HA W/O COLLAR S14 160MM

FDA Adverse Event
Injury ·DEPUY FRANCE SAS 3003895575·Product code KWA·May 23, 2019

GALAXY G3 XSFT 3MM X 8CM

FDA Adverse Event
Injury ·SEE H.10·Product code KRD·January 28, 2019

GALAXY G3 MINI 2MM X 4CM

FDA Adverse Event
Injury ·SEE H.10·Product code KRD·January 28, 2019

GALAXY G3 3.5MM X 7.5CM

FDA Adverse Event
Injury ·SEE H.10·Product code KRD·January 28, 2019

GALAXY G3 MINI 2MM X 4CM

FDA Adverse Event
Injury ·SEE H.10·Product code KRD·January 28, 2019

GALAXY G3 XSFT 3MM X 8CM

FDA Adverse Event
Injury ·SEE H.10·Product code KRD·January 28, 2019

Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

FDA Enforcement
Class II ·Terminated·GA Industries·May 6, 2015