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