15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TROJAN MAGNUM CONDOM WITH FIRE & ICE LUBRICANT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450191781·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197033589·Heymann Knight Nasal Scissor
right ...
JBAIDS INFLUENZA A/H5 DETECTION KIT, MODEL JRPD-ASY-0136
FDA 510(k)
FDA Class 2
·Microbiology
DENTITION INTEGRATING MATERIAL
FDA 510(k)
FDA Class 2
·Dental
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·May 29, 2025
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·June 2, 2025
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 17, 2023
UNKNOWN DEPUY FEMORAL HEAD
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KXA·May 20, 2013
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 26, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 10, 2011
I-STAT ACT CELITE CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JBP·December 10, 2012
OT ULTRA 2 METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE GMBH·Product code NBW·October 28, 2020
OT ULTRA 2 METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE GMBH·Product code NBW·October 28, 2020
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