15 results · 22ms · Sources: EU EUDAMED, 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