14 results · 29ms · Sources: EU EUDAMED, US FDA

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CELLTRACKS AUTOPREP SYSTEM

FDA 510(k)
FDA Class 2 ·Immunology

ArgenZ HT+ 95x30 C4

FDA UDI
ARGEN CORPORATION, THE·D818122821·Dental porcelain/ceramic restoration kit

Zavation

FDA UDI
Zavation LLC·00842166188815·21mm Dilator

22 G X 1.00 IN. (0.9 MM X 25 MM) BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 10, 2017

DISCOVRED

FDA 510(k)
FDA Class 2 ·Dental

ARAGON WIRING SYSTEM WIRE CARTRIDGE, MODELS I0007 WIRE CARTRIDGE, 22 GAUGE, I0008 WIRE CARTRIDGE, 24 GAUGE, I0009 WIRE E

FDA 510(k)
FDA Class 2 ·Dental

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 22, 2024

22 G X 1.00 IN. (0.9 MM X 25 MM) BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·October 20, 2017

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 20, 2025

LINOX SD 65/16

FDA Adverse Event
Malfunction ·BIOTRONIK SE & CO. KG·Product code NVY·May 21, 2013

SELF CENT HIP 46X28 BRN

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWY·September 26, 2014

MINICAP

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·June 14, 2011

MINMED QUICK SET

FDA Adverse Event
Malfunction ·UNOMEDICAL UM-D·Product code FPA·February 21, 2025

Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.

FDA Enforcement
Class II ·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025