19 results · 21ms · Sources: EU EUDAMED, US FDA

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Medtronic Model 5392 External Pulse Generator (EPG)

FDA 510(k)
FDA Class 2 ·Cardiovascular

MEDTRONIC DUAL CHAMBER TEMPORARY EXTERNAL PACEMAKER 510(K) K150246

FDA Adverse Event
Death ·MEDTRONIC, INC.·Product code DTE·February 10, 2021

AGXO

FDA UDI
Oticon A/S·05707131286215·H160V2 TI, RITE 312 WL STG AGXO

Vilex Guidewire

FDA UDI
VILEX IN TENNESSEE, INC.·00841731120588·Guidewire 2.4x150mm Sgl Trocar

Patella Trial Size 1

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215074111·

3 ML BD LUER-LOK LUER-LOK TIP

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 1, 2020

BD LUER-LOK TIP SYRINGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·August 17, 2020

3 ML BD LUER-LOK LUER-LOK TIP

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 26, 2020

MAX-IF1000

FDA 510(k)
FDA Class 2 ·Neurology

SIS DERMAL AUGMENTATION STRAND

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

BD 3 ML SYRINGE LUER-LOK TIP

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND COMPANY·Product code FMF·August 19, 2020

3 ML BD LUER-LOK LUER-LOK TIP

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 25, 2020

T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·December 3, 2024

PAINSMART IOD

FDA Adverse Event
Malfunction ·MOOG DEVICE GROUP·Product code FRN·May 29, 2013

3002 SECURE II

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FNL·June 10, 2011

SYNERGY

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO, MED REL·Product code LGW·September 3, 2008

BINAXNOW COVID-19 ANTIGEN SELF-TEST

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCABOROUGH·Product code QKP·August 20, 2021

ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU

FDA Enforcement
Class III ·Terminated·Ameditech Inc·December 30, 2015

STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.

FDA Enforcement
Class II ·Terminated·Advanced Sterilization Products·April 10, 2013