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

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Tornier Humeral Nail and Tornier Long Humeral Nail

FDA 510(k)
FDA Class 2 ·Orthopedic

Vilex Guidewire

FDA UDI
VILEX IN TENNESSEE, INC.·00841731120700·Steinmann Pin 3.5x230mm (9/64 x 9")

SONTEC GELPI RETRACTOR

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896026513·SONTEC GELPI RETRACTOR MULTIPLE LEVEL PARALLEL ...

Intrigue

FDA UDI
LANCER ORTHODONTICS, INC.·00817573020782·INTRG WHISP-Z MBT CUS HK -7T +3A 022 LL

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·December 13, 2022

Axis Spine Technologies ALIF

FDA 510(k)
FDA Class 2 ·Orthopedic

GGM Breathing Circuit Bacterial Filter

FDA 510(k)
FDA Class 2 ·Anesthesiology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

SPEEDBAND SUPERVIEW SUPER 7 LIGATOR

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MND·November 7, 2008

LCS COMP RP INSERT STD+ 12.5MM

FDA Adverse Event
Injury ·DEPUY RAYNHAM·Product code NJL·September 1, 2011

REAMER F/HIPSCR Ø6.5/4.5 F/AFN

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code HTO·July 16, 2013

BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

Model Number L111, ESSENTIO DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025