14 results · 22ms · Sources: EU EUDAMED, US FDA

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DigiLine Direct Print Aligner System

FDA 510(k)
FDA Class 2 ·Dental

PISCES-SA Standalone ALIF Interbody System

FDA 510(k)
FDA Class 2 ·Orthopedic

Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae)

FDA 510(k)
FDA Class 2 ·Microbiology

WALLFLEX ESOPHAGEAL

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·January 16, 2025

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 22, 2025

WALLFLEX ESOPHAGEAL

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·January 23, 2025

ALINITY I TOXO IGM REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code LGD·April 22, 2026

WALLFLEX ESOPHAGEAL

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·February 14, 2025

PUMP MMT-722LNAP PRDGM INS PL EN ML

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code LZG·November 14, 2008

ASR ACETABULAR IMPLANT 58

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·September 6, 2011

ZOOM STRETCHER, PRIME X

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code INK·July 18, 2013

ALINITY I TOXO IGM REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code LGD·June 2, 2025

WALLFLEX ESOPHAGEAL

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·May 28, 2025

ALINITY I TOXO IGM REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code LGD·September 11, 2025