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

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IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYTEM

FDA 510(k)
FDA Class 2 ·Immunology

AMEDICA DRUG SCREEN TEST CUP

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

TenoTac Soft Tissue Fixation System

FDA 510(k)
FDA Class 2 ·Orthopedic

TROCHANTERIC NAIL KIT, TI GAMMA3 11X200MM X 125

FDA Adverse Event
Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·November 7, 2012

CADD LEGACY PUMP

FDA Adverse Event
Malfunction ·ST PAUL·Product code FRN·April 11, 2022

CADD LEGACY PLUS PUMP

FDA Adverse Event
Malfunction ·ST PAUL·Product code FRN·September 8, 2022

CADD LEGACY PLUS PUMP

FDA Adverse Event
Malfunction ·ST PAUL·Product code FRN·September 23, 2022

CADD LEGACY PLUS PUMP

FDA Adverse Event
Malfunction ·ST PAUL·Product code FRN·September 22, 2022

INTERSTIM II

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·February 28, 2013

TRILOGY 100

FDA Adverse Event
Malfunction ·RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP·Product code CBK·July 2, 2014

ARCHITECT STAT TROPONIN-I

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code MMI·February 9, 2011

CADD LEGACY PLUS PUMP

FDA Adverse Event
Malfunction ·ST PAUL·Product code FRN·September 22, 2022

CADD LEGACY PLUS PUMP

FDA Adverse Event
Malfunction ·ST PAUL·Product code FRN·September 8, 2022

CADD LEGACY PLUS PUMPS

FDA Adverse Event
Malfunction ·ST PAUL·Product code FRN·October 29, 2022

CADD LEGACY PLUS PUMPS

FDA Adverse Event
Malfunction ·ST PAUL·Product code FRN·October 24, 2022

Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024