20 results · 24ms · Sources: EU EUDAMED, US FDA

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ISO-ELASTIC CERCLAGE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

SOLIDEA

FDA UDI
CALZIFICIO PINELLI SRL·08300496030256·VANITY 70 SHEER, SIZE L, SABBIA, GRADUATED COMP...

BUSCH®, BNA®

FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120302561·Diamond, medium grit

SCFE Screw

FDA UDI
ORTHOPEDIATRICS CORP.·00841132114698·4.0mm X 56mm SHORT THREAD CANNULATED SCREW

CAP PORP, CAP TORP

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

PCCR DIGITAL IMAGING DEVICE

FDA 510(k)
FDA Class 2 ·Radiology

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·February 4, 2025

TRIAGE CARDIAC TRIPLE MARKER PANEL

FDA Adverse Event
Malfunction ·QUIDEL CARDIOVASCULAR INC.·Product code MMI·October 12, 2018

TRIAGE CARDIAC HS PANEL

FDA Adverse Event
Malfunction ·QUIDEL CARDIOVASCULAR INC.·Product code MMI·October 22, 2019

TRIAGE CARDIAC TRIPLE MARKER PANEL

FDA Adverse Event
Malfunction ·QUIDEL CARDIOVASCULAR, INC.·Product code MMI·May 18, 2018

TRIAGE CARDIAC PANEL KIT

FDA Adverse Event
Malfunction ·QUIDEL CARDIOVASCULAR, INC.·Product code JHX·April 18, 2018

TRIAGE CARDIAC HS PANEL

FDA Adverse Event
Malfunction ·QUIDEL CARDIOVASCULAR INC.·Product code MMI·October 21, 2019

TRIAGE CARDIAC TRIPLE MARKER PANEL

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code MMI·October 5, 2017

LEVEEN¿ SUPERSLIM¿

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code GEI·April 2, 2013

STENOSCOP

FDA Adverse Event
Malfunction ·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD·Product code JAA·March 7, 2011

TSRH SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICA INC.·Product code KWP·April 17, 2008

TRIAGE CARDIAC TRIPLE MARKER PANEL

FDA Adverse Event
Malfunction ·QUIDEL CARDIOVASCULAR INC.·Product code MMI·November 1, 2018

TRIAGE CARDIAC TRIPLE MARKER PANEL

FDA Adverse Event
Injury ·ALERE SAN DIEGO, INC.·Product code MMI·May 17, 2017

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

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