14 results · 23ms · Sources: EU EUDAMED, US FDA

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OTA COLLAGEN BIOMATERIAL

FDA 510(k)
FDA Class 2 ·Dental

MODEL 342GE-64 HIGH RESOLUTION BRAIN COIL

FDA 510(k)
FDA Class 2 ·Radiology

PLLA CANNULATED INTERFERENCE SCREW

FDA 510(k)
FDA Class 2 ·Orthopedic

ZEPHIR ANTERIOR CERVICAL PLATE SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWQ·July 17, 2014

ZEPHIR ANTERIOR CERVICAL PLATE SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWQ·July 17, 2014

ZEPHIR ANTERIOR CERVICAL SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWQ·November 24, 2017

BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·August 22, 2024

ZEPHIR ANTERIOR CERVICAL SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWQ·November 15, 2016

ADVANTAGE SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 23, 2013

HOMECHOICE CYCLER-REFURBISHED

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FKX·July 3, 2008

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 13, 2011

NFLEX CURVED ROD 60MM-STERILE

FDA Adverse Event
Injury ·SYNTHES ELMIRA·Product code NQP·March 31, 2016

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

ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026