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

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STARLIGHT

FDA 510(k)
FDA Class 2 ·Neurology

SYNTHES 2.4 MM CANNULATED SCREW

FDA 510(k)
FDA Class 2 ·Orthopedic

AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA

FDA 510(k)
FDA Class 2 ·Immunology

EQUINOXE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·June 11, 2021

HEARTSTART XL

FDA Adverse Event
Injury ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 23, 2013

DERMABOND TOPICAL SKIN ADHESIVE

FDA Adverse Event
Other ·CLOSURE MEDICAL CORP.·Product code MPN·July 23, 2008

SULZER UNIVERSAL DISTAL STEM CENTRALIZER

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code JDI·May 3, 2011

T-PAL SPACER APPLICATOR HANDLE

FDA Adverse Event
Injury ·SYNTHES HAGENDORF·Product code LXH·August 26, 2015

BD POSIFLUSH SP PRE-FILLED FLUSH SYRINGE NACL 0.9%

FDA Adverse Event
Injury ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·July 1, 2021

T-PAL SPACER APPLICATOR INNER SHAFT

FDA Adverse Event
Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code MAX·April 8, 2019

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

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