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

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APK SPO2 PULSE OXIMETER SENSOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR

FDA 510(k)
FDA Class 2 ·Anesthesiology

ZIPPY, MODEL I88WA

FDA 510(k)
FDA Class 2 ·Physical Medicine

SPINNING SPIROS® CLOSED MALE LUER, RED CAP

FDA Adverse Event
Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·November 4, 2025

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·April 29, 2013

UNKNOWN DEPUY FEMORAL COMPONENT

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·May 3, 2011

GORE EXCLUDER THORACIC ENDOPROSTHESIS

FDA Adverse Event
Malfunction ·W.L. GORE & ASSOCIATES,INC.·Product code MIH·July 25, 2008

ISODUR PROSTHESIS HEAD 12/14 32MM XL

FDA Adverse Event
Malfunction ·AESCULAP AG AND CO KG·Product code LPH·March 28, 2014

AVAN TAP CORT SCR SS 4.5X26MM

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code LZO·December 29, 2025

AVAN TAP CORT SCR SS 4.5X58MM

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code LZO·December 29, 2025

AVAN TAP CORT SCR SS 4.5X48MM

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code LZO·December 29, 2025

AVAN TAP CORT SCR SS 4.5X56MM

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code LZO·December 29, 2025

AVAN TAP CORT SCR SS 4.5X60MM

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code LZO·December 29, 2025

AVAN TAP CORT SCR SS 4.5X20MM

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code LZO·December 29, 2025

AVAN TAP CORT SCR SS 4.5X52MM

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code LZO·December 29, 2025

M2A ACETABULAR COMPONENT

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWA·May 23, 2018

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