15 results · 27ms · Sources: EU EUDAMED, US FDA

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CA, MODEL: CAM

FDA 510(k)
FDA Class 2 ·Ophthalmic

Harvard Ionoresin Fill OptiCaps A2

FDA UDI
Harvard Dental International GmbH·EHAR70712501·Resin modified glass ionomer cement for restora...

KMEDIC

FDA UDI
TELEFLEX INCORPORATED·24026704293173·

Sklar®

FDA UDI
SKLAR CORPORATION·10649111096129·F.O. MILLER AMER STYLE SIZE 4

VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS)

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

CUB PEDIATRIC CRIB- FIXED BASE

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FMS·April 22, 2013

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·April 27, 2011

SELF CENT HIP 47X32 BRN

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWY·July 7, 2008

HEARTMATE 3 LVAS IMPLANT KIT

FDA Adverse Event
Injury ·THORATEC CORPORATION·Product code DSQ·March 14, 2023

HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

FDA Adverse Event
Injury ·THORATEC CORPORATION·Product code DSQ·March 15, 2023

EVOLUT FX DCS

FDA Adverse Event
Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 27, 2025

8100 ALARIS PUMP MODULE

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·January 8, 2021

GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.

FDA Enforcement
Class II ·Terminated·GE Healthcare, LLC·July 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