9 results · 28ms · Sources: EU EUDAMED, US FDA

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BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION

FDA 510(k)
FDA Class 2 ·Ophthalmic

DISP FIRSTPASS STR PASSR SELF

FDA Adverse Event
Malfunction ·ARTHROCARE CORP.·Product code HWQ·November 12, 2019

ORTHOSS RESORBABLE BONE VOID FILLER

FDA 510(k)
FDA Class 2 ·Dental

MICS INTERVENTION AID, CATALOG # MICS-MIA AND MICS-MIAS

FDA 510(k)
FDA Class 2 ·Radiology

STERILE BASIC PACK

FDA Adverse Event
Malfunction ·KIMBERLY-CLARK HEALTH CARE·Product code KKX·March 27, 2013

HEARTMATE II LVAS

FDA Adverse Event
Injury ·THORATEC CORPORATION·Product code DSQ·March 18, 2011

DORADO PTA BALLOON DILATATION CATHETER

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code LIT·March 27, 2008

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