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

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GERATHERM UNIQUERESC

FDA 510(k)
FDA Class 2 ·Cardiovascular

NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)

FDA 510(k)
FDA Class 2 ·Radiology

BIO-MARK RESORBABLE BIOPSY SITE MARKER AND BIO-MARK PERMANENT BIOPSY SITE MARKER

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

VELA VENTILATOR

FDA Adverse Event
Malfunction ·CAREFUSION·Product code CBK·July 21, 2015

ROUND FILTER POLYPROVPYLENE

FDA Adverse Event
Malfunction ·SPS MEDICAL SUPPLY CORP·Product code FRG·June 25, 2013

VELA VENTILATOR

FDA Adverse Event
Malfunction ·CAREFUSION·Product code CBK·February 19, 2015

ZIMMER M/L TAPER FEMORAL STEM

FDA Adverse Event
Injury ·ZIMMER INC·Product code LZO·May 1, 2013

CODMAN EXTERNAL DRAINAGE SYSTEM III

FDA Adverse Event
Injury ·CODMAN & SHURTLEFF, INC.·Product code JXG·September 16, 2014

PINNACLE MTL INS NEUT40IDX58OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·May 12, 2011

BD PEGASUS PNK 20GAX1.16IN PRN-CAPY NON-PVC

FDA Adverse Event
Injury ·BD SUZHOU (MDS)·Product code FOZ·February 20, 2024

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