10 results · 19ms · Sources: EU EUDAMED, US FDA

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ISIS MER SYSTEM/ELEKTA MER SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

JOBST forMen

FDA UDI
BSN MEDICAL, INC.·04042809874969·FOR MEN 15-20 MM HG THIGH MICRO DOT BAND CLOSED...

SOAR Retractor System

FDA UDI
SPINEOLOGY INC.·M7403042208·22mm x 80mm Portal Tube

OBC-250-PAN BREAST ARRAY COIL

FDA 510(k)
FDA Class 2 ·Radiology

ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895

FDA 510(k)
FDA Class 2 ·Immunology

HEARTMATE II LVAS

FDA Adverse Event
Injury ·THORATEC CORP·Product code DSQ·April 4, 2013

ZMR HIP XL TAPER STEM

FDA Adverse Event
Malfunction ·ZIMMER INC·Product code LPH·February 15, 2011

VITALITY DR

FDA Adverse Event
Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

FDA Enforcement
Class I ·Ongoing·Thoratec Corp.·May 8, 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