9 results · 20ms · Sources: EU EUDAMED, US FDA

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SURGIMEND

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

EBI VUECATH SPINAL ENDOSCOPIC SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

R&D RET-LINE KIT

FDA 510(k)
FDA Class 2 ·Hematology

BD INSYTE AUTOG BC PNK

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·March 13, 2024

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 29, 2013

RIATA ST ACTIVE FIXATION

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·May 11, 2011

ACCU-CHEK COMFORT CURVE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 28, 2008

MX 16-Slice CT Scanner System. Used as a whole-body computed tomography X-Ray system.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·October 23, 2013

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