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

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PS MEDICAL DELTA CSF-FLOW CONTROL VALVE

FDA 510(k)
FDA Class 2 ·Neurology

FIXION INTERLOCKING NAIL (FIXION IL NAIL)

FDA 510(k)
FDA Class 2 ·Orthopedic

DEBP

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

ULTRACISION HARMONIC SCALPEL HAND PIECE

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·August 25, 2016

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 9, 2013

ATTAIN OTW

FDA Adverse Event
Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·November 18, 2010

INFINITI VISION SYSTEM OZIL

FDA Adverse Event
Malfunction ·ALCON - IRVINE TECHNOLOGY CTR·Product code HQC·February 14, 2014

IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4

FDA Adverse Event
Injury ·MEDTRONIC XOMED INC.·Product code ERL·February 13, 2017

Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF Classic, Luminos Fusion or Luminos Select. Angiographic x-ray system.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·April 17, 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