11 results · 31ms · Sources: EU EUDAMED, US FDA

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CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

OsteoMed

FDA UDI
OSTEOMED LLC·00845694060325·14mm Angled Locking Screw ID Tag

ROUND FILTERS W/INDICATOR

FDA Adverse Event
Malfunction ·SPS MEDICAL·Product code FRG·February 28, 2014

CADHEALTH SYSTEM, MODEL CHP-001

FDA 510(k)
FDA Class 2 ·Cardiovascular

DIGIPAN / DPI

FDA 510(k)
FDA Class 2 ·Dental

MO.MA ULTRA

FDA Adverse Event
Injury ·INVATEC SPA·Product code NTE·April 17, 2013

ACCU-CHEK FLEXLINK PLUS

FDA Adverse Event
Injury ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FPA·April 7, 2011

BLUE MAX BALLOON DILATATION CATHETER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC·Product code LIT·June 18, 2008

ANGIODYNAMICS / SMART PORT

FDA Adverse Event
Malfunction ·ANGIODYNAMICS·Product code LJT·August 21, 2017

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

CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015