13 results · 22ms · Sources: EU EUDAMED, US FDA

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K-ETCHANT GEL

FDA 510(k)
FDA Class 2 ·Dental

iDMS™ Data Management System

FDA UDI
ACCURAY INCORPORATED·M65810624090·Software, iDMS™ Data Management System, (Versio...

OsteoMed

FDA UDI
OSTEOMED LLC·00845694018715·2.4mm x 9mm Lag Screw

OsteoMed

FDA UDI
OSTEOMED LLC·00845694066822·HPS 2.4 x 9mm Lag Screw Sterile Qty 5

BHR MODULAR HEAD 46MM

FDA Adverse Event
Injury ·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code KWY·January 4, 2018

MAXONE, BLOOD, BLOOD PRODUCTS AND IV FLUID WARMER

FDA 510(k)
FDA Class 2 ·General Hospital

LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

56MM AND R3 ACETABULAR SHELL

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code MBL·September 14, 2018

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 16, 2013

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 5, 2014

840 VENTILATOR

FDA Adverse Event
Malfunction ·PURITAN BENNETT CORP.·Product code CBK·March 18, 2011

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