12 results · 23ms · Sources: EU EUDAMED, US FDA

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CLAVIS

FDA 510(k)
FDA Class 2 ·Anesthesiology

BHR MODULAR HEAD 46MM

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

S/5 COMPACT ANESTHESIA MONITOR WITH S-00A05, S-00A06. L-00A07, L00A08

FDA 510(k)
FDA Class 2 ·Cardiovascular

MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

56MM AND R3 ACETABULAR SHELL

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

STONEBREAKER SINGLE USE PROBE

FDA Adverse Event
Malfunction ·COOK INC·Product code FFK·March 28, 2018

THORACIC PEDICLE PROBE

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code HXX·April 17, 2013

ENDOTAK RELIANCE

FDA Adverse Event
Malfunction ·CPI - DEL CARIBE·Product code LWS·April 19, 2011

UNKNOWN DEPUY CUP

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWB·June 17, 2008

TAMPONADE URETERINE BALLOON CATHETER SET

FDA Adverse Event
Injury ·COOK UROLOGICAL·Product code KNA·October 16, 2007

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