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

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STERILOX LIQUID CHEMICAL STERILANT SYSTEM

FDA 510(k)
FDA Class 2 ·General Hospital

Navagio

FDA UDI
Kalitec Direct LLC·B07330K0132100·Trial, TLIF, 27L OB CRV 7Deg, 10mm

Navagio

FDA UDI
Kalitec Direct LLC·B07330K0132080·Trial, TLIF, 27L OB CRV 7Deg, 8mm

NIDO Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07315K0132000·Rod Reducer, Axial, NIDO

HUB SPIN-LOC THREADED LOCKING OEM

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FPA·April 9, 2021

VARIANT II TOTAL GHB

FDA 510(k)
FDA Class 2 ·Hematology

TITANIUM COMPRESSION ANCHOR SYSTEM MODEL VERSION 2

FDA 510(k)
FDA Class 2 ·Orthopedic

ULTRA DRIVE 6MM PLUG PULLER

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JDX·July 20, 2022

BURRS

FDA Adverse Event
Malfunction ·MANSFIELD MANUFACTURING SITE·Product code HAB·March 20, 2013

INJECTOR, OPTIVANTAGE DH W/RFID

FDA Adverse Event
Injury ·LIEBEL-FLARSHEIM CO.·Product code IZQ·March 8, 2011

PULMONETIC

FDA Adverse Event
Malfunction ·CARDINAL HEALTH 203/PULMONETIC SYSTEMS, INC·Product code CBK·March 14, 2008

ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAT·March 9, 2022

PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code NEW·March 9, 2022

HUB SPIN-LOC THREADED LOCKING OEM

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FPA·March 19, 2021

ACTIVA

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·August 15, 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

Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022