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

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ZAVATION IBF SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197527040·TC Gorney-Freeman Facelift Scissors curved...

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197513890·TC Rees Facelift Scissors straig...

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197513746·TC Rees Facelift Scissors straig...

VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE

FDA 510(k)
FDA Class 2 ·Microbiology

HIGH PRESSURE SETS-400 PSI

FDA 510(k)
FDA Class 2 ·General Hospital

I-FLOW ECLIPSE DISPOSABLE PUMP

FDA Adverse Event
Malfunction ·I-FLOW·Product code MEB·March 16, 2007

BD¿ BLUNT FILTER NEEDLE WITH BLUNT FILL TIP

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code GAA·June 8, 2018

ARCHITECT STAT TROPONIN-I

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code MMI·May 20, 2013

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 26, 2014

LIGAMAX-5MM

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 10, 2011

MICROCLAVE CLEAR CONNECTOR

FDA Adverse Event
Malfunction ·ICU MEDICAL, INC.·Product code FPA·June 5, 2014

BD¿ BLUNT FILTER NEEDLE WITH BLUNT FILL TIP

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code GAA·February 6, 2018

1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Angle Hip Stem, Size #5 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Telephone # +1 201-831-5000 Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 MEYZIEU Cedex France Intended for cementless application in total or hemiarthroplasty procedures.

FDA Enforcement
Class II ·Terminated·Stryker Howmedica Osteonics Corp.·December 18, 2013

Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

FDA Enforcement
Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

FDA Enforcement
Class II ·Terminated·GA Industries·May 6, 2015

Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

FDA Enforcement
Class I ·Ongoing·Covidien·November 8, 2023

The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

FDA Enforcement
Class II ·Ongoing·Abbott Medical·January 1, 2025