18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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