21 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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V60 VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC·Product code MNT·July 9, 2015
V60 VENTILATOR, MODEL V8000
FDA 510(k)
FDA Class 2
·Anesthesiology
V60 VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC·Product code MNT·August 3, 2015
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16740826600·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674082660060·
Centaur Pedicle Screw System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215127039·
Zavation
FDA UDI
Zavation LLC·00842166150065·8x26x60mm, 0°, MILC
Zavation
FDA UDI
Zavation LLC·00842166150812·8x26x60mm, 6°, MILC
HARDYDISK LOMEFLOXACIN, 10MCG
FDA 510(k)
FDA Class 2
·Microbiology
GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HOLDER F/SET F/BONEGRAFT-HARVEST INCL NO
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWX·April 29, 2013
PRECISE PRO RX CAROTID STENT SYSTEM
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code NIM·May 10, 2011
GUIDE PIN
FDA Adverse Event
ARTHREX ARTHROSCOPY INSTRUMENTS, INC.·Product code MDM·July 16, 2008
LARGE EX-FIX COMBINATION CLAMP MR-CONDITIONAL
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
SELDRILL-SCHANZSCR Ø5 L200/80 SST
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
LARGE EX-FIX 11MM CRBN FBR ROD 250MM / MR-CONDITIONAL
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
LARGE EX-FIX 11MM CRBN FBR ROD 300MM / MR-CONDITIONAL
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
SELDRILL-SCHANZSCR Ø5 L200/80 SST
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
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