20 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NuVasive Modulus XLIF Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
HHM
FDA UDI
Oticon A/S·05707131357441·G300 SC, MINIRITE R LI-ION 2.4G C046 HHM
CODMAN
FDA UDI
Cerenovus, Inc.·10886704001706·CODMAN SLIM-LINE Aneurysm Clip 45 Degree Angle ...
NA
FDA UDI
Synthes GmbH·10886982142580·2.4MM CORTEX SCREW 3.5MM HEAD/SELF-TAPPING 44MM
ABSORBENT PAPER POINTS
FDA UDI
DiaDent Group International·08806383554602·"An absorbent paper points is an endodontic pap...
ABSORBENT PAPER POINTS
FDA UDI
DiaDent Group International·08806383512817·"An absorbent paper points is an endodontic pap...
CLC2000 CATHETER PATENCY DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8
FDA 510(k)
FDA Class 2
·Neurology
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·November 23, 2011
ONYX
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA·Product code MFE·August 4, 2016
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE REHABILITATION EQUIP·Product code ITI·October 27, 2014
UNKNOWN ZIMMER POLY LINER
FDA Adverse Event
Injury
·ZIMMER INC·Product code JDI·June 28, 2013
CONCERTO II CRT-D
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code NIK·August 11, 2011
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·January 31, 2012
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·November 23, 2011
SYNCHROMED II
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·November 21, 2016
UNK BACTISEAL CATHETER
FDA Adverse Event
Injury
·Product code JXG·March 24, 2017
COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·September 26, 2016
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
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