14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GE DISCOVERY NM/CT 570C
FDA 510(k)
FDA Class 2
·Radiology
N/A
FDA UDI
GEORGE TIEMANN & CO.·B582083504·INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
MODIFICATION TO: ECAT LSO PET/CT SCANNER
FDA 510(k)
FDA Class 2
·Radiology
RT-PLUS MODULAR CEMENTED KNEE COMPONENTS
FDA 510(k)
FDA Class 2
·Orthopedic
PRECISION XTRA
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code CGA·July 27, 2016
ENDURANT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·April 29, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 10, 2011
STERRAD NX STERILIZER
FDA Adverse Event
Injury
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·July 29, 2008
PRECISION XTRA
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code NBW·October 19, 2016
PRECISION XTRA
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code NBW·July 26, 2016
BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·June 6, 2018
PINNACLE SECTOR II CUP 60MM
FDA Adverse Event
Injury
·. DEPUY ORTHOPAEDIC INC, 1818910·Product code KWA·May 25, 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