14 results · 21ms · Sources: EU EUDAMED, 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