14 results
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30ms
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Sources: EU EUDAMED, US FDA
KYMCO FORU, MODEL EQ10
FDA 510(k)
FDA Class 2
·Physical Medicine
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702248081·Elvarex 2/Thigh High/Slant-Open Toe-Elephantias...
BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES
FDA 510(k)
FDA Class 1
·Dental
ACCESS UNCONJUGATED ESTRIOL CALIBRATORS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·January 9, 2012
QUILL SRS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·August 24, 2009
Micropuncture
FDA UDI
COOK INCORPORATED·00827002131170·Micropuncture, Introducer Set Push-Plus Design ...
URETEX SUPPORT PP TRANSOBTUR2 KIT X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code OTN·April 22, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 10, 2011
DIMENSION CLINICAL CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code MMI·July 25, 2008
HOLDER FOR REAMING GUIDES
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS INC US·Product code LXH·February 25, 2022
COOK Stiffened Micropuncture Introducer Set, 4 FR. Product Reorder Number: MPIS-401-20.0-SC-UA-082900
FDA Recall
Terminated
·Cook, Inc.·Product code DYB·November 25, 2002
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