12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STARLIGHT
FDA 510(k)
FDA Class 2
·Neurology
SYNTHES 2.4 MM CANNULATED SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA
FDA 510(k)
FDA Class 2
·Immunology
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·June 11, 2021
HEARTSTART XL
FDA Adverse Event
Injury
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 23, 2013
DERMABOND TOPICAL SKIN ADHESIVE
FDA Adverse Event
Other
·CLOSURE MEDICAL CORP.·Product code MPN·July 23, 2008
SULZER UNIVERSAL DISTAL STEM CENTRALIZER
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JDI·May 3, 2011
T-PAL SPACER APPLICATOR HANDLE
FDA Adverse Event
Injury
·SYNTHES HAGENDORF·Product code LXH·August 26, 2015
BD POSIFLUSH SP PRE-FILLED FLUSH SYRINGE NACL 0.9%
FDA Adverse Event
Injury
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·July 1, 2021
T-PAL SPACER APPLICATOR INNER SHAFT
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code MAX·April 8, 2019
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