9 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFICATION TO URESTA PESSARY
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES, MODEL 87
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
V-GNATHOS SUPRA
FDA 510(k)
FDA Class 2
·Dental
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·INVAMEX·Product code FSA·April 29, 2013
ACCU-CHEK AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 24, 2008
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·May 10, 2011
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code LZO·April 24, 2026
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