10 results
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36ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BIOPRO GO-EZ SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014609898·MIDMARK 2" SOFTCARE
DISPOSABLE BENDING CANNULA PR-233Q
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MODEL 750 WARMING UNIT, BAIR HUGGER BLANK
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 7, 2025
SOCKET WRENCH FOR 12PT NUT 11MM WIDTH ACROSS FLATS
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code HXC·April 26, 2013
DEFINIUM 8000
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS, LLC·Product code KPR·April 14, 2011
VAXCEL PASV PICC
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code LJS·July 11, 2008
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