13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VITALMIX (SET & BAG)
FDA 510(k)
FDA Class 2
·General Hospital
TI SCREW ES
FDA UDI
Biomet Orthopedics, LLC·00880304432109·
3M™ Victory Series™
FDA UDI
3M UNITEK CORPORATION·00652221112514·3M™ Victory Series™ First Molar Bands, 902-482,...
VISION 9000 PHASED ARRAY TORSO COIL
FDA 510(k)
FDA Class 2
·Radiology
TISSU TRANS FILTRON, MODELS 3-TT-FILTRON 2000-500
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·May 7, 2014
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
JUMAO MEDICAL EQUIPMENT·Product code IOR·January 8, 2013
LD304 MATERNITY BED
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIV.·Product code HDD·November 12, 2010
TO GORE-TEX® STRETCH VASCULAR GRAFT
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code DSY·July 27, 2021
GORE-TEX® STRETCH VASCULAR GRAFT
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code DSY·July 27, 2021
GORE-TEX® STRETCH VASCULAR GRAFT
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code DSY·July 27, 2021
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025
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