14 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MAMMOSITE CAVITY EVALUATION DEVICE
FDA 510(k)
FDA Class 2
·Radiology
SUPER NOVA, ACUBEAM
FDA 510(k)
FDA Class 2
·Physical Medicine
DELDENT ULTRASONIC INSERTS
FDA 510(k)
FDA Class 2
·Dental
QUATTRODE LEAD WIDE SPACED, 60 CM
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code LGW·May 1, 2024
QUATTRODE LEAD WIDE SPACED, 90 CM
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code LGW·December 8, 2023
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 26, 2013
FUSION NAVIGATION SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 21, 2011
LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)
FDA Adverse Event
Injury
·COSTA RICA·Product code LTI·July 23, 2008
QUATTRODE LEAD WIDE SPACED, 60 CM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZF·December 19, 2014
INDUCTIGRAFT
FDA Adverse Event
Injury
·BAXTER APATECH LTD·Product code MQV·January 16, 2014
INDUCTIGRAFT
FDA Adverse Event
Injury
·BAXTER APATECH LTD·Product code MQV·June 10, 2013
A.L.P.S. - Medium Bone Plate Forceps. Orthopedic manual surgical instrument.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·July 22, 2015
INDUCTIGRAFT
FDA Adverse Event
Injury
·BAXTER APATECH LTD·Product code MQV·February 16, 2012
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