10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SELF-ADHESIVE RESIN CEMENT
FDA 510(k)
FDA Class 2
·Dental
VERTE-STACK ANATOMIC PEEK STRUT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MQP·May 5, 2020
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 7, 2022
BIOSCANNER PLUS; LIPID PANEL TEST STRIPS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ASPIRE COVERED STENT AND DELIVERY CATHETER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
XIA 3 TITANIUM BLOCKER
FDA Adverse Event
Malfunction
·STRYKER SPINE-SWITZERLAND·Product code MNI·January 21, 2016
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·April 23, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·April 29, 2011
DURATA STS OPTIM ACTIVE-FIXATION LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008
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