10 results
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28ms
·
Sources: EU EUDAMED, US FDA
INTEGRATED BRACHYTHERAPY UNIT - DIGITAL
FDA 510(k)
FDA Class 2
·Radiology
Trumpf Medical
FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761979970·Universal section H V U
Back Section PST500
FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761973657·Universal section H V U
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 16, 2022
LIFEPAK 12DEFIBERLLATOR/MONITOR SERIES
FDA 510(k)
FDA Class 3
·Cardiovascular
EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
2.7MM/3.5MM VA-LCP OLECRANON PL 6H/LT/142MM
FDA Adverse Event
Malfunction
·SYNTHES ELMIRA·Product code HRS·April 23, 2013
BIOCOMPOSITE INTER- FERENCE SCREW
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code MAI·April 29, 2011
30MAY200CAPSURE SP NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 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