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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MICROSELECTRON HDR V2, MODEL 105.999
FDA 510(k)
FDA Class 2
·Radiology
Delta
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613327594928·Twist drill hex end
LEONE SPA
FDA UDI
LEONE SPA·08033707065708·INTRAORAL ELASTICS 4,5 oz 1/4" red
N PROTEIN STANDARD SL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PLAGIOCEPHALIC APPLIED PRESSURE ORTHOSIS P.A.P. ORTHOSIS
FDA 510(k)
FDA Class 2
·Neurology
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·May 3, 2013
NEXGEN LPS-FLEX PROLONG ARTICULAR SURFACE
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·May 11, 2011
ONE TOUCH ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·July 31, 2008
FAST-FIX 360 CURVED NDL DELIVERY SYS
FDA Adverse Event
Malfunction
·SMITH & NEPHEW, INC.·Product code GAT·July 5, 2023
INNOVA 3100-IQ
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS SCS·Product code OWB·May 30, 2017
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 25, 2025
ACMI REF E-9F Electrohydraulic Lithotripsy Probe, 9 FR x 60CM
FDA Recall
Terminated
·ACMI CORPORATION·Product code FFK·April 30, 2004
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