11 results
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27ms
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Sources: EU EUDAMED, US FDA
DSL ANDROSTANEDIOL GLUCURONIDE (DSL #6000)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Brigade
FDA UDI
Nuvasive, Inc.·00887517964274·Brigade Lateral Trial, 15x34x24mm 8°
Map-iT
FDA UDI
ACCESS POINT TECHNOLOGIES, INC.·00818083016043·STR, 4 electrode, MPD-CS-M, 2mm electrode spacing
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 11, 2020
V. MUELLER CAMERA CONTROLLER WITH STORAGE CART
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP
FDA 510(k)
FDA Class 2
·General Hospital
CURRENT ACCEL VR, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·June 30, 2014
GORE TAG THORACIC ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·January 3, 2013
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code LFR·October 26, 2007
OPTETRAK HI-FLEX TIBIAL INSERT SZ 3 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 18, 2023
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