11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AOS Fibonacci Lower Extremity Plating System AOS Proximal Tibia Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113554·IMPLANT BLADE 5.2MM (BX/5)
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113516·MINIATURE BLADE #69 (BX/5)
SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTEM, MODELS ABT4510, ABT4512 & ABT4514
FDA 510(k)
FDA Class 2
·Anesthesiology
INTUITIVE SURGICAL DA VINCI ENDOSCOPIC CONTROL SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DA VINCI ROBOTICS SYSTEM
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC.·Product code NAY·October 21, 2003
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·October 8, 2008
UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·August 5, 2011
PINNACLE MTL INS NEUT36IDX54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·July 2, 2013
IMPELLA 5.5
FDA Adverse Event
Injury
·ABIOMED, INC.·Product code OZD·December 31, 2024
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