13 results
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18ms
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Sources: EU EUDAMED, US FDA
EKOS PERIPHERAL INFUSION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
PLIF
FDA UDI
Nuvasive, Inc.·00887517242679·PLIF Broach, 14x9mm Guided Micro
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033214·Baltic Denture System BDLoad BDLoad Lw6 PLSEbi...
Humelock Reversed Shoulder
FDA UDI
FX SOLUTIONS·03701037307854·TRIAL HUMELOCK REVERSED STEMI Ø32/14
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0132140·Trial, TLIF, 27L OB CRV 7Deg, 14mm
SMITH & NEPHEW PISTONS
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
CEREBRAL BLOOD FLOW ANALYSIS SYSTEM (CBP), MODEL NUMBER CSCP-001A
FDA 510(k)
FDA Class 2
·Radiology
INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·December 2, 2024
ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIO·April 3, 2013
30 INCH TRANSPORT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·February 28, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 25, 2014
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024