10 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO PYRENEES CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·10304040064853·MOLAR BAND LR 1ST 35.5 (2)
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496063544·SOCKS FOR YOU BAMBOO TYPE, SIZE M, BLU NAVY, GR...
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096
FDA 510(k)
FDA Class 2
·Hematology
GENZYME CONTRAST II HCG URINE/SERUM TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·April 12, 2013
UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·April 19, 2011
ELECSYS 2010 RACK
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code MMI·June 20, 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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015