14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CLINIQA LIQUID QC CARDIAC MARKER CONTROL SP, LEVELS 1,2, &3
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Sklar®
FDA UDI
SKLAR CORPORATION·10649111155864·SCALPEL HANDLE #3 XL 10"
SURGI-VISION PROSTATE COIL
FDA 510(k)
FDA Class 2
·Radiology
FRONTIER ANTERIOR SCOLIOSIS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
INTERSTIM
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·January 24, 2013
WATCHPAT100
FDA Adverse Event
Injury
·ITAMAR MEDICAL LTD.·Product code MNR·November 12, 2007
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·March 5, 2014
INTERSTIM
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·January 15, 2013
ACRYSOF
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD./ HUNTINGTON·Product code HQL·April 12, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 21, 2011
ANGIOGUARD RX ECGW 6MM X 180CM - EXTRA SUPPORT
FDA Adverse Event
Injury
·CORDIS CORPORATION·Product code NTE·June 19, 2008
AXON ECLIPSE CONTROLLER
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC·Product code GWF·October 4, 2013
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