16 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
ANGIODYNAMICS / SMART PORT
FDA Adverse Event
Malfunction
·ANGIODYNAMICS·Product code LJT·August 21, 2017
OsteoMed
FDA UDI
OSTEOMED LLC·00845694000796·2.4mm x 14mm Screw
OsteoMed
FDA UDI
OSTEOMED LLC·00845694008297·2.4mm x 14mm Lag Screw
NITINOL TC ELECTRODE
FDA Adverse Event
Malfunction
·COSMAN MEDICAL·Product code GXI·September 6, 2017
OsteoMed
FDA UDI
OSTEOMED LLC·00845694035101·2.4 x 14mm Lag Screw, Sterile
OsteoMed
FDA UDI
OSTEOMED LLC·00845694059763·TAG, MMF SCREW, 14MM
OsteoMed
FDA UDI
OSTEOMED LLC·00845694062855·2.4 x 14mm Screw Sterile Qty 5
OsteoMed
FDA UDI
OSTEOMED LLC·00845694066921·HPS 2.4 x 14mm Lag Screw Sterile Qty 5
PRIME ECG SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE
FDA 510(k)
FDA Class 2
·General Hospital
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 16, 2013
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 5, 2014
MESH - DULEX
FDA Adverse Event
Injury
·DAVOL INC·Product code FTL·April 6, 2011
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