15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODULAR FOOT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO AGILENT COMPONENT MONITORING SYSTEM (CMS), V24/V26 PATIENT MONITORS, BLOOD ANALYSIS PORTAL SYSTEM PLUG-I
FDA 510(k)
FDA Class 2
·Cardiovascular
REFINITY SYSTEM, REFINITY HANDPIECE AND CABLE, REFINITY FOOTSWITCH, REFINITY POWER CORD, MODEL V5100-00,V5701-00,V5702
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 29, 2024
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
MEDEL S.P.A.·Product code BTI·April 23, 2013
CROSSER 14P RX
FDA Adverse Event
Injury
·BARD·Product code DQY·April 18, 2011
DAMON COPPER NITI WIRE
FDA Adverse Event
Malfunction
·ORMCO CORPORATION·Product code DZC·July 11, 2008
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 10, 2021
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·May 28, 2022
DIMENSION EXL WITH LM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JJE·June 13, 2013
PROFILE 3D
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·July 30, 2021
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·July 22, 2021
DIMENSION EXL 200
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code JJE·July 23, 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
Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·November 9, 2016