9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RESUSCITATION TIMER, MODEL L770-CPR
FDA 510(k)
FDA Class 2
·Anesthesiology
High Density 144 Sublative iD (20 Pulse), 10-Pk
FDA UDI
SYNERON MEDICAL LTD·37290109952209·High Density 144 Sublative iD (20 Pulse), 10-Pk
VERCISE CARTESIA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·October 12, 2020
NSI HEXED AND NON-HEXED IMPLANT SYSTEM AND IMMEDIATE LOADING
FDA 510(k)
FDA Class 2
·Dental
3420 DIGIT PULSE OXIMETER, MODEL 3420
FDA 510(k)
FDA Class 2
·Cardiovascular
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JJE·April 23, 2013
COLLEAGUE CXE VOLUMETRICINFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·April 29, 2011
RIATA PASSIVE FIXATION LEAD
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 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