12 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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nSpire Health
FDA UDI
NSPIRE HEALTH, INC.·00852417003118·Bronchial Challenge Kit, Disposable (single pat...
LIVESIRE ELECTROPHYSIOLOGY CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Reicodent
FDA UDI
devemed GmbH·04061644048236·Mouth mirror handle | M 2.5
hollow, chromium
Mariner Outrigger
FDA UDI
Seaspine Orthopedics Corporation·10889981173746·Closed, Axial Rod, Long, 380mm
MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL FLUOROSCOPY
FDA 510(k)
FDA Class 2
·Neurology
INFUSOR SV, INFUSOR LV, BAXTER PAIN MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
PENUMA IMPLANT
FDA Adverse Event
Injury
·NATIONAL MEDICAL DEVICES INC.·Product code MIB·March 1, 2018
IN TOUCH ZU
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·March 27, 2013
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·March 17, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·March 27, 2008
STOCKERT CORONARY PERFUSION CANNULAE
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DWF·March 7, 2019
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