12 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Toro-L Interbody Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
18M - Burn Relief
FDA UDI
Certified Safety Manufacturing, Inc.·00766588030319·18M - Burn Relief
16PW - Burn Relief
FDA UDI
Certified Safety Manufacturing, Inc.·00766588030302·16PW - Burn Relief
Needle aspiration and injection
FDA UDI
KATENA PRODUCTS, INC.·00841668113639·RETROBULBAR NEEDLE 25GA 38MM
Oph. Cystotomes
FDA UDI
KATENA PRODUCTS, INC.·00841668113707·CYSTOTOME FORMED 23GA
AGILENT COMPONENT MONITORING SYSTEM, AGILENT V24/26, AGILENT BIS MODULE, MODEL M1175A/76A/77A,REV.L,M1205A,REV.L,M1034A
FDA 510(k)
FDA Class 2
·Neurology
DUET DRF
FDA 510(k)
FDA Class 2
·Radiology
CAPSUREFIX
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 18, 2014
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·July 2, 2013
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·December 15, 2016
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