12 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SPINAL ELEMENTS BUTTRESS PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Epimed
FDA UDI
EPIMED INTERNATIONAL, INC·00818788023513·RX Coudé® Epidural Needle with Small Bore Conne...
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756140133·OEM Foley Catheter
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 9, 2020
ALUMINUM OXIDE POWDER, SUMICORUNDUM AAO4S
FDA 510(k)
FDA Class 2
·Dental
ULTRAGUIDE MR-GUIDE 3000
FDA 510(k)
FDA Class 2
·Radiology
NDEHP PRIMARY PLUM PREPIERCED Y
FDA Adverse Event
Malfunction
·HOSPIRA HOLDINGS DE COSTA RICA LTD.·Product code FRN·April 25, 2013
SYRINGE 10ML LL TIP BULK CONVENIENCE PAK
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·July 16, 2021
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·April 26, 2013
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·April 22, 2011
MEMORY HERNIA LARGE PATCHES
FDA Adverse Event
Injury
·Product code FTL·July 24, 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