12 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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ISOLA SPINAL SYSTEMS
FDA 510(k)
FDA Class 2
·Orthopedic
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033449011·
MTG - MINITUB HEATED STAGE SYSTEMS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
NAVIGUS TRAJECTORY GUIDE BIOPSY KIT, MODELS BK-7000 AND 8000
FDA 510(k)
FDA Class 2
·Neurology
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/17MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·May 12, 2022
4-CH DBS EXTENSION KIT, 50CM
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code MHY·June 19, 2025
UNK BACTISEAL CATHETER
FDA Adverse Event
Injury
·Product code JXG·November 20, 2017
TERUMO PERFUSION SYSTEM 8000
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·March 1, 2013
MBT POR KEEL TIB TRAY SZ5
FDA Adverse Event
Injury
·DEPUY (IRELAND)·Product code NJL·February 24, 2011
TAXUS EXPRESS2 PACLITAXEL - ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code NIQ·March 13, 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
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025