19 results
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36ms
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Sources: EU EUDAMED, US FDA
AMS SACRAL COLPOPEXY SLING, MODEL 72403501
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BIODESIGN URETHRAL SLING
FDA Adverse Event
Injury
·COOK BIOTECH·Product code FTM·July 29, 2013
Zirlux
FDA UDI
HENRY SCHEIN, INC.·H65890109310·Zirlux Bite Ver Cyl N Eng
Intess L
FDA UDI
Kalitec Direct LLC·B07312K0100310·Assembly,Caddie, Lumbar Implants, Hinged
Matira
FDA UDI
Kalitec Direct LLC·B073DRK010031·Drill Guide, Straight, Featureless, Amann
A NEW DAY
FDA UDI
FGX INTERNATIONAL INC.·00193033344224·
A NEW DAY
FDA UDI
FGX INTERNATIONAL INC.·00193033249017·
Inseption
FDA UDI
Kalitec Direct LLC·B07314K0100310·Assembly, Caddie, ISP Implants, Hinged
A NEW DAY
FDA UDI
FGX INTERNATIONAL INC.·00191905788794·
A NEW DAY
FDA UDI
FGX INTERNATIONAL INC.·00193033249000·
A NEW DAY
FDA UDI
FGX INTERNATIONAL INC.·00193033248997·
MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·May 23, 2008
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/AEROSET
FDA 510(k)
FDA Class 2
·Immunology
AU5 ULTRASOUND IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
ALARIS PUMP MODULE
FDA Adverse Event
Injury
·CAREFUSION CORP.·Product code FRN·March 14, 2013
OCTRODE PERCUTANEOUS LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 4, 2011
TENDRIL ST
FDA Adverse Event
Injury
·ST JUDE MEDICAL AB·Product code DTB·March 10, 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