18 results
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31ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ANATOMIC PEEK PTC Cervical Fusion System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169357655·CAGE 5030241 ANATOMIC PTC 14X11X12MM
Latitude™ EV
FDA UDI
TORNIER, INC.·00846832002719·Ulnar Stem - Coated
Gingivamoll opaque 20g
FDA UDI
DETAX GmbH·EDET030241·
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120302411·Diamond, inverted cone, medium grit
ABBOTT STARCLOSE SE
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR·Product code MGB·May 22, 2017
RADIOTHERAPEUTICS RF 3000 RADIOFREQUENCY GENERATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ECAT PET SCANNER
FDA 510(k)
FDA Class 2
·Radiology
ABBOTT VASCULAR CLOSURE DEVICE
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR·Product code MGB·May 22, 2017
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MGB·April 17, 2023
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MGB·April 17, 2023
MAXI MOVE
FDA Adverse Event
Injury
·ARJO HOSPITAL EQUIPMENT AB·Product code FSA·March 28, 2013
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC·Product code GJS·March 21, 2011
X SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·July 15, 2014
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·June 8, 2017
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·June 6, 2017
SAW 20.1X21.4X4.0X0.6MM FOR PIEZOELECTRIC SYSTEM-STER
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code DZI·September 26, 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