19 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Root canal posts Mooser
FDA UDI
Cendres+Métaux SA·07640166518952·Root canal posts Mooser
Adhesive head Ceramicor...
Needle Holder
FDA UDI
KATENA PRODUCTS, INC.·00841668115930·NeedleHldr, Cvd W/Lock, Del., Titanium
VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT
FDA 510(k)
FDA Class 2
·Immunology
URANUS, COMFORTOUCH LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RU NOVOSIBIRSK
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·October 16, 2013
SPINEMED TABLE - FDA 510(K) K051013
FDA Adverse Event
Other
·CERT HEALTH SCIENCES, LLC·Product code ITH·July 16, 2007
ST JOSEPHS PHOENIX, AZ 1
FDA Adverse Event
Malfunction
·SORIN GROUP USA·Product code DWF·July 31, 2009
RU NOVOSIBRIRSK
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·April 11, 2013
RU NOVOSIBIRSK
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DWF·October 16, 2013
CP87170 DE MUENCHEN
FDA Adverse Event
Death
·SORIN GROUP ITALIA·Product code DTZ·July 15, 2011
ATTAIN OTW
FDA Adverse Event
Injury
·MPRI·Product code LWP·April 10, 2013
IDENTITY DR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·May 27, 2008
EON RECHARGEABLE IPG, 16-CHANNEL
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEURMODULATION DIV.·Product code LGW·April 4, 2011
CP87641 GB SOUTHAMPTON
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DWE·March 22, 2010
MENTOR MEMORYGEL XTRA BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·November 5, 2025
D 100 PH.I.S.I.O. NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH RESERVOIR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA S.R.L.·Product code DTZ·March 28, 2017
Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 8000 is a fully automated system for clinical chemistry analysis.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·December 12, 2012
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