10 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SMITH & NEPHEW FEMORAL HEADS
FDA 510(k)
FDA Class 2
·Orthopedic
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197152143·Austin Micro Suture Typing Forceps
0.8mm ...
MODIFICATION TO HI-TORQUE WHISPER LS AND MS GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING
FDA 510(k)
FDA Class 2
·Cardiovascular
AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JSM·April 25, 2018
ENDURANT II ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code MIH·March 27, 2013
ATTAIN OTW
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·March 18, 2011
EAGLE 4000
FDA Adverse Event
Malfunction
·GE HEALTHCARE·Product code MHX·March 20, 2008
Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water - in some cases small quantities of disinfectant solutions - for dental treatments. The bottle is pressurized on the device during use. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 2024
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