14 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BLACK COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
MICRO-TOUCH
FDA UDI
Ansell Healthcare Product·20884792040529·MICRO-TOUCH Nitrile EP S405 313025 Size M, Nitr...
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091034052·Baltic Denture System BDLoad BDLoad Mn6 PLSEbi...
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710410340520·Anterior Closing Osteotomy Guide, 34mm x 52mm
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710420340520·Anterio Lateral Closing Wedge Osteotomy Guide, ...
EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL
FDA 510(k)
FDA Class 2
·Cardiovascular
MERIT MEDICAL 1-ML SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
466FXXXX
FDA Adverse Event
Injury
·CORDIS CASHEL·Product code DTK·November 19, 2018
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·April 3, 2013
PFC SIG MOD TIB TRAY CEM SZ2.5
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code JWH·March 24, 2011
TRUWAVE DISPOSABLE PRESSURE TRANSDUCER W/VAMP KIT
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DRS·April 24, 2008
UC-PLUS Solution Unicondylar Knee System, Model Numbers: 26014 Femoral Component Size 4, 26016 Femoral Component Size 6, 26018 Femoral Component Size 8 and 26020 Femoral Component Size 10
FDA Recall
Terminated
·Plus Orthopedics USA·Product code HRY·July 18, 2006
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
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012