19 results
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27ms
·
Sources: EU EUDAMED, US FDA
TEKNO-MEDICAL OBSTETRICAL FORCEPS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304045693·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304045686·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304045716·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304045723·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304045709·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304045662·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304045679·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304045747·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304045730·
C1-INHIBITOR MICROTITER ASSAY DEVICE
FDA 510(k)
FDA Class 2
·Immunology
OPC OXYGEN CONSERVING REGULATOR, MODEL AHG 1968, LIN-7005, MDL-7609, MEM-7612, OPC-830
FDA 510(k)
FDA Class 2
·Anesthesiology
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·March 20, 2013
TAPERLOC MICROPLASTY FEMORAL 11MM X 107.5MM POROUS
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code MBL·March 10, 2011
HYLAMER 10D 60 OR 72ODX32ID
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWY·March 13, 2008
HEARTMATE 3 LVAS IMPLANT KIT
FDA Adverse Event
Death
·THORATEC CORPORATION·Product code DSQ·December 16, 2020
GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·December 28, 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
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022