20 results
·
22ms
·
Sources: EU EUDAMED, US FDA
HEMESPEC II
FDA 510(k)
FDA Class 2
·Hematology
Leica Biosystems
FDA UDI
Leica Biosystems Richmond, Inc.·10849832027055·CLEAR BASE MOLDS 8X10 400/BOX
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515211117·Castro Micro Corn Sci, left
Rampart-O
FDA UDI
SPINEOLOGY INC.·M7402803015·Rampart-O
Rampart-O
FDA UDI
SPINEOLOGY INC.·M7403803015·Asm, Rampart-O
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PLATE CDC ANAEROBE 5% SB 100 EA JP
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·September 9, 2021
COBAS C 503 ANALYTICAL UNIT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·October 16, 2024
COBAS C 503 ANALYTICAL UNIT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·October 8, 2024
COBAS C 503 ANALYTICAL UNIT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·November 6, 2024
PLATE CDC ANAEROBE 5% SB 20 EA
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JSG·June 28, 2021
SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 9, 2014
GORE VIABIL BILIARY ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code FGE·October 16, 2012
EZLIFT
FDA Adverse Event
Injury
·EZ WAY, INC.·Product code FNG·August 10, 2010
COBAS C 303 ANALYTICAL UNIT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·July 22, 2024
COBAS C 503 ANALYTICAL UNIT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·October 31, 2024
PLATE CDC ANAEROBE AGAR 5% SB 90MM 20
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JSG·February 17, 2022
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
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018