20 results · 22ms · Sources: EU EUDAMED, US FDA

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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