15 results
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30ms
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Sources: EU EUDAMED, US FDA
FOLATE 125I RADIOIMMUNOASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CODMAN® HARDY™
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780517184·CODMAN® HARDY™ Bayonet Bipolar Forceps Insulate...
CODMAN HARDY
FDA UDI
Cerenovus, Inc.·10886704039570·CODMAN HARDY Bayonet Bipolar Forceps Insulated ...
APK
FDA UDI
APK Technology Co.,Ltd.·06946725536544·BCI Compatible sensor, 3 foot cable:Multi-site ...
SuperCable® ISO-Elastic™ Cerclage System
FDA UDI
Kinamed, Inc.·00818720013299·TalonPasser™, Large, 60mm
REPROCESSED HARMONIC SCALPEL
FDA 510(k)
FDA Unclassified
·Unknown
PLASMAKINETIC GENERATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UNKNOWN CUP
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·December 19, 2017
M-1 COT - BASE HIGH LOAD 28
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·May 9, 2014
NOVASURE IMPEDANCE CONTROLLED EA SYSTEM
FDA Adverse Event
Injury
·HOLOGIC·Product code MNB·October 17, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 26, 2007
M2A-MAGNUM MOD HEAD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·April 22, 2020
M2A-MAGNUM PF CUP
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·April 22, 2020
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