17 results
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19ms
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Sources: EU EUDAMED, US FDA
REAADS ANTI-SM TEST KIT
FDA 510(k)
FDA Class 2
·Immunology
GRASPING FORCEP INSERT
FDA UDI
SONTEC INSTRUMENTS, INC.·B09929012300·GRASPING FORCEPS DOUBLE-ACTION SHARP CROSS-WISE...
Mariner
FDA UDI
Seaspine Orthopedics Corporation·10889981140557·Head Inserter
Invenio
FDA UDI
GRI Medical & Electronic Technology Co., Ltd.·16931918157948·Surgical Gown_Set-In Sleeve_W/reinforcement_XL_...
Invenio
FDA UDI
GRI Medical & Electronic Technology Co., Ltd.·16931918156248·Surgical Gown_Set-In sleeve_reinforcement_XL_No...
TCP
FDA UDI
WRIGHT MEDICAL TECHNOLOGY, INC.·00840420170224·
HDR PROSTATE TEMPLATE AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Radiology
HEARING AID, UNITRON MODEL C4-55
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Alleset
FDA UDI
GRI Medical & Electronic Technology Co., Ltd.·16931918190389·Alleset Gown_W/reinforcement_X-Large_Handi-Bin_...
RIATA ACTIVE FIXATION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·June 30, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 8, 2013
OPTICAL MODULE II
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code ISN·November 17, 2010
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·November 6, 2024
BD SYRINGE WITH NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·December 4, 2019
Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
FDA Enforcement
Class I
·Ongoing·Zyno Medical LLC·June 18, 2025
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
The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·April 10, 2019