12 results
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19ms
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Sources: EU EUDAMED, US FDA
MILENIA(TM) CANNABINOIDS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Printed Lower ROC Pack for Herbst LR7 14mm
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199015680·
Map-iT
FDA UDI
ACCESS POINT TECHNOLOGIES, INC.·00818083010591·Fixed, 10 electrode, CS, 5mm electrode spacing
LH-75 PHOTOTHERAPY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODEL SB100II FINGER PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 14, 2024
TRILOGY 200
FDA Adverse Event
Malfunction
·RESPIRONICS INC.,·Product code CBK·May 7, 2014
HS III PROXIMAL SEAL SYTEM 3.8MM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code DXC·January 4, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·November 10, 2010
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·December 11, 2024
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