12 results · 19ms · Sources: EU EUDAMED, US FDA

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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