10 results · 27ms · Sources: EU EUDAMED, US FDA

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MINOCYCLINE 30MCG. SENSI DISC

FDA 510(k)
FDA Class 2 ·Microbiology

ACUMED

FDA UDI
Acumed LLC·10806378095320·12mm x 14mm Concave Joint Reamer

TREATVISION

FDA 510(k)
FDA Class 2 ·Radiology

LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002

FDA 510(k)
FDA Class 2 ·Orthopedic

HEARTSINE SAMARITAN 300P AND PAD PAK

FDA Adverse Event
Malfunction ·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·February 12, 2014

FREESTYLE FLASH

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·August 22, 2007

RESTORE ADVANCED

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 28, 2015

ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 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

ACCOLADE SR SL MRI (Model L310)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025