13 results
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21ms
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Sources: EU EUDAMED, US FDA
MINRAD INC. NASAL SCAVENGING CIRCUIT
FDA 510(k)
FDA Class 2
·Anesthesiology
Genius Total Knee System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215021979·
Crescendo Meniscal Insert CR Ultracongruent 11mm Size 5
FDA UDI
AMPLITUDE SAS·03701089524704·
MEDTRONIC SOFAMOR DANEK CEMENT RESTRICTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC)
FDA 510(k)
FDA Class 2
·Anesthesiology
QUADRA H FEMORAL STEM SIZE 3 LATERALIZED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·September 5, 2014
SPECTRA WAVEWRITER?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 4, 2025
SIMULUS SEMI-RIGID ANNULOPASTY RING
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 10, 2020
EXTRACTION SCREWDRIVER
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HXX·April 23, 2013
QUICK FLEX LV LEAD
FDA Adverse Event
Death
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code OJX·April 28, 2011
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008
Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021
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