13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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I.C. MEDICAL SMOKE EVACUATOR ACTIVATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Synergy
FDA UDI
Rmo, Inc.·00885797101051·SYN RICKETT 18 HK3 5-5 20 EA
ALLthread Titanium
FDA UDI
Biomet Orthopedics, LLC·00880304563698·
SONARMED AIRWAY MONITORING SYSTEM, MODEL 0901
FDA 510(k)
FDA Class 2
·Anesthesiology
SIGNA MFO/I MAGNETIC RESONANCE SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
13MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/360MM-STERILE
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HSB·May 10, 2021
13MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/360MM-STERILE
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HSB·May 10, 2021
ASKU
FDA Adverse Event
Death
·MEDTRONIC MILACA INC.·Product code DTE·November 18, 2010
UNIFY CRT-D
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·January 8, 2013
VASO VIEW HEMOPRO
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·May 9, 2014
Lumbar Laminectomy Pack, part number AMS2501 Lumbar Laminectomy Pack, part number AMS2501(A Lumbar Laminectomy Pack, part number AMS2501(B
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017