13 results
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18ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ELECTRODE, ELECTROSURGERY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Brigade
FDA UDI
Nuvasive, Inc.·00887517960658·Brigade Lateral Trial, 7x34x24mm 8°
Signature III
FDA UDI
Rmo, Inc.·00885797101921·SIG III MBT.022 HK NON-EXT 1CS
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515228641·Lancet Knife 2mmx3mm tip, ang 45deg, 6 1/2"
STEMPRO MSC SFM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
IM-5A INJECTOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
LAND AMERICA HEALTH & FITNESS·Product code FNL·June 30, 2014
ACRYSOF
FDA Adverse Event
Malfunction
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·December 14, 2012
UNKNOWN DEPUY ASR HIP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWY·November 16, 2010
Medtronic Passive Biopsy Needle Kit, Part Number 9733068 - Passive Biopsy Needle Kit. The image guided Passive Biopsy Needle is an accessory instrument with the StealthStation System. The Biopsy Needle is intended to be used for stereotaxy biopsy of brain tissue.
FDA Recall
Terminated
·Medtronic Navigation, Inc.·Product code HAW·July 17, 2015
Medtronic Passive Biopsy Needle Kit, Part Number 9731754 - Passive Biopsy Fee Per Use (FPU) Kit. The image guided Passive Biopsy Needle is an accessory instrument with the StealthStation System. The Biopsy Needle is intended to be used for stereotaxy biopsy of brain tissue.
FDA Recall
Terminated
·Medtronic Navigation, Inc.·Product code HAW·July 17, 2015
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
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023