22 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control
FDA 510(k)
FDA Class 2
·Ophthalmic
ProLift
FDA UDI
Life Spine, Inc.·00190837106010·Static Expandable Cage Trial, 12mm x 28mm x 9mm...
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869607865·TELIX K Ti Cage 16x36mm 5°
REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAM
FDA 510(k)
FDA Class 1
·Physical Medicine
CAMLOG DENTAL IMPLANT ABUTMENTS, HEALING CAPS, AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Dental
KRD DEVICE, EMBOLIZATION, VASCULAR
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·September 19, 2019
AIRFLOW RESUSCITATION BAG
FDA Adverse Event
Injury
·VENTLAB CORP.·Product code BTM·October 2, 2014
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 7, 2013
HIRES 90K
FDA Adverse Event
Injury
·ADVANCED BIONICS LLC·Product code MCM·June 30, 2011
RETRACTA DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Injury
·COOK INC·Product code KRD·June 20, 2019
RETRACTA DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·September 17, 2018
RETRACTA DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·September 17, 2018
RETRACTA DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·January 2, 2020
RETRACTA DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·January 2, 2020
RETRACTA DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·March 11, 2020
RETRACTA DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·July 31, 2019
RETRACTA DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Injury
·COOK INC·Product code KRD·February 25, 2019
RETRACTA DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·February 3, 2020
Precise Digital Accelerator Delivery of radiation to defined target volumes
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 26, 2012
Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 20, 2013