10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Model 9160 VitaloQUB
FDA 510(k)
FDA Class 2
·Anesthesiology
DURALOC
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295107019·DURALOC SCREW-IN TRIAL LINER 32mm ID 58mm OD NE...
FIBERFILL AGP
FDA 510(k)
FDA Class 2
·Dental
URSA ANGIOGRAPHIC CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·July 13, 2018
TENDRIL SDX
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2008
HYDROSET INJECTABLE CEMENT KIT 10CC
FDA Adverse Event
Other
·STRYKER ORTHOPAEDICS LIMERICK·Product code GXP·August 18, 2011
PRIME BIG WHEEL STRETCHER,30"
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·July 12, 2013
bvi Beaver Xstar Safety Crescent, 2.5mm, 55o Bevel Up, REF 378234 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
FDA Enforcement
Class II
·Terminated·Beaver-Visitec International Inc.·February 7, 2018
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026