13 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES
FDA 510(k)
FDA Class 1
·Dental
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033449·Baltic Denture System BDLoad BDLoad ↓ Lw6 PLSEu...
PS CONSTRAINED INSERT XLG
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code JWH·July 20, 2017
E MOTION WHEELCHAIR DRIVE SYSTEM (POWER-ASSIST FOR MANUAL WHEELCHAIRS)
FDA 510(k)
FDA Class 2
·Physical Medicine
MODIFICATION TO FIXION INTERLOCKING INTRAMEDULLARY NAILING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VERICHIP HEALTH INFORMATION MICROTRANSPONDER AND POCKET READER
FDA Adverse Event
Injury
·DIGITAL ANGEL CORPORATION/ JAMM TECHNOLOGIES·Product code NRV·August 5, 2022
RUNWAY GUIDE CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·May 8, 2013
GOBED+
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·April 3, 2013
NEXGEN TRABECULAR METAL TIBIAL TRAY
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code MBH·March 24, 2011
POLYFLUX S CAPILLARY DIALYZER
FDA Adverse Event
Malfunction
·GAMBRO DIALYSATOREN GMBH·Product code KDI·April 23, 2008
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x50 mm Catalog Number: 18965050S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x40 mm Catalog Number: 18965040S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024