40 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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QUINTEX CERVICAL PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777600·LUMBAMED BASIC DORSAL STAY WM SILVER III
LEONE SPA
FDA UDI
LEONE SPA·08033707092865·BKT 43 F1000 SELF-LIGATING 22 T-11A+7BH
Metzenbaum Scissors
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896107427·Metzenbaum Scissors Straight
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319736203·Jorgensen Scissors 9" (22.5cm), strongly curved...
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780178736·Integra® Jarit® Lillehei-Potts Scissors, 7", Cu...
Manta Ray™
FDA UDI
Seaspine Orthopedics Corporation·10889981056223·Plate - 2 Level - 43 mm
TRI-FIT FEMORAL STEM
FDA 510(k)
FDA Class 2
·Orthopedic
COROENT XLR STANDALONE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LINER #L FOR MOBILE LINER Ø42
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code LZO·August 26, 2022
G7 HI-WALL E1 LINER 32MM B
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code PBI·July 12, 2022
T25 STARDRIVE SHAFT FOR MATRIX
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HXX·May 16, 2011
TREATMENT RECLINER
FDA Adverse Event
Injury
·STRYKER MEDICAL-KALAMAZOO·Product code FRK·May 8, 2013
ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC IRELAND, LTD.·Product code JCT·May 21, 2008
MOBILE LINER ØINT 28 MM Ø42 MM
FDA Adverse Event
Malfunction
·LIMACORPORATE S.P.A.·Product code LZO·December 29, 2021
UNSPECIFIED BD VACUTAINER TUBE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JKA·August 2, 2022
Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation
FDA Enforcement
Class II
·Terminated·Primus Corporation·November 11, 2020
The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sensor Assembly: (a) Symbia Pro.specta Q3, Model 11364751; (b) Symbia Pro.specta X3, Model 11364752; (c) Symbia Pro.specta X7, Model 11364753.
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·August 9, 2023
Brilliance iCT, Model No. 728306; To produce cross-sectional images of the body.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·August 17, 2016
Brilliance iCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015