32 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SPECIMEN RETRIEVAL SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Sharps
FDA UDI
SHARPS COMPLIANCE CORP.·00634188001919·1-Gallon Sharps Container - Flexible Petal Lid
Endo Carry-On Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964066948·Endo Carry-On Procedure Kit
BETA TITANIUM ARCHWIRE
FDA UDI
Ortho Organizers, Inc.·00190707067250·.021 X .025 Lower Pro Form™ Beta Titanium Archw...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450567517·
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
VERDICT -II BAR; VERDICT -II BZO
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CRITERION 60 OR PM 60
FDA 510(k)
FDA Class 2
·Anesthesiology
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970362·
VERCISE GENUS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·January 5, 2024
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 8, 2013
X SERIES
FDA Adverse Event
Death
·ZOLL MEDICAL CORPORATION·Product code MKJ·July 22, 2014
TEMNO NEEDLE BIOPSY 20GX20CM ADJ COAXIAL
FDA Adverse Event
Injury
·CAREFUSION·Product code FCG·May 24, 2011
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
FDA Adverse Event
Injury
·SYNTHES USA·Product code NKB·January 18, 2016
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·June 7, 2013
5.5MM TI CURVED ROD 45MM
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code NKB·February 6, 2020
Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103-001 and Articulated Arm Camera, 7700-103-001U Product Usage: The Navigation System II-Cart is intended to be used as a platform for computer assisted surgery as part of the Stryker Navigation System. The intended use of the complete Stryker Navigation System is defined by the Stryker application modules.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·June 24, 2015
IVEA Product Part Number 16100 Model 500A
FDA Enforcement
Class II
·Terminated·Firefly Medical, Inc.·October 11, 2017