13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TRI Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
CASTROVIEJO NEEDLE HOLDER
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896074538·CASTROVIEJO NEEDLE HOLDER WITHOUT LOCK STRAIGHT...
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100264·KATENA DBL-X ASPIRATING SPECULUM K-WIRE
CASTROVIEJO NEEDLE HOLDER
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896017726·CASTROVIEJO NEEDLE HOLDER WITHOUT LOCK STRAIGHT...
POLAR CATH PERIPHERAL DILATATION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
JOULE MULTI-PLATFORM SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BALL HEADS: COCR BALL HEAD 12/14 Ø 36 SIZE S -3.5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·May 20, 2023
TARGIS SYSTEM
FDA Adverse Event
Malfunction
·UROLOGIX, INC.·Product code MEQ·July 7, 2011
CAPSUREFIXNOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 7, 2013
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES CARE INC.·Product code LZG·October 6, 2014
TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain.
FDA Recall
Terminated
·Theralase Inc.·Product code NHN·September 26, 2019
TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain.
FDA Recall
Terminated
·Theralase Inc.·Product code NHN·September 26, 2019
IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.
FDA Enforcement
Class II
·Terminated·Medical Intelligence Medizintechnik Gmbh·July 31, 2019