1,272 results · 23ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

LEAD 2 V4 WB F CH

FDA UDI
UTAK LABORATORIES, INC.·B800LEAD2V4WBFCH0·LEAD 2 V4 WB F CH

MICROELECTRODE RECORDING PRODUCT

FDA Adverse Event
Malfunction ·FHC, INC.·Product code GZL·August 12, 2023

WHOLE BLOOD MATRIX

FDA UDI
UTAK LABORATORIES, INC.·B800BLKWBFCH0·WHOLE BLOOD MATRIX

FENTANYL NEGATIVE

FDA UDI
UTAK LABORATORIES, INC.·B800FENTNEGFCH0·FENTANYL NEGATIVE

DAU POSITIVE

FDA UDI
UTAK LABORATORIES, INC.·B800DAUPOSV2FCH0·DAU POSITIVE

PETH LEVEL 2

FDA UDI
UTAK LABORATORIES, INC.·B800PETH2WBFCH0·PETH LEVEL 2

PETH LEVEL 3

FDA UDI
UTAK LABORATORIES, INC.·B800PETH3WBFCH0·PETH LEVEL 3

LEAD LEVEL 5

FDA UDI
UTAK LABORATORIES, INC.·B800LEAD5WBFCH0·LEAD LEVEL 5

OXYCODONE PLUS POSITIVE

FDA UDI
UTAK LABORATORIES, INC.·B800OXYBUPPOSFCH0·OXYCODONE PLUS POSITIVE

DAU NEGATIVE

FDA UDI
UTAK LABORATORIES, INC.·B800DAUNEGV2FCH0·DAU NEGATIVE

PETH LEVEL 1

FDA UDI
UTAK LABORATORIES, INC.·B800PETH1WBFCH0·PETH LEVEL 1

CATHETER NEEDLE SET

FDA Adverse Event
Injury ·COOK, INC.·Product code DQR·May 21, 2010

LEAD LEVEL 4 V4

FDA UDI
UTAK LABORATORIES, INC.·B800LEAD4V4WBFCH0·LEAD LEVEL 4 V4

LEAD LEVEL 1

FDA UDI
UTAK LABORATORIES, INC.·B800LEAD1V2WBFCH0·LEAD LEVEL 1

LEAD LEVEL 3 V4

FDA UDI
UTAK LABORATORIES, INC.·B800LEAD3V4WBFCH0·LEAD LEVEL 3 V4

LEAD LEVEL 4 V3

FDA UDI
UTAK LABORATORIES, INC.·B800LEAD4V3WBFCH0·LEAD LEVEL 4 V3

LEAD LEVEL 2 V3

FDA UDI
UTAK LABORATORIES, INC.·B800LEAD2V3WBFCH0·LEAD LEVEL 2 V3

LEAD LEVEL 3 V3

FDA UDI
UTAK LABORATORIES, INC.·B800LEAD3V3WBFCH0·LEAD LEVEL 3 V3

BD PYXIS¿ MEDSTATION¿ ES

FDA Adverse Event
Malfunction ·CAREFUSION 303, INC.·Product code BRY·August 8, 2025

BD PYXIS¿ MEDSTATION¿ ES

FDA Adverse Event
Malfunction ·CAREFUSION 303, INC.·Product code BRY·August 7, 2025