ARK™ Ethyl Glucuronide 1000 Cutoff Calibrator

FDA UDI

ARK DIAGNOSTICS INC·00858724003537·ARK™ Ethyl Glucuronide 1000 Cutoff Calibrator i...

ARK™ Methylphenidate Negative Calibrator

FDA UDI

ARK DIAGNOSTICS INC·00858724003575·ARK™ Methylphenidate Metabolite Negative Calibr...

ARK™ Voriconazole II Control

FDA UDI

ARK DIAGNOSTICS INC·00858724003247·ARK™ Voriconazole II Control is intended for us...

ARK™ Ethyl Glucuronide Control (375/625)

FDA UDI

ARK DIAGNOSTICS INC·00858724003490·ARK™ Ethyl Glucuronide Control is intended for ...

ARK™ AB-PINACA Control

FDA UDI

ARK DIAGNOSTICS INC·00812101030387·ARK™ AB-PINACA Control is intended for use in q...

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia

Medline Industries, Inc.

FDA UDI

MEDLINE INDUSTRIES, INC.·10193489287141·ORTHO ARK KNEE ARTHR SET UP-LF

N/A

FDA UDI

INNOVATIVE HEALTH LLC·10841898129803·Reprocessed BRK-1 Transseptal Needle, 98 cm

Medline Industries, Inc.

FDA UDI

MEDLINE INDUSTRIES, INC.·10889942772940·ORTHO ARK KNEE ARTHR SET UP-LF

N/A

FDA UDI

MEDTRONIC SOFAMOR DANEK, INC.·00613994166333·INSTRUMENT 7350145 T HNDLE BRK OFF DRIVR

Medline Industries, Inc.

FDA UDI

MEDLINE INDUSTRIES, INC.·10193489955897·ORTHO ARK KNEE ARTHR SET UP-LF

N/A

FDA UDI

INNOVATIVE HEALTH LLC·10841898129766·Reprocessed BRK-1 Transseptal Needle, 71 cm

N/A

FDA UDI

INNOVATIVE HEALTH LLC·10841898129834·Reprocessed BRK XS Transseptal Needle, 89 cm

N/A

FDA UDI

INNOVATIVE HEALTH LLC·10841898129780·Reprocessed BRK-1 Transseptal Needle, 89 cm

n/a

FDA UDI

MEDTRONIC SOFAMOR DANEK, INC.·00613994850461·MODULE 7068518 BRK OFF SET SCREW MODULE

General Instruments

FDA UDI

MEDTRONIC SOFAMOR DANEK, INC.·00763000584931·DRIVER 5597070 BRK-OFF SET SCREW REDUCER

N/A

FDA UDI

INNOVATIVE HEALTH LLC·10841898129858·Reprocessed BRK XS Transseptal Needle, 98 cm

ACCU-CHEK AVIVA PLUS

FDA UDI

Roche Diagnostics Operations, Inc.·00365702405103·ACCU-CHEK AVIVA PLUS 10CT STRIP BRK

N/A

FDA UDI

INNOVATIVE HEALTH LLC·10841898129810·Reprocessed BRK XS Transseptal Needle, 71 cm