9 results · 24ms · 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.

Arrow Endurance Extended Dwell Peripheral Catheter System

FDA 510(k)
FDA Class 2 ·General Hospital

Sklar®

FDA UDI
SKLAR CORPORATION·10649111282683·TC METZ SCISS STR DEL B/B 5.75

Custom Leg Adapter Puller

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215137410·

ECHELON MR-RCC-150 CARDIAC COIL

FDA 510(k)
FDA Class 2 ·Radiology

LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; MIDSHAFT SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; ANTERIOR CLAVICLE PLA

FDA 510(k)
FDA Class 2 ·Orthopedic

UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER·Product code GKZ·June 11, 2013

OASIS DRY SUCTION CHEST DRAIN

FDA Adverse Event
Malfunction ·ATRIUM MEDICAL CORP.·Product code KDQ·June 8, 2011

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 10, 2014

Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05

FDA Enforcement
Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016