20 results · 22ms · Sources: EU EUDAMED, US FDA

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First Ray Internal Bone Staple System

FDA 510(k)
FDA Class 2 ·Orthopedic

CS 2100

FDA UDI
CARESTREAM HEALTH, INC.·60889975153629·CS 2100 110V205CM LONG WALL MTD

Bard® Extension Cable

FDA UDI
C. R. Bard, Inc.·00801741045875·Bard® Extension Cable

Prime Medical LLC

FDA UDI
Prime Medical LLC·00850055249295·PrimePadPlus-K15-3422

LINK Endo-Model EVO Knee System

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575183487·Proximal tibial spacer, uncemented, Ti6Al4V, fo...

LINK Endo-Model EVO Knee System

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575183562·Proximal tibial spacer, uncemented, Ti6Al4V, fo...

BARD® EXTENSION CABLE

FDA Adverse Event
Malfunction ·C.R. BARD INC. (COVINGTON) -1018233·Product code EZL·April 28, 2023

SURGISIS OCULAR GRAFT

FDA 510(k)
FDA Class 2 ·Ophthalmic

ORION II CT CVC

FDA 510(k)
FDA Class 2 ·General Hospital

BARD® EXTENSION CABLE

FDA Adverse Event
Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code EZL·April 4, 2023

BARD® EXTENSION CABLE

FDA Adverse Event
Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code EZL·December 30, 2021

BARD® EXTENSION CABLE

FDA Adverse Event
Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code EZL·December 31, 2021

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 28, 2024

BARD® EXTENSION CABLE

FDA Adverse Event
Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code EZL·December 31, 2021

BARD® EXTENSION CABLE

FDA Adverse Event
Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code EZL·October 6, 2023

RIATA ST ACTIVE FIXATION

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·October 8, 2014

SELECTSECURE

FDA Adverse Event
Malfunction ·MPRI·Product code NVY·June 8, 2013

ENDOTAK RELIANCE

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVY·July 7, 2011

ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023

CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024