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