19 results
·
22ms
·
Sources: EU EUDAMED, US FDA
CT Sim Laser System
FDA 510(k)
FDA Class 1
·Radiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04064984699557·GENUMEDI PSS BLUE SIZE III
2.0 LACTOSORB SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036055059·
Dilator
FDA UDI
ELLIQUENCE, LLC·00846338005412·
ATTUNE
FDA UDI
DEPUY (IRELAND)·10603295057567·ATTUNE KNEE SYSTEM REVISION TIBIAL AUGMENT 15MM...
ATTUNE
FDA UDI
DEPUY (IRELAND)·10603295057543·ATTUNE KNEE SYSTEM REVISION TIBIAL AUGMENT UNIV...
ATTUNE
FDA UDI
DEPUY (IRELAND)·10603295057574·ATTUNE KNEE SYSTEM REVISION TIBIAL AUGMENT 10MM...
ATTUNE
FDA UDI
DEPUY (IRELAND)·10603295057581·ATTUNE KNEE SYSTEM REVISION TIBIAL AUGMENT 15MM...
ATTUNE
FDA UDI
DEPUY (IRELAND)·10603295057550·ATTUNE KNEE SYSTEM REVISION TIBIAL AUGMENT 10MM...
BLOOD PRESSURE METER, MODEL CH-658
FDA 510(k)
FDA Class 2
·Cardiovascular
READMYHEART, MODEL RMH2.0
FDA 510(k)
FDA Class 2
·Cardiovascular
COLLEAGUE PRE 1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011
CONCERTO II CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 7, 2013
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 2008
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
Precise Treatment Table. To be used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 17, 2013
All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 12, 2014
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 9, 2014
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