23 results
·
19ms
·
Sources: EU EUDAMED, US FDA
MEDOS HILITE 7000 & 7000 LT OXYGENATOR
FDA 510(k)
FDA Class 2
·Cardiovascular
Oticon
FDA UDI
Oticon A/S·05707131260178·RIA, BTE 13 WL 100 CBE
DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS)
FDA 510(k)
FDA Class 2
·Radiology
EUROIMMUN ANTI-NRNP/SM ELISA (IGG)
FDA 510(k)
FDA Class 2
·Immunology
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code LZG·October 10, 2016
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 29, 2013
SILS STITCH SUTURING DEVICE
FDA Adverse Event
Malfunction
·UNITED STATES SURGICAL·Product code OCW·May 11, 2011
PUMP MMT-508GB EA INSULIN BL DE
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·August 21, 2008
syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment Material Number: 10496180
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·September 22, 2021
RayStation 14.0.0.3338. Radiation Therapy Treatment Planning System.
FDA Recall
Open, Classified
·RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden·Product code MUJ·March 28, 2024
RayStation 9.1.0.933 and 9.2.0.483. Radiation Therapy Treatment Planning System.
FDA Recall
Open, Classified
·RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden·Product code MUJ·March 28, 2024
RayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System.
FDA Recall
Open, Classified
·RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden·Product code MUJ·March 28, 2024
RayStation 7.0.0.19. Radiation Therapy Treatment Planning System.
FDA Recall
Open, Classified
·RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden·Product code MUJ·March 28, 2024
RayStation 10.1.0.613 and 10.1.1.54. Radiation Therapy Treatment Planning System.
FDA Recall
Open, Classified
·RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden·Product code MUJ·March 28, 2024
RayStation 9.0.0.113 and 9.0.1.142. Radiation Therapy Treatment Planning System.
FDA Recall
Open, Classified
·RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden·Product code MUJ·March 28, 2024
RayStation 15.0.0.430. Radiation Therapy Treatment Planning System.
FDA Recall
Open, Classified
·RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden·Product code MUJ·March 28, 2024
K-Wire 1.4mm x 12in Non-Threaded, Part Number 9080-12U; K-Wire Threaded 1.4mm x 18, Part Number 9080-18T; K-Wire Non-Threaded 1.4mm x 18, Part Number 9080-18U; 1.4mm x 24 Threaded Guide Wire, Part Number 9080-24T; K-Wire Non-Threaded 24, Part Number 9080-24U; Blunt K-Wire, 18 inches, Threaded, Part Number 9080B-18T; Blunt K-Wire, 18 inches, Unthreaded, Part Number 9080B-18U; Blunt K-Wire, 24 inches, Unthreaded, Part Number 9080B-24U; 1.4mm x 18 Blunt Threaded Nitinol Guide Wire, Part Number 9080B-N-18T; 1.4mm x 18" Blunt Non-Threaded Nitinol Guide Wire, Part Number 9080B-N-18U; Lodestar K-wire Non-Threaded, 18, Part Number 9080L-18U; 1.4mm x 18 Threaded Nitinol Guide Wire, Part Number 9080-N-18T; 1.4mm x 18 Non-Threaded Nitinol Guide Wire, Part Number 9080-N-18U The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone
FDA Enforcement
Class II
·Terminated·Amendia, Inc·December 28, 2016
RayStation 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 &12.3.0.119. Radiation Therapy Treatment Planning System.
FDA Recall
Open, Classified
·RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden·Product code MUJ·March 28, 2024
RayStation 8.1.0.47, 8.1.1.8 and 8.1.2.5. Radiation Therapy Treatment Planning System.
FDA Recall
Open, Classified
·RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden·Product code MUJ·March 28, 2024
RayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89. Radiation Therapy Treatment Planning System.
FDA Recall
Open, Classified
·RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden·Product code MUJ·March 28, 2024