16 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Discovery 24
FDA 510(k)
FDA Class 2
·Neurology
ECG Module(AHA)
FDA UDI
SAMSUNG MEDISON CO., LTD.·08806167712532·
OSS™ Orthopedic Salvage System
FDA UDI
Biomet Orthopedics, LLC·00880304452824·
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100141·KRATZ-BARRAQUER HEAVY WIRE SPECULUM
Tibial Trial Insert Base Size 2
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215073947·
OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY
FDA 510(k)
FDA Class 2
·Orthopedic
V-PRO 60 LOW TEMPERATURE STERILIZATION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
BINAXNOW COVID-19 ANTIGEN SELF-TEST
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·April 21, 2022
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·June 6, 2013
BD INSYTE AUTOGUARD SHIELDED IV CATHETER
FDA Adverse Event
Injury
·BECTON DICKINSON INFUSION THERAPY SYSTEMS·Product code FOZ·June 23, 2011
NXSTAGE SYSTEM ONE
FDA Adverse Event
Injury
·NXSTAGE MEDICAL, INC.·Product code KDI·September 4, 2008
EOS PMP, EOS PMP INTEGRATED
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·May 5, 2021
DIDECO EOS ECMO M PHISIO
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·May 13, 2021
SORIN LIFEKIT D905 EOS ECMO
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·October 14, 2021
EOS PMP, EOS PMP INTEGRATED
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·March 23, 2022
Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·April 8, 2026