20 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SwiftMR
FDA 510(k)
FDA Class 2
·Radiology
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·34546540355646·Bone Screws, Cross-Pin
APEX PS Knee
FDA UDI
Omni Life Science, Inc.·00841690113256·PS Insert, Size 4 x 16mm
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676220416150·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676220416070·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676220416000·
INSULATION TESTER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Boston One Step Liquid Enzymatic Cleaner
FDA 510(k)
FDA Class 2
·Ophthalmic
VERSACROSS CONNECT LAAC ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DRE·April 6, 2023
SPECTRUM IQ INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·March 23, 2022
SPECTRUM IQ INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·June 13, 2022
SPECTRUM IQ INFUSION PUMP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code FRN·May 25, 2022
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code NIQ·October 31, 2008
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 23, 2011
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013
HERBAL PAD
FDA Adverse Event
Injury
·SHUXIAO INDUSTRY CO.,LTD·Product code HHL·February 23, 2023
SPECTRUM IQ INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·June 16, 2022
KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 3 / Child ClearSeal Flexible King LAD¿ Patient Size: 30-50kg " Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
VERSACROSS CONNECT LAAC ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DXF·April 25, 2023
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021