9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IPI ALGO-LINE CATHETER
FDA 510(k)
FDA Class 2
·Anesthesiology
XTRAC EXCIMER LASER SYSTEM, MODEL AL 7000
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CELVER
FDA 510(k)
FDA Unclassified
·Unknown
LEVEL 1 HOTLINE LOW FLOW SYSTEMS
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code LGZ·January 23, 2024
LEVEL 1 HOTLINE LOW FLOW SYSTEMS
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code LGZ·January 23, 2024
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·January 11, 2013
MONOCRYL (POLIGLECAPRONE 25) SUTURE
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code GAM·November 24, 2010
OT PING ENHANCED METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 3, 2014
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024