9 results
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23ms
·
Sources: EU EUDAMED, US FDA
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
FDA 510(k)
FDA Class 2
·Cardiovascular
MIRADA RT
FDA 510(k)
FDA Class 2
·Radiology
VALLEYLAB MICROWAVE ABLATION GENERATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 5, 2025
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·July 22, 2011
SM204 M-SERIES W/BIG WHEEL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·June 17, 2013
RSVR MMT-103 24PK 3CC 13L
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code FMF·September 19, 2008
IPSOGEN JAK2 PCR KIT IVD
FDA Adverse Event
QIAGEN GMBH·Product code PSU·September 4, 2018
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