13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MultiGen 2 RF Generator System
FDA 510(k)
FDA Class 2
·Neurology
AUTO SUTURE ENDO CLIP III5MM CLIP ADAPTER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-05
FDA 510(k)
FDA Class 2
·Cardiovascular
TRULIANT TIB IMP CRC INSERT SZ 4, 15MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 30, 2022
XIENCE PRO EVEROLIMUS ELUTING RX CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·June 14, 2013
CENTRICITY
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS, LLC.·Product code LLZ·July 19, 2011
D-FLEX TRIANGULAR RETRACTOR 80MM 5MM
FDA Adverse Event
Injury
·CAREFUSION·Product code GCJ·August 20, 2014
TRULIANT TIB IMP PS INSERT SZ 3.5 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 23, 2024
TRULIANT PS CEM FEM PS CEM LEFT SZ 4
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 19, 2022
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 28, 2022
ADVANCED PATELLA 29M 3 PEG IMPLANT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 15, 2024
TRULIANT PS CEM FEM PS CEM RIGHT SZ 4
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 19, 2022
Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026