13 results
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29ms
·
Sources: EU EUDAMED, US FDA
PARKE-DAVIS TOTAL HIP PROSTHESIS
FDA 510(k)
FDA Class 2
·Cardiovascular
Owgels Oxygen Concentrator
FDA 510(k)
FDA Class 2
·Anesthesiology
E-PULSE
FDA 510(k)
FDA Unclassified
·Unknown
TRULIANT PS CEM FEM PS CEM LEFT SZ 4
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 19, 2022
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 15, 2012
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 3, 2014
RAPIDLOC 2/0 PANACRYL (PLA/PDS) STRAIGHT
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code MBI·August 4, 2010
NEURO SPG-1X1"-STERILE- 20/CS
FDA Adverse Event
Malfunction
·MEDSORB DOMINICANA, S.A.·Product code EFQ·February 20, 2025
NEURO SPNG-1/2X3"-STRL- 20/CS
FDA Adverse Event
Malfunction
·MEDSORB DOMINICANA, S.A.·Product code EFQ·January 20, 2025
NEURO-SP-1/2X1/2"-STRL 20/CS
FDA Adverse Event
Malfunction
·MEDSORB DOMINICANA, S.A.·Product code EFQ·January 20, 2025
NEURO-SP-1/2X1/2"-STRL 20/CS
FDA Adverse Event
Malfunction
·MEDSORB DOMINICANA, S.A.·Product code EFQ·January 20, 2025
NEURO-SP-1/2X1/2"-STRL 20/CS
FDA Adverse Event
Malfunction
·MEDSORB DOMINICANA, S.A.·Product code EFQ·February 7, 2025
Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AB14W050020150, Size: 5MM X 20MM X 150CM; 3) AB14W050040090, Size: 5MM X 40MM X 90CM; 4) AB14W050040150, Size: 5MM X 40MM X 150CM; 5) AB14W050060150, Size: 5MM X 60MM X 150CM; 6) AB14W050080090, Size: 5MM X 80MM X 90CM; 7) AB14W050080150, Size: 5MM X 80MM X 150CM; 8) AB14W050100150, Size: 5MM X 100MM X 150CM; 9) AB14W050120150, Size: 5MM X 120MM X 150CM; 10) AB14W050150150, Size: 5MM X 150MM X 150CM; 11) AB14W050200090, Size: 5MM X 200MM X 90CM; 12) AB14W050200150, Size: 5MM X 200MM X 150CM; 13) AB14W060040090, Size: 6MM X 40MM X 90CM; 14) AB14W060040150, Size: 6MM X 40MM X 150CM; 15) AB14W060060150, Size: 6MM X 60MM X 150CM; 16) AB14W060080150, Size: 6MM X 80MM X 150CM; 17) AB14W060100150, Size: 6MM X 100MM X 150CM; 18) AB14W060120150, Size: 6MM X 120MM X 150CM; 19) AB14W060150150, Size: 6MM X 150MM X 150CM; 20) AB14W060200150, Size: 6MM X 200MM X 150CM; Balloon Dilatation Catheter
FDA Enforcement
Class II
·Ongoing·ev3 Inc·January 22, 2025