13 results · 29ms · Sources: EU EUDAMED, US FDA

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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