11 results
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18ms
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Sources: EU EUDAMED, US FDA
SKYTRON ELITE 6000 & 6001 SURGICAL TABLES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CAD/CAM Software
FDA UDI
SIRONA Dental Systems GmbH·E27668534800·CEREC SW 5.2 Full version, Primary, EDU
MONOJECT M560 60CC SYRINGES
FDA 510(k)
FDA Class 2
·General Hospital
ClearVue850 Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
LEAD EXTRACTION BYRD POLYPROPYLENE EXTRA LONG DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code GCC·January 22, 2021
MULTIPOLAR BIPOLAR LINER
FDA Adverse Event
Malfunction
·ZIMMER·Product code KWY·April 4, 2014
TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·November 30, 2012
REPAIR TPS SAG SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·September 28, 2010
LEAD EXTRACTION BYRD POLYPROPYLENE DILATOR SHEATH SET
FDA Adverse Event
Malfunction
·COOK VANDERGRIFT INC·Product code GCC·March 9, 2022
OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·June 26, 2024
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM UNCUFFED , Product Code/List Number/Item Code 60P030; c) PAED. TRACHEOSTOMY TUBE 3.5MM UNCUFFED , Product Code/List Number/Item Code 60P035; d) PAED. TRACHEOSTOMY TUBE 4.0MM UNCUFFED , Product Code/List Number/Item Code 60P040; e) PAED. TRACHEOSTOMY TUBE 4.5MM UNCUFFED , Product Code/List Number/Item Code 60P045; f) PAED. TRACHEOSTOMY TUBE 5.0MM UNCUFFED , Product Code/List Number/Item Code 60P050; g) PAED. TRACHEOSTOMY TUBE 5.5MM UNCUFFED , Product Code/List Number/Item Code 60P055
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024