10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRIOCLEAR System
FDA 510(k)
FDA Class 2
·Dental
ATELLICA CH 930 CALCIUM_2 (CA_2)
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code CJY·June 9, 2023
AVENIR CEMENTED HIP STEM
FDA 510(k)
FDA Class 2
·Orthopedic
INTERFERENTIAL STIMULATOR, MODEL NETWAVE
FDA 510(k)
FDA Class 2
·Physical Medicine
TEXIUM
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS S.A DE C.V.·Product code FMF·March 19, 2026
GRAVITY ADMINSTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION CORP·Product code FPA·October 17, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 17, 2013
ATELLICA CH 930 CALCIUM_2 (CA_2)
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CJY·May 30, 2023
Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239
FDA Enforcement
Class I
·Ongoing·Bard Peripheral Vascular Inc·March 12, 2025