16 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Celerity ECG Cable Accessory Pack
FDA 510(k)
FDA Class 2
·General Hospital
CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223
FDA 510(k)
FDA Class 2
·Neurology
GLIASITE RTS
FDA 510(k)
FDA Class 2
·Radiology
JAMSHIDI BONE MARROW TRAY 11G X4 15G ASP
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code KNW·March 12, 2026
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 7, 2013
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 19, 2008
BABYLOG 8000
FDA Adverse Event
Other
·DRAEGER MEDICAL AG & CO. KG·Product code CBK·August 23, 2006
HAART 200 AORTIC ANNULOPLASTY RING
FDA Adverse Event
Injury
·CORCYM INC.·Product code KRH·May 8, 2025
HAART 200 AORTIC ANNULOPLASTY RING
FDA Adverse Event
Injury
·CORCYM INC.·Product code KRH·May 9, 2025
TRIFORCE¿ PERIPHERAL CROSSING SET
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·February 4, 2020
JAMSHIDI BONE MARROW TRAY 11G X4 15G ASP
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code LWE·October 8, 2025
TRIFORCE¿ PERIPHERAL CROSSING SET
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·January 2, 2020
TRIFORCE¿ PERIPHERAL CROSSING SET
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·February 4, 2020
TRIFORCE¿ PERIPHERAL CROSSING SET
FDA Adverse Event
Injury
·COOK INC·Product code KRA·January 2, 2020
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022
Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021