10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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(STAMEY) T.U.R.P. SUPRAPUBIC CATHETER SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Zenysis Dual Lumen Acute Dialysis Catheter
FDA UDI
Bard Access Systems, Inc.·00801741109782·Zenysis DL, 12.5cm PC Kit
Power-Trialysis Slim-Cath catheter
FDA UDI
Bard Access Systems, Inc.·00801741107276·12Fr Trialysis PC 12.5cm Kit
4CIS® Spinal System and 4CIS® Low Back System
FDA UDI
ALPHA AI CO.,LTD.·08806373533310·Rod, Smooth Type
COLOR LCD MONITOR, RADIFORCE, MODEL RX210
FDA 510(k)
FDA Class 2
·Radiology
EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
ATTAIN ABILITY PLUS
FDA Adverse Event
Injury
·MPRI·Product code OJX·June 10, 2014
TRANSVENE
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code LWS·October 9, 2010
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·December 10, 2012
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024