10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CEPTRE® Knotted UHMWPE Suture PEEK Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
Mediflex 3.5mm Laparoscopic Instruments
FDA UDI
FLEXBAR MACHINE CORPORATION·00842102100420·Maryland Dissector, Curved w/ Flush Port & non-...
Intrigue
FDA UDI
LANCER ORTHODONTICS, INC.·00817573020973·INTRG WHISP ROTH BIC -7T 0A 018 UP
EN SNARE
FDA Adverse Event
Injury
·MERIT MEDICAL SYSTEMS, INC.·Product code MMX·September 8, 2011
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
FDA 510(k)
FDA Class 1
·General Hospital
GIVEN DIAGNOSTIC SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RESTORE ADVANCED RECHARGEABLE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·October 30, 2008
ACCESS
FDA Adverse Event
Malfunction
·BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS·Product code FPA·September 1, 2011
8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 12, 2013
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