21 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
VITAL-PORT DUAL LUMEN VASCULAR ACCESS SYSTEM 1121
FDA 510(k)
FDA Class 2
·General Hospital
Leksell Stereotactic System Neurosurgical Instruments
FDA UDI
Elekta Instrument AB·07340048308014·DISPOSABLE BIOPSY NEEDLE AND ASPIRATION TUBE
REVELATION DIAMOND
FDA UDI
Ss White Burs, Inc.·D6909124652·REVELATION DIAMOND 847KR-018SC - 5 PACK
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668110904·TIP GUARDS VENTED ORANGE PACK OF 100
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668110881·TIP GUARDS VENTED RED PACK OF 100
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450272183·
MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
VITAL SIGNS MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
PORTEX® BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code BTO·April 26, 2017
PORTEX® BIVONA® UNCUFFED NEONATAL TRACHEOSTOMY TUBE
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD, INC.·Product code BTO·April 13, 2017
Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inner box of REF 911761 contains a Tyvek bag labeled REF 912465, Disposable Biopsy Needle and Aspirator Tube.
FDA Enforcement
Class I
·Ongoing·Elekta Instrument AB·April 24, 2024
BIVONA® UNCUFFED PEDIATRIC STRAIGHT NECK FLANGE TRACHEOSTOMY TUBES
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD INC.·Product code JOH·August 18, 2016
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·May 14, 2014
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
LERADO GLOBAL·Product code ILS·January 12, 2013
BUCKYDIAGNOST
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code KPR·November 12, 2010
Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inner box of REF 911761 contains a Tyvek bag labeled REF 912465, Disposable Biopsy Needle and Aspirator Tube. The system is used for for localization and diagnosis of intracranial disorders and their surgical treatment including radiosurgery and stereotactic radiation therapy.
FDA Enforcement
Class I
·Ongoing·Elekta Instrument AB·November 13, 2024
BIVONA UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE
FDA Adverse Event
Injury
·SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.·Product code JOH·February 29, 2024
BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD INC.·Product code BTO·August 15, 2016
Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inner box of REF 911761 contains a Tyvek bag labeled REF 912465, Disposable Biopsy Needle and Aspirator Tube.
FDA Recall
Open, Classified
·Elekta Instrument AB Kungstensgatan 18 Stockholm Sweden·Product code HAW·March 15, 2024
Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inner box of REF 911761 contains a Tyvek bag labeled REF 912465, Disposable Biopsy Needle and Aspirator Tube. The system is used for for localization and diagnosis of intracranial disorders and their surgical treatment including radiosurgery and stereotactic radiation therapy.
FDA Recall
Open, Classified
·Elekta Instrument AB Kungstensgatan 18 Stockholm Sweden·Product code HAW·September 25, 2024