18 results
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39ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Dozee VS
FDA 510(k)
FDA Class 2
·Anesthesiology
CD HORIZON® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074362229·SCREW 7221555 HA COATED CANN 5.5 X 55
Symmetry Sofield
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482059241·Symmetry® Retractor, Sofield, 102 x 19 mm and 7...
J & J INSTRUMENTS
FDA UDI
J & J INSTRUMENTS INC·00817524025613·STRABISMUS SCISSOR 4.5"" CVD
Sklar®
FDA UDI
SKLAR CORPORATION·10649111006739·OPER SCISS DEL CRV S/B 5 1/2
STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
CENTURION VISION SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
HNM Medical
FDA UDI
HNM STAINLESS, LLC.·00842962113837·SOFIELD RETRACTOR, 102MMX19MM AND 70MMX19MM, DO...
LAUREATE WORLD PHACO SYSTEM
FDA Adverse Event
Malfunction
·ALCON- IRVINE TECHNOLOGY CENTER·Product code HQC·November 5, 2008
ACCU-CHEK SPIRIT
FDA Adverse Event
Injury
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·August 18, 2011
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·July 3, 2013
MECTALIF ANT - LAG
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code OVD·April 12, 2024
BIPLATE SCHAEDLER/SCHAED KV 5% SB 20
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JSJ·June 25, 2021
BD BBL¿ SCHAEDLER K-V AGAR WITH 5% SHEEP BLOOD
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JSJ·August 2, 2021
BIPLATE SCHAEDLER/SCHAED KV 5% SB 20
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JSJ·July 1, 2021
BD BBL Schaedler K-V Agar with 5% Sheep Blood, carton of 20 plates, catalog # 221555, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Vancomycin Screen Agar is used to test entercocci for resistance to vancomycin and to predict the synergistic activity of this antimicrobial with an aminoglycoside antimicrobial.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·July 31, 2013
BD BBL Schaedler K-V Agar with 5% Sheep Blood, carton of 20 plates, catalog # 221555, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Vancomycin Screen Agar is used to test entercocci for resistance to vancomycin and to predict the synergistic activity of this antimicrobial with an aminoglycoside antimicrobial.
FDA Recall
Terminated
·Becton Dickinson & Co. BD Diagnostic Systems·Product code JSJ·June 6, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025