19 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODED MDL. 3
FDA 510(k)
FDA Class 2
·Physical Medicine
ENDO-SCRUB®
FDA UDI
MEDTRONIC XOMED, INC.·20681490697761·SHEATH 1912015 5PK 4MM/45DEG XOMED
JuggerKnot Soft Anchors
FDA UDI
Biomet Orthopedics, LLC·00880304516557·
REVELATION DIAMOND
FDA UDI
Ss White Burs, Inc.·D6909120152·REVELATION DIAMOND 801-033C - 5 PACK
ELMED INCORPORATED
FDA UDI
ELMED INCORPORATED·00198506088407·BECKMANN ENDAURAL SPECULUM, CURVED TO THE SIDE ...
Sapphire ULTRA Coronary Dilatation Catheter
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955979088·
"2.0" SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036053420·
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0120150·Assembly, Screwdriver, Polyaxial, Lockable
PREMIER HB9210 HBA1C ANALYZER
FDA 510(k)
FDA Class 2
·Hematology
Faico Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
BALFOUR MALLEABLE BLADE
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896011403·BALFOUR MALLEABLE BLADE WITH PROTECTIVE EDGE
CELLEX PROCEDURAL KIT
FDA Adverse Event
Malfunction
·THERAKOS·Product code LNR·May 29, 2014
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·January 11, 2013
RENAL - DISPOSABLE
FDA Adverse Event
Injury
·Product code KDJ·December 1, 2010
BD NANO¿ 2ND GEN PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·November 22, 2022
BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT)
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·October 25, 2023
BD NANO¿ 2ND GEN PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·February 14, 2022
Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 1.5%, Part# 9120-15, 9100-15. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques
FDA Enforcement
Class II
·Terminated·Superstat Corp·November 28, 2012
Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 1.5%, Part# 9120-15, 9100-15. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques
FDA Recall
Terminated
·Superstat Corp·Product code LMF·October 24, 2012