23 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RenaPure Endotoxin Retentive Filter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OMNI Mod Hip
FDA UDI
Omni Life Science, Inc.·00841690103035·Modular Neck 13 degree Anteversion, Medium 47.5
OsteoMed
FDA UDI
OSTEOMED LLC·00845694036719·FPS 10mm Cannulated Metatarsal Reamer
Meridian
FDA UDI
Seaspine Orthopedics Corporation·10889981309930·Trial Rasp, 39mm x 30mm x 14mm, 10 Deg
Meridian
FDA UDI
Seaspine Orthopedics Corporation·10889981215620·No-Profile Interbody, 39mm x 30mm x 14mm, 10 Deg
3D Printed Interbody Systems
FDA UDI
Seaspine Orthopedics Corporation·10889981304058·2-Hole No-Profile Interbody, 39mm x 30mm x 14mm...
X SERIES
FDA UDI
Zoll Medical Corporation·00847946019266·Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFI...
X SERIES
FDA UDI
Zoll Medical Corporation·00847946062095·X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP...
X SERIES
FDA UDI
Zoll Medical Corporation·00847946004361·Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFI...
Tecomet
FDA UDI
TECOMET INC.·00841435121119·RONGEUR STRAIGHT
DRILL, AO, STERILE 4, 2X340 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·September 23, 2011
VITEK 2 GRAM POSITIVE LINEZOLID FOR STREPTOCOCCUS PNEUMONIAE
FDA 510(k)
FDA Class 2
·Microbiology
CO2/O2 NASAL CANNULA (WITH 4 (10CM) O2 AND CO2 TUBE), CO2/O2 NASAL CANNULA (WITH 8 (240CM) O2 AND 4 (10CM) CO2 TUBE),
FDA 510(k)
FDA Class 2
·Anesthesiology
Specials
FDA UDI
Seaspine Orthopedics Corporation·10889981331078·Lollipop Trial, Anterior-Angled, 23mm x 14mm x ...
BLACKHAWK Cervical Spacer System
FDA UDI
Choice Spine, LP·00840996164702·BLACKHAWK,STERILE,CONVEX,14X12X10
Specials
FDA UDI
Seaspine Orthopedics Corporation·10889981441500·Lollipop Trial 23mm x 14mm x 55mm, 10°
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·November 17, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011
CLARION IMPLANT
FDA Adverse Event
Injury
·ADVANCED BIONICS, LLC·Product code MCM·July 15, 2013
CIVCO Needle Guide Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 674-030, 674-030-T, 674-031, 674-031-T, 674-035, 674-036, 674-044, 674-052, 674-059, 674-061. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
FDA Enforcement
Class II
·Terminated·Civco Medical Instruments Co. Inc.·November 25, 2015