15 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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IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT
FDA 510(k)
FDA Class 2
·Immunology
AOS CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 130mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665020915·
n.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR60601301·Safe-facebow-system complete with facebow 601-1020
TRIOSITE
FDA UDI
BIOMATLANTE·H132000060130001·Synthetic Bone Resorbable Graft
Granules 0.5-1mm
Canaveral®
FDA UDI
FLOSPINE LLC·B183120601300·6.0mm Curved Rod, Ti Alloy 130mm
HARDYDISK, NALIDIXIC ACID, 30MCG
FDA 510(k)
FDA Class 2
·Microbiology
POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Widex
FDA UDI
Widex A/S·05706069673173·Widex EVOKE E-CIC (Light beige ) 330, Right, RC...
Widex
FDA UDI
Widex A/S·05706069673197·Widex EVOKE E-CIC (Dark brown ) 330, Right, RC ...
Widex
FDA UDI
Widex A/S·05706069673180·Widex EVOKE E-CIC (Clay brown ) 330, Right, RC ...
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 20, 2013
LADARVISION 4000
FDA Adverse Event
Malfunction
·ALCON - ORLANDO TECHNOLOGY CENTER·Product code LZS·June 11, 2008
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·April 15, 2011
Instructions For Use document of the GPS Trackers.
FDA Enforcement
Class II
·Terminated·Blue Ortho·November 4, 2020
Aqauapak 728 SW, 760 ML W/028 Adaptor, Intl, Product No. 403728; Aqauapak 1028 SW, 1070 ML/W028 Adaptor, Intl, Product No. 404128; Aqauapak 428 SW, 440 ML W/028 Adaptor, Intl, Product No. 404428; Aquapak 728 SW, 760 ML W/028 Adaptor, Product No. 037-28; Aquapak SW/EAU Sterile, 760 ML W/Adaptor, Product No. 037-28C; Aquapak 728 SW, 760 ML W/28 Adaptor, French, Product No. 037-02F; Aquapak 733 SW, 760 ML W/033 Adaptor, Product No. 037-33; Aquapak 735 HNS, 760 ML W/028 Adaptor, Product No. 037-35; Aquapak 739 FNS, 760 ML W/028 Adaptor, Product No. 037-39; Aquapak 0.9% NACL, 760 ML W/Adaptor, Product No. 037-39C; Aquapak 770 HNS, 760 ML W/033 Adaptor, Product No. 037-70; Aquapak 1028 SW, 1070 ML W/028 Adaptor, Product No. 041-28; Aquapak SW/EAU Sterile, 1070 ML W/Adaptor, Product No. 041-28C; Aquapak 1033 SW, 1070 ML W/033 Adaptor; Product No. 041-33; Aquapak 1035 HNS, 1070 ML W/028 Adaptor, Product Code 041-35; Aquapak 428 SW, 440 ML W/028 Adaptor, Product No. 044-28; Aquapak SW/EAU Sterile, 440 MLW/Adaptor, Product No. 044-28C; Aquapak 428 SW, 440 ML W/028 Adaptor, French, Product No. 044-28F; Aquapak 433 SW, 440 ML W/033 Adaptor, Product No. 044-33; Aquapak 435 HNS, 440 ML W/028 Adaptor, Product No. 044-35; Aquapak 470 HNS, 440 ML W/033 Adaptor, Product No. 044-70. Used in anesthesiology.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·December 10, 2014