34 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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6-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CALIBRATORS AND CONTROLS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Bur PM2-125 80K Diam C Ø5.0 St
FDA UDI
Bien-Air Surgery SA·17630055514650·
MegaBeam® Fiber Optic Delivery System with Additional Tips and Handpiece
FDA UDI
Ceram Optec SIA·04049089100566·
DD Bio Splint P
FDA UDI
Dental Direkt GmbH·EDDIK101151·DD Bio Splint P are transparent dental milling ...
Orascoptic - Endeavour Headlight System
FDA UDI
METREX RESEARCH, LLC·00615375000380·NA
S-Core™
FDA UDI
SUBCHONDRAL SOLUTIONS, INC.·00850017962361·Size 9 Cannulated Sizer
Zavation
FDA UDI
Zavation LLC·00197157009823·9.5mm TAP, CANNULATED
PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB
FDA 510(k)
FDA Class 1
·Ophthalmic
NDS SURGICAL IMAGING, LLC FOR THE ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, MODEL WU-WX-WY (WHERE U=R OR T, W=P, X
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GALAXY G3 XSFT 2MM X 2CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·January 25, 2021
UNIFY CRT-D
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·May 9, 2013
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 3, 2014
SPEEDSCREW 5.5 IMPLANT WITH INSERTER HANDLE
FDA Adverse Event
Other
·ARTHROCARE CORP.·Product code HWC·May 19, 2011
VASOPRESS DIGITAL MINI PUMP
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL, INC.·Product code JOW·January 6, 2020
I-STAT TROPONIN (CTNI) CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code MMI·February 8, 2023
VASOPRESS DIGITAL MINI PUMP
FDA Adverse Event
Malfunction
·COMPRESSION THERAPY CONCEPTS, INC.·Product code JOW·February 18, 2020
VASOPRESS DIGITAL MINI PUMP
FDA Adverse Event
Malfunction
·COMPRESSION THERAPY CONCEPTS, INC.·Product code JOW·September 17, 2019
VASOPRESS DIGITAL MINI PUMP
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL, INC.·Product code JOW·November 19, 2019
VASOPRESS DIGITAL MINI PUMP
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL, INC.·Product code JOW·November 19, 2019
VASOPRESS DIGITAL MINI PUMP
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL, INC.·Product code JOW·December 10, 2019