44 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ENDOPATH ETS 35MM ENDOSCOPIC LINEAR CUTTER AND RELOADS, AND ETS-FLEX 35MM ENDOSCOPIC ARTICULATING LINEAR CUTTER AND RELO
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902784118·CASE 8111111 X-10 XLINK OUTER BASE
Advanced Instruments GloCyte® Low Level Control Vial (Single)
FDA UDI
Advanced Instruments, LLC·00816068020184·3 mL vial of Low Level Control
Mission U120 Urine Analyzer
FDA UDI
Acon Laboratories, Inc.·20682607200041·Mission U120 Urine Analyzer with Barcode Reader
EXACT REAMER HANDLE
FDA UDI
Biomet Orthopedics, LLC·00880304440128·
ITOTAL PS
FDA Adverse Event
Injury
·CONFORMIS, INC.·Product code JWH·November 6, 2015
Sterile Sphincterotome
FDA UDI
Micro-Tech (Nanjing) Co., Ltd.·06932503512220·Sterile Sphincterotome/ lumen 3/ TIP length 2/ ...
Sterile Sphincterotome
FDA UDI
Micro-Tech (Nanjing) Co., Ltd.·06932503513036·Sterile Sphincterotome, lumen 3, TIP length 5, ...
Sterile Sphincterotome
FDA UDI
Micro-Tech (Nanjing) Co., Ltd.·06932503513203·Sterile Sphincterotome/ lumen 3/ TIP length 2/ ...
Sterile Sphincterotome
FDA UDI
Micro-Tech (Nanjing) Co., Ltd.·06932503513180·Sterile Sphincterotome/ lumen 3/ TIP length 2/ ...
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167310111111110·
Sterile Sphincterotome
FDA UDI
Micro-Tech (Nanjing) Co., Ltd.·06932503513050·Sterile Sphincterotome, lumen 3, TIP length 5, ...
Sterile Sphincterotome
FDA UDI
Micro-Tech (Nanjing) Co., Ltd.·06932503513012·Sterile Sphincterotome, lumen 3, TIP length 5, ...
iUni iPoly Implant
FDA UDI
Conformis, Inc.·M572UKA1111111031·IUNI–IPOLY–IMPLANT KIT–RIGHT or Left LATERAL or...
iDuo
FDA UDI
Conformis, Inc.·M572BKA1111111021·IDUO–IPOLY–IMPLANT KIT–LEFT or right MEDIAL or ...
iTotal PS
FDA UDI
Conformis, Inc.·M572TPS1111111011·ITOTAL PS IPOLY IMPLANT KIT LEFT or right
HALO ABLATION CATHETER MODEL 90-9100, HALO90 ULTRA ABLATION CATHETER MODEL 90-9200
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MXD100/MX 20, OR MX 30, OR MX 40 OR MX 50--(MXD 100 SERIES)
FDA 510(k)
FDA Class 2
·Radiology
SURESIGNS VS2+ NBP/SPO2/WIRELESS
FDA Adverse Event
Malfunction
·PHILIPS NORTH AMERICA LLC·Product code MHX·August 26, 2021
Orantech
FDA UDI
Orantech Inc.·06941691972686·NIBP Y Type with Connectors