21 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DMi Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
VIVID POST DRILL
FDA UDI
BIOLOREN SRL·08056099233449·Cylindrical drill kit ass.(4 drills)
Mariner Cortical
FDA UDI
Seaspine Orthopedics Corporation·10889987168340·CORTICAL SHANK, Cannulated, 6.0 X 60
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319705346·Webster Needle Holder 5" (12.5cm), serrated jaws
Mariner Cortical
FDA UDI
Seaspine Orthopedics Corporation·10889981168346·CORTICAL SHANK, Cannulated, 6.0 X 60
ESI
FDA UDI
FTT MEDICAL, INC.·B3961600600·YANKAUER SUCTION, STANDARD SIZE. ACMI FITTING.
ARTHREX ANGEL PRP KIT (US TRAY)
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code ORG·June 23, 2023
Apelo® / Apelo® MIS
FDA UDI
ATLAS SPINE, INC.·M68111001600600·5.5mm x 60mm MIS Contoured Rod
GBR System
FDA UDI
Surgident Co.,Ltd.·08800041000104·
Canaveral®
FDA UDI
FLOSPINE LLC·B183121600600·6.0mm Straight Rod, Ti Alloy 60mm
EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BIOGRAPH 6
FDA 510(k)
FDA Class 2
·Radiology
PROTECTA XT DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·October 10, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 10, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 13, 2011
SERIES PATELLA THIN 3-PEG
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 7, 2018
VANGUARD FEMORAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 7, 2018
CC CRUCIATE TRAY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 7, 2018
DUO FLUID CART WITH SMOKE EVACUATOR
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·September 17, 2019
MAGNETOM Verio Dot. Model Number: 10684333.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025