12 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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ANATOMIC MODULAR KNEE POLYETHYLENE TIBIAL TRAY
FDA 510(k)
FDA Class 2
·Orthopedic
Navina™ Smart System
FDA UDI
Wellspect AB·07333387052625·Navina Smart Transanal Irrigation. 1 Navina Sma...
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756380485·OPC DERMATOLOGY SURGICAL PACK
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668112359·SURG-I-BAND PURPLE GLOW
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668112298·SURG-I-BAND BLACK
ELOX P 53 BP
FDA Adverse Event
Other
·BIOTRONIK GMBH & CO.·Product code DTB·January 28, 2004
ZIMMER SEGMENT SYSTEM TRABECULAR METAL PROXIMAL TIBIAL COMPONENT, TRABECULAR METAL PROXIMAL COMPONENT, ADDITIONAL SEGMEN
FDA 510(k)
FDA Class 2
·Orthopedic
SEALAPEX 4
FDA 510(k)
FDA Class 2
·Dental
RESTORE SENSOR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·January 11, 2013
QUATTRODE PERCUTANEOUS LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·November 23, 2010
SERIES A PATELLA STD 34 3 PEG
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·July 2, 2014
BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020