38 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LOCKING BONE PLATES AND SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
CoRoent
FDA UDI
Nuvasive, Inc.·00887517565136·CoRoent Ant TLIF PEEK, 13x10x34mm 0°
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169604780·SPACER 2130340 OLIF25 27MM 0 DEG 12X40
ArgenZ HT+ 98x16 ML C1B
FDA UDI
ARGEN CORPORATION, THE·D818130340·Dental porcelain/ceramic restoration kit
Mariner Outrigger
FDA UDI
Seaspine Orthopedics Corporation·10889981176037·Z-Rod, Dia. 6.0mm, Titanium, 340mm
Apex
FDA UDI
ORTHOXEL DESIGNATED ACTIVITY COMPANY·05391529586522·Apex Femoral Nail GT Left Ø 13.0 x 340mm
Apex
FDA UDI
ORTHOXEL DESIGNATED ACTIVITY COMPANY·05391529585624·Apex Femoral Nail PF Right Ø 13.0 x 340mm
Apex
FDA UDI
ORTHOXEL DESIGNATED ACTIVITY COMPANY·05391529588397·Apex Femoral Nail Retrograde Ø 13.0 x 340mm
Apex
FDA UDI
ORTHOXEL DESIGNATED ACTIVITY COMPANY·05391529581510·Apex Femoral Nail PF Left Ø 13.0 x 340mm
Apex
FDA UDI
ORTHOXEL DESIGNATED ACTIVITY COMPANY·05391529587420·Apex Femoral Nail GT Right Ø 13.0 x 340mm
AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
UniSyn Hip System
FDA UDI
Shalby Advanced Technologies, Inc.·00840286836449·Neck, Standard, Cementless, 30mm, 34mm
UniSyn® Hip System
FDA UDI
CONSENSUS ORTHOPEDICS, INC.·00844588012259·Neck, Standard, Cementless
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·November 24, 2021
Truliant
FDA UDI
Exactech, Inc.·10885862314697·
TRULIANT TIB IMP CRC INSERT SZ 4, 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 4, 2025
TRULIANT KNEE IMPLANTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 18, 2022
TRULIANT TIB IMP CRC INSERT SZ 4, 15MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 30, 2022
OPTIFLUX 200NR DIALYZER FINISHED ASSBLY
FDA Adverse Event
Malfunction
·OGDEN MANUFACTURING·Product code KDI·May 22, 2013