44 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FIGURE 8 STERNOTOMY CLOSURE DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
Fletcher CT/MR Applicator
FDA UDI
Nucletron B.V.·08717213035201·Micro Ovoid (right) 15mm, R7.5
MYSTIQUE® MB
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K110531101·MYSTIQUE® MB RT RX 018 U5-5/L3-3 CS HK
MYSTIQUE® MB
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K110531111·MYSTIQUE® MB RT RX 018 U 5-5/L3-3 CS-BC HK
ENDOLOGIX GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
PREVISION CHEM
FDA 510(k)
FDA Class 2
·Dental
UNIDENTIFIED SIGMA PARTIAL GCK
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS·Product code JWH·May 14, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 23, 2014
FLEXCATH STEERABLE SHEATH
FDA Adverse Event
Malfunction
·MEDTRONIC CRYOCATH LP·Product code DRA·June 1, 2011
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 22, 2024
LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 13MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 13, 2023
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 17, 2024
LOGIC FEMORAL PS CEM LEFT SZ 3.5
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·March 5, 2025
LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·June 30, 2022
LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 5, 2024
StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411.
FDA Enforcement
Class II
·Terminated·Abbott Vascular·February 22, 2017
LOGIC TIBIA IMPLANT PSC INSERT, SZ 1, 13MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 11, 2024
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MGB·August 22, 2022
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 22, 2024
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 26, 2023