44 results · 23ms · Sources: EU EUDAMED, 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