2,086 results · 25ms · Sources: EU EUDAMED, US FDA

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6430 MyLabX75, 6430 MyLab XPro75

FDA 510(k)
FDA Class 2 ·Radiology

Thino Roth Bracket, .022, Mini Size, UR1

FDA UDI
Astar Orthodontics Inc.·06941673501545·

Temena

FDA UDI
Temena GmbH·03700339712076·Stimulation needle 20º bevel 21G x 120 mm

Temena

FDA UDI
Temena GmbH·03700339711888·Stimulation needle 45º bevel 21G x 120 mm

Cosmolock

FDA UDI
Kalitec Direct LLC·B07311K0120210·Assembly, Screwdriver, Extended Tab, Cannulated...

STERISPINE LC CAGE

FDA 510(k)
FDA Class 2 ·Orthopedic

Axon Therapy

FDA 510(k)
FDA Class 2 ·Neurology

670G INSULIN PUMP MMT-1780KL

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·October 29, 2021

MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·December 24, 2021

INSULIN PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 29, 2014

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 15, 2011

MECHANICAL WALKER, ROLLATOR

FDA Adverse Event
GENTEEL HOMECARE PRODUCTS·Product code ITJ·July 8, 2013

PUMP MMT-1780KPK 670G PATHWAY BLACK MG

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·September 27, 2021

640G INSULIN PUMP MMT-1712K

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·March 19, 2022

PUMP MMT-1780KPK 670G PATHWAY BLACK MG

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·December 27, 2021

670G INSULIN PUMP MMT-1780KL

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·October 29, 2021

NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE

FDA Adverse Event
Injury ·COCHLEAR LIMITED·Product code MCM·September 20, 2021

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FCY·July 21, 2021

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX OFFICE·Product code FCY·July 21, 2021

CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Recall
Open, Classified ·Smiths Medical ASD Inc.·Product code FRN·February 27, 2024