2,740 results · 39ms · Sources: EU EUDAMED, US FDA

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Arm Blood Pressure Monitor

FDA 510(k)
FDA Class 2 ·Cardiovascular

Bernafon

FDA UDI
Bernafon AG·05711584086971·ZR3, KIT 312 NFM PB T L BE ZERENA 3

DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, MODEL APOGEE 3500, CONVEX ARRAY TRANSDUCER, MODEL C3L60C

FDA 510(k)
FDA Class 2 ·Radiology

NAVIJECT SUB2-1P, MODEL: LP604430

FDA 510(k)
FDA Class 1 ·Ophthalmic

PUMP MMT-1711KL 640G V4.10 BK SF MM

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 14, 2023

670G INSULIN PUMP MMT-1780KL

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·May 31, 2023

640G INSULIN PUMP MMT-1711K

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 7, 2023

DURALOC 300 SERIES 58MM OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·October 6, 2008

MONARC SLING SYSTEM

FDA Adverse Event
Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code OTM·June 20, 2013

OT ULTRA2 METER

FDA Adverse Event
Injury ·LIFESCAN INC.·Product code NBW·August 4, 2011

640G INSULIN PUMP MMT-1711K

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·February 27, 2024

670G INSULIN PUMP MMT-1780KL

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·May 2, 2023

PUMP MMT-1712KL 640G V4.10 BK SF MG

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·September 7, 2023

640G INSULIN PUMP MMT-1711K

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 13, 2023

PUMP MMT-1880L MM770G BLE MG

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·August 8, 2023

PUMP MMT-1780KPK 670G PATHWAY BLACK MG

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·March 10, 2023

NI

FDA Adverse Event
Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·August 11, 2023

MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·September 12, 2023

MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·August 9, 2023

PUMP MMT-1780KPK 670G PATHWAY BLACK MG

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·November 8, 2023