429 results · 23ms · Sources: EU EUDAMED, US FDA

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OrthoNext Platform System

FDA 510(k)
FDA Class 2 ·Radiology

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112946·CORNEAL TREPHINE BLADE8.25MM

VITREA 2, VERSION 2.1

FDA 510(k)
FDA Class 2 ·Radiology

LDL CHOLESTEROL (AUTOMATED)

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

630G INSULIN PUMP MMT-1715K 630G BLACK MG

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·January 30, 2025

MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·August 21, 2025

PUMP 1886 780G OUS BLE PUMP MG/DL

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·April 16, 2025

MX40 1.4 GHZ SMART HOPPING

FDA Adverse Event
Death ·PHILIPS MEDICAL SYSTEMS·Product code MHX·September 16, 2025

MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·September 11, 2025

PATIENT INFORMATION CENTER IX

FDA Adverse Event
Death ·PHILIPS MEDICAL SYSTEMS·Product code MHX·October 8, 2025

INFUSOMAT®

FDA Adverse Event
Malfunction ·B BRAUN MELSUNGEN AG·Product code FRN·July 28, 2025

PUMP 1886 780G OUS BLE PUMP MG/DL

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·October 23, 2025

PUMP 1886 780G OUS BLE PUMP MG/DL

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·October 15, 2025

I-STAT CHEM8+ CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code JPI·May 13, 2025

HAMILTON-G5

FDA Adverse Event
Malfunction ·HAMILTON MEDICAL AG·Product code CBK·January 8, 2026

MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·December 1, 2025

MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·July 29, 2025

MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·May 22, 2025

MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·November 6, 2025

PUMP MMT-1884L MM780G BLE 3.0 MG/ML

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·May 14, 2025