36 results · 27ms · Sources: EU EUDAMED, US FDA

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AMES TDA THEOPHYL-LINE TEST

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

Polishers

FDA UDI
DFS - DIAMON GmbH·04057176151896·2ceram pol.flame CA 6pcs

ADVIA Centaur® ACS:180® Calibrator A

FDA UDI
Siemens Healthcare Diagnostics Inc.·00630414555317·Thyroid (2PK) - CENTAUR - CAL - 2x2x5mL

DISPOSABLE INJECTOR OR DISPOSABLE SCLEROTHERAPY NEEDLE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645

FDA 510(k)
FDA Class 2 ·Radiology

STAT DL 9.5 FR. 40 CC. IAB

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·June 4, 1998

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 8, 2014

TAPER SLEEVE ADAPTER 12/14 +2

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD.·Product code KWA·October 22, 2012

FREESTYLE FLASH

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC., USA·Product code LFR·September 7, 2007

MINIMED 780G PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code OZP·February 19, 2026

MEDTRONIC 780G TRANSMITTER

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OZP·April 1, 2026

MEDTRONIC 780G TRANSMITTER

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OZP·April 1, 2026

MEDTRONIC 780G TRANSMITTER

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OZP·April 1, 2026

MEDTRONIC MINIMED

FDA Adverse Event
*·Product code LZG·July 28, 2006

MINIMED 780G INSULIN PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OZP·March 26, 2026

InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA

FDA Recall
Open, Classified ·Medtronic MiniMed, Inc.·Product code FMF·March 4, 2025

Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, MMT-7040D1, MMT-7040D2, MMT-7040MA, MMT-7040QC1, MMT-7040QC2, MMT-7040QC3

FDA Recall
Open, Classified ·Medtronic MiniMed, Inc.·Product code OZP·November 15, 2023

CareLink Clinic, REF: MMT-7350

FDA Recall
Open, Classified ·Medtronic MiniMed, Inc.·Product code PHV·October 21, 2025

InPen App, Model/CFN Number: MMT-8061 (Android Users)

FDA Recall
Open, Classified ·Medtronic MiniMed, Inc.·Product code NDC·November 13, 2025