9 results · 14ms · Sources: EU EUDAMED, US FDA

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AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.

FDA Recall
Open, Classified ·Aesculap AG Am Aesculap-Platz 1 Tuttlingen Germany·Product code HBB·August 18, 2025

AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.

FDA Recall
Open, Classified ·Aesculap AG Am Aesculap-Platz 1 Tuttlingen Germany·Product code HBB·August 18, 2025

One Step P in vitro diagnostic test REF: 8194

FDA Recall
Open, Classified ·DFI Co., Ltd. 388-25 Gomo-Ro Jillye-Myeon Gimhae Korea (the Republic of)·Product code JIR·April 2, 2026

One Step pH in vitro diagnostic test REF: 31I4P

FDA Recall
Open, Classified ·DFI Co., Ltd. 388-25 Gomo-Ro Jillye-Myeon Gimhae Korea (the Republic of)·Product code CEN·April 2, 2026

QUCARE Total Cholesterol in vitro diagnostic test REF: 6407

FDA Recall
Open, Classified ·DFI Co., Ltd. 388-25 Gomo-Ro Jillye-Myeon Gimhae Korea (the Republic of)·Product code CHH·April 2, 2026

Uric Acid in vitro diagnostic test REF: 31H0P

FDA Recall
Open, Classified ·DFI Co., Ltd. 388-25 Gomo-Ro Jillye-Myeon Gimhae Korea (the Republic of)·Product code KNK·April 2, 2026

One Step UTI in vitro diagnostic test REF: 3374

FDA Recall
Open, Classified ·DFI Co., Ltd. 388-25 Gomo-Ro Jillye-Myeon Gimhae Korea (the Republic of)·Product code LJX·April 2, 2026

One Step 10A in vitro diagnostic test

FDA Recall
Open, Classified ·DFI Co., Ltd. 388-25 Gomo-Ro Jillye-Myeon Gimhae Korea (the Republic of)·Product code MVO·April 2, 2026

One Step K in vitro diagnostic test REF: 81A4

FDA Recall
Open, Classified ·DFI Co., Ltd. 388-25 Gomo-Ro Jillye-Myeon Gimhae Korea (the Republic of)·Product code JIN·April 2, 2026