69 results · 20ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

Medtronic Reusable Instruments

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00673978959061·DISTRACTOR 9091312 STR 12MM 4 DEG

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772003105·HUMERAL FRACTURE BRACE, RIGHT, SM

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690199021·AK3 Congruent Insert Trial Size 3, 12mm

EVIVA 0913-12

FDA UDI
Hologic, Inc.·15420045505322·PRODUCT, EVIVA, 9 GA, 13 CM LENGTH, 12MM APERTURE

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450450550·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450412510·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450458891·

K091319

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·January 9, 2026

MODEL 473SI-64E QUADRATURE LOWER EXTREMITY COIL

FDA 510(k)
FDA Class 2 ·Radiology

BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM

FDA 510(k)
FDA Class 2 ·Anesthesiology

EVIVA 0913-12

FDA Adverse Event
Injury ·HOLOGIC, INC·Product code KNW·January 5, 2024

EVIVA 0913-12

FDA Adverse Event
Injury ·HOLOGIC, INC·Product code KNW·January 5, 2024

EVIVA 0913-12

FDA Adverse Event
Injury ·HOLOGIC, INC·Product code KNW·June 25, 2025

REMSTAR AUTO A-FLEX

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·January 12, 2026

REMSTAR AUTO A-FLEX, SYS ONE, 60 SRS, FR

FDA Adverse Event
Injury ·RESPIRONICS, INC·Product code BZD·August 5, 2021

BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·June 24, 2022

REMSTAR PRO C-FLEX

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·December 31, 2025

REMSTAR

FDA Adverse Event
Injury ·RESPIRONICS, INC.·Product code BZD·October 22, 2024

BIPAP PRO BIFLEX

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·March 5, 2026