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HEMOSPHERE ALTA

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES·Product code DQE·May 29, 2026

UNKINVOS

FDA Adverse Event
Injury ·NELLCOR PURITAN BENNETT IRELAND·Product code QEM·April 23, 2019

FORESIGHT IQ

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES IRVINE·Product code DQE·April 3, 2026

FORESIGHT IQ

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES IRVINE·Product code DQE·April 3, 2026

HEMOSPHERE ALTA

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES IRVINE·Product code DQE·December 17, 2025

HEMOSPHERE ALTA

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES·Product code DQE·November 26, 2025

HEMOSPHERE ALTA

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES·Product code DQE·September 24, 2025

HEMOSPHERE ALTA

FDA Adverse Event
Malfunction ·EDWARDS LIFE SCIENCES·Product code DQK·February 12, 2026

HEMOSPHERE

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES·Product code DQK·January 29, 2026

Cerebral Oximeter

FDA classification
FDA Class 2 ·Cerebral Oximeter

AEM CORP.

FDA registration
AEM CORP.·1 product·🇺🇸 United States

N/A

FDA UDI
SOUTHERN IMPLANTS (PTY) LTD·06009544037804·Passive Abutment for Ø3.3 Provata®, Engaging

EQM RESEARCH, INC.

FDA registration
EQM RESEARCH, INC.·1 product·🇺🇸 United States

DEM FACTORY S.R.L.

FDA registration
DEM FACTORY S.R.L.·2 products·🇮🇹 Italy

EM3 AEM MONITOR AEM CONNECTORS

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Welch Allyn, Inc.

FDA UDI
WELCH ALLYN, INC.·00732094093865·Welch Allyn CP 200 12-Lead Resting Electrocardi...

ABPM cuff

FDA UDI
IEM GmbH·04041346101033·

Welch Allyn

FDA UDI
IEM GmbH·04041346101132·

Welch Allyn

FDA UDI
IEM GmbH·04041346101354·

Welch Allyn

FDA UDI
IEM GmbH·04041346030517·