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

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HUMELOCK II CEMENTLESS SHOULDER SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

Gyrus ACMI

FDA UDI
Gyrus ACMI, LLC·00821925040250·BUCK WAX CURETTE DISPOSABLE SIZE 0 (6/PK)

LITTLE COACH

FDA 510(k)
FDA Class 2 ·Physical Medicine

ATLANTIS ABUTMENT IN ZIRCONIA FOR OSSEOSPEED TX PROFILE IMPLANT

FDA 510(k)
FDA Class 2 ·Dental

CRE PULMONARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KTI·March 31, 2025

CRE PULMONARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KTI·June 11, 2025

CRE PULMONARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KTI·May 30, 2025

CRE PULMONARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KTI·March 5, 2025

CRE PULMONARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KTI·June 5, 2025

CRE PULMONARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KTI·January 28, 2025

CRE PULMONARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KTI·July 28, 2025

MONOPOLAR CURVED SCISSORS INSTRUMENT

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·May 24, 2013

FORTIFY DR

FDA Adverse Event
Death ·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·September 30, 2014

ATTAIN ABILITY

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·June 16, 2011

INTELLAMAP ORION¿

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code DRF·February 18, 2016

CRE PULMONARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KTI·September 30, 2025

CRE PULMONARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KTI·May 12, 2025

CRE PULMONARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KTI·January 10, 2025

PLATE,FIXATION,BONE

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code HRS·July 21, 2016

Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

FDA Enforcement
Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015