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2100-SX2 FINAL FEATURE ITEM

FDA UDI
PARKS MEDICAL ELECTRONICS, INC.·00816787024173·

AUDIOTONE MODEL FFI ITE HEARING AID

FDA 510(k)
FDA Class 1 ·Ear, Nose, Throat

COBAS C 303 ANALYTICAL UNIT

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·April 13, 2026

PLATE, FIXATION, BONE

FDA Adverse Event
Injury ·ACUMED, LLC·Product code HRS·January 30, 2024

PLATE, FIXATION, BONE

FDA Adverse Event
Injury ·ACUMED, LLC·Product code HRS·January 30, 2024

PLATE, FIXATION, BONE

FDA Adverse Event
Injury ·ACUMED, LLC·Product code HRS·January 30, 2024

PLATE, FIXATION, BONE

FDA Adverse Event
Injury ·ACUMED, LLC·Product code HRS·January 30, 2024

PLATE, FIXATION, BONE

FDA Adverse Event
Injury ·ACUMED, LLC·Product code HRS·January 30, 2024

PLATE, FIXATION, BONE

FDA Adverse Event
Injury ·ACUMED, LLC·Product code HRS·January 30, 2024

PLATE, FIXATION, BONE

FDA Adverse Event
Injury ·ACUMED, LLC·Product code HRS·January 30, 2024

OLYMPUS

FDA Adverse Event
Malfunction ·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code FFY·June 19, 2009

CODE ALERT SYSTEM

FDA Adverse Event
Death ·R.F. TECHNOLOGIES, INC.·Product code FFI·April 28, 1993

LITHOVUE EMPOWER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code FFY·August 2, 2022

STORZ

FDA Adverse Event
Injury ·KARL STORZ ENDOSCOPY-AMERICA, INC.·Product code FFY·September 2, 1994

DORA

FDA Adverse Event
Injury ·BAIN MEDICAL EQUIPMENT(GUANGZHOU) CO., LTD.·Product code FFI·November 20, 2023

AW-500-G VERSION C

FDA Adverse Event
Injury ·FUJI FILM MEDICAL SYSTEMS·Product code FFY·July 12, 2017

CLEANASCOPE LINERS

FDA Adverse Event
Malfunction ·CANTEL ITALY S.R.L.·Product code FFY·November 11, 2022

MONOPOLAR CABLE FOR ENDOSCOPIC INSTRUMENTS

FDA Adverse Event
Other ·BOWA-ELECTRONIC GMBH & CO KG·Product code FFY·August 9, 2006

MONOPOLAR CABLE, ELECTROSURGICAL ACCESSORIES

FDA Adverse Event
Malfunction ·BOWA-ELECTRONIC·Product code FFY·July 14, 2006

UNKNOWN

FDA Adverse Event
Injury ·WELCH/ALLEN BULB·Product code FFY·January 5, 1993