22 results · 26ms · 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.

SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)

FDA 510(k)
FDA Class 2 ·Orthopedic

EVO 2 ST

FDA UDI
DENTAL MANUFACTURING SPA·08056865012834·

N/A

FDA UDI
BIOMET MICROFIXATION, INC·00841036031398·

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197029216·Iris Scissor 11.5 c...

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197029193·Iris Scissors curved...

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197411516·Iris Scissors curved...

TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601

FDA 510(k)
FDA Class 2 ·Orthopedic

ESTHETICA

FDA 510(k)
FDA Class 2 ·Dental

RESPIRONICS

FDA Adverse Event
Malfunction ·Product code MNT·April 8, 2021

MG II®

FDA UDI
Zimmer, Inc.·00889024186798·

INDIGO SYSTEM ASPIRATION CATHETER 7D

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code QEW·August 3, 2022

INDIGO SYSTEM ASPIRATION CATHETER 7D

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code QEW·August 20, 2022

PULSE GEN MODEL 102

FDA Adverse Event
Injury ·CYBERONICS, INC.·Product code LYJ·May 20, 2013

M SERIES

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORP·Product code MKJ·May 26, 2011

IN TOUCH

FDA Adverse Event
Malfunction ·STRYKER MEDICAL QUEBEC LP·Product code FNL·August 15, 2008

INDIGO SYSTEM SEPARATOR 7D

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code QEW·September 13, 2022

V.A.C. FREEDOM THERAPY SYSTEM

FDA Adverse Event
Injury ·KINETIC CONCEPTS, INC.·Product code OMP·February 15, 2021

INDIGO SYSTEM ASPIRATION CATHETER 7D

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code QEW·October 13, 2023

MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software

FDA Enforcement
Class II ·Ongoing·Auris Health, Inc·February 25, 2026

Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.

FDA Enforcement
Class II ·Ongoing·AURIS HEALTH INC·October 16, 2024