16 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MALLINCKRODT
FDA Adverse Event
Injury
·COVIDIEN·Product code BTR·February 26, 2014
TAPERGUARD ENDOTRACHEAL TUBES, TAPERGUARD EVAC ENDOTRACHEAL TUBES
FDA 510(k)
FDA Class 2
·Anesthesiology
RMO
FDA UDI
Rmo, Inc.·00885797100290·DUAL-TOP TAD SYSTEM KIT
LEONE SPA
FDA UDI
LEONE SPA·08033707065654·INTRAORAL ELASTICS 2,5 oz 1/4" red
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036028916·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450053195·
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 1, 2023
CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Dental
SURGICAL DYNAMICS OGDEN SUTURE ANCHOR WITH SUTURE
FDA 510(k)
FDA Class 2
·Orthopedic
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 28, 2024
VERCISE GENUS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·February 25, 2022
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·May 2, 2013
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·September 15, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 16, 2011
SPECTRA WAVEWRITER?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 24, 2026
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024