13 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector
FDA 510(k)
FDA Class 2
·General Hospital
EMS HEPA FILTER AND HME COMBINATIONS
FDA 510(k)
FDA Class 2
·Anesthesiology
FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT24238-001
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HEARTSINE SAMARITAN 300P AND PAD PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES LTD, CANABERRA HOUSE,·Product code MKJ·September 1, 2014
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·August 16, 2011
MOUNTAINEER OCT THORACIC PEDICLE PROBE
FDA Adverse Event
Malfunction
·DEPUY SYNTHES SPINE·Product code LXH·July 9, 2013
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·February 20, 2026
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·January 23, 2026
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·June 25, 2025
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·January 23, 2026
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·January 29, 2026
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refurb) - 10440017 S3000 10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023