12 results
·
21ms
·
Sources: EU EUDAMED, US FDA
CardioPhase® hsCRP
FDA 510(k)
FDA Class 2
·Immunology
Bernafon
FDA UDI
Bernafon AG·05711584114018·CO9 B 105, 2.4G NFM SABE DEMO CAPTO 9 GPL
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970812·
POLY STAT HCG TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
OVERJET CARIES ASSIST
FDA Adverse Event
Malfunction
·OVERJET·Product code MYN·February 18, 2025
FG 6301 DUAL CHNL VOL INF PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·October 29, 2008
EXCLAIM 60-CM SCS PADDLE LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·August 11, 2011
ALTRUA
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 9, 2013
Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021