27 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
QIAstat-Dx Gastrointestinal Panel 2
FDA 510(k)
FDA Class 2
·Microbiology
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551126720·HALO, 1220-5 VEST MEDIUM, ACRYLIC LINER, 1211-1...
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112557·BARRON VACUUM TREPHINE 9.0MM
XERAFIT
FDA 510(k)
FDA Class 2
·Dental
DRX-REVOLUTION MOBILE X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
NA
FDA UDI
Zimmer, Inc.·00889024187580·
NA
FDA UDI
Zimmer, Inc.·00889024187603·
NA
FDA UDI
Zimmer, Inc.·00889024187597·
NA
FDA UDI
Zimmer, Inc.·00889024187573·
NA
FDA UDI
Zimmer, Inc.·00889024187566·
ACCU-CHEK COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS CORP.·Product code LFR·October 31, 2008
INRATIO2
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC·Product code GJS·August 12, 2011
ATLAS PLUS DR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2013
AlluraXper FD20 System Code: (1) 722006 (2) 722012 (3) 722028
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·January 13, 2025
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·January 13, 2025
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis·Product code OWB·March 3, 2026
Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot 122336 Opthalmic
FDA Enforcement
Class II
·Terminated·Surgical Instrument Service And Savings, Inc.·July 10, 2013
AlluraXper FD20 System Code: (1) 722006 (2) 722012 (3) 722028
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 12, 2025
Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot 122336 Opthalmic
FDA Recall
Terminated
·Surgical Instrument Service And Savings, Inc.·Product code HRH·May 3, 2013
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026