129 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Creo Electrosurgical System with NP1 Instrument
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PANCREATIC DRAINAGE TUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AFT PROXIMAL HUMERUS FRACTURE PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
TruFit 2.0
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730085566·Trufit™ 2.0 .022 MC UR6 CONV OCBT HG-OCC -14T 1...
TruFit 2.0
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730086228·TruFit™2.0 .022 MC UR6 CONV OCBT HG-OCC -14T 10...
E360 VENTILATOR
FDA Adverse Event
Injury
·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·November 3, 2014
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·August 15, 2011
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·July 1, 2013
Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla Arms and spatula Art. No. 06-06-285 and 06-06-285MOD. surgical instrument.
FDA Enforcement
Class II
·Ongoing·Medagent Inc·March 6, 2024
TruFit™
FDA UDI
Ortho Organizers, Inc.·00190707176464·TruFit™ 2.0 ASM .022 MC UR6 CONV OCBT -14T 10DO...
TruFit™
FDA UDI
Ortho Organizers, Inc.·00190707153007·*TruFit™ 2.0 ASM .022 MC UR6 CONV OCBT -14T 10D...
TruFit 2.0
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730070494·TruFit™ 2.0 ASM .022 MC UR6 CONV OCBT -14T 10DO...
TruFit™
FDA UDI
Ortho Organizers, Inc.·00190707176518·TruFit™ 2.0 ASM .022 MC UR6 CONV OCBT -14T 10DO...
TruFit 2.0
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730070579·TruFit™ 2.0 ASM .022 MC UR6 CONV OCBT -14T 10DO...
TruFit 2.0
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730070425·TruFit™ 2.0 ASM .022 MC UR6 CONV OCBT -14T 10DO...
TruFit™
FDA UDI
Ortho Organizers, Inc.·00190707176426·TruFit™ 2.0 ASM .022 MC UR6 CONV OCBT -14T 10DO...
TruFit™
FDA UDI
Ortho Organizers, Inc.·00190707152963·*TruFit™ 2.0 ASM .022 MC UR6 CONV OCBT -14T 10D...
TruFit 2.0
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730044266·TruFit™ 2.0 ASM .022 MC UR6 CONV OCBT -14T 10DO...
TruFit 2.0
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730044488·TruFit™ 2.0 ASM .022 MC UR6 CONV OCBT -14T 10DO...
TruFit 2.0
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730070593·TruFit™ 2.0 ASM .022 MC UR6 CONV OCBT -14T 10DO...