129 results · 22ms · Sources: EU EUDAMED, US FDA

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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...