13 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LAERDAL POCKET MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78614011·Sprint II Bracket Roth .022" mand. 3 right w. hook
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78614010051·Sprint II Bracket Roth .022" mand. 3 right w. hook
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78614011001·Sprint II Bracket Roth .022" mand. 3 right w. hook
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78614010101·Sprint II Bracket Roth .022" mand. 3 right w. hook
INTERPLATE VBR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CARDIOPULMONARY BYPASS TUBING
FDA 510(k)
FDA Class 2
·Cardiovascular
WIRE, GUIDE, CATHETER
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code DQX·June 10, 2014
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·October 8, 2010
ASPHERE M SPEC 12/14 40 +5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·December 7, 2012
PRESSON
FDA Adverse Event
Injury
·NEXUS SPINE, LLC·Product code MNI·January 18, 2024
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012