12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TB SERIES BIPOLAR PACING LEADS
FDA 510(k)
FDA Class 2
·Cardiovascular
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78614031·Sprint II Bracket Roth .018" mand. 3 right w. hook
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78614030051·Sprint II Bracket Roth .018" mand. 3 right w. hook
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78614031001·Sprint II Bracket Roth .018" mand. 3 right w. hook
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78614030101·Sprint II Bracket Roth .018" mand. 3 right w. hook
A.R.C. Laser Surgical Fibers and Probes
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX1-4U
FDA 510(k)
FDA Class 2
·Cardiovascular
SPRINT QUATTRO
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 10, 2014
INTEGRATED APD SET W/CASSETTE3-PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 8, 2010
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·December 7, 2012
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