12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EPOC CHLORIDE TEST AND EPOC CREATININE TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
N/A
FDA UDI
HANS RUDOLPH, INC.·00874750004799·MED QUEST MASK/HG GRN 22ID SWL
WEGO-PGA Absorbable Surgical Suture With Needle
FDA UDI
Foosin Medical Supplies Inc., Ltd.·06941813600305·
Plateau C
FDA UDI
Life Spine, Inc.·00190837094607·
BIO-MODULAR SHOULDER SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304433656·
LINEAR? ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·July 7, 2025
JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ROCHE ACETAMINOPHEN ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
MASTERS SERIES MECHANICAL HEART VALVE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL PUERTO RICO·Product code LWQ·May 10, 2013
HEARTSTART FRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 17, 2014
EXPEDIUM SINGLE INNIE SET SCREW
FDA Adverse Event
Injury
·DEPUY SPINE, INC.·Product code NKB·June 2, 2011
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021