19 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STANDING WHEELER
FDA 510(k)
FDA Class 2
·Physical Medicine
K2-HF OPAQUER powder, O-C4, 20g.
FDA UDI
Yeti Dentalprodukte GmbH·EYET38620130·
Eusol-C
FDA 510(k)
FDA Unclassified
·Unknown
CELLSEARCH CIRCULATING TUMOR CELL KIT
FDA 510(k)
FDA Class 2
·Immunology
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code DTK·June 13, 2016
VerSys®
FDA UDI
Zimmer, Inc.·00889024366787·
VerSys®
FDA UDI
Zimmer, Inc.·00889024173323·
VerSys®
FDA UDI
Zimmer, Inc.·00889024138902·
VerSys®
FDA UDI
Zimmer, Inc.·00889024173309·
VerSys®
FDA UDI
Zimmer, Inc.·00889024138889·
VerSys®
FDA UDI
Zimmer, Inc.·00889024173316·
VerSys®
FDA UDI
Zimmer, Inc.·00889024138896·
VerSys®
FDA UDI
Zimmer, Inc.·00889024138872·
METASUL HD 32 12/14 SZXL/+7 L/+7
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code KWA·April 4, 2023
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 23, 2014
ALTRX +4 10D 32IDX48OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·December 7, 2012
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code FPA·June 23, 2015
METASUL TAPER LINER GG/32
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code KWA·April 4, 2023
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