317 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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QUICKTEST SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89200151·Mand. 1. Molar band W-Fit left 15
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690126447·Modular Tibia Tray Trial Size 5
Sapphire ULTRA Coronary Dilatation Catheter
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955979187·
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89200150101·Mand. 1. Molar band W-Fit left 15
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89200150501·Mand. 1. Molar band W-Fit left 15
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89200150051·Mand. 1. Molar band W-Fit left 15
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955937781·Percutaneous Transluminal Angioplasty Balloon C...
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955938955·Percutaneous Transluminal Angioplasty Balloon C...
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955936616·Percutaneous Transluminal Angioplasty Balloon C...
BENT ROD TI 5.5X75MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWP·January 27, 2022
Arthrex®
FDA UDI
ARTHREX, INC.·00888867136854·UNIVERS TRIAL STEM, 5MM
IMPLANT GUIDANCE SYSTEM APPLICATOR SET
FDA 510(k)
FDA Class 2
·Radiology
OSTEOMED WRIST PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 24, 2024
VIRTUOSO VR
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA·Product code LWS·April 10, 2018
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·January 17, 2013
ANALYTICAL E MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·December 10, 2010
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code DTB·July 8, 2014
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC(R) TRANSVENE LEAD SYSTEM