20 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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OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ArgenZ HT+ 95x20 B3
FDA UDI
ARGEN CORPORATION, THE·D818122759·Dental porcelain/ceramic restoration kit
NA
FDA UDI
Smith & Nephew, Inc.·03596010069825·STAINLESS STEEL HALF PIN 5MM X 80MM
CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTION
FDA 510(k)
FDA Class 2
·Clinical Chemistry
APCLO PEDICLE SCREW SYSTEMS
FDA 510(k)
FDA Class 2
·Orthopedic
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970515·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970522·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973127·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973554·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970492·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970546·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970485·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973011·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970539·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970553·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973417·
CLINICAL CHEMISTRY CARBON DIOXIDE
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code KHS·May 21, 2013
ASR UNI FEMORAL IMPL SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KXA·June 3, 2011
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORP·Product code LGW·August 18, 2008
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.
FDA Enforcement
Class II
·Ongoing·Abbott Medical·January 1, 2025