11 results
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21ms
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Sources: EU EUDAMED, US FDA
LASER THERMAL THERAPY KIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772412488·PROTECT.LUMBOSTYLE BACK SUPPORT BLACK II
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772412495·PROTECT.LUMBOSTYLE BACK SUPP BLACK III
Stainless Steel Co-axial Wire
FDA UDI
Ortho Arch Company Inc·D90926063216·.0215 LOWER LEVEL 6 COAXIAL SS RIGHT FORM WIRES...
Vantage Titan 1.5T, MRT-1510, V3.6 Software
FDA 510(k)
FDA Class 2
·Radiology
VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRATORS,RANGE VERIFIERS,680 2156,680 2157,680 2158
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DEXTRUS 4136
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.·Product code DTB·December 9, 2008
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·September 22, 2011
COBRA GRASPER INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·August 1, 2013
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024