52 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Immunohistochemistry Antibody Assay, C-Kit
FDA Pre-Market Approval
FDA Class 3
·C-KIT PHARMDX
Immunohistochemistry Antibody Assay, C-Kit
FDA Pre-Market Approval
FDA Class 3
·C-Kit pharmDx
Immunohistochemistry Antibody Assay, C-Kit
FDA Pre-Market Approval
FDA Class 3
·C-KIT PHARMDX
Immunohistochemistry Antibody Assay, C-Kit
FDA Pre-Market Approval
FDA Class 3
·DAKO C-KIT PHARMDX
Ormco
FDA UDI
ORMCO CORPORATION·00889989024746·BONDABLE LINGUAL RETAINER CUSPID 1
20GA Curved Illuminating Probe, SMA 905
FDA UDI
Peregrine Surgical, Llc·00632307001765·20GA Curved Illuminating Probe, SMA 905
n/a
FDA UDI
Ortho Development Corporation·00822409073764·10/12 Distal Reamer 11mm
LEONE SPA
FDA UDI
LEONE SPA·08033707001966·LEOWIRE SPRING HARD 1,1mm
Medline Industries, Inc.
FDA UDI
MEDLINE INDUSTRIES, INC.·10884389048917·CIRCUIT-MAPLESON D
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710820400110·Zadik Calcaneal Guide, 40mm x 11°
IMPACTOR HEAD
FDA Adverse Event
Malfunction
·STRYKER GMBH·Product code LXH·January 13, 2021
POLARIS 2004 CAPNOGRAPH
FDA 510(k)
FDA Class 2
·Anesthesiology
IMPACTOR ASSEMBLY OMEGA
FDA Adverse Event
Malfunction
·STRYKER GMBH·Product code LXH·October 13, 2020
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·BIODIVYSIO AS PS (PHOSPHORYLCHOLINE)COATED STENT DELIVERY SYSTEM
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·VERSANT HCV RNA QUALITATIVE ASSAY
X-STOP PEEK INTERSPINOUS SPACER
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NQO·February 1, 2019
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·Aptima HCV RNA Qualitative Assay
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·BIODIVYSIO AS OTW
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·Aptima HCV RNA Qualitative Assay
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·Aptima HCV RNA Qualitative Assay