102 results
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36ms
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Sources: EU EUDAMED, US FDA
Enzyme Immunoassay, Tracrolimus
FDA Pre-Market Approval
FDA Class 2
·PRO-TRAC II TACROLIMUS ELISA KIT
artegral
FDA UDI
Merz Dental GmbH·D7091970025·anteriors; shade A1; mould UBS
PCRopsis
FDA UDI
ENTOPSIS, LLC·B55059700250·PCRopsis™ Lysis Beads (25 grams, bulk) facilita...
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89700251·Mand. 2. Molar band W-Fit right 25
Bioseal Inc.
FDA UDI
BIOSEAL·00630094197005·Silicone Tubing
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108697445·PAI Dental Implant Ø6mm L11.5mm
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89700250051·Mand. 2. Molar band W-Fit right 25
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89700250501·Mand. 2. Molar band W-Fit right 25
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89700250101·Mand. 2. Molar band W-Fit right 25
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 2
·Aptima HBV Quant Assay
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·ABBOTT HBE DIAGNOSTIC KIT
NexGen®
FDA UDI
Zimmer, Inc.·00889024214293·
NexGen®
FDA UDI
Zimmer, Inc.·00889024214309·
THERMACHOICE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code MKN·June 16, 2006
THERMACHOICE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code MKN·June 16, 2006
THERMACHOICE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code MKN·June 16, 2006
PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50 tubes, REF 597850; d) 25 grams, REF 5970025; e) 1000 kilogram, REF 5971000; coated beads that facilitate lysis of microorganisms; nucleic acid extraction from a variety of biological samples
FDA Enforcement
Class II
·Ongoing·Entopsis , Inc.·April 5, 2023
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 2
·Aptima HBV Quant Assay
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 2
·Aptima HBV Quant Assay
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 2
·Aptima HBV Quant Assay