70 results · 22ms · Sources: EU EUDAMED, US FDA

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Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·VIRTIS SACRAL NEUROMODULATION SYSTEM

Paltop

FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108695458·Dynamic Dental Implant Ø3.75mm L10mm

Guide Pin 2.7 x 100mm w Olive

FDA UDI
Osteocentric Technologies, Inc.·00816950029325·Guide Pin 2.7 x 100mm Olive

INTREPED, Intraosseous Fusion Device

FDA UDI
Auxano Medical LLC·00850055649262·INTREPED Tray System

NA

FDA UDI
Biedermann Motech GmbH & Co. KG·04250869602914·MOSS 100 Ti Head, Standard Polyaxial, rod syste...

NA

FDA UDI
Biedermann Motech GmbH & Co. KG·04250869610490·MOSS VRS Ti Polyaxial Reduction Head

NA

FDA UDI
Biedermann Motech GmbH & Co. KG·04250869628419·MOSS VRS MIS Ti polyaxial long head extended tabs

MINIMALLY INVASIVE DEFORMITY CORRECTION (MID-C) SYSTEM

FDA Adverse Event
Malfunction ·APIFIX LTD.·Product code QGP·July 8, 2024

MID-C 125

FDA Adverse Event
Malfunction ·APIFIX LTD.·Product code QGP·March 27, 2024

MINIMALLY INVASIVE DEFORMITY CORRECTION (MID-C) SYSTEM

FDA Adverse Event
Malfunction ·APIFIX LTD.·Product code QGP·October 8, 2024

Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens

FDA 510(k)
FDA Class 2 ·Ophthalmic

Qualitative And Quantitative Hepatitis B Virus Antibody Assays

FDA Pre-Market Approval
FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLS

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·PRODISC TM-C TOTAL DISC REPLACEMENT

MOSS VRS

FDA Adverse Event
Injury ·BIEDERMANN MOTECH GMBH & CO. KG·Product code NKB·February 12, 2025

OPTILOCK IMPLANTABLE ACCESS PORT, MODELS #1700-01, 1700-02, 1700-03, 1700-04 AND 1700-05

FDA 510(k)
FDA Class 2 ·General Hospital

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·Vitros Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·VITROS ANTI-HBE

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·PRODISC-C TOTAL DISC REPLACEMENT

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·VITROS Anti-HBe