199 results · 28ms · Sources: EU EUDAMED, US FDA

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TRULENE MESH

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Ormco

FDA UDI
ORMCO CORPORATION·00889989026368·ARCH PREFORMED UPPER 18 DIA. PK/20

n/a

FDA UDI
Ortho Development Corporation·00822409074716·12/14 Centralizer Trial 18mm

Encompass Hip Stem

FDA UDI
Ortho Development Corporation·00822409011933·18mm Distal Centralizer

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

FDA UDI
FX SOLUTIONS·03701037312629·LONG BASE PLATE IMPACTOR

Kalitec Special

FDA UDI
Kalitec Direct LLC·B073DRK0100180·SNII Tap, 6.50mm

Kalitec Disc Prep

FDA UDI
Kalitec Direct LLC·B07319K0600080·Tray Insert, Disc Prep 1

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·PRESTIGE CERVICAL DISC SYSTEM

MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE

FDA 510(k)
FDA Class 2 ·Cardiovascular

BRANEMARK NOVUM

FDA 510(k)
FDA Class 2 ·Dental

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·PRESTIGE CERVICAL DISC

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·PRESTIGE CERVICAL DISC SYSTEM

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·PRESTIGE® Cervical Disc

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·PRESTIGE CERVICAL DISC

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·PRESTIGE CERVICAL DISC

BD PHOENIX PMIC110

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·October 19, 2021

BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·August 23, 2021

BD PHOENIX PANEL PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·November 10, 2023

BD PHOENIX PANEL PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·November 10, 2023

BD PHOENIX¿ PMIC/ID-106

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·September 2, 2025