500 results · 27ms · Sources: EU EUDAMED, US FDA

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MAKO SURGICAL UNICONDYLAR KNEE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

SEMI-TUBULAR PLATE, 17-HOLE

FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665029017·

n/a

FDA UDI
Ortho Development Corporation·00822409074709·12/14 Centralizer Trial 17mm

Encompass Hip Stem

FDA UDI
Ortho Development Corporation·00822409011926·17mm Distal Centralizer

Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

FDA Pre-Market Approval
FDA Class 3 ·GENESEARCH BREAST LYMPH NODE(BLN) ASSAY

Kalitec Universal Instruments

FDA UDI
Kalitec Direct LLC·B07301K0600070·Tray Insert, 1.5" Blank

Cosmolock

FDA UDI
Kalitec Direct LLC·B07311K0600120·Tray Insert 5, Cosmolock Deformity

Kalitec Special

FDA UDI
Kalitec Direct LLC·B073DRK0100170·SNII Tap, 5.50mm

PARSET SECONDARY ADMINISTRATION SET, LUERLOCK, MODEL A14001E, PARSET SECONDARY SECONDARY ADMINISTRATION SET, MODEL A1400

FDA 510(k)
FDA Class 2 ·General Hospital

MEDX 1000 SERIES

FDA 510(k)
FDA Class 2 ·Physical Medicine

Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

FDA Pre-Market Approval
FDA Class 3 ·GENESEARCH BREAST LYMPH NODE (BLN) ASSAY

Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

FDA Pre-Market Approval
FDA Class 3 ·GENESEARCH BREAST LYMPH NODE

Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

FDA Pre-Market Approval
FDA Class 3 ·GENESEARCH BREAST LYMPH NODE ASSAY

HEART START XL

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 19, 2013

COGNIS

FDA Adverse Event
Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 15, 2011

SUMMIT TORQUE LIMITING DRIVER

FDA Adverse Event
Malfunction ·DEPUY SPINE, INC.·Product code LXH·June 11, 2008

Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.

FDA Enforcement
Class II ·Terminated·BioHorizons Implant Systems Inc·December 26, 2012

BD PHOENIX¿ NMIC/ID-307

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 15, 2026

BD PHOENIX¿ NMIC/ID-307

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 8, 2026

BD PHOENIX¿ NMIC/ID-307

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 5, 2026