17 results · 20ms · Sources: EU EUDAMED, US FDA

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STIMULATOR, NIC-106 VISUAL

FDA 510(k)
FDA Class 2 ·Neurology

MEGA PLUS MIS SPINE SYSTEM

FDA UDI
BK MEDITECH CO.,LTD.·08809916490248·MIS Fenestrated Screw M, Ø10.5 x 70mm, Ø6.0mm Rod

STAINLESS STEEL CABLE/SLEEVE COMBO

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JDQ·July 24, 2017

RANAWAT/BURSTEIN ACETABULAR SHELL

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWA·July 24, 2017

TI LOW PROFILE SCREW

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JWH·July 24, 2017

RINCLOC AND QUICK CONNECT DRILL BIT

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code HTW·July 24, 2017

RING LOC ACETABULAR LINER

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JDI·July 24, 2017

COLLARLESS BI-METRIC POROUS STEM

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code LPH·July 24, 2017

MODULAR HEAD COMPONENT

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JDI·July 24, 2017

CALCIUM/MAGNESIUM ANALYZER

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ROBINSON MIDDLE EAR PROSTHESIS

FDA 510(k)
FDA Class 1 ·Dental

SECURA VR

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code LWS·October 15, 2012

SPECTRUM INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·December 31, 2013

ICON 25 HCG (COMBO CASSETTE)

FDA Adverse Event
Other ·BIOSITE INCORPORATED·Product code JHI·August 2, 2010

PROPONENT DR SL (Model L201)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018