14 results · 33ms · Sources: EU EUDAMED, US FDA

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RETINA CAMERA TRC-NW7SF MARK II

FDA 510(k)
FDA Class 2 ·Ophthalmic

BONE GRAFT WASHER

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00673978958910·WASHER 9090115 TI BONE GRAFT 15MM

DeRoyal

FDA UDI
DEROYAL INDUSTRIES, INC.·00749756002752·Wrist Splint

TiWAVE L Lumbar Cage System

FDA UDI
Kalitec Direct LLC·B07323K0101150·Distractor, Smooth Paddle, Lordotic, 15mm

InTess Lumbar Cage

FDA UDI
Kalitec Direct LLC·B07312K0101150·Distractor, Smooth Paddle, 15mm

REFLEX ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

RETIC CHEX LINEARITY

FDA 510(k)
FDA Class 2 ·Hematology

LINEAR ST

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 4, 2024

LUX 1440

FDA Adverse Event
Malfunction ·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012

ORTHOPILOT CAP SINGLE-USE MARKERS

FDA Adverse Event
Injury ·AESCULAP AG·Product code HAW·February 15, 2022

DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·May 2, 2013

TOTALCARE BED

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FNL·July 17, 2014

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·May 5, 2011

Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

FDA Enforcement
Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024