411 results · 23ms · Sources: EU EUDAMED, US FDA

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EXACTRAC ROBOTICS NOVALIS ROBOTICS

FDA 510(k)
FDA Class 2 ·Radiology

Unity Total Knee System

FDA UDI
CORIN LTD·05056139243981·UNITY KNEE™ PS-C INSERT - Size 5 x 20mm

ATLANTIS® Anterior Cervical Plate System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994241191·SCREW 3120520 4.0 X 20 SELF DRILL VAR

Novo Surgical Inc.

FDA UDI
NOVO SURGICAL, INC.·00842331161612·silvers miniature skin graft knife/dermatome, p...

LEONE SPA

FDA UDI
LEONE SPA·08033707009573·CALIBRA 1ST MOLAR BANDS n.UR 20

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450191439·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450193860·

NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

EASYTEM EAR THERMOMETER, MODEL BT-020

FDA 510(k)
FDA Class 2 ·General Hospital

PINNACLE MTL INS NEUT36IDX50OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·May 20, 2013

DISTAL LATERAL FIBULA PLATE, 5 HOLE

FDA Adverse Event
Malfunction ·STRYKER LEIBINGER FREIBURG·Product code HRS·September 26, 2014

HYPERFORM OCCLUSION BALLOON SYSTEM

FDA Adverse Event
Malfunction ·EV3 NEUROVASCULAR·Product code MJN·June 10, 2011

Diversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20

FDA Recall
Open, Classified ·Diversatek Healthcare·Product code KNQ·March 18, 2026

Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20

FDA Enforcement
Class II ·Ongoing·Diversatek Healthcare·April 29, 2026

CAPIOX®FX

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·February 19, 2026

KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 5 / Adult Silicone King LAD¿ Patient Size: >70kg Product Usage: Laryngeal airway

FDA Enforcement
Class II ·Terminated·King Systems Corp.·November 28, 2012

CAPIOX FX25 OXYGENATOR

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·June 9, 2022

CAPIOX®FX

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·March 30, 2026

CAPIOX FX25 OXYGENATOR

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·October 6, 2025

CAPIOX FX OXYGENATOR

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·August 25, 2021