411 results
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23ms
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Sources: EU EUDAMED, US FDA
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