31 results · 31ms · Sources: EU EUDAMED, US FDA

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Ti3Z Cervical Interbody System

FDA 510(k)
FDA Class 2 ·Orthopedic

Ophthalmic Knife

FDA UDI
KATENA PRODUCTS, INC.·00841668113318·PHACO KNIFE 1.8MM ANGLED (BX/5)

Ophthalmic Knife

FDA UDI
KATENA PRODUCTS, INC.·00841668113370·CLEAR CORNEA KNIFE 3.2MM (BX/5)

REUSABLE BRONCHIAL BIOPSY FORCEPS

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

ENDOPATH ETS45, ETS FLEX45, ETS COMPACT-FLEX45 LINEAR CUTTERS, ETS FLEX45 AND ETS COMPACT-FLEX45 NO-KNIFE ARTICULATING

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

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·July 21, 2023

ACCU-CHEK ® GUIDE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIABETES CARE, INC.·Product code NBW·September 26, 2023

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·October 27, 2020

HUDSON ET TUBE, UNCUFFED, PED-SOFT, 2.5MM

FDA Adverse Event
Malfunction ·TELEFLEX·Product code BTR·September 15, 2014

UNKNOWN FEMORAL TRIAL HEAD

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code LXH·August 4, 2011

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·August 25, 2022

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·August 25, 2022

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·August 25, 2022

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·August 25, 2022

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·April 8, 2021

CD HORIZON SOLERA VOYAGER SPINAL SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·May 27, 2024

CD HORIZON® SPINAL SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NKB·August 20, 2025

CD HORIZON® SPINAL SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code KWP·August 20, 2025

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·August 25, 2022