39 results · 22ms · Sources: EU EUDAMED, US FDA

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Zavation IBF System

FDA 510(k)
FDA Class 2 ·Orthopedic

CoRoent

FDA UDI
Nuvasive, Inc.·00887517628435·CoRoent Ant TLIF Ti, 10x12x30mm 15°

NA

FDA UDI
Stryker GmbH·07613154639762·Screw Marker 23,5

Accufit

FDA UDI
Ortho Organizers, Inc.·00190707184018·Accufit Molar Bands Lower Left Second Molar 30 1/2

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112748·BARRON VACUUM PUNCH 7.25MM

Ophthalmic Knife

FDA UDI
KATENA PRODUCTS, INC.·00841668113394·MICS TRAP KNIFE 1.8/2.2 (BX/5)

MULTIPLE LABELS, POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE

FDA 510(k)
FDA Class 1 ·General Hospital

HASS ZIRTOOTH MODEL ZORTOOTH H. ZIRTOOTH T. ZIRTOOTHC, ZIRTOOTH P

FDA 510(k)
FDA Class 2 ·Dental

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·January 10, 2024

DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·November 16, 2015

G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·September 2, 2015

G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·August 31, 2015

DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·November 17, 2015

ONESTEP

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS·Product code MLN·October 13, 2014

EZ BREATHE ATOMIZER

FDA Adverse Event
HEALTH & LIFE (SUZHOU) CO., LTD.·Product code CCQ·June 25, 2013

QUADROX D

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·August 5, 2011

Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (Agar)(100mm), 10/pk, REF 01503. For In Vitro Diagnostic Use.

FDA Enforcement
Class II ·Ongoing·Remel, Inc·July 5, 2023

PUMP 1886 780G OUS BLE PUMP MG/DL

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·August 25, 2023

regard GS0098C - RESUSABLE RT BRONCH, Item Number: 830086003

FDA Enforcement
Class II ·Terminated·ROi CPS LLC·June 15, 2022

Medtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSC

FDA Enforcement
Class II ·Ongoing·Covidien·May 8, 2024