39 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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