7,021 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112755·BARRON VACUUM PUNCH 7.5MM
Plasmage System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Operon
FDA UDI
Berchtold Holding GmbH·07613327412581·Berchtold Surgical Table, D 820
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112700·BARRON VACUUM PUNCH 6.0MM
NIHON KHDEN PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATION
FDA 510(k)
FDA Class 2
·Cardiovascular
NEW BIO-MOORE ENDO HEAD, TAPER ADAPTER
FDA 510(k)
FDA Class 2
·Orthopedic
TENDRIL ST
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC. CRMD·Product code NVN·January 13, 2014
ACRYSOF
FDA Adverse Event
Injury
·ALCON LABORATORIES IRELAND LTD.·Product code HQL·August 5, 2011
SECURE 3 MED/SURG BEDOBS 01/13
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 2, 2013
PUMP MMT-1780KPK 670G PATHWAY BLACK MG
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·January 12, 2023
PUMP MMT-1782K 670G V4.11 MM
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·September 15, 2021
PUMP MMT-1712KL 640G V4.10 BK SF MG
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 12, 2021
630G INSULIN PUMP MMT-1715KL 630G
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·February 8, 2022
Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 1.50 BC 8.6 DIA 13.8, Rx, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.
FDA Enforcement
Class II
·Completed·Lens.com·December 11, 2019
BD 10mL Syringe Luer-Lok Tip Catalog number 301997 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·July 26, 2017
BD 3ml Syringer Luer-Lok Tip Catalog #309604 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·July 26, 2017
PUMP MMT-1780KPK 670G PATHWAY BLACK MG
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·July 28, 2021
HEART LUNG MACHINE
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code KFM·March 25, 2021
MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·March 15, 2022
Guidezilla II Guide Extension Catheter Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493933515060, 6F; 2. REF/Catalog No H7493933515070, 7F.
FDA Enforcement
Class II
·Terminated·Boston Scientific Corporation·December 4, 2019