10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CARE BAND ANTIBACTERIAL BANDAGES
FDA 510(k)
FDA Class 1
·General Hospital
NEWBORN CALF SERUM, CATALOG NO. 110-1130
FDA 510(k)
FDA Class 1
·Hematology
VINYL EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
REUSABLE NEONATAL SINGLE HEATED BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 9, 2017
PROLIFT PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON INC·Product code OTP·February 28, 2013
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·February 4, 2011
ACCURUS 600DS
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CTR·Product code HQC·July 7, 2014
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·October 15, 2025
REUSABLE NEONATAL SINGLE HEATED BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·May 23, 2023
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024