11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACCUSIGN, BIOSIGN PCP
FDA 510(k)
FDA Unclassified
·Unknown
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994237538·HOLDER 6961266 HOLDER 6 MM
SYNCHRON URIC ACID
FDA Adverse Event
BECKMAN COULTER INC.·Product code KNK·June 10, 2011
Athena Breast Pump
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ORTHO ORGANIZERS TEMPORARY ORTHODONTIC ANCHOR
FDA 510(k)
FDA Class 2
·Dental
COMPRESSION FORCEPS
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWN·March 10, 2020
SPACEMAKER BLUNT TIP TROCAR 10MM
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY USSC PUERTO RICO·Product code GCJ·May 28, 2014
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·January 28, 2013
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·December 21, 2010
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026