8 results
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35ms
·
Sources: EU EUDAMED, US FDA
Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197399463·Tebbet Breast Retractor
130x16...
Jimushi Sterile Urethral Catheter for single use
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
APOLLO IR HEAT LAMP SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
ORTHOLOC(TM) 3DSI CLAW(R) II PLATE
FDA Adverse Event
Malfunction
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code HRS·November 18, 2014
UNICEL DXC 800 SYNCHRON SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·August 26, 2011
UNKNOWN
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·August 1, 2013
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Monitor is a patient monitoring device providing the patient with a continuous vital physiological monitoring of arterial blood oxygen saturation (SpO2), Pulse Rate and CO2 in a hospital, hospital type facilities environment and intra-hospital moves. Component: No
FDA Enforcement
Class II
·Ongoing·Edan Diagnostics·January 28, 2026