10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EPISCREEN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
artegral
FDA UDI
Merz Dental GmbH·D7091970357·anteriors; shade C4; mould BOS
SPHYGMOMANOMETER, ELECTRONIC
FDA 510(k)
FDA Class 2
·Cardiovascular
FLEXCATH STEERABLE SHEATH & DILATOR
FDA 510(k)
FDA Class 2
·Cardiovascular
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON INC·Product code OTN·February 20, 2013
PATROL PUMP
FDA Adverse Event
Injury
·ABBOTT NUTRITION·Product code LZH·January 14, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 31, 2014
CORD 300MM
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code QHP·September 29, 2020
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021