12 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STA R Max 3, STA Compact Max 3
FDA 510(k)
FDA Class 2
·Hematology
MLKJ
FDA UDI
Weifang Mingliang Electronics Co., Ltd.·06974077940023·
CADD
FDA UDI
ICU MEDICAL, INC.·10610586035012·
SYRINGE 5ML LL TIP BULK CONVENIENCE PAK
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·April 16, 2026
BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
AUGMENT AND SCREW, PSA TYPE
FDA 510(k)
FDA Class 2
·Orthopedic
AEYE-DS RETINA SCREENING
FDA Adverse Event
Injury
·AEYE HEALTH INC.·Product code PIB·January 22, 2025
GMK PRIMARY TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 9, 2024
SOLETRA
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·October 22, 2008
CONCEPT SUTURE PASSER NEEDLE
FDA Adverse Event
Injury
·CONMED LINVATEC·Product code LXH·August 15, 2011
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·July 8, 2013
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