29 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Vesocclude Polymer Ligating Clip
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704283525·LAHEY FINGER RETRACTOR 4 3/4" 1 PRONG SHARP
EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020
FDA 510(k)
FDA Class 2
·Immunology
ZEPHYR XL DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CARDIAC RHYTHM MANAGEMENT DIVISI·Product code DXY·January 13, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011
PELVICOL ACELLULAR COLLAGEN MATRIX
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTL·May 29, 2013
OHICHO3
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·August 30, 2022
OHICHO3
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·March 18, 2026
IMP,TSV,4.1MM,DUAL SEL,HA
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·February 5, 2024
METACROSS OTW PTA BALLOON DILATATION CATHETER
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·August 19, 2019
IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·February 5, 2024
OHICHO NEO
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·February 7, 2024
OHICHO3
FDA Adverse Event
Injury
·Product code LIT·December 26, 2019
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038402; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·May 20, 2026
SHIRANUI EX
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·August 12, 2020
METASUL, ALPHA INSERT, GG/28
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·March 13, 2020
METASUL HEAD 28MM M 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·November 11, 2019
OHICHO3
FDA Adverse Event
Injury
·Product code LIT·July 19, 2019
PTA BALLOON CATHETER(OHICHO3)
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·December 13, 2017