31 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M
FDA 510(k)
FDA Class 2
·Cardiovascular
Preclean Kit
FDA UDI
MEDIVATORS INC.·40677964010949·Preclean Plus Kit includes DEFENDO Olympus 4-pi...
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00311391·
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001139·artVeneer life upper anteriors, BOL, A4
THE IMPLEX HEDROCEL MODULAR ELLIPTICAL ACETABULAR CUP
FDA 510(k)
FDA Class 2
·Orthopedic
MIDAS TOUCH BLUE NITRILE EXAMINATION GLOVES-POWDERED
FDA 510(k)
FDA Class 1
·General Hospital
QUICK SET
FDA Adverse Event
Malfunction
·UNOMEDICAL UM-D·Product code FPA·March 30, 2026
HERO GRAFT
FDA Adverse Event
Injury
·CRYOLIFE, INC.·Product code DSY·June 8, 2015
CARDIOSAVE HYBRID, TYPE G PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·March 11, 2025
TUFF IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·October 15, 2025
TUFF IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·July 24, 2025
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·February 26, 2013
FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN (CALCIUM ZINC GANTREZ SALT 33%, CELLU
FDA Adverse Event
Other
·PROCTER & GAMBLE MANUFACTURING CO.·Product code KOO·February 18, 2011
BREEZE2 TEST STRIPS (50)
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·February 15, 2008
Catalog Number: 9001139 FOLEY CATHETER TRAY 18 FR -5CC-2WAY SILICONE COATED FOLEY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code NWR·January 7, 2016
Foley Catheter Kit, Catalog number 900-1139 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code NWR·October 8, 2014
Foley Catheter Kit, Catalog number 900-1139 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Enforcement
Class I
·Terminated·Customed, Inc·December 10, 2014
FOLEY CATHETER KIT II 18 FR 20/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
FDA Enforcement
Class II
·Terminated·Customed, Inc·September 9, 2015
Catalog Number: 9001139 FOLEY CATHETER TRAY 18 FR -5CC-2WAY SILICONE COATED FOLEY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Enforcement
Class II
·Terminated·Customed, Inc·April 20, 2016
Various models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 139038-01 139039-01 139040-01 139041-01 139043-01 139044-01 139045-01 139046-01 139049-01 139051-01 139052-01 139053-01 139054-01 139055-01 139056-01 139058-01 139059-01 139060-01 139061-01 139064-01 139065-01 139066-01 139067-01 139068-01 139069-01 139070-01 139071-01 139072-01 139164-01 139165-01 300
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code BRY·September 30, 2025