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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