52 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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MEDLINE NON-STERILE PVP SOLUTION, STERILE PACKAGING REF DYNDA2232A
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 19, 2023
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: EAR CDS, Model Number CDS980089O
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 19, 2023
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: HYSTERO PACK, Model Number DYNJ61448A
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 19, 2023
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: TOTAL KNEE THEDA, Model Number DYNJ908683A
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 19, 2023
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: OISC HAND BEAR, Model Number DYNJ902348L
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 19, 2023
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) OCULOPLASTY PACK, Model Number DYNJ64572A; b) EYE PACK, Model Number VAL050EEPKB
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 19, 2023
Centurion- P151659 BIOPSY TRAY P243133 LATEX TUBING PACK P243133 LATEX TUBING PACK P243133 LATEX TUBING PACK P261569 PACK BIOPSY P392929 BMT-LACERATION PACK P429589A TRAY BONE MARRO ASC LTX SAFE P734457 SUTURE REMOVAL PACK LATEX SAFE P751651A BIOPSY PROCEDURE PACK P758486 PVP PREP PACK P758486 PVP PREP PACK P922260 ALCOHOL PREP PACK P928310 WET PREP TRAY P928310 WET PREP TRAY P948416 LACERATION PACK P966455A BREAST BIOPSY PACK-LF
FDA Enforcement
Class II
·Terminated·Centurion Medical Products Corporation·February 12, 2020
CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution
FDA Enforcement
Class II
·Terminated·Custom Medical Specialties, Inc.·September 19, 2012
Bard Midstream Urine Collector with Rigid Funnel and Iodophor Prep Pads. Product Packaging: Three (3) PVP-I prep pads are packed into each urine collection kit carton along with a pre-connected drainage funnel, specimen container, funnel lid, specimen lid and a room label.
FDA Enforcement
Class II
·Terminated·Bard Medical Division·September 5, 2018
STERILE PVP, REF DYNDA1649
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·December 20, 2023
STERILE PVP SOLUTION, REF DYNDA1907
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·December 20, 2023
PVP SOLUTION SING STRL, REF DYNDA1858
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·December 20, 2023
STERILE PVP SLN KIT, REF DYNDM1097
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·December 20, 2023
MEDLINE SWABSTICKS PVP 3 PK, Product Code DYNDA2724
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 10, 2024
CATHETER SECUREMENT SYSTEM
FDA Enforcement
Class II
·Terminated·Centurion Medical Products Corporation·March 28, 2018
TUBING CHANGE KIT
FDA Enforcement
Class II
·Terminated·Centurion Medical Products Corporation·March 28, 2018
BLOOD DRAW KIT
FDA Enforcement
Class II
·Terminated·Centurion Medical Products Corporation·March 28, 2018
SorbaView Shield Dressing Change Tray
FDA Enforcement
Class II
·Terminated·Centurion Medical Products Corporation·March 28, 2018
SKIN STAPLE REMOVER
FDA Enforcement
Class II
·Terminated·Centurion Medical Products Corporation·March 28, 2018
NEONATAL IV ACCESS SET
FDA Enforcement
Class II
·Terminated·Centurion Medical Products Corporation·March 28, 2018