14 results
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41ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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Regard, Item Number 830067009, custom cardiovascular procedure kit
FDA Enforcement
Class II
·Ongoing·ROi CPS LLC·April 14, 2021
regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.
FDA Enforcement
Class I
·Ongoing·ROi CPS LLC·February 12, 2025
regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
FDA Enforcement
Class II
·Ongoing·ROi CPS LLC·September 25, 2024
Regard Kit containing the Microtek decanter
FDA Enforcement
Class II
·Ongoing·ROi CPS LLC·August 28, 2024
Sterile surgical convenience kit: regard Item Number: 800718003, GY00923C - WPH Major Vaginal Pack.
FDA Enforcement
Class II
·Ongoing·ROi CPS LLC·May 3, 2023
Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
FDA Enforcement
Class II
·Ongoing·ROi CPS LLC·November 22, 2023
Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath.
FDA Enforcement
Class II
·Ongoing·ROi CPS LLC·May 3, 2023
Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU00961E - OH Laminectomy Cust Pack; 2. regard Item Number: 880411008, NU01018H - Lumbar Universal ; 3. regard Item Number: 880396007, NU01001G - Craniotomy ; 4. regard Item: 880387005, NU00991E - Ant/Cervical Spine ; and 5. regard Item Number: 800716005, NU00921E - ORMC Major Crani Pack.
FDA Enforcement
Class II
·Ongoing·ROi CPS LLC·May 3, 2023
Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I - Laparotomy Pk; 2. regard Item Number: 880429002, GS01036B - Universal Custom ; 3. regard Item Number: 800725004, GS00930D - OH Base Robot Pack ; 4. regard Item Number: 800725005, GS00930E - OH Base Robot Pack ; 5. regard Item Number: 800395003, GS01000C - Colon Lithotomy and 6. regard Item Number: 880391002, GS00995B - Basic Laparotomy.
FDA Enforcement
Class II
·Ongoing·ROi CPS LLC·May 3, 2023
Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.
FDA Enforcement
Class II
·Ongoing·ROi CPS LLC·May 3, 2023
Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E - WPH GYN Laparoscopy Pack.
FDA Enforcement
Class II
·Ongoing·ROi CPS LLC·May 3, 2023
Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General Laparoscopy; 2. regard Item Number: 880424004, GS01031D - Thoracic.
FDA Enforcement
Class II
·Ongoing·ROi CPS LLC·May 3, 2023
GS0008 2Y - Burn Pack - STL, Item Number 880082025
FDA Enforcement
Class II
·Ongoing·ROi CPS LLC·October 11, 2023
Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shoulder/Hip; 2. regard Item Number: 880426004, OR01033D - Total Hip; 3. regard Item Number: 880427003, OR01034C - Total Knee; 4. regard Item Number: 880474001, OR01106A - Knee Arthroscopy; 5. regard Item Number: 800772006, OR00977F - OH Total Knee Pack ; 6. regard Item Number: 880403004, OR01009D - Extremity Pack; 7. regard Item Number: 880472001, OR01104A - Basic Pack ; 8. regard Item Number: 880470001, OR01102A - Total Knee ; 9. regard Item Number: 800755006, OR00960F - OH Hip Pack ; 10. regard Item Number: 880471001, OR01103A - Shoulder Arthroscopy ; 11. regard Item Number: 880480001, OR01112A - Hand and Foot ; and 12. regard Item Number: 880468001, OR01100A - Spine.
FDA Enforcement
Class II
·Ongoing·ROi CPS LLC·May 3, 2023