27 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
×
XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes: a) X-SCRIBE CPI KIT WIRELESS USB 608 MHz, 41000-030-50; b) X-SCRIBE CPI KIT WIRELESS USB 2500 MHz, 41000-030-51; c) X-SCRIBE CPI KIT DIRECT CONNECT USB, 41000-030-52; d) X-SCRIBE CPI KIT QUICK CONNECT USB, 41000-030-53; e) XSCRIBE CP KIT WIRELESS, 41000-030-60; f) XSCRIBE CP KIT WIRED, 41000-030-62; g) XSCRIBE CP SW KIT, 41000-030-64
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·January 17, 2024
API JAMES 2AMP, CATALOG 70542
FDA Enforcement
Class II
·Ongoing·Biomerieux Inc·January 11, 2023
API NIT1 NIT2 REAGENTS, CATALOG 70442
FDA Enforcement
Class II
·Ongoing·Biomerieux Inc·January 11, 2023
API VP1 VP2 REAGENTS, CATALOG 70422
FDA Enforcement
Class II
·Ongoing·Biomerieux Inc·January 11, 2023
API 20 E 25 STRIPS, CATALOG 20100
FDA Enforcement
Class II
·Ongoing·Biomerieux Inc·January 11, 2023
API STAPH 25 STRIPS+25 MEDIA, CATALOG 20500
FDA Enforcement
Class II
·Ongoing·Biomerieux Inc·January 11, 2023
API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300
FDA Enforcement
Class II
·Ongoing·Biomerieux Inc·January 11, 2023
API 20 C AUX 25 STRIPS+25 MEDIA, CATALOG 20210
FDA Enforcement
Class II
·Ongoing·Biomerieux Inc·January 11, 2023
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
Regard, Item Number 830067009, custom cardiovascular procedure kit
FDA Enforcement
Class II
·Ongoing·ROi CPS LLC·April 14, 2021
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