115 results
·
10ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
×
Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA05100 Product Usage: Recommended for use in catheterization for angiography of cardiovascular vessels and I or chambers. It can be used for injection of contrast medium and pressure measurement in any chamber or vessel.
FDA Enforcement
Class II
·Terminated·Numed Inc·December 5, 2018
Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA06100 Product Usage: Recommended for use in catheterization for angiography of cardiovascular vessels and I or chambers. It can be used for injection of contrast medium and pressure measurement in any chamber or vessel.
FDA Enforcement
Class II
·Terminated·Numed Inc·December 5, 2018
BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
FDA Enforcement
Class II
·Terminated·Numed Inc·May 21, 2025
Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS100 Model/Catalog Number: VS100 Software Version: Software version 3.2.0.1 Product Description: Welch Allyn Spot Vision Screener VS100, FDA product code name: Refractometer, ophthalmic One unit per package
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·March 25, 2026
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Number: 4329RD Product Description: ROLLING WALKER MOBILITY AID
FDA Enforcement
Class II
·Ongoing·Nova Ortho-Med Inc·October 23, 2024
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR BLUE Model/Catalog Number: 4329BL Product Description: ROLLING WALKER MOBILITY AID
FDA Enforcement
Class II
·Ongoing·Nova Ortho-Med Inc·October 23, 2024
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR PURPLE Model/Catalog Number: 4329PL Product Description: ROLLING WALKER MOBILITY AID
FDA Enforcement
Class II
·Ongoing·Nova Ortho-Med Inc·October 23, 2024
Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK HARRIS METHODIST Model/Catalog Number: 555498 Software Version: N/A Product Description: CESK HARRIS METHODIST Component: No
FDA Enforcement
Class II
·Ongoing·B Braun Medical Inc·June 10, 2026
Brand Name: B. BRAUN MEDICAL INC. Product Name: BPSK, BLOCKJOCKS TRAY Model/Catalog Number: 570246 Software Version: N/A Product Description: BPSK, BLOCKJOCKS TRAY Component: No
FDA Enforcement
Class II
·Ongoing·B Braun Medical Inc·June 10, 2026
Brand Name: B. BRAUN MEDICAL INC. Product Name: SESK UPMC DOUBLE CATHETER TRAY Model/Catalog Number: 530134 Software Version: N/A Product Description: SESK UPMC DOUBLE CATHETER TRAY Component: No
FDA Enforcement
Class II
·Ongoing·B Braun Medical Inc·June 10, 2026
Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK SHANDS JACKSONVILLE 20055717 Model/Catalog Number: 555884 Software Version: N/A Product Description: CESK SHANDS JACKSONVILLE 20055717 Component: No
FDA Enforcement
Class II
·Ongoing·B Braun Medical Inc·June 10, 2026
Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK RIVERSIDE HEALTH SYSTEM Model/Catalog Number: 552126 Software Version: N/A Product Description: CESK RIVERSIDE HEALTH SYSTEM Component: No
FDA Enforcement
Class II
·Ongoing·B Braun Medical Inc·June 10, 2026
Brand Name: B. BRAUN MEDICAL INC. Product Name: NES1725KFXL SPINAL EPID CLOSED TIP CATH Model/Catalog Number: 530201 Software Version: N/A Product Description: NES1725KFXL SPINAL EPID CLOSED TIP CATH Component: No
FDA Enforcement
Class II
·Ongoing·B Braun Medical Inc·June 10, 2026
Brand Name: B. BRAUN MEDICAL INC. Product Name: LYNDON B JOHNSON HOSPITAL SPINAL EPID Model/Catalog Number: 530184 Software Version: N/A Product Description: LYNDON B JOHNSON HOSPITAL SPINAL EPID Component: No
FDA Enforcement
Class II
·Ongoing·B Braun Medical Inc·June 10, 2026
Brand Name: B. BRAUN MEDICAL INC Product Name: CESK NORTHSIDE ANESTHESIA TRAY Model/Catalog Number: 555076 Software Version: N/A Product Description: CESK NORTHSIDE ANESTHESIA TRAY Component: No
FDA Enforcement
Class II
·Ongoing·B Braun Medical Inc·June 10, 2026
Brand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot Model / Catalog Number: O2U2012 Lot Number: 20170403 Product Description: Nasal Cannulas for use with Oxygen Concentrators
FDA Enforcement
Class II
·Ongoing·3B Medical, Inc.·January 15, 2025
ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·May 16, 2018
Brand Name: Tacy Medical, Inc. Product Name: Dressing Change Tray CS/20 Model/Catalog Number: TM6180CP Software Version: N/A Product Description: Dressing change tray, case of 20, lot #600032, 50 cases affected. Component: No
FDA Enforcement
Class II
·Ongoing·Trinity Sterile, Inc.·January 29, 2025
TriMed Peg Guide Extender, REF PEG-XTNDR, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
FDA Enforcement
Class II
·Ongoing·TriMed Inc.·November 20, 2019
TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
FDA Enforcement
Class II
·Ongoing·TriMed Inc.·November 20, 2019