8,084 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
×
Medline convenience kits: a. VENOUS ACCESS PACK-LF, Model Number DYNJ36725B, Lot codes: 19UBB149, b. KIT LB SHUNT, Model NumberDYNJ905860A, Lot codes: 22OBG246, 21LBU048, 21GBI196, 21KBK242, 21EBH567 Model/Catalog Number: a. Model Number DYNJ36725B, b. Model Number DYNJ905860A
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - SPT·August 3, 2022
Identity Imprint PS Tibial Tray Size 4: Lot 540287
FDA Enforcement
Class II
·Ongoing·Conformis, Inc.·April 24, 2024
Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A
FDA Enforcement
Class II
·Ongoing·New Standard Device Inc·June 29, 2022
Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694
FDA Enforcement
Class II
·Ongoing·Integra LifeSciences Corp.·November 6, 2024
Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
FDA Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·April 19, 2023
Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457
FDA Enforcement
Class II
·Ongoing·Integra LifeSciences Corp.·January 18, 2023
NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 units
FDA Enforcement
Class II
·Ongoing·Delta Med SpA·August 25, 2021
Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846
FDA Enforcement
Class II
·Ongoing·MICROVENTION INC.·January 29, 2025
Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995561 All lots
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·May 11, 2022
ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10491445 All lots
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·May 11, 2022
Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995562 All lots
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·May 11, 2022
HENRY SCHEIN, BASIC PACK, Item No.570-2719, UDI/DI (case) H65857027191, UDI/DI (kit)M75257027190, Serial/Lot Numbers: 22242489505
FDA Enforcement
Class II
·Ongoing·Stradis Medical, LLC dba Stradis Healthcare·December 21, 2022
ADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10490889 All lots
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·May 11, 2022
Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 11206250 All lots
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·May 11, 2022
ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative detection of estradiol SMN: 10697757 All lots
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·May 11, 2022
Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-MB and Troponin I), 97000HSEU, 97000HSEUJP, 97000HZ01, 97000QIL. Lots T13664 - T14045.
FDA Enforcement
Class I
·Ongoing·QUIDEL CARDIOVASCULAR INC·July 12, 2023
Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico, DJO, LLC.
FDA Enforcement
Class II
·Ongoing·DJO, LLC·July 24, 2019
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
REF CH3582 5 IN (13cm) APPX 0.57 ml, EXT SET, ANTI-SHIPHON VALVE, Spiros LOT 5125197 - Product Usage: for use in the preparation and patient administration of cytotoxic medications.
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·May 19, 2021
REF CH3397 Oncology Kit w/Spiros¿, Red Cap, Bag Spike w/Clave Additive Port LOT 5118610 - Product Usage: for use in the preparation and patient administration of cytotoxic medications.
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·May 19, 2021