194 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 Manufactured: 2020-10-29 Expires: 2020-12-28 Container Type: 15x100mm plate, 18 ml
FDA Recall
Terminated
·Hardy Diagnostics·Product code JSO·December 21, 2020
1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile REF# 1009-00J Product Usage: The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves
FDA Enforcement
Class II
·Terminated·LeMaitre Vascular, Inc.·August 24, 2016
Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 Manufactured: 2020-10-29 Expires: 2020-12-28 Container Type: 15x100mm plate, 18 ml
FDA Enforcement
Class II
·Terminated·Hardy Diagnostics·February 3, 2021
XP-XP Tibial Tray - Interlok 91mm Item # 195761
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
MANI TROCAR KIT 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery, Ref: MTK 23S
FDA Enforcement
Class II
·Terminated·Mani, Inc. - Kiyohara Facility·December 16, 2020
4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP604H
FDA Enforcement
Class II
·Terminated·Biocare Medical, LLC·June 17, 2020
Sterile Custom Packs to be used in surgical procedures.
FDA Enforcement
Class II
·Terminated·American Contract Systems·June 10, 2020
Caviwave Pro Ultrasonic Cleaning System, Product Usage: To wash (remove tissue, blood and other contaminants) or dry laparoscopic and general surgical instruments prior to final disinfection and sterilization as required.
FDA Enforcement
Class II
·Terminated·Steris Corporation·May 6, 2015
Espiner Tissue Retrieval System-Eco-Sac Trocar 12mm Vol: 1200 ml EMP160ECO-US-5 (GTIN:5060358120367) Product Usage: Tissue Retrieval sac made from ripstop nylon. The EMP160ECO-US-5 is a semi-automatic sac, which incorporates a monofilament drawstring around the mouth of the bag, so that it can be pulled closed and removed from the body cavity.
FDA Enforcement
Class II
·Terminated·Espiner Medical Ltd·November 21, 2018
7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used to dilute samples when assay values exceed the reportable (dynamic) range using the VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.
FDA Enforcement
Class II
·Terminated·Ortho Clinical Diagnostics Inc·January 1, 2020
SoftPath Laboratory Information System. Versions 4.3.0.8, 4.3.0.9, 4.3.0.10, 4.3.0.11, 4.3.0.12, 4.3.0.14, 4.3.0.15, and 4.4.0.0
FDA Enforcement
Class II
·Terminated·SCC Soft Computer·February 18, 2015
Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - In vitro diagnostic test for the quantitative measurement of alkaline phosphatase in human serum and plasma Catalog Number: K2115, SMN# 10642444
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·October 28, 2020
Eon Mini Neurostimulation (IPG) System (Model 3788); The product is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.
FDA Enforcement
Class II
·Terminated·Advanced Neuromodulation Systems Inc.·July 18, 2012
Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use
FDA Enforcement
Class II
·Terminated·Microbiologics Inc·March 13, 2019
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
FDA Enforcement
Class II
·Terminated·Avid Medical, Inc.·March 25, 2020
FUSO Analyzer 300F Abbott Point of Care, Princeton, NJ 08540 Model 200. the 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i-stat portable analyzer as part of the i-STAT system, are intended for use in the in vitro quantization of arterial, venous or capillary whole blood.
FDA Recall
Terminated
·Abbott Point Of Care Inc.·Product code CHL·September 20, 2010
i-STAT Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i-stat portable analyzer as part of the i-STAT system, are intended for use in the in vitro quantization of arterial, venous or capillary whole blood.
FDA Recall
Terminated
·Abbott Point Of Care Inc.·Product code CGA·September 20, 2010
Military Kit i-STAT1; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i-stat portable analyzer as part of the i-STAT system, are intended for use in the in vitro quantization of arterial, venous or capillary whole blood.
FDA Recall
Terminated
·Abbott Point Of Care Inc.·Product code CHL·September 20, 2010
i-STAT Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. the 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i-stat portable analyzer as part of the i-STAT system, are intended for use in the in vitro quantization of arterial, venous or capillary whole blood.
FDA Recall
Terminated
·Abbott Point Of Care Inc.·Product code CHL·September 20, 2010
Military Kit Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i-stat portable analyzer as part of the i-STAT system, are intended for use in the in vitro quantization of arterial, venous or capillary whole blood.
FDA Recall
Terminated
·Abbott Point Of Care Inc.·Product code CGA·September 20, 2010