127 results
·
13ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
Depuy Mitek LUPINE BR DS W/ORTHCRD Catalog Number: 210712 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
FDA Recall
Terminated
·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code MAI·January 27, 2012
Depuy Mitek Lupine Loop DS w/Orthocord Catalog Number: 222981 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
FDA Recall
Terminated
·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code MAI·January 27, 2012
iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological
FDA Enforcement
Class II
·Terminated·Iba Dosimetry Gmbh·December 18, 2013
Maquet Getinge- BEQ-TOP 54500 BSW-McLANE 3/8 Quadrox iD Material:709000496R01
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Dow Corning Silastic brand Medical Adhesive Silicone, Type A, non-sterile, 57 gram tube; material numbers 3242901 (100 tubes) and 3242897 (6 tubes).
FDA Recall
Terminated
·Dow Corning Corp.·September 5, 2003
VTI BAYONET DOPPLER, 20MHz DOPPLER PROBE, SLIM, BX 4, REF 108660 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
FDA Recall
Terminated
·Vascular Technology, Inc.·Product code DPW·May 28, 2014
Immunoglobulin G is an in vitro diagnostic assay for the quantitative determination of immunoglobulin G in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 700 nm, which correlates with the concentration of immunoglobulin G in the sample.
FDA Recall
Terminated
·Abbott Laboratories, Inc·Product code DEW·May 16, 2018
GREER M. FAENI, 0.25 mL 20 MG/ML, Item: K6, Analyte Specific Reagent, HYPERSENSITIVITY PNEUMONITIS test system, gel diffusion kit for demonstrating precipitating antibodies.
FDA Recall
Terminated
·Greer Laboratories, Inc.·Product code DGW·October 25, 2022
Philips HDI 4000 Ultrasound System Part numbers 9896 053 15031 (8500-0066-01), 9896 053 18811 (8500-0080-01), 9896 053 22011 (8500-0087-01)
FDA Recall
Terminated
·Philips Ultrasound, Inc.·Product code DPW·May 6, 2005
Parks Medical Ultrasonic Doppler Flow Detector with Cautery Suppressor, Model 811-BL (finished assembly without accompanying probes), Parks Medical Electronics, Inc., Aloha, OR 97007
FDA Recall
Terminated
·Parks Medical Electronics Inc·Product code DPW·November 8, 2007
PD Access Vascular Access Device. Escalon Vascular Access, Inc., 2440 South 179th Street, New Berlin, WI 53146: Model 78050 18 Gauge GA Doppler Guided Bare Needle Assembly, 2 3/4 in Length, 0.038 in guidewire, Sterile EO, PD Access Vascular Access Device. Model 78060 Extended 18 Gauge Doppler Guided Bare Needle Assembly, 3 1/2 in Length, 0.038 in Guidewire, Sterile EO, PD Access Vascular Access Device Model 75010 18 Gauge 2 3/4 in Length, 0.038 in guidewire, Sterile EO, SmartNeedle Vascular Access Devices
FDA Recall
Terminated
·Escalon Medical Corp·Product code DPW·May 5, 2010
FlowCOUPLER. An implantable device that is used to detect blood flow in vessels. Used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site. Baxter Healthcare.
FDA Recall
Terminated
·Baxter Healthcare Corporation·Product code DPW·July 11, 2014
Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV -- Product Usage: to measure flow intra-operatively.
FDA Recall
Terminated
·Transonic Systems Inc·Product code DPW·July 27, 2015
Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI). All the devices are vascular blood flow machines. Devices are distributed with pressure cuffs of varying sizes as accessories. Affected models include *2100-SX, 3000 series, 2017, 2016, 2015, 2014, 1059, 1059-A, *1059-C, *1058-C, 4000 series, 1100 series, 1060 series, 1080 series, 234 and 246. (* = current production model) All the devices are used in the study and diagnosis of vascular disease and blockages in the upper and lower extremities.
FDA Recall
Terminated
·Parks Medical Electronics, Inc·Product code DPW·August 8, 2012
Transonic Flow Probe, 2 mm, Catalog Number HQC2MP -- Product Usage: to measure flow intra-operatively.
FDA Recall
Terminated
·Transonic Systems Inc·Product code DPW·July 27, 2015
Transonic Flow Probe, 2 mm, Catalog Number HQD2FMC -- Product Usage: to measure flow intra-operatively.
FDA Recall
Terminated
·Transonic Systems Inc·Product code DPW·July 27, 2015
Parks Medical Dual Frequency Doppler Vascular Flow Detector, Model 915-BL (finished assembly without accompanying probes), Parks Medical Electronics, Inc., Aloha, OR 97007
FDA Recall
Terminated
·Parks Medical Electronics Inc·Product code DPW·November 8, 2007
SYNCHRON System(s) Immunoglobulin A (Ig-A) Reagent, Part Number: 467920
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code DEW·June 28, 2010
GEM(TM), FLOWCOUPLER(R), 3.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2754-FC Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the FlowCOUPLER Device is used in conjunction with the FlowCOUPLER Monitor, the FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site.
FDA Recall
Terminated
·Baxter Healthcare Corp.·Product code DPW·April 21, 2016
Product is CSN00200 4MHz blood flowmeter probe used with the Quantix/OR system.
FDA Recall
Terminated
·Neoprobe Corp·Product code DPW·December 13, 2004