852 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179
FDA Recall
Terminated
·Diagnos Inc·Product code NFJ·January 11, 2022
CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179
FDA Enforcement
Class II
·Terminated·Diagnos Inc·April 6, 2022
Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 - Product Usage: designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.
FDA Enforcement
Class II
·Terminated·Northgate Technologies, Inc.·March 3, 2021
ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery
FDA Recall
Terminated
·Alcon Research, Ltd.·Product code NCF·June 30, 2017
ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery
FDA Recall
Terminated
·Alcon Research, Ltd.·Product code NCF·June 30, 2017
Healing Labs Rite Choice Pregnancy Test Kit, packed in a cellophane display box, containing one test strip and materials for one test, and labeled in part ***Distributed by Core Brands, 1301 Wicomico St Baltimore, MD 21230 USA***Made in China***UPC 087399430205***. Packed 48 boxes/case.
FDA Recall
Terminated
·Core Brands·Product code LCX·June 22, 2005
Medtronic brand KyphX HV-R Bone Cement, a polymethyl bone cement consisting of a quantity of powder (20 g) and a volume of liquid (10 ml/9 g) mixed in a Kyphon mixer for up to two minutes. Model Number: CO1A; Manufactured by Elmdown LTD, London, England, for Medtronic Spine LLC, Sunnyvale, CA. Product is a medical device used during balloon kyphoplasty to cement structures in fractured vertebral bodies.
FDA Recall
Terminated
·Medtronic Spine LLC, formerly Kyphon Inc·Product code NDN·November 10, 2009
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
One Touch Basic/Profile and One Touch Ultra Blood Glucose Test Strips
FDA Recall
Terminated
·Core Care Technologies, Inc·Product code NBW·October 14, 2006
Alcon Clareon IOL with AutonoMe Delivery System
FDA Recall
Terminated
·Alcon Laboratories Ireland, Ltd Cork Business And Technology Park Model Farm Road Cork Ireland·Product code HQL·May 11, 2022
EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70, iM60, iM8, iM8A, iM8B Patient Monitors and iM60 Vet, iM70 Vet Veterinary Monitors EtCO2 module is an optional component of the following machines: iM80, iM50, M50, iM70, iM60 and iM8, iM8A, iM8B, iM60 Vet, iM70 Vet Monitors, and is intended to be used to measuring expired CO2 as part of multi parameter patient monitors. The Patient Monitors are intended to be used for monitoring, storing, and reviewing of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates, such as ECG, Respiration (RESP), IBP, NIBP, Cardiac Output (C.O.), Temperature (dual-TEMP), Expired CO2 and Anesthetic gas (AG).
FDA Enforcement
Class II
·Terminated·Edan Diagnostics·August 17, 2016
Minicon Clinical Sample Concentrators for In Vitro Diagnostic Use 9031 (Model: Minicon B-15) & 9051 (Model: Minicon CS-15) Minicon concentrators are non-sterile, disposable, multiwall ultrafiltration devices. Minicon clinical sample concentrators are for in vitro diagnostic use and are intended for concentrating serum, urine, cerebrospinal fluid, and other body fluids prior to analysis.
FDA Recall
Terminated
·Merck Millipore Ltd. Tullagreen Carrigtwohill County Cork Ireland·Product code JJH·May 14, 2018
Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
FDA Enforcement
Class II
·Terminated·Volcano Corp·June 22, 2022
Trochar Scalpel Instrument (Surgical Punch) OrthoPediatrics intramedullary rods (nails) are generally rod-shaped devices, with screw holes at either end for fixation to bone. This device is intended to be inserted into the medullary canal of the femur for fixation of fractures by aligning and stabilizing the bone fragments. Additional stabilization may be realized by installing transverse screws through holes in the rod. These devices are made of medical grade stainless steel. The OrthoPediatrics PediNail" system is used for pediatric and small stature adult patients as indicated to stabilize fractures of the femoral shaft; subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunions and malunions; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.
FDA Enforcement
Class II
·Terminated·OrthoPediatrics Corp·November 14, 2012
Acidified Concentrate Distribution and Storage System (ACDS System) with a Finish Thompson Centrifugal Pump Model #110192-3
FDA Enforcement
Class II
·Terminated·Isopure Corp·January 29, 2020
Chromovision High Definition (HD) Wireless Camera, Pt # CC-9715900. Visual recording of surgical procedures.
FDA Enforcement
Class III
·Terminated·Berchtold Corp.·August 15, 2012
AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest, abdomen, and other body parts. Agfa's DX-D 100 is not indicated for use in mammography.
FDA Enforcement
Class II
·Terminated·AGFA Corp.·July 30, 2014
Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #110192-3
FDA Enforcement
Class II
·Terminated·Isopure Corp·January 29, 2020
NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath device Part Number: NN-8024
FDA Enforcement
Class II
·Terminated·Nico Corp.·August 22, 2018
13.5 mm x 60 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sheaths (three lengths available for each: 50mm, 60mm, and 75mm). The obturator and sheath are assembled in the OR immediately prior to use. These two components are held together by an interference fit. The device when used as intended is designed to provide access to neurological tissues.
FDA Enforcement
Class II
·Terminated·Nico Corp.·August 22, 2012