16 results
·
28ms
·
Sources: EU EUDAMED, US FDA
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX
FDA 510(k)
FDA Class 2
·Immunology
LIFEPAK® 15 monitor/defibrillator
FDA UDI
PHYSIO-CONTROL, INC.·00883873872055·15AABBABBABBAAAAAAAAAAAFLP15 MONITOR/DEFIB
MDI SCL-70 TEST
FDA 510(k)
FDA Class 2
·Immunology
MODEL APS ALTERNANS PROCESSING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
ACS VIKING CORONARY GUIDING CATHETER
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code DRA·October 27, 2008
ACS VIKING CORONARY GUIDING CATHETER
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code DRA·October 27, 2008
PULSE GEN MODEL 102
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·March 13, 2013
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·February 27, 2011
2-DAY INFUSION KIT
FDA Adverse Event
Injury
·STRYKER INSTRUMENTS KALAMAZOO·Product code MEB·February 18, 2008
6F Viking Guiding Catheter, Percutaneous catheter, Shape ALR 1.2, Part Number: 1001934-06, Abbott Vascular, Santa Clara, CA 95054. Designed to provide a pathway trough which therapeutic and diagnostic devices are introduced.
FDA Recall
Terminated
·Abbott Vascular-Cardiac Therapies dba Guidant Corporation·Product code DQY·March 17, 2008
ACS VIKING CORONARY GUIDING CATHETER
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code DRA·October 27, 2008
ACS VIKING CORONARY GUIDING CATHETER
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code DRA·October 27, 2008
ACS VIKING CORONARY GUIDING CATHETER
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code DYB·April 17, 2008
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·March 27, 2013
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024
OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021