110 results
·
12ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
GENT-L-KARE Sterile 3OZ. EAR/ULCER BULB SYRINGE SINGLE USE
FDA Recall
Terminated
·Medegen Medical Products, LLC·Product code KCP·April 30, 2003
ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device is intended for use in conjunction with certain materials to measure a variety of analytes.
FDA Enforcement
Class II
·Terminated·Horiba Instruments, Inc dba Horiba Medical·July 4, 2018
Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0. Product is labeled sterile. The product is sealed inside an inner foil pouch with an outside Tyvek pouch. It is an undyed, monofilament synthetic absorbable suture with needle size 3/0.
FDA Enforcement
Class II
·Terminated·C P Medical, Inc.·November 5, 2014
ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device is intended for use in conjunction with certain materials to measure a variety of analytes.
FDA Recall
Terminated
·Horiba Instruments, Inc dba Horiba Medical·Product code PFT·April 26, 2018
Cardiovascular Custom Procedure Kits, Rev O X-Coated 8:1 CP No OXY Item Number: 73329 Terumo Cardiovascular Systems Corp. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code MJJ·August 11, 2011
Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0. Product is labeled sterile. The product is sealed inside an inner foil pouch with an outside Tyvek pouch. It is an undyed, monofilament synthetic absorbable suture with needle size 3/0.
FDA Recall
Terminated
·C P Medical, Inc.·Product code NEW·September 22, 2014
VITROS Chemistry Products AcP Slides, 90 slides/pack; catalog number 8168122 VITROS Chemistry Products AcP Slides quantitatively measure acid phosphatase (AcP) activity in serum and plasma using VITROS 950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·November 27, 2013
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System
FDA Enforcement
Class II
·Terminated·Inpeco S.A.·May 16, 2018
Ocean Water Seal Chest Drain, SINGLE W/AC P/N: 2002-100
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·July 8, 2015
Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·July 8, 2015
Oasis Dry Suction Water Seal Chest Drain, DRY SINGLE W/AC P/N: 3600-100
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·July 8, 2015
PRE2055: Prevena Customizable Dressing 5-Pack Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
FDA Recall
Terminated
·KCI USA, INC.·Product code OMP·January 30, 2014
AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #M4268882 used with InfoVAC Model M825999,, InvoVac Canadian Model M8260027, and Vac ATS Model 8259968.
FDA Recall
Terminated
·KCI USA, Inc.·Product code OMP·November 4, 2009
PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
FDA Recall
Terminated
·KCI USA, INC.·Product code OMP·January 30, 2014
CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manufactured for: KCI USA, Inc. Part Number CT-H50 or CT-H25 The CelluTome Epidermal Harvesting System is intended to reproducibly cut a thin skin graft for autologous skin grafting.
FDA Recall
Terminated
·KCI USA, INC.·Product code GFD·November 19, 2014
500 mL InfoV.A.C. Canister (without Gel); Part #M8275071/5 (5 canister pack) and Part #M8275071/10 (10 canister pack); products are single use and labeled as STERILE; distributed by Kinetic Concepts, Inc., San Antonio, TX.
FDA Recall
Terminated
·KCI USA, Inc.·Product code JCX·July 29, 2008
500 mL InfoV.A.C. Canisters (with Gel); Part #M8275063/5 (5 canister pack) and Part #M8275063/10 (10 canister pack); products are single use and labeled as STERILE; distributed by Kinetic Concepts, Inc., San Antonio, TX.
FDA Recall
Terminated
·KCI USA, Inc.·Product code JCX·July 29, 2008
AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #4102204 used with Tricell 60601 Model 212857, First Step Select Model 215200 , and Plexipulse Model 205835.
FDA Recall
Terminated
·KCI USA, Inc.·Product code IOQ·November 4, 2009
KCI RotoProne Critical Care Therapy System buckles for securing patient to the surface during proning therapy, Model 209500. Indicated for treatment and prevention of pulmonary complications.
FDA Recall
Terminated
·KCI USA, Inc.·Product code IKZ·February 18, 2011
Zuma Mobility System Models: Zuma Mobility Assist 412045-01 and Zuma Mobility Trainer 412046-01. Product Usage: Human Non-AC-Powered Patient Lift
FDA Recall
Terminated
·KCI USA, Inc.·Product code FSA·April 6, 2012