343 results · 25ms · Sources: EU EUDAMED, US FDA

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BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial Needle MCXS1615BP. QTY.: 5/CS - Product Usage: The disposable, automatic BioPince Full Core Biopsy Instrument is used to obtain multiple core samples from soft tissue such as liver, kidney, abdominal masses, etc.

FDA Recall
Terminated ·Argon Medical Devices, Inc·Product code KNW·December 2, 2019

ReShape Integrated Dual Balloon System, Gen 1, Model No. 01-0013-001, Catalog No. RSM110 product Usage: The ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conjunction with diet and exercise, in obese patients with a Body Mass Index (BMI) of 30 40 kg/m2 and one or more obesityrelated comorbid conditions. It is indicated for use in adult patients who have failed weight reduction with diet and exercise alone.

FDA Recall
Terminated ·Reshape Medical Inc 100 Calle Iglesia San·Product code LTI·October 14, 2016

ReShape Integrated Dual Balloon System, Gen 1, Catalog No. RSM110, Model No. 01-0013-001 The ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conjunction with diet and exercise, in obese patients with a Body Mass Index (BMI) of 30 40 kg/m2 and one or more obesity related comorbid conditions. It is indicated for use in adult patients who have failed weight reduction with diet and exercise alone.

FDA Recall
Terminated ·Reshape Medical Inc 100 Calle Iglesia San·Product code LTI·May 4, 2016

Synthes CMF Distraction System The product is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus, where gradual bone distraction is required. It is intended for single use only.

FDA Recall
Terminated ·Synthes USA HQ, Inc.·Product code MQN·June 12, 2013

Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 16 System Number: 882470 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.

FDA Recall
Open, Classified ·Philips North America Llc·Product code KPS·May 1, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 64 System Number: 882471 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.

FDA Recall
Open, Classified ·Philips North America Llc·Product code KPS·May 1, 2021

The LightSpeed RT16 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. The system is capable of generating images for the guidance of minimally invasive procedures such as biopsy and ablation of tumors and pathology. The system allows imaging of obese patients, up to and including the obese population (BMI > 40). When used in the LightSpeed RT 16 configuration, the system acquires CT anatomical images that are clinically useful in the simulation and planning of radiation therapy for the treatment of cancer.

FDA Recall
Terminated ·GE Healthcare·Product code JAK·December 8, 2006

Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini GXL 16 Slice System Number: 882410 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.

FDA Recall
Open, Classified ·Philips North America Llc·Product code KPS·May 1, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - CT Vision ACQSIM CT System Number: 728209 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.

FDA Recall
Open, Classified ·Philips North America Llc·Product code JAK·May 1, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - TruFlight Select PET/CT System Number: 882438 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.

FDA Recall
Open, Classified ·Philips North America Llc·Product code KPS·May 1, 2021

Centurion Healthcare Products Pump Fill Kit DT10175. CONTENTS: 1 CSR WRAP, 2 GLOVES, 1 FENESTRATED DRAPE, 1 EXTENSION LINE Approx. Priming Vol.: 0.3mL, 1 SYRINGE, 1 Exel Huber NEEDLE, 1 ChloraPrep(R), 1 TRAY The recalled Exel Huber Needles are used to access subcutaneously implanted ports used for the withdrawal of blood samples and infusion of medication. The firm places the recalled needles in pump fill kit.

FDA Recall
Terminated ·Centurion Medical Products·Product code FMI·February 1, 2010

Exel Huber Needles (Right angle and Straight Models with Catalog Numbers: 26901CE, 26902CE, 26903CE, 26904CE, 26905CE, 26906CE, 26907CE, 26908CE, 26909CE, 26910CE, 26911CE, 26921CE, 26922CE, 26923CE, 26924CE, 26925CE, 26926CE, 26927CE, 26928CE, and 26929CE).

FDA Recall
Terminated ·Exelint International Co.·Product code FMI·December 23, 2009

Kendall TURKEL Safety Thoracentesis Tray 8F x 3.5 inch Product Number: 566059

FDA Recall
Terminated ·Kendall Healthcare Products Co·Product code FMI·October 8, 2004

Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 25G X 5/8 inch Product Number: 5551833558

FDA Recall
Terminated ·Kendall Healthcare Products Co·Product code FMI·October 8, 2004

Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 22G X 1.5 inch Product Number: 8881833215

FDA Recall
Terminated ·Kendall Healthcare Products Co·Product code FMI·October 8, 2004

Goldenberg Snarecoil Bone Marrow Biopsy / Aspiration Basic Tray with Safety Components, 11G x 4 inch Bone Marrow needle only Product Number: SCE4511

FDA Recall
Terminated ·Kendall Healthcare Products Co·Product code FMI·October 8, 2004

Sensi-Touch Pediatric Lumbar Puncture Tray with Safety Components 22G X2.5 inch Product Number: 8888714113

FDA Recall
Terminated ·Kendall Healthcare Products Co·Product code FMI·October 8, 2004

Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 22G X 1.5 inch Product Number: 5551833215

FDA Recall
Terminated ·Kendall Healthcare Products Co·Product code FMI·October 8, 2004

Kendall MONOJECT MAGELLAN SAFETY NEEDLE 21G X 1 inch Product Number: 8881850110

FDA Recall
Terminated ·Kendall Healthcare Products Co·Product code FMI·October 8, 2004

Curity Adult Lumbar Puncture Tray with Safety Components 20G x 3.5 inch Product Code: 1032

FDA Recall
Terminated ·Kendall Healthcare Products Co·Product code FMI·October 8, 2004