142 results · 12ms · Sources: EU EUDAMED, US FDA

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AMS 700 CX Preconnected penile Prosthesis with InhibiZone, product length 18 cm, product number 72402987. Penoscrotal Approach - with InhibiZone, 8 Extenders, one pair each .5cm, 1cm, 2cm 3cm; 1 Pump, 2 Cylinders.

FDA Recall
Terminated ·American Medical Systems·Product code JCW·February 9, 2007

AMS 700 Ultrex Preconnected penile Prosthesis with InhibiZone, Product length 18 cm, product number 72403924. Penoscrotal Approach - with InhibiZone, 8 Extenders, one pair each .5cm, 1cm, 2cm 3cm; 1 Tactile Pump, 2 Cylinders.

FDA Recall
Terminated ·American Medical Systems·Product code JCW·February 9, 2007

CIVCO Needle Guide Starter Kit, REF 674-039, Reusable non-sterile bracket with sterile needle guides (1cm, 1.5cm, 2cm depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transducers, 22 GAUGE, Rx.

FDA Recall
Terminated ·CIVCO Medical Instruments Co., Inc.·Product code ITX·November 2, 2018

CIVCO Needle Guide Starter Kit, REF numbers P12922-01 and P12922-02, Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers (5) for use with SonoSite L25 series transducers, 21 GAUGE, Rx.

FDA Recall
Terminated ·CIVCO Medical Instruments Co., Inc.·Product code ITX·November 2, 2018

CIVCO Needle Guide Starter Kit, REF numbers P12924-01 and P12924-02, Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers (5) for use with SonoSite L25 series transducers, 22 GAUGE, Rx.

FDA Recall
Terminated ·CIVCO Medical Instruments Co., Inc.·Product code ITX·November 2, 2018

CIVCO Needle Guide Starter Kit, REF 674-038, Reusable non-sterile bracket with sterile needle guide (1cm, 1.5cm, 2cm depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transducers, 21 GAUGE, Rx. The firm name on the label is CIVCO, Kalona, IA..

FDA Recall
Terminated ·CIVCO Medical Instruments Co., Inc.·Product code ITX·November 2, 2018

Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cm, product code VG0106N, 0.8 cm x 8 cm, product code VG0108N, 1 cm x 10 cm, product code VG0110N, and 2 cm x 9 cm, product code VG0209N. VASC U-GUARD is prepared from bovine pericardium which is cross-linked with glutaraldehyde. Sterilized using aseptic processing techniques. The pericardium is procured from cattle originating in the United States. VASC-Guard is chemically sterilized using ethanol and propylene oxide. UPDATE 9/1/2016 Retrieval of devices only includes Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cm, product code VG0106N, 0.8 cm x 8 cm, product code VG0108N.

FDA Recall
Terminated ·Baxter Healthcare Corp.·Product code DXZ·June 24, 2016

VVD Veronikis Vaginal Dilator - Complete Set Catalog No. 270-000. Set Includes: VVD Veronikis Vaginal Dilator - 3cm Tip: Width: 1.00in Catalog No. 270-003 (sold individually) VVD Veronikis Vaginal Dilator - 5cm Tip: Width: 1.00in Cat No. 270-005 (sold individually) VVD Veronikis Vaginal Dilator - 7cm Tip: Width: 1.00in Catalog Np. 270-007 (sold individually) VVD Veronikis Vaginal Dilator - 1cm Spacer: Width: 1.00in Catalog No. 270-009 (sold individually) VVD Veronikis Vaginal Dilator - 2cm Spacer: Width: 1.00in Catalog No. 270-011 (sold individually) VVD Veronikis Vaginal Dilator - 7cm Coupler: Width: 1.00in Catalog No. 270-013 (sold individually) VVD Veronikis Vaginal Dilator - Small Base, Screw 4cm: Width: 1.00in Catalog No. 270-015 (sold individually) VVD Veronikis Vaginal Dilator - Large Base, Screw 4cm: Width: 1.75in Catalog No. 270-017 (sold individually). For use in securing open the opening during examination of the vaginal body cavity. for the Post-Surgical Vagina.

FDA Recall
Terminated ·Marina Medical Instruments Inc.·Product code HDQ·April 9, 2009

EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Product Usage: The EPi-Sense Guided Coagulation System with VisiTrax, consists of a sterile, single-use, disposable coagulation electrode device (1cm, 2cm, and 3cm sizes provided) intended to be used to coagulate cardiac tissue. The flexible, cooled electrode device, with a suction stabilizer feature, transmits radiofrequency (RF) energy from an Electrosurgical Generator (non-sterile, re-useable) connected through an Instrument Cable (sterile). A temporary sensing electrode feature may be used with an off-the-shelf electrogram recording system with the use of an additional instrument cable (non-sterile). An accessory Cannula may be used to facilitate coagulation device access and visibility of the heart. The EPi-Sense Guided Coagulation System with VisiTrax technology is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy using thoracoscopic, endoscopic, and laparoscopic surgical techniques and may be used for temporary cardiac signal sensing and recording during surgery when connected to a temporary external recording device.

FDA Recall
Terminated ·AtriCure, Inc.·Product code OCL·May 29, 2019

AMS DURA-II Universal Tips, 2cm, Product Number 72009361, Sterile, American Medical Systems, Inc. Minnetonka, MN

FDA Recall
Terminated ·American Medical Systems·Product code FAE·February 19, 2007

progenamatrix Human Keratin Matrix, sterile, Rx, with the following model numbers: (1) PM2012, 12 x 2 cm; (2) PM3002, 2 x 2 cm; (3) PM3004, 4 x 4 cm; PM3006, 6 x 6 cm; and PM3010, 10 x 10 cm.

FDA Recall
Terminated ·ProgenaCare·Product code KGN·April 18, 2022

Endura No-React Dural Substitute 2 cm x 10 cm

FDA Recall
Terminated ·Integra LifeSciences Corp.·Product code DTZ·May 4, 2007

GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm).

FDA Recall
Terminated ·Codman & Shurtleff Inc·Product code HCG·May 16, 2019

ANGIODYNAMICS PROFILER BALLOON DILATATION CATHETER, Catalog No./REF 16801101, BALLOON DIAMETER 4MM, BALLOON LENGTH 2 CM, CATHETER LENGTH 40 CM, STERILE, MANUFACTURED IN USA AngioDynamics 603 Queensbury Avenue, Queensbury, NY 12804 Cardiovascular catheterization

FDA Recall
Terminated ·Angiodynamics Worldwide Headquarters·Product code DQY·February 25, 2011

METRx II Tube, 22mm x 3cm stainless steel tubular retractor, Part No. 9569730

FDA Recall
Terminated ·Medtronic Sofamor Danek Instrument Manufacturing·Product code LXH·January 25, 2006

METRx II Tube, 18mm x 3cm stainless steel tubular retractor, Part No. 9569680

FDA Recall
Terminated ·Medtronic Sofamor Danek Instrument Manufacturing·Product code LXH·January 25, 2006

METRx II Tube, 14mm x 3cm stainless steel tubular retractor, Part No. 9569660

FDA Recall
Terminated ·Medtronic Sofamor Danek Instrument Manufacturing·Product code LXH·January 25, 2006

METRx II Tube, 16mm x 3cm stainless steel tubular retractor, Part No. 9569670

FDA Recall
Terminated ·Medtronic Sofamor Danek Instrument Manufacturing·Product code LXH·January 25, 2006

Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 3cm UPN: M00536610

FDA Recall
Terminated ·Boston Scientific Corporation·Product code FGE·October 21, 2019

METRx II Tube, 20mm x 3cm stainless steel tubular retractor, Part No. 9569720

FDA Recall
Terminated ·Medtronic Sofamor Danek Instrument Manufacturing·Product code LXH·January 25, 2006