514 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Gyrus ACMI PKS Seal Open Forceps, model 915005PK, 9-3/4" Straight Jaw. Sterile EO. The device is intended to be used with the G400 electrosurgical generator. Gyrus ACMI, Inc., 136 Turnpike Road, Southborough, MA 01772-2104 USA.
FDA Recall
Terminated
·Gyrus ACMI Corporation·Product code GEI·August 18, 2009
E-Z CLEAN Non Stick Cautery Tip. Label reads in part: "MEGADYNE 11506 SOUTH STATE STREET DRAPER, UTAH 84020 USA***CAT/REF 0029M E-Z CLEAN NON STICK CAUTERY TIP***STERILE *** Expiration Date: 2104-07***" The device is intended to conduct monopolar electrosurgical energy from an electrosurgical generator to target tissue during general surgical procedures. This device is intended to be used whenever monopolar electrosurgical cutting and coagulation are indicated.
FDA Recall
Terminated
·Megadyne Medical Products, Inc.·Product code GEI·October 13, 2009
Starion Instruments TLS3 35C Thermal Ligating Shears, Electrosurgical cutting and coagulation device and accessories, manufactured by Starion Instruments Corp, Sunnyvale, CA. Intended use: medical device for use in cutting and cauterization of soft tissue during surgery, as well as cutting of natural or synthetic, non-metallic sutures during surgery.
FDA Recall
Terminated
·Starion Instruments·Product code GEI·February 6, 2008
Mitek VAPR Flexible Side Effect Electrode (integrated) Product Code: 227312 The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrodes (S9 and S ) with Integrated Handpiece with Integrated Handpiece, when used with the DePuy Mitek VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist.
FDA Recall
Terminated
·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code GEI·June 7, 2010
Mitek VAPR Side Effect Electrode (integrated) Product Code: 227301 The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrodes (S9 and S ) with Integrated Handpiece with Integrated Handpiece, when used with the DePuy Mitek VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist.
FDA Recall
Terminated
·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code GEI·June 7, 2010
ABC Bend-A-Beam Handpiece REF 134009 Handcontrol Malleable Handpiece, 9" (22.8 cm) QTY: 1 STERILE CONMED CORPORATION 525 FRENCH RD UTICA, NY 13205 ASSEMBLED IN MEXICO (Pouch label) ABC Bend-A-Beam Handpiece REF 134006 Handcontrol Malleable Handpiece, 9" (22.8 cm) QTY: 10 STERILE CONMED CORPORATION 525 FRENCH RD UTICA, NY 13205 ASSEMBLED IN MEXICO (Case label) Usage: Electrosurgical handpiece for use as monopolar electrosurgical accessory in conjunction with CONMED electrosurgical units equipped with argon beam coagulation.
FDA Recall
Terminated
·ConMed Electrosurgery·Product code GEI·December 18, 2008
RITA StarBurst (2-3cm Diameter/25cm Length), Electro-surgical Device, Manufactured by: RITA Medical Systems, Inc., One Horizon Way, Manchester, GA 31816
FDA Recall
Terminated
·Rita Medical Systems, Inc.·Product code GEI·April 3, 2007
Precision Bipolar Device ClearGlide EVH Small (endoscopic vessel harvesting system) The kit included three Precision BiPolar Devices, an Optical Vessel Dissector, a Small Ultra Retractor and a Vessel Dissector. Datascope Cardiac Assist Sterile R Manufactured for: Datascope Cardiac Assist 15 Law Drive Fairfield, NJ 07004
FDA Recall
Terminated
·Datascope Corporation·Product code GEI·May 7, 2007
ConMed Goldline Hand Controlled With Blade Electrode, Rocker Switch, Safety Holster and 15 FT Cable, REF 130327A, Sterile R, Assembled in Mexico, ConMed Corporation, 525 French Rd., Utica, NY 13502.
FDA Recall
Terminated
·ConMed Electrosurgery·Product code GEI·March 29, 2010
Basic Core Pack # OR1805, Sterile, Tri State Hospital Supply Corporation Manufacturers of Centurion Healthcare Products.
FDA Recall
Terminated
·Centurion Medical Products·Product code GEI·April 9, 2010
AEM Disposable Electrode, Spatula, 45cm, REF ES0301-45, Qty 10 each Sterile R, Manufactured for: Encision Inc., Boulder, CO 80301, made in Taiwan. Electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures.
FDA Recall
Terminated
·Encision, Inc.·Product code GEI·April 5, 2010
Button Switch Electrosurgical Pencil with Holster
FDA Recall
Terminated
·Megadyne Medical Products, Inc·Product code GEI·April 6, 2006
DePuy Mitek VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpiece Catalog Number: 227305 The DePuy Mitek VAPR Electrodes for use with the VAPR Radiofrequency System are intended for resection, ablation, excision, hemostasis of blood vessels, and coagulation of soft tissue in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow, and/or wrist.
FDA Recall
Terminated
·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code GEI·March 12, 2012
AngioDynamics RITA Main Cable, 9 Pin to 14 Pin, REF 700-101892. RITA Main Cables are indicated for use with the RITA RF Generators and RITA electrosurgical devices.
FDA Recall
Terminated
·Angiodynamics, INC·Product code GEI·June 11, 2013
-90 Degree L-Hook Tip Arthroscopic Electrode, for use with 7205440 Switchpen, (Blue) 170mm. Ref. 7205441 Lot 122502 -Acromioplasty Electrode (Grey) 6.5" x 165mm. Ref. C5012A Lot 122288 -CAPSure 30 ArthroWand, CW, 30 Degree Shaft Angle, (Grey) 3.0mm. Ref. AC 1830-01 Lot 122494 -Coblator II Evac 70 Xtra Plasma Wand, w/Integrated Saline Line & Integrated Cable. Ref. EIC 5872-01 Lot 122295, 122308, 122626, 122325, -Coblator II, ENT ReFlex Ultra 45 w/Integrated Cable, (Blue). Ref. EIC 4845-01 Lot 122651, 122419, 122671, 122633 Electrosurgical cutting and coagulation device and accessories. -CoVac 50, Suction ArthroWand, w/Integrated Cable, (White/Grey). Ref. ASC 2530-01 Lot 122483, 122745 -CoVac 70, ICW ArthroWand 70 angle 3.0mm. Ref. ASC 3730-01 Lot 122483, -Eliminator, Right Angle ArthroWand (Beige). Ref. A 1345-01 Lot 122446 -Eliminator, Right Angle ArthroWand, 90 Degree w/Integrated Cable, (Grey) 4.5mm. Ref. AC 1345-01 Lot 122494, 122446 -ENT Coblator II PROcise XP Wand, w/Integrated Cable, Suction & Saline, (Blue). Ref. EIC 8872-01 Lot 122651, 122762 -Ligament Chisel Probe,Curved w/Integrated Cable, (Grey/Green). Ref. 7209647 Lot 122512 -LightWave Suction Ablator, 90 Degree, Hand Control, Multi-Angle, (Blue/White) 4.5mm x 142mm. Ref. IA-2000-S Lot 122512 -Lo-Pro 90 Degree ArthroWand, w/Integrated Cable, (Grey) 3.6mm. Ref. AC1336-01 Lot 122654, 122325 -Meniscectomy Electrode, Standard Design (Grey) 165mm. Ref. C5010A Lot 122765 -MeniVac ArthroWand w/Suction, w/Integrated Cable, (Grey) 3.0mm. Ref. ASC 5500-01 Lot 122630, 122494 -Microblastor 30 Wand, 30 Degree, w/Integrated Cable, (Grey) 0.9mm Tip. Ref. AC 40500-01 Lot 122293 -Right Angle ArthroWand, 90 Degree, w/Integrated Cable, (Grey) 3.5mm. Ref. AC 1340-01 Lot 123044, 122673 -Saber 30 ArthroWand, 30 Degree, w/Integrated Cable, (Grey) 3.0mm. Ref. AC 4330-01 Lot 122630, 122494, 123044, 122283, 122765 -SAPHYRE II Bipolar Ablation Probe, w/suction, High Profile 50 Degree, (Pewter). Ref. 7210112 Lot 122734 -SERFAS ENERGY Hook Probe 3.5mm. Ref. 279-350-501 Lot 123266 -Small Joint ArthroWand, Short Bevel 35, w/Integrated Cable, Suction (Grey/White) 2.3mm. Ref. AC 2823-01 Lot 122494, 122663 -StarVac ArthroWand, Short Bevel 35, w/Integrated Cable, Suction (Grey)5.5mm. Ref. ASC 4251-01 Lot 122630, 122593, 122483, 123044, 122283, 122595 -Super MultiVac 50, 50 Degree, w/Suction and Integrated Cable, (Grey/Black) 3.0mm. Ref. ASC 4830-01 Lot 122029, 123044, 122663 -Super TurboVac 90, 90 Degree Suction ArthroWand, (White/Grey) 3.5mm. Ref. ASC 4250-01 Lot 122029,122654, 122651, 122427, 122630, 122494, 122626, 122745, 122293, 122663, 122325, 122765 -TAC-C II Probe, w/Integrated Cable, (Blue/Grey). Ref. 7209628 Lot 122486 -TriStar 50 Suction ArthroWand, 50 Degree w/Integrated Cable, (White/Grey). Ref. ASC 4630-01 Lot 122283 -Turbinate, Tissue Coagulating Electrode, (White). Ref. 1120-4110-01 Lot 122486 -VAPR Hook Electrode W/Integrated Handpiece 3.5mm. Ref. 227305 Lot 122288, 122466 -VAPR LD, Suction Electrode, Large Diameter (Blue) 4.0mm. Ref. 225360 Lot 122512 -VAPR Premiere50-, w/Integrated Cable, Suction, (Black/White) 3.0mm. Ref. 227504 Lot 122029, 122455 -VAPR Premiere90 w/Suction tion, Integrated Cable, (Black/White) 3.3mm. Ref. 227204 Lot 122029, 122446, 122466, 122306, 122435, 122293, -VAPR S90 Suction Electrode, w/Integrated Cable, (Black/White). Ref. 225370 Lot 122577, 122455, 122593, 122288, 122466, 122589, 122356, 122639, 122325, 122318 -VAPR Side Effect Electrode (Blue) 3.5mm. Ref. 225301 Lot 122512 -VAPR Side Effect Electrode, w/Integrated Handpiece 3.5mm. Ref. 227301 Lot 122288, 122356, -VAPR Wedge Electrode (Short,) w/Integrated Cable (Black/White) 2.3mm x 85 mm. Ref. 227213 Lot 122409 -VAPR Wedge Electrode, w/Integrated Cable (Black/White) 2.3mm. Ref. 227203 Lot 122486, 122639 -VAPR Angled, Side Effect Electrode (Blue) 3.5mm. Ref. 225302 Lot 122512 -Vulcan Sa
FDA Recall
Terminated
·Surgical Instrument Service And Savings, Inc.·Product code GEI·May 3, 2013
E-Z Clean Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. Expiration dates of 05/2018 to 07/2018. Sterile. RX ONLY. This product is packaged individually in a chevron Tyvek - polyester peel pouch, 6 pouches per box. The E-Z Clean laparoscopic electrode is intended to conduct monopolar electrosurgical energy from an electrosurgical generator to target tissue during laparoscopic surgical procedures. This device is intended to be used whenever monopolar electrosurgical cutting and coagulation are indicated.
FDA Recall
Terminated
·Megadyne Medical Products, Inc.·Product code GEI·August 7, 2013
Encision AEM Suction Irrigation Electrode, L-Hook, REF ES3883, Encision Inc., Boulder, CO 80301. The Suction Irrigation Electrodes and Adapters combine AEM shielding technology with suction and irrigation of fluids during laparoscopic electrosurgery to cut and coagulate tissue. The electrodes connect to a compatible electrosurgical generator via an adapter on the Encision AEM Monitor.
FDA Recall
Terminated
·Encision, Inc.·Product code GEI·August 24, 2011
VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System; Manufactured by Maquet Cardiovascular, LLC; 170 Baytech Drive, San Jose, CA 95134. Product Usage: Endoscopic vessel harvesting systems are indicated for use in minimally invasive surgery allowing access for vessel harvesting and are primarily indicated for patients undergoing endoscopic surgery for arterial bypass.
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code GEI·December 17, 2009
Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360I, 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel pouch, 10 plastic Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar Forceps and Cords are intended for use in coagulating tissue during surgical procedures.
FDA Recall
Terminated
·PSC Industries Inc·Product code GEI·June 1, 2012
Bayonet Forceps 8.25 (209.6 mm) 0.5mm Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-13420, 510 (k) #K884175. The surgical device is package one (1) per Tyvek peel pouch with ten (10) Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar Forceps and Cords are intended for use in coagulating tissue during surgical procedures
FDA Recall
Terminated
·PSC Industries Inc·Product code GEI·June 1, 2012