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16ms
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Sources: EU EUDAMED, US FDA
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Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System Model/Catalog Number: 38-1007SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 7H 38-1008SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 8H; 38-1009SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 9H; 38-1010SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 10H; 38-1011SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 11H; 38-1012SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 12H; 38-1013SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 13H; 38-1014SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 14H; 38-1707SP FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 7H; 38-1708SP FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 8H; 38-1709SP FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 9H; 38-1710SP FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 10H; 38-1711SP FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 11H; 38-1712SP FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 12H; 38-1713SP FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 13H; 38-1714SP FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 14H; 38-1807SP FORZA PTC Spacer, Curved, 0¿, 11W x 27L x 7H; 38-1808SP FORZA PTC Spacer, Curved, 0¿, 11W x 27L x 8H; 38-1809SP FORZA PTC Spacer, Curved, 0¿, 11W x 27L x 9H; 38-1810SP FORZA PTC Spacer, Curved, 0¿, 11W x 27L x 10H; 38-1811SP FORZA PTC Spacer, Curved, 0¿, 11W x 27L x 11H; 38-1812SP FORZA PTC Spacer, Curved, 0¿, 11W x 27L x 12H; 38-1813SP FORZA PTC Spacer, Curved, 0¿, 11W x 27L x 13H; 38-1814SP FORZA PTC Spacer, Curved, 0¿, 11W x 27L x 14H; 38-3007SP FORZA PTC Spacer, Straight, 0¿, 9W x 27L x 7H; 38-3008SP FORZA PTC Spacer, Straight, 0¿, 9W x 27L x 8H; 38-3009SP FORZA PTC Spacer, Straight, 0¿, 9W x 27L x 9H; 38-3010SP FORZA PTC Spacer, Straight, 0¿, 9W x 27L x 10H; 38-3011SP FORZA PTC Spacer, Straight, 0¿, 9W x 27L x 11H; 38-3012SP FORZA PTC Spacer, Straight, 0¿, 9W x 27L x 12H; 38-3013SP FORZA PTC Spacer, Straight, 0¿, 9W x 27L x 13H; 38-3014SP FORZA PTC Spacer, Straight, 0¿, 9W x 27L x 14H; 38-4007SP FORZA PTC Spacer, Straight, 0¿, 11W x 27L x 7H; 38-4008SP FORZA PTC Spacer, Straight, 0¿, 11W x 27L x 8H; 38-4009SP FORZA PTC Spacer, Straight, 0¿, 11W x 27L x 9H; 38-4010SP FORZA PTC Spacer, Straight, 0¿, 11W x 27L x 10H; 38-4011SP FORZA PTC Spacer, Straight, 0¿, 11W x 27L x 11H; 38-4012SP FORZA PTC Spacer, Straight, 0¿, 11W x 27L x 12H; 38-4013SP FORZA PTC Spacer, Straight, 0¿, 11W x 27L x 13H; 38-4014SP FORZA PTC Spacer, Straight, 0¿, 11W x 27L x 14H; 38-4207SP FORZA PTC Spacer, Curved, 0¿, 11W x 31L x 7H; 38-4208SP FORZA PTC Spacer, Curved, 0¿, 11W x 31L x 8H; 38-4209SP FORZA PTC Spacer, Curved, 0¿, 11W x 31L x 9H; 38-4210SP FORZA PTC Spacer, Curved, 0¿, 11W x 31L x 10H; 38-4211SP FORZA PTC Spacer, Curved, 0¿, 11W x 31L x 11H; 38-4212SP FORZA PTC Spacer, Curved, 0¿, 11W x 31L x 12H; 38-4213SP FORZA PTC Spacer, Curved, 0¿, 11W x 31L x 13H; 38-4214SP FORZA PTC Spacer, Curved, 0¿, 11W x 31L x 14H; 38-4508SP FORZA PTC Spacer, Curved, 8¿, 9W x 27L x 8H; 38-4509SP FORZA PTC Spacer, Curved, 8¿, 9W x 27L x 9H; 38-4510SP FORZA PTC Spacer, Curved, 8¿, 9W x 27L x 10H; 38-4511SP FORZA PTC Spacer, Curved, 8¿, 9W x 27L x 11H; 38-4512SP FORZA PTC Spacer, Curved, 8¿, 9W x 27L x 12H; 38-4513SP FORZA PTC Spacer, Curved, 8¿, 9W x 27L x 13H; 38-4514SP FORZA PTC Spacer, Curved, 8¿, 9W x 27L x 14H; 38-6007SP FORZA PTC Spacer, Straight, 0¿, 11W x 31L x 7H; 38-6008SP FORZA PTC Spacer, Straight, 0¿, 11W x 31L x 8H; 38-6009SP FORZA PTC Spacer, Straight, 0¿, 11W x 31L x 9H; 38-6010SP FORZA PTC Spacer, Straight, 0¿, 11W x 31L x 10H; 38-6011SP FORZA PTC Spacer, Straight, 0¿, 11W x 31L x 11H; 38-6012SP FORZA PTC Spacer, Straight, 0¿, 11W x 31L x 12H; 38-6013SP FORZA PTC Spacer, Straight, 0¿, 11W x 31L x 13H; 38-6014SP FORZA PTC Spacer,
FDA Enforcement
Class III
·Ongoing·Orthofix U.S. LLC·December 17, 2025
Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Number: 38-2006SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 6H; 38-2007SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 7H; 38-2008SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 8H; 38-2009SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 9H; 38-2010SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 10H; 38-2011SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 11H; 38-2012SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 12H; 38-2013SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 13H; 38-2014SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 14H; 38-2106SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 6H; 38-2107SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 7H; 38-2108SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 8H; 38-2109SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 9H; 38-2110SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 10H; 38-2111SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 11H; 38-2112SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 12H; 38-2113SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 13H; 38-2114SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 14H; 38-2206SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 6H; 38-2207SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 7H; 38-2208SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 8H; 38-2209SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 9H; 38-2210SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 10H; 38-2211SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 11H; 38-2212SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 12H; 38-2213SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 13H; 38-2214SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 14H; 38-2309SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 9H; 38-2310SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 10H; 38-2311SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 11H; 38-2312SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 12H; 38-2313SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 13H; 38-2314SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 14H; 38-2508SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 8H; 38-2509SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 9H; 38-2510SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 10H; 38-2511SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 11H; 38-2512SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 12H; 38-2513SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 13H; 38-2514SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 14H; 38-3206SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 6H; 38-3207SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 7H; 38-3208SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 8H; 38-3209SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 9H; 38-3210SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 10H; 38-3211SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 11H; 38-3212SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 12H; 38-3213SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 13H; 38-3214SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 14H; 38-3409SP FORZA Ti Spacer, Straight, 8¿, 11W x 31L x 9H; 38-3410SP FORZA Ti Spacer, Straight, 8¿, 11W x 31L x 10H; 38-3411SP FORZA Ti Spacer, Straight, 8¿, 11W x 31L x 11H; 38-3412SP FORZA Ti Spacer, Straight, 8¿, 11W x 31L x 12H;
FDA Enforcement
Class III
·Ongoing·Orthofix U.S. LLC·December 17, 2025
Block Versions Used by Dental Offices often referred to as chairside milling: Lava Ultimate Restorative for CEREC, Compatible with Sirona mill 2912x, 2914x, 3312x, 3314x. Lava Ultimate Restorative for E4D Compatible with E4D mills, same mandrel format as Planmill 3112x, 3114x, 4012x, 4014x. Lava Ultimate for Straumann milling centers 1334x. Lava Ultimate CAD/CAM Restorative for TS150, Compatible with TS150 (IOS Technologies), Glidewell Laboratories, 2614x. Lava Ultimate Restorative with Blue Mandrel, Pedestal Mandrel, compatible with Carestream CS 3000, Roland DWX-50, Roland DWX-4, 1314x, 2012x, 2110x. Lava Ultimate Restorative for Planmill, Compatible with Planmill mills, same mandrel format as E4D, 4212x, 4214x, 4312x, 4414x, 5072x, 5074x. Lava Ultimate Restorative for Ceramill, Compatible with Ceramill mills manufactured by Amann Girrbach, 4514x, 4714x, 5044x. Frame/Blank Version Used by Dental Laboratories: Lava Ultimate Implant Crown Restorative, Compatible with Lava Milling Equipment (Lava blocks bonded into frames. These are also known as blanks.), 69140-69149, 69150-69159, 69160-69163.
FDA Enforcement
Class II
·Terminated·3M Company - Health Care Business·July 15, 2015
DR Systems Unity PACS software, now known as Merge Unity PACS
FDA Enforcement
Class II
·Terminated·Merge Healthcare, Inc.·March 15, 2017
Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only Manufactured for Cardio Medical Products 385 Franklin Avenue, Suite L Rockaway, New Jersey 07866 www.cardiomedicalproducts.com (800) 227-3633 (973) 586-9624 FAX Defibrillator
FDA Enforcement
Class II
·Terminated·Cardio Medical Products·July 17, 2013
Maquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG Kehler Strabe 31 76437 Rastatt Germany Phone +49 7222 932-0 Fax: +49 7222 932-1888 [email protected] www.maquet.com Used to introduce blood and sterile solution to the circulation system during extracorporeal circulation procedures
FDA Enforcement
Class II
·Terminated·Maquet Inc.·August 22, 2012
LATITUDE¿ Patient Management System, Model 6488, Version 7.3. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·May 29, 2013
Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0264B, Oxoid Ltd., UK, [email protected] (Both Remel & Oxoid, Ltd are a part of Thermo Fisher Scientific) An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure, by a disc-agar diffusion technique or a disc-broth elution technique, the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents (Aztreonam).
FDA Enforcement
Class II
·Terminated·Remel Inc·February 13, 2013
Poly stat Flu A & B Test Manufactured for Polymedco 510 Furnace Dock Road Cortlandt Manor, NY 10567 Tel 800-431-2123 914-739-5400 Fax 914-739-5890. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it recommended that these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.
FDA Enforcement
Class II
·Terminated·Princeton Biomeditech Corp·September 12, 2012
Sleek ***OTW ***Ref ***426-1501X***Inflated Balloon Dia/mm 1.5 Inflated Balloon Length/mm 15 Usable Catheter Length/cm 150***Lot 50026688***2013-09***Cordis***PTA Dilatation Catheter***Cordis***Johnson Johnson Company***Sterile***EO***Method of Sterilization: ETO***ClearStream***Clearstream Technologies, Ltd.***Moyne Upper, Enniscorthy Co Wexford, Ireland***Phone: +353-53-92-37111***Fax: +353-53-92-37-100***Made in Ireland***Distributed by: Cordis Cashel***Cahir Road, Cashel, Co. Tipperary, Ireland***". The SLEEK OTW Percutaneous Transluminal Angioplasty (PTA) Peripheral Catheter Family is a non-reusable semi-compliant coaxial design catheter with a balloon mounted on its distal tip. The hub/"Y" connector consists of a through lumen, allowing the catheter to track over a guidewire, and a balloon port, used to inflate the balloon. The catheter shaft is small beneath the balloon achieve low profile. The distal tip is further tapered to accept the appropriate guidewire. Platinum iridium bands serve to locate the balloon under fluoroscopy. A 0.014" (0.356 mm) guidewire is recommended for use with the SLEEK OTW Catheter.
FDA Enforcement
Class II
·Terminated·Cordis Corporation·October 3, 2012
Sleek OTW***REF 426-1201X***Inflated Balloon Dia/mm***1.25***Inflated Balloon Length/mm***15***Usable Catheter Length/cm***150*** Lot 50027149***2013-09***Cordis*** Sleek***OTW***REF Cat. No. 426-1201X***PTA Dilatation Catheter***Cordis***Johnson Johnson Company***LOT Lot No. 50027149***Use by 2013-09***Sterile***EO***Method of Sterilization: ETO***ClearStream***Clearstream Technologies, Ltd.***Moyne Upper, Enniscorthy Co Wexford, Ireland***Phone: +353-53-92-37111***Fax: +353-53-92-37-100***Made in Ireland***Distributed by: Cordis Cashel***Cahir Road, Cashel, Co. Tipperary, Ireland***Tel: +353--(0)62-70000. The SLEEK OTW Percutaneous Transluminal Angioplasty (PTA) Peripheral Catheter Family is a non-reusable semi-compliant coaxial design catheter with a balloon mounted on its distal tip. The hub/"Y" connector consists of a through lumen, allowing the catheter to track over a guidewire, and a balloon port, used to inflate the balloon. The catheter shaft is small beneath the balloon achieve low profile. The distal tip is further tapered to accept the appropriate guidewire. Platinum iridium bands serve to locate the balloon under fluoroscopy. A 0.014" (0.356 mm) guidewire is recommended for use with the SLEEK OTW Catheter.
FDA Enforcement
Class II
·Terminated·Cordis Corporation·October 3, 2012
Integra Meshed Dermal Regeneration Template 5 cmx 5 cm (2 in x 2in) Rx Only Meshed Integra¿ Dermal Regeneration Template, (Integra template) is a bilayer membrane system for skin replacement. The dermal replacement layer is made of a porous matrix of fibers of cross-linked bovine tendon collagen and glycosaminoglycan (chondroitin-6-sulfate) that is manufactured with a controlled porosity and defined degradation rate. The epidermal substitute layer is made of a thin polysiloxane (silicone) layer to control moisture loss from the wound. Integra template is indicated for the postexcisional treatment of life-threatening full-thickness or deep partial-thickness thermal injuries where sufficient autograft is not available at the time of excision or not desirable due to the physiological condition of the patient. Integra template is also indicated for the repair of scar contractures when other therapies have failed or when donor sites for repair are not sufficient or desirable due to the physiological condition of the patient Manufactured by: Integra LifeSciences Corporation 311 Enterprise Drive, Plainsboro, NJ 08536 877-444-1122 USA n 609-936-5400 outside USA 866-800-7742 fax
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·September 21, 2016
Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210
FDA Enforcement
Class II
·Ongoing·FX SHOULDER·February 7, 2024
Fx SOLUTIONS OFFSET HEAD CoCr 50x20, REF 106-5000 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
FDA Enforcement
Class II
·Terminated·Fx Solutions·July 25, 2018
Fx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
FDA Enforcement
Class II
·Terminated·Fx Solutions·July 25, 2018