BEUDAMED
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    ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100 tests), 2K91-25 and 2K91-27 (1 x 100 tests); Product Usage: The ARCHITECT CA 19-9XR assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 1116-NS-19-9 reactive determinants in human serum or plasma on the ARCHITECT i System. The ARCHITECT CA-19-9XR assay is to be used as an aid in the management of pancreatic cancer patients in conjunction with other clinical methods.

    FDA Recall
    Terminated ·Abbott Laboratories·Product code NIG·May 30, 2012

    ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100 tests), 2K91-25 and 2K91-27 (1 x 100 tests); Product Usage: The ARCHITECT CA 19-9XR assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 1116-NS-19-9 reactive determinants in human serum or plasma on the ARCHITECT i System. The ARCHITECT CA-19-9XR assay is to be used as an aid in the management of pancreatic cancer patients in conjunction with other clinical methods.

    FDA Enforcement
    Class II ·Terminated·Abbott Laboratories·July 4, 2012

    Patient tables of CT systems with brand name: CT/e; CT/e Dual; CT/e Plus, CT/e Dual Plus; CT/e Lite; ProSpeed AI; ProSpeed AII; ProSpeed FI; ProSpeed FII; ProSpeed EII; CT HiSpeed Series.

    FDA Recall
    Terminated ·General Electric Med Systems LLC·Product code IXR·October 21, 2004

    OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black; Part Number: 72201996 Biodegradable suture anchor

    FDA Recall
    Terminated ·Smith & Nephew, Inc. Endoscopy Division·Product code JDR·August 6, 2013

    OSTOSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Blue; Part Number: 72201994 Biodegradable suture anchor

    FDA Recall
    Terminated ·Smith & Nephew, Inc. Endoscopy Division·Product code JDR·August 6, 2013

    OSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture, Black; Part Number: 72203291 Biodegradable suture anchor

    FDA Recall
    Terminated ·Smith & Nephew, Inc. Endoscopy Division·Product code JDR·August 6, 2013

    Sonesta 6210 Fluoroscopy Procedure Table; a motorized procedure table with adjustments (via a remote control) for height, tilt, back and seat cushion position; Stille Surgical AB, Sundbybergsvagen 1A, SE-17173 Solna, Sweden

    FDA Recall
    Terminated ·Stille AB Gardsvagen·Product code IXR·August 27, 2008

    MotoCLIP(TM) Super Elastic Fusion System, Size 18mm x 14mm x 14mm, REF 1442-1814, Rx Only, STERILE R.

    FDA Recall
    Terminated ·Crossroads Extremity Systems Llc·Product code JDR·February 16, 2017

    BIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit, Item # 212000022, DVR 2.2MM DRILL BIT], [ALPS Drill Bit, Item # 214227160, 2.7X160MM CALIBRATED DRILL], [ALPS Drill Bit, Item # 824273100, 4.5X150MM DRILL], [ALPS Drill Bit, Item # 829029170, 2.5X140MM DRILL], [ALPS Drill Bit, Item # 829032170, 3.5X140MM DRILL], [ALPS Tap, Item # 824150170, 3.5X140MM CORTICAL TAP], [ALPS Guide Pin, Item # 829516150, 1.6X150MM BAYONET TIP GUIDE PIN], [ALPS Guide Pin, Item # 829516151, 1.6X150MM THREADED TIP GUIDE PIN]. Instruments are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient record labels. Identifying labels on the pouch and the carton.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code JDR·February 14, 2022

    OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue ; Part Number: 72201995 Biodegradable suture anchor

    FDA Recall
    Terminated ·Smith & Nephew, Inc. Endoscopy Division·Product code JDR·August 6, 2013

    Rapid Response HUT (Head Up Tilt) Table. Model 1117. Powered electrophysiology tilt table with single drop section. Table that can tilt -15 degrees to 90 degrees (Trendelenburg). Medical Positioning Incorporated.800-593-3246. Used in clinical and hospital settings by trained radiologists.

    FDA Recall
    Terminated ·Medical Positioning Inc·Product code IXR·February 1, 2010

    Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code IXR·February 6, 2017

    Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x14; b) ES-20x20; c) ES-25x22

    FDA Recall
    Terminated ·TriMed Inc.·Product code JDR·April 13, 2018

    Philips Easy Diagnost X-Ray System

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code IXR·July 23, 2007

    Lupine BR Anchor w/Orthocord TCP/PLGA Absorbable Anchor, size 2 (5 metric) Braided Composite Suture, violet 36" (91cm) Size 2 (5metric) eyelet loop. Made in Switzerland; Sterile. The Lupine BR Anchor System is indicated for use in soft tissue bone fixation.

    FDA Recall
    Terminated ·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code JDR·April 29, 2008

    Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642, 70643, 706030, 706031, 706032 Stationary x-ray system, Universal RF system for general use.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code IXR·July 11, 2012

    OSTEORAPTOR 2.3 mm Suture Anchor with ULTRABRAID COBRAID Suture, Blue; Part Number: 72201993 Biodegradable suture anchor

    FDA Recall
    Terminated ·Smith & Nephew, Inc. Endoscopy Division·Product code JDR·August 6, 2013

    UroDiagnost; x-ray system. Product Code: 708033

    FDA Recall
    Terminated ·Philips Electronics North America Corporation·Product code IXR·July 19, 2016

    708033 URODiagnost As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.

    FDA Recall
    Terminated ·Philips Medical Systems Nederlands Veenpluis 4-6 Best Netherlands·Product code IXR·March 26, 2018

    Advantx Legacy Radiographic and Fluoroscopic systems, model 2102424, 2118104, 2157009, 2183000, 2206038, 2206048, 2206056, 2224559, 2258627, 2268730, 2330340, 2333974, 2118104-2, 2118104-3, 2118104-4, 2118104-5, 2118104-6, 2118104-7, 2118104-8, 2139574-2, 2147592-13, 2171204-2, 46-262751G6, 46-262751G7, 46-262751G8, 46-275382G58, and 46-302056G1. GE Medical Systems - Americas: Milwaukee, USA. The device is used to perform fluoroscopic examination of human anatomy.

    FDA Recall
    Terminated ·GE Healthcare·Product code IXR·January 2, 2008