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Sources: EU EUDAMED, US FDA
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AMS brand GreenLight PV Laser System, Model-P/N: 0010-9230; Product is manufactured and distributed by AMS Solutions, San Jose, CA The GreenLight Surgical Laser System and accessories are intended for use in endoscopic (cystscopic) KTP 532 nm laser resection of the prostate for the treatment of benign prostatic hyperplasia (BPH). The entire laser unit and controls are contained in a single console that is connected to external electricity and water sources. Fibers are sterile, single-use, disposable fiber optic delivery systems, designed to deliver 532nm laser energy, the fiber is connected to the laser console and used to cut, coagulate and vaporize prostate tissue.
FDA Recall
Terminated
·AMS Innovative Center San Jose·Product code GEX·February 8, 2010
American Medical Systems, Inc., (AMS) GreenLight HPS Fiber Optic (ADDStat) Part Number 0010-2090B. Fiber optic laser for treatment of BPH (Benign Prostatic Hyperplasia). AMS Innovative Center, San Jose, CA 95134
FDA Recall
Terminated
·AMS Innovative Center San Jose·Product code GEX·June 18, 2007
GreenLight HPS (High Performance System) GreenLight XPS (Xcelerated Performance System) Manufactured by AMS, Solutions for Life Innovation Center. GreenLight HPS and XPS Surgical Lasers Systems and accessories are intended for use in endoscopic 532 nm laser resection of the prostate for the treatment of benign prostatic hyperplasia.
FDA Recall
Terminated
·AMS Innovative Center San Jose·Product code GEX·December 11, 2012
GreenLight MoXy Fiber Optic, part number 0010-2400, for use with the GreenLight XPS Laser System, manufactured by American Medical Systems Inc., San Jose, CA The XPS Laser system is indicated for surgical incision and excision, vaporization, ablation, hemostasis and coagulation of soft tissue.
FDA Recall
Terminated
·AMS Innovative Center San Jose·Product code GEX·July 14, 2010
O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG #(s): 01BM1000 --- INTENDED USE: The Adult Ventilation Timer is intended to guide the rescuer to provide ventilations at a rate appropriate for adult patients
FDA Recall
Terminated
·O-Two Medical Technologies, Inc.·Product code JBS·June 23, 2015
Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen
FDA Recall
Open, Classified
·Cardinal Health 200, LLC·Product code FOS·May 2, 2025
Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen
FDA Recall
Open, Classified
·Cardinal Health 200, LLC·Product code FOS·May 2, 2025
Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). Intended for use to insert an Umbilical Venous Catheter (UVC) into the umbilical artery or vein of neonate. Product Code: 43201
FDA Recall
Terminated
·Cardinal Health·Product code FOS·June 16, 2021
Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen
FDA Recall
Open, Classified
·Cardinal Health 200, LLC·Product code FOS·May 2, 2025
Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen
FDA Recall
Open, Classified
·Cardinal Health 200, LLC·Product code FOS·May 2, 2025
Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs
FDA Recall
Open, Classified
·Cardinal Health 200, LLC·Product code FOS·May 2, 2025
Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen
FDA Recall
Open, Classified
·Cardinal Health 200, LLC·Product code FOS·May 2, 2025
Nova 8 Analyzer Calibrator Pack (Catalog/REF # 15196), Nova Biomedical, Waltham, MA
FDA Recall
Terminated
·Nova Biomedical Corporation·Product code JBS·September 17, 2007
Micrus Endovascular Microcoil Delivery System; The Micrus Microcoil Delivery System consists of three components, a Microcoil System, a Connecting Cable, and a Detachment Control Box (DCB). Each component is sold separately. Catalog Numbers: PC4180933, SSR181128, CPL100252, PC4181647, SSR181640, CPL100404, DFS100254, SSR181230, CPL100406, DFS100410, DPL100206, SRC141230, CRC140304, DFS100716, CRC140406, CPL100203, DFS100204, DPL100408, SSR100253, PC4181240, DPL100202, CDF100408, PC4181137, CSP100500, CDF100154, PC4180830, CSP100350, DFS100152, SRC140408, PC4181034, CPL100206, CDF100152, SRC141025, SRC140225, CPL100304, CRC141025, CPL 100254, PC4181447, DPL100252, DFS100154, SRC140303, DFS100720, DPL 100204, PC4181343, CSP180500, DFS1 0031 0, DPL100306, DPL100256, CPL100306, CDF100304, CDF100203, CDF100410, PC4100412, DPL 100254, DPL 100053, PC41 00626, CDF100208, CRC140306, PC4100517, DFS100203, CSP181400, CPL 100152, DFS100210, CDF100720, CPL100204, CSP180200, DFS100204, CDF100510, DFS101025, DFS100408, PC41 00730, SSR181740, CRC140615, CPL100256, CDF100206, DFS100308, CPL100151, CSP100200, CDF100616, CRC140711, SSR181334, CDF100310, SRC140445, DFS100252, CPL100408, CDF100306, DFS100250, DPL 100152, DPL 100201, CDF100258, SRC140306, CDF100156, DPL 100153, DPL100304, SRC140922, SSR100825, DFS100206, DPL 100203, PC4181550, DFS100616, CSP180900, PC4181950, DFS100406, SRC140717, PC4181750, DFS100925, CSP100400, PC4181846, SRC140711, CPL100153, PC4182050, DFS100306, SRC140406, CSP100900, SRC140615, CDF100308, CSP100300, DFS1 0051 0, CDF100406, CDF1 0021 0, DFS100156, CDF100515, DPL100151, CDF100925, SSR181028, CDF101025, SSR181540, CPL 100201, SSR180825, CPL 100202; Manufactured and distributed by Micrus Endovascular Corporation, San Jose, CA
FDA Recall
Terminated
·Micrus Endovascular Corp., 821 Fox Lane, San Jose, CA 95131
821 Fox Ln
San Jose CA 95131-1601·Product code HCG·October 21, 2010
Santajoy Ornament & Giftware Co., Ltd E-Z Illuminations Northern Lights E-Z Illuminations Galaxy Laser projectors that emit various colors and light patterns for entertainment and decorative purposes.
FDA Recall
Terminated
·SANTA JOY ORNAMENT & GIFTWARE CO 3rd Block Changtian Ind Hengli Town Dongguan City China·Product code RDZ·November 21, 2017