10,000 results · 17ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Medacta AMIS Universal Table for Leg Positioner, Model Number: 01.15.10.0172. The AMIS universal table for leg positioner and AMIS Leg Positioner are used during Anterior Minimally Invasive Surgery for hip arthroplasty. The system aids the surgical procedure by providing support and alignment of the limb.

FDA Recall
Terminated ·Medacta Usa Inc·Product code FWX·May 21, 2008

Cmax Surgical Table, Model No. 2182625, Manufactured by STERIS Corporation, 2720 Gunter Park East, Montgomery, AL 36109 USA, TEL: 334 277 6660, FAX: 334 271 5450

FDA Recall
Terminated ·Steris Corporation·Product code GDC·February 6, 2007

PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water Valve. As an alternative, the optionally available Gas/Water Valve may be used in place of the standard Air/Water Valve to deliver a non-explosive gas for insufflation.

FDA Recall
Terminated ·Pentax Medical Company·Product code FCX·September 16, 2013

Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 - Product Usage: designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.

FDA Recall
Terminated ·Northgate Technologies, Inc.·Product code FCX·January 15, 2021

LIGHT DIAGNOSTICS SimulFluor Flu A/Flu B DFA Kit Immunofluorescence Assay Cat. No. 3121 FOR IN VITRO DIAGNOSTIC USE Authorized Representative: Millipore (UK) Ltd. Fleming Road, Kirkton Campus Livingston EH54 7BN UK. Tel +44 1506 404000 Fax +44 1506 404073 MILLIPORE 28820 Single Oak Drive Temecula, CA 92590 " USA & Canada Phone: +1(800) 437-7500 " Fax: +1 (951) 676-9209. The kit consists of Catalog #5250 Simulfluor Flu A/B; Catalog #5010 Flu A/B Control Slide; Catalog #5013 Mounting Fluid; Catalog #5037 Tween 20/Sodium Azide, 100X; Catalog #5087 PBS Packet

FDA Recall
Terminated ·Millipore Corporation·Product code GNW·November 24, 2008

ThermoSuit Manufactured for Life Recovery Systems. HD, LLC, 170 Kinnelon Rd. Kinnelon, NJ 07405 USA Tel.: (973) 283-2800 FAx.: (973) 283-2910 Temperature reduction in patients where clinically indicated; Monitoring of patient temperature

FDA Recall
Terminated ·Life Recovery Systems HD, LLC·Product code NZE·October 21, 2011

Hydrophilic Guidewire, Catalog Number: TVS3010, .035/150 cm, regular/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Total Vein Solutions, 901 Yale Street - Houston, Texas 77008, (713) 863-1600 Fax 713 863-1601, www.totalvein.com.

FDA Recall
Terminated ·Argon Medical Devices, Inc·Product code DQX·February 26, 2009

Minutex D-Dimer ; Trinity Biotech plc, Bray, Co. Wicklow, Ireland. Tel: (353) 1 276 9800, Fax: (353) 1 276 9888, Web: www.trinitybiotech.com Minutex D-Dimer is a latex agglutination test for semiquantitative determination of fibrin D-Dimer.

FDA Recall
Terminated ·Tcoag Us, Incorporated·Product code GHH·June 13, 2011

Faaborg patient lift/hoist, battery operated lifts. The PL series lifts have electric parallel base widening, with a weight capacity of 365 lbs. to 550 lbs. depending on the base model. Please note: the Faaborg Person Lift arm assembly can be interchanged on the various lift series bases. The arm assembly is labeled ''Faaborgliften Made in Denmark'', while the base plate reads in part ''Faaborg Rehab Technic Lift Model: VL-***** Serial No: **** Capacity: *** KG. Manufactured: **-**** 5600 Faaborg Phone+4570205553 Fax+4570205554'' A sticker is also present on the base reading ''Moving Solutions 800-228-7980 Fax 630-963-9588''. The Users Guide refers to the lift as a ''Faaborghoist''.

FDA Recall
Terminated ·Moving Solutions, Inc.·Product code FSA·January 21, 2004

Faaborg patient lift/hoist, battery operated lifts. The VL series lifts have electric V-shape base widening, with a weight capacity of 365 lbs. to 550 lbs. depending on the base model. Please note: the Faaborg Person Lift arm assembly can be interchanged on the various lift series bases. The arm assembly is labeled ''Faaborgliften Made in Denmark'', while the base plate reads in part ''Faaborg Rehab Technic Lift Model: VL-***** Serial No: **** Capacity: *** KG. Manufactured: **-**** 5600 Faaborg Phone+4570205553 Fax+4570205554'' A sticker is also present on the base reading ''Moving Solutions 800-228-7980 Fax 630-963-9588''. The Users Guide refers to the lift as a ''Faaborghoist''.

FDA Recall
Terminated ·Moving Solutions, Inc.·Product code FSA·January 21, 2004

Faaborg patient lift/hoist, battery operated lifts. The Solution/Nordic series lifts have electric V-shape base widening, with a weight capacity of 210 lbs. to 365 lbs. depending on the base model. Please note: the Faaborg Person Lift arm assembly can be interchanged on the various lift series bases. The arm assembly is labeled ''Faaborgliften Made in Denmark'', while the base plate reads in part ''Faaborg Rehab Technic Lift Model: VL-***** Serial No: **** Capacity: *** KG. Manufactured: **-**** 5600 Faaborg Phone+4570205553 Fax+4570205554'' A sticker is also present on the base reading ''Moving Solutions 800-228-7980 Fax 630-963-9588''. The Users Guide refers to the lift as a ''Faaborghoist''.

FDA Recall
Terminated ·Moving Solutions, Inc.·Product code FSA·January 21, 2004

STAT-Check, Adult Manual Emergency Resuscitator with A.C.E./STAT-Check CO Indicator, Single Patient Use, Non-Sterile, Rx only, Latex Free, Re-Order SC 9000 Series, Ventlab Corporation, 155 Boyce Drive, Mocksville, NC 27028, (336) 753-5000, (336) 753-5002 FAX

FDA Recall
Terminated ·Ventlab Corporation·Product code BTM·March 26, 2004

STAT-Check, Pediatric Manual Emergency Resuscitator with A.C.E./STAT-Check CO Indicator, Single Patient Use, Non-Sterile, Rx only, Latex Free, Re-Order SC-8000 Series, Ventlab Corporation, 155 Boyce Drive, Mocksville, NC 27028, (336) 753-5000, (336) 753-5002 FAX

FDA Recall
Terminated ·Ventlab Corporation·Product code BTM·March 26, 2004

Bari Maxx II, KCI''s BariMaxx II bariatric bed, P/N 310611, November 2001, KCI The Clinical Advantage, P. O. Box 659508, San Antonio, Texas 78265-9508, Call Toll Free 1-800-531-5346, FAX (210) 308-3998, Http://www.kci1.com

FDA Recall
Terminated ·Kinetic Concepts, Inc·Product code FNL·August 16, 2004

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 Recall
Terminated ·Cardio Medical Products·Product code LDD·April 26, 2013

STAT-Check Infant Disposable Manual Resuscitators, with 40 cmHO Pressure Limiting System & Pressure Port Adapter, Single Patient Use Non-Sterile, Re-Order SC7000 Series, Non Latex, Ventlab Corporation, 155 Boyce Drive, Mocksville, NC 27028, (336) 753-5000, (336) 753-5002 FAX

FDA Recall
Terminated ·Ventlab Corporation·Product code BTM·March 26, 2004

Novoste, Beta-Cath 3.5F System, New B-Rail 3.5F Delivery Catheter, with Indicator of Source Train (IST), Novoste Corporate, 3890 Steve Reynolds Blvd, Norcross, GA 30093, Tel: +1770-717-0904, Fax: +1770-717-1283, 1-800-NOVOSTE (1-800-668-6783), www.novoste.com.

FDA Recall
Terminated ·Novoste Corporation·Product code JAJ·January 25, 2002

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 Recall
Terminated ·Maquet Inc.·Product code NCP·May 29, 2012

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

Digisonics, Digiview and ERS software releases 3.6.44, 3.6.4.6, and 3.6.5, Digisonics, Inc., 3701 Kirby Drive, Houston, TX 77098, Tel: (800) 940-3240, Fax: (713) 529-7999 Software used to make on-screen (2-D, M-Mode and Doppler) measurements of left ventricle, right ventricle, etc.

FDA Recall
Terminated ·Digisonics, Inc·Product code LLZ·February 6, 2009