26 results
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54ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AtriAmp - Pacing Cable
FDA UDI
Atrility Medical LLC·00860004773726·Pacing Cable, 6FT, 2mm Shrouded Connector
AtriAmp
FDA UDI
Atrility Medical LLC·00860004773702·AtriAmp
AtriAmp - Pacing Cable
FDA UDI
Atrility Medical LLC·00860004773719·Pacing Cable, 6FT, Medtronic® Connector
Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device.
FDA Recall
Terminated
·Ebi, Llc·Product code MAX·April 9, 2013
Cypress Medical Products LLC, MediChoice Umbilical cord clamp, sterile; single use; Distributed by Owens & Minor, Mechanicsville, VA. The product is used to clamp the umbilical cord after childbirth.
FDA Recall
Terminated
·Cypress Medical Products LLC·Product code HFW·April 15, 2013
Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,
FDA Recall
Open, Classified
·Allergan Sales, LLC·Product code KDD·March 14, 2024
Draco Enzymatic Deep-Cleaning Pad with Enzymatic Detergent Catalogue Number: HY0305Z
FDA Recall
Terminated
·Madison Polymeric Engineering·Product code LKB·April 17, 2017
Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (850011)), *Distributed outside the United States
FDA Recall
Open, Classified
·Respironics California, LLC·Product code MNT·February 28, 2022
Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137276)
FDA Recall
Open, Classified
·Respironics California, LLC·Product code MNT·February 28, 2022
Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618, 1076709, 1076716, 1076717, 1137292, DU1053617, U1053617, R1053618, R1076709)
FDA Recall
Open, Classified
·Respironics California, LLC·Product code MNT·February 28, 2022
Material DT9345E, DRESSING CHANGE TRAY, CENTURION, STRATEGIC HEALTHCARE SOLUTIONS LLC. DRESSING CHANGE TRAY, REORDER DT9345E, STERILE, LATEX FREE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895, USA 800.248.4058 www.centurionmp.com FACILITATES DRESSING CHANGE
FDA Recall
Terminated
·Centurion Medical Products Corporation·Product code MCY·March 31, 2011
Product is labeled in part: "***REF: 01-7036, LOT 999999, "1.5MM" SYSTEM PLATE L-SHAPE, 3 X 3 HOLE, 100 DEGREE, QTY 00001, CE 0086, 2010-04 *** NON-STERILE PRODUCT ***, LEFT, X-LONG, 0.6 MM TITANIUM, BIOMET MICROFIXATION, 1540 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA, 01-736, LOT 999999, QTY 00001, L-SHAPE, 3 X 3 HOLE, 100 DEGREE, LEFT, X-LONG, 0.6 MM, CE 0086.***" Product Usage - CTS Usage: Bone-plate - internal fixation devices intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system.
FDA Recall
Terminated
·Biomet Microfixation, LLC·Product code JEY·April 26, 2010
Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD
FDA Recall
Terminated
·Implant Direct Sybron Manufacturing, LLC·Product code DZE·May 2, 2017
Carl Zeiss Microimaging Laser-TIRF (Total Internal Reflection Fluorescence) Imaging System is a component used in conjunction with Laser Scanning Microscopes, Non-Medical Devices for Research Use. The Laser-TIRF Imaging-System is a Class 3B laser system. The Laser TIRF Imaging System allows the visualization of substances or molecules being capable of fluorescing (excitable by light) by means of an electromagnetic (evanescent) field produced by total internal reflection.
FDA Recall
Terminated
·Zeiss, Carl Inc·Product code REK·April 28, 2011
Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle Part Number: 08-4000-LB The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KPO·April 10, 2014
Precision Ice One-Patient-Use Control Unit and Wrap System (Model # 4BB02BK). The device is intended to reduce edema and promote healing of soft-tissue injuries and lymphedema through stimulation of the lymphatic system. The device is a therapeutic system which consists of a control unit and fluid circulating pads. The pads are mounted in wraps designed for specific parts of the body such as ankle, knee, elbow, and shoulder. The pads provide cold treatment and pressure which help promote healing. The owner's manual is labeled in part: "PRO TRAINERS' CHOICE COMPANY, INC.***www.precisionice.com***[email protected]***Mailing Address PO Box 27***Kingston, WA 98346 USA***Phone: 360-297-3902***Shipping Address***26129 Calvary Lane NE, Suite 200***Kingston, WA 98346 USA***Fax: 360-297-3903". The sticker which is placed on the back of the control board is labeled in part: "MOD#4BB02BK***SER#100***". The shipping box is labeled in part: "Pro Trainers' Choice' LLC***Model #4BB02BK***Serial #100____***". The knee wrap is labeled in part: "***Pro Trainers' Choice Co. Inc./Precision Ice One Patient Use Knee Wrap***#1BK01051KN***This device is to be used for one patient only; do not re-use!***".
FDA Recall
Terminated
·Pro Trainers' Choice Company·Product code ILO·April 18, 2011
DirectFRAP (Direct Flourescence Recovery After Photobleaching) Imaging System is an extension unit for Axio Observer that is used for microscopic analyses of dynamic processes within living cells. The DirectFRAP module is a component used in conjunction with Laser Scanning Microscopes, Non-Medical Devices for Research Use. The DirectFRAP Imaging System is a Class 3B laser system. The DirectFRAP Imaging System is a laser manipulation slider which allows coupling of laser light simultaneously with the conventional fluorescence illumination into the reflected-light beam path of the microscope system. Depending on the application, the laser light is used for the targeted bleaching of fluorophores for FRAP experiments or for the conversion of fluorophores within the cell.
FDA Recall
Terminated
·Zeiss, Carl Inc·Product code REK·April 28, 2011
S-Series Long Range Headpiece Model Number AB-5301-00 (beige) and AB-5301-10 (brown) ADVANCED BIONICS LLC 12740 San Fernando Rd. Sylmar, CA 91342 USA. The headpiece is used in conjunction with speech processors manufactured by Advanced Bionics.
FDA Recall
Terminated
·Advanced Bionics LLC·Product code MCM·July 24, 2008
S-Series Short Range Headpiece Model Number MMT-5300-00 (beige) and MMT-5300-10 (brown) ADVANCED BIONICS LLC 12740 San Fernando Rd. Sylmar, CA 91342 USA. The headpiece is used in conjunction with speech processors manufactured by Advanced Bionics.
FDA Recall
Terminated
·Advanced Bionics LLC·Product code MCM·July 24, 2008
HLD Systems Model 610 Washer/High Level Disinfector. Maximum weight of the Model 610 when filled with water is approximately 450 pounds. The dimensions of the system are: Width: 26.5" (67 cm); Depth: 33" (83 cm); Height: 46.5" (118 cm) to top of control panel; 64" (162.6 cm)- height clearance with lid open. Product Usage: Usage: This device washes reusable medical devices and disinfects them with high temperature hot water (pasteurization). The devices are washed with a cleaning solution (containing NaClO (sodium hypochlorite), surfactants, and detergents) to aid in the removal of debris and visible stains. Next, the medical devices and rinsed two times with water. The final, disinfection step uses only hot water at 160 F 2 F for 30 minutes.
FDA Recall
Terminated
·Cenorin, LLC·Product code LDS·April 24, 2014