963 results
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21ms
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Sources: EU EUDAMED, US FDA
Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip. Model Number ERGF01330. The Edwards Surgical Instruments are designed to perform specialized functions in specific cardiac surgical or endoscopic procedures.
FDA Recall
Terminated
·Edwards Lifesciences, LLC·Product code HTD·November 20, 2013
outer box: Ref 906768, CurvTek Eye Needle 22 MM X-large Stainless Steel, Single Use Gamma Sterilized, Rx inner incorrect label: CurvTek 7 MM Medium, Single Pack Quantity -3, REF 906760 To pass the CurvTek needle, place the jaws of the instrument utilized to grasp the needle on the sides of the needle and orient and needle parallel to the long axis of the instrument. Position the needle to follow the path of the tunnel created by the cartridges. This aligns the needle with the radius of the transosseous tunnel. Advance the needle while rotating the instrument away from the entry point. Gently feed the needle through the length of the tunnel.
FDA Recall
Terminated
·Biomet, Inc.·Product code HTD·November 26, 2013
SYNTHES PLATE HOLDING FORCEPS, Catalog # SD347.900
FDA Recall
Terminated
·Synthes USA (HQ), Inc.·Product code HTD·September 3, 2009
Holding Forceps for Trident Acetabular System; non Sterile; Catalog number 2105-0000; Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ 07430; Authorized representative in Europe: Stryker France, Cedex. France The Holding Forceps for Acetabular trial cups help facilitate the insertion / correction of the Acetabular trial inserts.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code HTD·January 24, 2007
Pilling Center-Action Forceps with Insulated Shafts- Elongated Cup Biopsy Jaws, Catalog Number: 505039, Non Sterile, Rx Only, (30 CM), Manufactured for: Teleflex Medical, Research Triangle Park, NC 27709 USA
FDA Recall
Terminated
·Telefelx Medical·Product code HTD·October 31, 2007
Pilling Center-Action Forceps with Insulated Shafts- Serrated Grasping Jaws, Catalog Number: 505015, Non Sterile, Rx Only, (ALLIG GRASPING FCPS 30 CM INSUL), Manufactured for : Teleflex Medical, Research Triangle Park, NC 27709 USA
FDA Recall
Terminated
·Telefelx Medical·Product code HTD·October 31, 2007
Pilling Center-Action Forceps with Insulated Shafts- Circular Cup Biopsy Jaws, Catalog Number: 505045, Non Sterile, Rx Only, (30 CM), Manufactured for: Teleflex Medical, Research Triangle Park, NC 27709 USA
FDA Recall
Terminated
·Telefelx Medical·Product code HTD·October 31, 2007
SYNTHES 2.0MM SCREW MANIPULATION FORCEPS, Catalog #SD397.300. Synthes Titanium Matrix Mandible Sagittal Plates and Instruments are intended for general use in orthognathic surgery.
FDA Recall
Terminated
·Synthes USA (HQ), Inc.·Product code HTD·September 3, 2009
OLA Buffer For Laboratory Use; Contents: 1 tube with buffered solution containing MgCl2 (80 M) and KCL (300 M. 10.0ml.) PN: 50003300; Store at d - 15C. Product Usage: General Purpose Reagent for laboratory use.
FDA Recall
Terminated
·Celera Corporation·Product code LDT·July 12, 2013
There is a complaint regarding internal check cable guide mechanism failure for the Nucletron Flexitron brachytherapy afterloader system. Due to an obstruction during the check cable out drive, the internal guiding tube became displaced and the check cable became damaged. This issue could cause treatment interruption or in a very unlikely scenario, incorrect source positioning and radiation treatment errors.
FDA Recall
Terminated
·Nucletron BV Waardgelder 1 POBox 930 Veenendaal Netherlands·Product code JAQ·November 18, 2019
Elastic Traction Device, 11mm Lower. UPN: ER56041 Reference Number: ETD-D-26-235-C-N - Product Usage: indicated for use in flexible Endoscopy to provide retraction to assist in tissue resection, exposure, and removal of tissue within the gastrointestinal tract.
FDA Recall
Terminated
·Micro-Tech Usa·Product code MND·October 5, 2020
ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patient position, and to provide a beam hold signal in case of a deviations in order to treat lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
FDA Recall
Terminated
·Brainlab AG Olof-palme-str. 9 Munich Germany·Product code IYE·May 14, 2021
Skytron Infinity Series surgical light, 4 bulbs in 1 - 22' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF54, IF54EL, IF54LH and IF54S.
FDA Recall
Terminated
·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007
Skytron Infinity series (also called Astro series) minor surgery light, 3 bulbs in 1 - 19' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Japan; Models IN19, IN19EL, IN19LH and IN19S.
FDA Recall
Terminated
·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229035A Model:VST60DF
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code FTD·May 28, 2019
Skytron Infinity Series surgical light with triple lightheads, 4 bulbs in each of 3 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF545454 and IF545454EL.
FDA Recall
Terminated
·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007
Harmony Lux Advantage LA Surgical Lighting and Visualization System, also known as the Harmony LA 700, B129382393. Designed to provide visible immunization of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff. Intended to be used in a surgical setting.
FDA Recall
Terminated
·Steris Corporation·Product code FTD·February 23, 2010
PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube
FDA Recall
Terminated
·Gyrus Acmi, Incorporated·Product code ETD·October 17, 2012
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229001A Model: VST60DF AIM
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code FTD·May 28, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568812910 Model: VLT400SF STP
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code FTD·May 28, 2019