26 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities
FDA Recall
Terminated
·Sensus Healthcare, Inc.·Product code JAD·February 10, 2023
Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities
FDA Enforcement
Class II
·Terminated·Sensus Healthcare, Inc.·March 15, 2023
MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.
FDA Recall
Terminated
·Invivo Corporation·Product code MOS·September 14, 2020
MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.
FDA Enforcement
Class III
·Terminated·Invivo Corporation·October 28, 2020
BleaseSirius Anaesthesia System, gas machine. Blease Beech House, Chiltern Court Asheridge Road, Chesham, Bucks HP5 2PX, England Intended for use in the hospital environment and operating room.
FDA Recall
Terminated
·Spacelabs Healthcare, Llc·Product code BSZ·June 24, 2010
Blease Sirius Anaesthesia System is a anaesthesia Gas Machine. The system has the capability to mount two anaesthetic vapourisers on the back bar via a demountable system. The delivery of anaesthetic agent is achieved by the rotation of a control knob which actuates a feature designed "shot bold" mechanism. The purpose of which is to prevent two vapourisers being turned on simultaneously.. The product is labeled in part: "BleaseSirius Anesthesia System...SPACELABS Healthcare...Blease Medical Equipment Limited Beech House, Chiltern Court, Asheridge Road, Chesham, Bucks HP5 2PX, England...Spacelabs Healthcare Company Headquarters 5150 220th Ave. SE, Issaquah, WA 98029 PO Box 7018, Issaquah, WA 98027-7018".
FDA Recall
Terminated
·Spacelabs Healthcare, Llc·Product code BSZ·June 25, 2009
Shower Seat, Non-rotating, Catalog number 727152000
FDA Recall
Terminated
·Nutech Manufacturing Corp·Product code IKX·July 9, 2009
Norco Folding Shower Bench; Features a nonskid surface and handholds for added security. holes allow excess water to drain away easily. Sturdy legs have non-skid rubber feet. Supports up to 200 lbs. North Coast Medical Inc. 8100 Camino Arroyo Gilroy, CA 95020 Comfort and safety in shower
FDA Recall
Terminated
·North Coast Medical Inc 8100 Camino Arroyo·Product code IKX·March 20, 2012
Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Latex Free Sterile EO Rx, 1/4" X 4 ", 6 mm X100 mm, (2 Cards/pouch, 1,000 Pouches/box); Distributed in Europe: " Product Number: 39-0058: Medicare Reinforced Wound Closure Strips 1/4" X 4 ", Sterile, Box 1000 pouches 5 strips /pouch, Pouch , 5 strips 6 mm X100 mm Sterile EO Product Number: 40-2893: Wound Closure Strips , Sterile (1,000pouches/box) Rx; Pouch Label: Wound Closure Strips 6 mm X100 mm, 1/4" X 4 ", Rx Product Usage: intended for skin closure and closure support for sutures and staples
FDA Recall
Terminated
·Aspen Surgical Products, Inc.·Product code FPX·July 18, 2013
ReTurn belt, wipeable, sizes Small through Extra Large, Plastic pouch, 1 item per pouch. Patient transfer aid.
FDA Recall
Terminated
·Handicare USA, Inc.·Product code IKX·March 26, 2015
Bath Safe Adjustable Shower Seat, With Arms and Back, Catalog numbers 727142120, 727142121, 727142124, and MDS89755R
FDA Recall
Terminated
·Nutech Manufacturing Corp·Product code IKX·July 9, 2009
Transfer/Gait Belt, Plastic, Wipeable, packaged in plastic bag, 36 plastic bags per box.
FDA Recall
Terminated
·Medline Industries Inc·Product code IKX·August 10, 2017
Bath Safe Adjustable Transfer Bench, Catalog numbers 727142500, 727142501, and MDS86960R
FDA Recall
Terminated
·Nutech Manufacturing Corp·Product code IKX·July 9, 2009
Zimmer Patient Helper Reinforce Overhead Bar for Hill-Rom Versa Care beds; Zimmer Inc., Warsaw, The product is a L shaped bar that is used with hospital beds set up for traction. The bar allows mounting of a trapeze to help the patient pull themselves up when in the hospital bed. IN; Prod. Nos. 00-2700-965-02 and 00-0965-001-00.
FDA Recall
Terminated
·Zimmer Inc.·Product code IKX·July 7, 2008
ReTurn 7500/7500 Aid, transfer
FDA Recall
Terminated
·Handicare USA, Inc.·Product code IKX·April 15, 2014
Bath Safe Adjustable Shower Seat, With Arms, Model numbers 727142020, 727142021, and MDS89750R
FDA Recall
Terminated
·Nutech Manufacturing Corp·Product code IKX·July 9, 2009
ROTH MOBELI Grab Handles used with EOS System: MOBELI Stabi Vario Grab Handle, ROTH Catalogue Number 14002 96 S, EOS Imaging Catalogue Number 9000111773; and MOBELI Dual Grip Grab Handle, ROTH Catalogue Number 14002 25 S, EOS Imaging Catalogue Number 9000111774.
FDA Recall
Terminated
·Product code IKX·May 30, 2017
Regenesis Biomedical PROVANT Wound Therapy System, Model 4201 - The Provant Wound Therapy System is a solid-state, fixed-power output radio frequency generator and transmitter designed to operate at the FCC authorized medical device frequency of 27.12 MHz. Provant transmits a fixed dose of non-ionizing, non-thermal RF energy via an applicator pad that is placed adjacent to the patient's dressed wound. The Provant Wound Therapy System is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue.
FDA Recall
Terminated
·Regenesis Biomedical Inc·Product code ILX·September 29, 2008
Alimed Gait Belt (Transfer Aid) Antimicrobial Plastic Buckle, 70" Model: 72109
FDA Recall
Terminated
·AliMed Corporation·Product code IKX·October 30, 2008
Bath Safe Adjustable Shower Seat, Without Back and Arms, Catalog number 727142001
FDA Recall
Terminated
·Nutech Manufacturing Corp·Product code IKX·July 9, 2009