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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LAY LOW ENTERPRISES LLC
FDA registration
LAY LOW ENTERPRISES LLC·1 product·🇺🇸 United States
Ducera® Lay
FDA UDI
DeguDent GmbH·EDD153681901410·
Ducera® Lay
FDA UDI
DeguDent GmbH·EDD153681820110·
LAY FLAT RECLINER
FDA Adverse Event
Malfunction
·HILL-ROM·Product code INN·October 17, 2017
LAY LOOP APPLICATOR
FDA Adverse Event
Malfunction
·R. WOLF, GMBH·Product code HET·July 18, 1994
LAY OPTIMA URETERAL STENT
FDA Adverse Event
Malfunction
·PRODUCTOS PARA EL CUIDADO DE LA SALUD·Product code FAD·August 17, 2012
UPRO HRN MSH 10CM U/LAY
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·September 29, 2025
UPRO HRN MSH 10CM U/LAY
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code FTL·August 5, 2025
UPRO HRN MSH 10CM U/LAY
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·June 18, 2025
UPRO HRN MSH 10CM U/LAY
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·June 18, 2025
UPRO HRN MSH 10CM U/LAY
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·June 5, 2025
Winco Nocturnal Elite Care Cliner - with Nylon Casters Lay Flat Clinical Patient Recliner w/ Trendelenburg (Long Term Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities)
FDA Recall
Terminated
·Winco Mfg., LLC·Product code INN·April 2, 2015
Winco Nocturnal Elite Care Cliner - with Nylon Casters Lay Flat Clinical Patient Recliner w/ Trendelenburg (Long Term Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities)
FDA Enforcement
Class II
·Terminated·Winco Mfg., LLC·August 26, 2015
Winco Inverness 24-Hour Treatment Recliner - with Nylon Casters Lay Flat Clinical Patient Recliner w/ Trendelenburg (Long Term Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities)
FDA Recall
Terminated
·Winco Mfg., LLC·Product code INN·April 2, 2015
Winco Inverness 24-Hour Treatment Recliner - with Nylon Casters Lay Flat Clinical Patient Recliner w/ Trendelenburg (Long Term Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities)
FDA Enforcement
Class II
·Terminated·Winco Mfg., LLC·August 26, 2015
NOCTURNAL ELITE CARE CLINER 6980(STD)/6990(X-LG) products are labeled in part: "***NOCTURNAL ELITE CARE CLINER 6980/6990***Winco***ISO 9001-2008 Certified***An infinite position recliner, independent leg rest and lay-flat all in one chair!***With lay-flat positioning and an independent leg rest, Winco's Nocturnal Elite Care Cliner provides optimal comfort for use in nocturnal dialysis, oncology, acute care and other patient care areas.***HEAT MASSAGE (Optional)***KEY FEATURES***Left side swing-arm for modified entry and ease of cleaning***User-adjustable positioning***Attendant controlled Trendelenburg foot release (on left & right side)***Left side fold down table***Right side Pivot Table***Rear push handle**Lay Flat***Hide-away foot rest***Independent leg rest***LiquiCell for added comfort***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 334474***www.wincomfg.com***". The Care Cliner is a multi position recliner with a steel frame used primarily in clinics, hospitals and treatment centers for recovery, dialysis, oncology, examination, infusion. Sticker with serial number is labeled in part: "***Manufactured By***Winco***Ocala, FL 34474***www.wincomfg.com*** Model No. ***Serial No.***" Note: Model 6988 is a version of the 6980 without the footplate. We have a single, but high volume customer, that requested the chair without the footplate. We put the model in the system so as to call out a specific Bill of Materials to leave off the footplate. Since it was a unique request, there is not a piece of literature for it.
FDA Recall
Terminated
·Winco Mfg., LLC·Product code INM·February 6, 2012
Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm. It allows one to take exposures of patients in standing, sitting, or laying position.
FDA Recall
Open, Classified
·SEDECAL SA PELAYA, 9 POL. POL. IND. RIO DE JANEIRO Algete Spain·Product code KPR·December 13, 2023
Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm. It allows one to take exposures of patients in standing, sitting, or laying position.
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·January 31, 2024
Vivoo Protein Test
FDA Enforcement
Class II
·Ongoing·Changchun Wancheng Bio-Electron Co., Ltd.·February 11, 2026
Vivoo pH Test
FDA Enforcement
Class II
·Ongoing·Changchun Wancheng Bio-Electron Co., Ltd.·February 11, 2026