27 results
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31ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BERT®
FDA UDI
VERNACARE INTERNATIONAL CHORLEY & BOLTON LIMITED·05019829239992·BERT Endo Tissue Retrieval Bag
nubert
FDA UDI
VERNACARE INTERNATIONAL CHORLEY & BOLTON LIMITED·05019829239947·Impervious, assymetric bag for the endoscopic r...
albert
FDA UDI
VERNACARE INTERNATIONAL CHORLEY & BOLTON LIMITED·05019829239985·Impervious bag for the endoscopic retrieval of ...
nubert
FDA UDI
VERNACARE INTERNATIONAL CHORLEY & BOLTON LIMITED·05019829239961·Impervious, assymetric bag for the endoscopic r...
nubert
FDA UDI
VERNACARE INTERNATIONAL CHORLEY & BOLTON LIMITED·05019829239923·Impervious, assymetric bag for the endoscopic r...
BERT®
FDA UDI
VERNACARE INTERNATIONAL CHORLEY & BOLTON LIMITED·05019829239954·NUBERT Plus New Bag for Endoscopic Retrieval of...
BERT®
FDA UDI
VERNACARE INTERNATIONAL CHORLEY & BOLTON LIMITED·05019829239930·NUBERT DS New Bag for Endoscopic Retrieval of T...
hubert
FDA UDI
VERNACARE INTERNATIONAL CHORLEY & BOLTON LIMITED·05019829239978·Impervious bag for the endoscopic retrieval of ...
VERSACARE MRS W/O X-RAY
FDA Adverse Event
Malfunction
·HILL-ROM MEXICO·Product code IOQ·April 28, 2023
Hillrom Hospital Bed Accessory, WatchCare Incontinence Management System for VersaCare Bed Rev. K, Product Code/Part Number P00697902
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·November 9, 2022
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for VersaCare Bed Rev. A-J, Product Code/Part Number P00697901
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·November 9, 2022
VersaCare P500 Microclimate Management Surface Upgrade Kits P3218A and P3219A Hill-rom Batesville, IN. The TotalCare Bed Systems is intended to provide a patient support ideally suited to be used in health care environments. The TotalCare Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution
FDA Recall
Terminated
·Hill-Rom, Inc.
125 E Pearl St
1069 State Route 46 East
Batesville IN 47006·Product code FNL·February 21, 2011
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for VersaCare Bed Rev. A-J, Product Code/Part Number P00697901
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code KPN·September 30, 2022
Hillrom Hospital Bed Accessory, WatchCare Incontinence Management System for VersaCare Bed Rev. K, Product Code/Part Number P00697902
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code KPN·September 30, 2022
VERSACARE FRAME
FDA Adverse Event
Malfunction
·HILL-ROM BATESVILLE·Product code FNL·May 6, 2016
TotalCare beds P1900 with P500 Microclimate Management Surface Hill Rom, Batesville, IN. The TotalCare Bed Systems is intended to provide a patient support ideally suited to be used in health care environments. The TotalCare Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution
FDA Recall
Terminated
·Hill-Rom, Inc.
125 E Pearl St
1069 State Route 46 East
Batesville IN 47006·Product code FNL·February 21, 2011
P3200 VERSACARE BED
FDA Adverse Event
Malfunction
·HILL-ROM BATESVILLE·Product code FNL·October 4, 2022
VERSACARE FRAME
FDA Adverse Event
Malfunction
·HILL-ROM BATESVILLE·Product code FNL·January 13, 2022
PROGRESSA BED SYSTEM
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FNL·September 3, 2025
VERSACARE MED SURG BED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FNL·April 10, 2026