71 results
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33ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PEARL INC.
FDA registration
PEARL INC.·2 products·🇺🇸 United States
PEARL DIAGNOSTICS, INC.
FDA registration
PEARL DIAGNOSTICS, INC.·2 products·🇺🇸 United States
Second Opinion 3D
FDA UDI
Pearl Inc.·00860003567944·
Second Opinion
FDA UDI
Pearl Inc.·00860003567920·
Second Opinion
FDA UDI
Pearl Inc.·00198715016079·
XVWEB
FDA Adverse Event
Injury
·PLANET DDS·Product code LLZ·March 13, 2025
SECOND OPINION
FDA Adverse Event
Injury
·PEARL INC.·Product code MYN·March 13, 2025
PEARL SECOND OPINION
FDA Adverse Event
Malfunction
·PEARL INC.·Product code MYN·April 15, 2024
POLARUS PLUS HUMERAL ROD
FDA Adverse Event
Other
·ACUMED/POLARUS, SEA PEARL, INC.·Product code HTW·September 17, 2004
POLARIS PLUS HUMERAL ROD
FDA Adverse Event
Other
·ACUMED/POLARUS/SEA PEARL, INC·Product code HTW·October 25, 2004
THERA PEARL 3-in-1 BREAST THERAPY, 2 hot and cold packs in plastic box. The Thera Pearl 3-in-1 Breast Therapy is a reusable therapeutic hot and cold pack for use with pain, swelling, engorgement, plugged ducts or mastitis associated with breast feeding or to help encourage let-down while using a breast pump.
FDA Recall
Terminated
·Lansinoh Laboratories Inc·Product code IME·August 14, 2012
Liko Sabina Comfort Lift, Liko, Sweeden. The Sabina and Capella sit-to-stand lifts are especially designed for people who have difficulty in standing on their own. The lifts are intended to be used with patients who are able to bear weight on their legs and actively participate in the standing exercise.
FDA Recall
Terminated
·Hill-Rom, Inc.
125 E Pearl St
1069 State Route 46 East
Batesville IN 47006·Product code FSA·January 27, 2011
Liko Sabina 200 Lift, Liko, Sweeden. The Sabina and Capella sit-to-stand lifts are especially designed for people who have difficulty in standing on their own. The lifts are intended to be used with patients who are able to bear weight on their legs and actively participate in the standing exercise.
FDA Recall
Terminated
·Hill-Rom, Inc.
125 E Pearl St
1069 State Route 46 East
Batesville IN 47006·Product code FSA·January 27, 2011
Liko Sabina EM Lift, Liko, Sweeden. The Sabina and Capella sit-to-stand lifts are especially designed for people who have difficulty in standing on their own. The lifts are intended to be used with patients who are able to bear weight on their legs and actively participate in the standing exercise.
FDA Recall
Terminated
·Hill-Rom, Inc.
125 E Pearl St
1069 State Route 46 East
Batesville IN 47006·Product code FSA·January 27, 2011
Hill-Rom 1000 bed model P1160.
FDA Recall
Terminated
·Hill-Rom, Inc.
125 E Pearl St
1069 State Route 46 East
Batesville IN 47006·Product code FNL·April 13, 2009
Liko Sabina EE Lift, Liko, Sweeden. The Sabina and Capella sit-to-stand lifts are especially designed for people who have difficulty in standing on their own. The lifts are intended to be used with patients who are able to bear weight on their legs and actively participate in the standing exercise.
FDA Recall
Terminated
·Hill-Rom, Inc.
125 E Pearl St
1069 State Route 46 East
Batesville IN 47006·Product code FSA·January 27, 2011
Hill-Rom Basic Care Bed, P1440A (Electric), Hill Rom Batesville, IN. Intended for low to moderate acuity patients in the low end acute care area of the hospital.
FDA Recall
Terminated
·Hill-Rom, Inc.
125 E Pearl St
1069 State Route 46 East
Batesville IN 47006·Product code FNL·September 16, 2009
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
Hill-Rom TotalCare Bed, P1900, Hill-Rom, Batesville, IN. TheTotalCare Bed System is intended to porvide 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).
FDA Recall
Terminated
·Hill-Rom, Inc.
125 E Pearl St
1069 State Route 46 East
Batesville IN 47006·Product code FNL·February 3, 2011
Hill-Rom 405 Bed, P1440B, (electric) Hill Rom Batesville, IN. Intended for low to moderate acuity patients in the low end acute care area of the hospital.
FDA Recall
Terminated
·Hill-Rom, Inc.
125 E Pearl St
1069 State Route 46 East
Batesville IN 47006·Product code FNL·September 16, 2009