13 results
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18ms
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Sources: EU EUDAMED, US FDA
FINGER, HAND & WRIST EXERCISER
FDA 510(k)
FDA Class 1
·Physical Medicine
CODMAN®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780515098·CODMAN® Surgical Strips 1" x 6" (25mm x 152mm)
CODMAN
FDA UDI
Cerenovus, Inc.·20886704036613·CODMAN Surgical Strips 1 Inch x 6 Inches (25mm ...
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209134014·
VITALA NATURAL RESORBABLE COLLAGEN MEMBRANE
FDA 510(k)
FDA Class 2
·Dental
BIOGRAPH HD FAMILY
FDA 510(k)
FDA Class 2
·Radiology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 8, 2014
2520274-2012-02449
FDA Adverse Event
Injury
·Product code UNK·October 23, 2012
PRECISION PCX
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·July 9, 2007
SURG STRP 1X6-200 Model/Catalog Number: 801453. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
FDA Enforcement
Class II
·Ongoing·Integra LifeSciences Corp.·November 6, 2024
SURG STRP 1X6-200 Model/Catalog Number: 801453. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
FDA Recall
Open, Classified
·Integra LifeSciences Corp.·Product code HBA·September 20, 2024
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012