12 results
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27ms
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Sources: EU EUDAMED, US FDA
ACCU-CORE DISPOSABLE BIOPSY NEEDLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CODMAN®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780515135·CODMAN® Surgical Strips 3 1/2" x 6" (89mm x 152mm)
CODMAN
FDA UDI
Cerenovus, Inc.·20886704036651·CODMAN Surgical Strips 3 1/2 Inches x 6 Inches ...
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209133345·
EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ATRILAZE LASER ABLATION SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 8, 2014
REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 9
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code MEH·October 17, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·July 9, 2007
SURG STRP 3-1/2X6 Model/Catalog Number:801457. 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 3-1/2X6 Model/Catalog Number:801457. 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
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