13 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CERASMART
FDA 510(k)
FDA Class 2
·Dental
Oticon
FDA UDI
Oticon A/S·05707131264725·RIA PRO, KIT 312 WL DIR 90 L V BE
Black Silicone
FDA UDI
COOK INCORPORATED·00827002151284·Black Silicone Filiform Double Pigtail Ureteral...
Cook
FDA UDI
COOK INCORPORATED·00827002464353·Black Silicone Filiform Double Pigtail Ureteral...
OPTICROSS? HD
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·July 1, 2025
VITRO FIL LC
FDA 510(k)
FDA Class 2
·Dental
HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS
FDA 510(k)
FDA Class 2
·Immunology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 29, 2025
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 1, 2014
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 29, 2013
EYE SURGERY STRETCHER
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·May 12, 2011
FILIFORM DOUBLE PIGTAIL URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·May 24, 2017
Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 283910000 (GTIN: (01)10705034209630) The CONFIDENCE SPINAL CEMENT SYSTEM¿ 11cc Kit is intended for percutaneous delivery of CONFIDENCE 11cc Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma).
FDA Enforcement
Class II
·Terminated·DePuy Spine, Inc.·April 11, 2018