11 results
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18ms
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Sources: EU EUDAMED, US FDA
VARI-SET
FDA 510(k)
FDA Class 2
·General Hospital
CVS Health
FDA UDI
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED·00050428310229·Sterile Surgical Pads, 5 IN x 9 IN (12.7 cm x 2...
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690197638·AK3 PS-C Insert Trial Size 1, 11mm
ANTACHE ANTI-HEADACHE DEVICE
FDA 510(k)
FDA Class 2
·Neurology
DERATA MEDI-JECTOR III
FDA 510(k)
FDA Class 2
·General Hospital
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Injury
·COOK, INC.·Product code DTZ·June 20, 2014
HEARTSTART MRX -EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·November 4, 2010
ALIGN TO URETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·BARD SHANNON LTD.·Product code FTL·December 27, 2012
(1) CVS Health Sterile Surgical Pads, Cushion Comfort, packaged 12 pads 5 in. x 9 in. per box, ASO Item No. 781083, SKU 894111 (2) CVS Health 30 Piece Wound Care Kit, For Large Size Wounds, ASO Item No. 781240, SKU 998842; and (3) equate First Aid Kit, 120 Items, containing 1 generic Sterile Trauma Pad 5 in. x 9 in., ASO Item No. 192636, SKU #30174479.
FDA Recall
Open, Classified
·ASO LLC·Product code FQM·June 22, 2022
(1) CVS Health Sterile Surgical Pads, Cushion Comfort, packaged 12 pads 5 in. x 9 in. per box, ASO Item No. 781083, SKU 894111 (2) CVS Health 30 Piece Wound Care Kit, For Large Size Wounds, ASO Item No. 781240, SKU 998842; and (3) equate First Aid Kit, 120 Items, containing 1 generic Sterile Trauma Pad 5 in. x 9 in., ASO Item No. 192636, SKU #30174479.
FDA Enforcement
Class II
·Ongoing·ASO LLC·August 24, 2022
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020