13 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PILLAR PALATAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
Premier
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·D6911040417·CUBE PESSARY W/O DRAINAGE HOLES #7
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319700112·Scalpel Handle #3 Round Handle with Ruler Gradu...
Myo/Wire II
FDA UDI
A & E MEDICAL CORPORATION·10841291102250·SS Suture, 1 per sleeve
CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304
FDA 510(k)
FDA Class 2
·Radiology
CONVERTORS EQUIPMENT DRAPES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AXXENT FLEXISHIELD MINI (K090417)
FDA Adverse Event
Injury
·XOFT, INC.·Product code IXI·January 7, 2011
DONJOY ARMOR FP, ACL,STD,RT,M
FDA Adverse Event
Injury
·DJO, LLC·Product code ITQ·June 26, 2019
Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
FDA Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·August 20, 2025
CARDIAC CATH LAB KIT
FDA Adverse Event
Malfunction
·ICU MEDICAL, INC.·Product code DQO·March 12, 2013
60" HIGH FLOW RATE EXTENSION SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code FPA·April 5, 2011
SPEEDBAND SUPERVIEW SUPER 7 LIGATOR
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code MND·May 7, 2008
Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
FDA Recall
Open, Classified
·Merit Medical Systems, Inc.·Product code OJA·June 5, 2025