11 results
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24ms
·
Sources: EU EUDAMED, US FDA
Nobel Biocare S Series Implants
FDA 510(k)
FDA Class 2
·Dental
CerfiSoft Foam Cytology Collection Swab
FDA UDI
Puritan Medical Products·00609576325021·CerviSoft 7” Sterile Foam Cytology Collection S...
FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Skypro, SP01 Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 9, 2025
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·November 14, 2014
WMT SLT TAPER COBALT-CHROME FEMORAL HEAD
FDA Adverse Event
Malfunction
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LZO·September 16, 2011
QUATTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 25, 2013
ONE TOUCH ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·March 24, 2010
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·October 1, 2010
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024