10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
(MULTIPLE LABELS) POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: YELLOW
FDA 510(k)
FDA Class 1
·General Hospital
EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN
FDA 510(k)
FDA Class 2
·Anesthesiology
IMP,TSV,4.1MM,DUAL SEL,HA
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·October 12, 2023
ANGLED ABUTMENT
FDA Adverse Event
Malfunction
·SYBRON IMPLANT SOLUTIONS CORP.·Product code NHA·November 7, 2008
AFFINITY BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code HDD·August 17, 2011
GYNECARE PROLIFT ANTERIOR PELVIC FLOOR REPAIR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTP·July 11, 2013
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·December 19, 2019
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025