33 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Easy On Universal Glaze & Stain
FDA 510(k)
FDA Class 2
·Dental
BD BBL™ Sensi-Disc™ Ampicillin 10 µg
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902312643·BD BBL™ Sensi-Disc™ Ampicillin 10 µg
ELMED
FDA UDI
ELMED INCORPORATED·00842180170742·Prism Cervical Curette, 10", Reverse Angle 3-0,...
Sklar®
FDA UDI
SKLAR CORPORATION·10649111162428·SKLIT SKLCT OP SCIS CRV SS 5.5
KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
PORTA PRESSOVER
FDA 510(k)
FDA Class 2
·Dental
COCHLEAR OSIA OSI300 IMPLANT
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code PFO·March 8, 2026
COCHLEAR OSIA OSI300 IMPLANT
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code PFO·January 15, 2024
COCHLEAR OSIA OSI300 IMPLANT
FDA Adverse Event
Injury
·COCHLEAR LIMITED·Product code PFO·January 15, 2024
BD BBL Sensi Disc Ampicillin - 10 ¿g, Catalog No. 230705 and 231264; 2 ¿g, Catalog No. 231263. Used for semi-quantitative in vitro susceptibility testing.
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·November 17, 2008
X8000 LIGHTSOURCE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·July 25, 2011
SAGITTAL SAW ATTACHMENT FOR PEN DRIVE
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HWE·July 17, 2013
BD BBL Sensi Disc Ampicillin - 10 g, Catalog No. 230705 and 231264; 2 g, Catalog No. 231263. Used for semi-quantitative in vitro susceptibility testing.
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code JTN·January 8, 2024
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·May 22, 2024
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·December 19, 2023
CARTO 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·June 14, 2024
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·June 3, 2024
CARTO 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·November 27, 2023
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·December 26, 2023