11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Oticon
FDA UDI
Sbo Hearing A/S·05714464057535·OTICON PLAY PX 1 MINIRITE T C044
OSTEOMED LOW PROFILE ORBITAL FLOOR PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Dental
TANITA SCALE PLUS BODY FAT MONITOR WITH BODY WATER PERCENTAGE
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 29, 2025
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·October 27, 2023
WAVELIGHT EX500 EXCIMER LASER
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code LZS·November 5, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE-SINGAPORE·Product code FRN·September 9, 2011
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·July 22, 2013
NEEDLE SPINAL S/SU 25GA 3-1/2IN QUINCKE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code BSP·August 5, 2025
PKG, PKG, PERITONEAL SCISSORS, P/N 0250080262. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014