11 results · 20ms · Sources: EU EUDAMED, 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