26 results · 21ms · Sources: EU EUDAMED, US FDA

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BONASIL A+ IMPRESSION MATERIALS

FDA 510(k)
FDA Class 2 ·Dental

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772814572·GENUMEDI SAND SIZE VI

Endo Carry-On Procedure Kit

FDA UDI
MEDIVATORS INC.·00677964073656·Endo Carry-On Procedure Kit

Carbide rotary dental burs

FDA UDI
PRIMA DENTAL MANUFACTURING LIMITED·05056020747345·

GUTTA PERCHA POINTS

FDA UDI
DiaDent Group International·08806383548793·Gutta Percha Points is used to root canal filin...

MEDIA FOR GAMETE PREPARATION AND EMBRYO CULTURE

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

MODIFICATION TO: LIGHTSPEED PLUS MOBILE CT SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

AGX

FDA UDI
Widex A/S·05706069749083·Audigy AGXWU-FP (Midnight black S-330 ) Telecoi...

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 30, 2025

TARGET DEVICE 300X160MM

FDA Adverse Event
Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·March 2, 2012

HOMECHOICE PRO

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·January 25, 2012

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·July 3, 2024

ACCU-CHEK ® AVIVA PLUS TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·May 9, 2013

HOMECHOICE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·September 19, 2014

LC PCA III INFUSER

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code MEA·April 12, 2011

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·April 14, 2022

INTERGRATED APD SET

FDA Adverse Event
Malfunction ·VANTIVE US HEALTHCARE LLC·Product code FKX·April 4, 2025

ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and coagulation of tissue in open, laparoscopic , and endoscopic surgeries Model/Catalog Number: WA91307C

FDA Enforcement
Class II ·Ongoing·Olympus Corporation of the Americas·July 31, 2024

Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.

FDA Enforcement
Class II ·Ongoing·Olympus Corporation of the Americas·August 27, 2025

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012