26 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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