10 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EvoEndo Single-Use Endoscopy System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ABSORBENT PAPER POINTS
FDA UDI
DiaDent Group International·08806383515306·"An absorbent paper points is an endodontic pap...
ACS 180 HOMOCYSTEINE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NNC GOLD ABUTMENT FOR BRIDGES
FDA 510(k)
FDA Class 2
·Dental
RAD-G
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code DQA·October 17, 2024
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code FPA·August 16, 2011
PLUM XLD 110V L. A.
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·October 24, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 9, 2013
MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·July 16, 2025
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refurb) - 10440017 S3000 10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017