10 results · 24ms · Sources: EU EUDAMED, 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