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

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SILJETR SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

Posted Stainless Steel Archwire

FDA UDI
Ortho Arch Company Inc·D90911064211·.016 X.022 POSTED SS RIGHT FORM WIRES 42MM (10)

PLEURX PLEURAL CATHETER AND DRAINAGE KITS

FDA 510(k)
FDA Class 2 ·Cardiovascular

MANUKATEX

FDA 510(k)
FDA Unclassified ·Unknown

AQUILEX FLUID CONTROL SYSTEM

FDA Adverse Event
Malfunction ·W.O.M. WORLD OF MEDICINE GMBH·Product code HIG·March 12, 2020

BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code FPA·April 15, 2024

PINNACLE MTL INS NEUT36IDX50OD

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·May 14, 2013

FLUENCY PLUS ENDOVASCULAR STENT GRAFT

FDA Adverse Event
Malfunction ·ANGIOMED GMBH & CO. MEDIZINTECHNIK KG·Product code PFV·September 16, 2014

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·June 1, 2011

Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.

FDA Enforcement
Class II ·Terminated·Pentax of America Inc·August 30, 2017

Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024