32 results · 24ms · Sources: EU EUDAMED, US FDA

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ECT DIGITAL THERMOMETER

FDA 510(k)
FDA Class 2 ·General Hospital

Bur PM2-70 80K Diamond coarse Ø2.0 sterile

FDA UDI
Bien-Air Surgery SA·17630055514148·

SEMIAL 10°

FDA UDI
SIGNUS Medizintechnik GmbH·04047844000830·The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ impl...

10M - Southwest Gas Corp

FDA UDI
Certified Safety Manufacturing, Inc.·00766588010434·10M - Southwest Gas Corp

OsteoMed

FDA UDI
OSTEOMED LLC·00845694033329·Lone Surgeon Plate, 30 Degree, Mini, 4Hole, Short

BD PLASTIPAK STERILE LUER SLIP 1ML SYRINGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·September 3, 2021

OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)

FDA 510(k)
FDA Class 1 ·Microbiology

KAWASUMI LABORATORY BLOOD DRAWING KIT

FDA 510(k)
FDA Class 2 ·Hematology

SYRINGE 1ML LS SP120

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·September 3, 2021

CAPSURE EPICARDIAL LEAD

FDA Adverse Event
Injury ·MEDTRONIC, INC.·Product code NVN·February 19, 2025

OT VERIO METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 9, 2013

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code MGB·May 24, 2011

CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code LWR·August 4, 2008

PERCLOSE PROGLIDE¿

FDA Adverse Event
Injury ·ABBOTT VASCULAR INC.·Product code MGB·December 5, 2024

4.5 BROAD SCP PLT 26-H STER

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic catheterization and/or electrophysiology studies, for cardiac as well as interventional Radiology.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 9, 2020

Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·June 10, 2015

Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016

Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016

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