32 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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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