30 results · 20ms · Sources: EU EUDAMED, US FDA

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RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER

FDA 510(k)
FDA Class 2 ·Radiology

NA

FDA UDI
Stryker Leibinger GmbH & Co. KG·07613327122923·MESH CLIPPER

OsteoMed

FDA UDI
OSTEOMED LLC·00845694031240·2.0mm, 12 Hole Double Row Straight Rigid Plate

NeoGuard™ Transducer Cover

FDA UDI
CIVCO MEDICAL INSTRUMENTS CO., INC.·10841436101803·Sterile (2.6 x 30cm) cover

TAPER-LOCK DENTAL IMPLANT SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

DISPOSABLE REFLECTIVE MARKER SPHERES

FDA 510(k)
FDA Class 2 ·Neurology

SCR REPLACEMENT SW-V GOLD COPING

FDA Adverse Event
Malfunction ·ZIMMER DENTAL·Product code DZE·October 19, 2017

SCR FIXATION REPLACE SPEC TRA-CONE & TAPERED ABU

FDA Adverse Event
Malfunction ·ZIMMER DENTAL·Product code DZE·December 8, 2020

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 30, 2024

1010-38 A.I.M. FEMORAL NAIL

FDA Adverse Event
Injury ·DEPUY ACE MEDICAL CO.·Product code HSB·May 6, 1998

OT VERIO IQ METER

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

NATURALYTE

FDA Adverse Event
Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 17, 2014

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 24, 2011

BD PLASTIPAK LUER-LOK SYRINGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·July 29, 2021

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

INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

FDA Enforcement
Class II ·Terminated·Synthes, Inc.·July 22, 2015