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