16 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
HD Mediastinoscope
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
VIDEO MEDIASTINOSCOPE
FDA Adverse Event
Injury
·KARL STORZ SE & CO. KG·Product code EWY·December 21, 2021
VIDEO MEDIASTINOSCOPE
FDA Adverse Event
Injury
·KARL STORZ SE & CO. KG·Product code EWY·December 21, 2021
VIDEO MEDIASTINOSCOPE
FDA Adverse Event
Injury
·KARL STORZ SE & CO. KG·Product code EWY·December 21, 2021
VIDEO MEDIASTINOSCOPE
FDA Adverse Event
Injury
·KARL STORZ SE & CO. KG·Product code EWY·December 21, 2021
UNIMARK HCG COMBO PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE COLOR
FDA 510(k)
FDA Class 1
·General Hospital
QUADRA GENERAL BROACH HANDLE
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LXH·May 9, 2018
TEC 6 NAD VARIANT
FDA Adverse Event
Malfunction
·DATEX-OHMEDA·Product code CAD·October 21, 2008
ASR ACETABULAR CUPS 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 12, 2011
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 9, 2013
Roche CoaguChek XS System, CoaguChek XS PST Kit, Roche Diagnostics, Indianapolis, IN; Catalog/Model Number 04837738001. CoaguChek XS System and CoaguChek XS Plus System are point of care monitoring devices for people taking oral anticoagulation medication.
FDA Recall
Terminated
·Roche Diagnostics Operations, inc.·Product code GJS·July 22, 2009
Roche CoaguChek XS System, CoaguChek XS Professional Care Kit, Roche Diagnostics, Indianapolis, IN; Catalog/Model Number 04837975001. CoaguChek XS System and CoaguChek XS Plus System are point of care monitoring devices for people taking oral anticoagulation medication.
FDA Recall
Terminated
·Roche Diagnostics Operations, inc.·Product code GJS·July 22, 2009
Roche CoaguChek XS System, CoaguChek XS Plus Care Kit, Roche Diagnostics, Indianapolis, IN; Model Number 05021537001. CoaguChek XS System and CoaguChek XS Plus System are point of care monitoring devices for people taking oral anticoagulation medication.
FDA Recall
Terminated
·Roche Diagnostics Operations, inc.·Product code GJS·July 22, 2009
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refurb) - 10440017 S3000 10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023