14 results
·
39ms
·
Sources: EU EUDAMED, US FDA
S-Line
FDA 510(k)
FDA Class 2
·General Hospital
POWER FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
FDA 510(k)
FDA Class 1
·General Hospital
PASS SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 6, 2025
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
MULTI-LINK RX VISION CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·October 21, 2008
ASR ACETABULAR CUPS 48
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 12, 2011
ATW MARKER GUIDEWIRE
FDA Adverse Event
Injury
·CORDIS CORPORATION·Product code DQX·July 9, 2013
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
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021