13 results
·
30ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Disposable Polypectomy Snare
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ND LOWSPEED AIRMOTOR,ND HIGHSPEED AIRTURBINE HANDPIECE
FDA 510(k)
FDA Class 1
·Dental
SUMMIT OCCIPITO-CERVICO- THORACIC (OCT) SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
JDICON PLUS
FDA Adverse Event
Injury
·J DENTAL CARE SRL·Product code DZE·February 4, 2026
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·August 12, 2022
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·April 10, 2019
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 23, 2024
VUEPOINT OCT SYSTEM
FDA Adverse Event
Malfunction
·NUVASIVE, INC.·Product code KWP·October 2, 2014
ASR ACETABULAR CUPS 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 12, 2011
VITALITY 2
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 9, 2013
INTELLIS
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·September 14, 2024
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