9 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Senhance Surgical System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Carevix Suction Cervical Stabilizer
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 (500 & 5000 TEST KITS)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
IMPLANT, ENDOSSEOUS, ROOT-FORM
FDA Adverse Event
Injury
·J DENTAL CARE SRL·Product code DZE·August 28, 2025
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 22, 2025
NAVISTAR RMT THERMOCOOL DIAGNOSTIC/ABLATION STREERABLE TIP CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC. (IRWINDALE)·Product code OAD·November 13, 2008
BHR
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS, LTD.·Product code NXT·September 5, 2011
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·July 18, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025