22 results
·
24ms
·
Sources: EU EUDAMED, US FDA
HM-LAMP II
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OPERATING SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896046726·OPERATING SCISSORS CURVED SHARP BLADES
COOLEY MULTI PURPOSE CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896002067·COOLEY MULTI PURPOSE CLAMP ANGLED
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA UDI
FX SOLUTIONS·03701037308158·HUMERAL STEM REAMER S11-14
COOLEY MULTI PURPOSE CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·B09921002340·COOLEY MULTI PURPOSE CLAMP ANGLED
LEONE SPA
FDA UDI
LEONE SPA·08033707092896·BKT 34 F1000 SELF-LIGATING 22 T-17 BH
CORNERSTONE PSR CERVICAL INTERBODY FUSION DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
SONALIS
FDA 510(k)
FDA Class 2
·Radiology
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·October 22, 2021
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·November 18, 2020
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·January 15, 2020
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 18, 2021
WA4000 20# N20 CONN
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code GEH·May 7, 2023
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 28, 2025
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·May 8, 2013
G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·September 18, 2014
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·May 16, 2011
SMR GLENOSPHERE DIA.36MM
FDA Adverse Event
Malfunction
·LIMACORPORATE S.P.A.·Product code PHX·June 16, 2022
Tracheostomy Tubes, Jackson Improved Stainless Steel with Adapter, item number 8100465 size 1, item number 8100373 size 3, item number 1034924 size 4, item number 1034925 size5, item number 1034926 size 6, item number 1034927 size 7, item number 1034928 size 8, item number 8100468 size 9, and item number 8100234 size 10.
FDA Recall
Terminated
·Premier Dental Products Co·Product code JOH·August 5, 2004
MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19
FDA Enforcement
Class II
·Ongoing·Micro-X Ltd.·October 5, 2022