22 results · 24ms · Sources: EU EUDAMED, US FDA

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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