36 results
·
24ms
·
Sources: EU EUDAMED, US FDA
T12S TELEMETRY TRANSMITTER
FDA 510(k)
FDA Class 2
·Cardiovascular
CARDINAL HEALTH
FDA UDI
Cardinal Health 200, LLC·10885380076275·0.8mm Guide Wire 100mm
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702546019·ELVAREX FORTE 3/THIGH HIGH/SLANT, OPEN TOE, E-V...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702247411·Elvarex 2/Thigh High/Slant-Open Toe-Elephantias...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04059993098866·ELVAREX 2/BODY BAND WITHOUT LEG EXTENSION/SLIP...
ZAVATION
FDA UDI
Zavation LLC·00842166186507·8mm X 18mm 0° Trial
VANGUARD REPROCESSED ELECTRIC BIOPSY FORCEPS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACCUWARM EMG HEAT LAMP
FDA 510(k)
FDA Class 2
·Physical Medicine
TORNADO PLATINUM EMBOLIZATION MICROCOIL
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·June 20, 2018
STELO GLUCOSE BIOSENSOR SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code SAF·April 8, 2025
Tornado Embolization Microcoil, RPN GPN MWCE-18S-5/2-TORNADO G08356 MWCE-18S-6/2-TORNADO G08259 MWCE-18S-3/2-TORNADO-01 G47416 MWCE-18S-4/2-TORNADO-01 G47417 MWCE-18S-3/2-TORNADO-081800 G13102 MWCE-18S-3/2-TORNADO G08261 MWCE-18S-4/2-TORNADO-081800 G13103 MWCE-18S-4/2-TORNADO G08357 MWCE-18S-5/2-TORNADO-01 G47418 MWCE-18S-6/2-TORNADO-01 G47419 MWCE-18S-6/2-TORNADO-081800 G13105 MWCE-18S-5/2-TORNADO-081800 G13104 MWCE-18S-2/4-TORNADO-LEF G09945 MWCE-18S-2/5-TORNADO-LEF-081800 G13108 MWCE-18S-4/3-TORNADO G12924 MWCE-18S-2/3-TORNADO-LEF G09944 MWCE-18S-2/3-TORNADO-LEF-081800 G13106 MWCE-18S-2/4-TORNADO-LEF-081800 G13107
FDA Recall
Open, Classified
·Cook Incorporated·Product code KRD·May 5, 2022
Tornado Embolization Microcoil, RPN GPN MWCE-18S-5/2-TORNADO G08356 MWCE-18S-6/2-TORNADO G08259 MWCE-18S-3/2-TORNADO-01 G47416 MWCE-18S-4/2-TORNADO-01 G47417 MWCE-18S-3/2-TORNADO-081800 G13102 MWCE-18S-3/2-TORNADO G08261 MWCE-18S-4/2-TORNADO-081800 G13103 MWCE-18S-4/2-TORNADO G08357 MWCE-18S-5/2-TORNADO-01 G47418 MWCE-18S-6/2-TORNADO-01 G47419 MWCE-18S-6/2-TORNADO-081800 G13105 MWCE-18S-5/2-TORNADO-081800 G13104 MWCE-18S-2/4-TORNADO-LEF G09945 MWCE-18S-2/5-TORNADO-LEF-081800 G13108 MWCE-18S-4/3-TORNADO G12924 MWCE-18S-2/3-TORNADO-LEF G09944 MWCE-18S-2/3-TORNADO-LEF-081800 G13106 MWCE-18S-2/4-TORNADO-LEF-081800 G13107
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·June 15, 2022
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 29, 2013
RANFAC BREAST MARKING/BRACKENING
FDA Adverse Event
Malfunction
·RANFAC. CORP·Product code MIJ·May 3, 2011
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FPO·July 18, 2008
TORNADO PLATINUM EMBOLIZATION MICROCOIL
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·March 2, 2026
TORNADO PLATINUM EMBOLIZATION MICROCOIL
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·November 21, 2016
BD ULTRASAFE PLUS X100L PNG CLEAR
FDA Adverse Event
Malfunction
·BECTON DICKINSON HUNGARY KFT (BD)·Product code MEG·November 22, 2019
Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and other vascular lesions, RPN MWCE-18S-3/2-TORNADO (GPN G08261), RPN MWCE-18S-3/2-TORNADO-081800 (GPN G13102), RPN MWCE-18S-4/2-TORNADO (GPN G08357)
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·May 21, 2025
CANNULA & CATHETER
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code DWF·April 22, 2025