35 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Non-contact Infrared Thermometer
FDA 510(k)
FDA Class 2
·General Hospital
THREADED CR-Ti
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902170645·7MM X 14MM THREADED CR-TI
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780379621·Integra® Jarit® Probe With Eye, 10"
BALANCE MICROPLASTY HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304446489·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694034135·Profile Zero 9mm Square Plate
OsteoMed
FDA UDI
OSTEOMED LLC·00845694065740·Profile 0 9mm Square Plate Sterile Qty 5
DANYANG HUAYI K2 AND K7 WHEELCHAIRS
FDA 510(k)
FDA Class 1
·Physical Medicine
NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8F
FDA 510(k)
FDA Class 2
·Ophthalmic
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·November 18, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·May 24, 2023
Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP 18392-03 14HDFF CATARACT SWAGEL WOOTTON EYE INSTITUTE 18527-03 14JM57 DOSS CATARACT ALLIANCE EYE SURG PARTNERS 11802-07 14KFAF GANS BASIC PACK NOVAMED EYE SURG CTR 11802-07 14LTRW GANS BASIC PACK NOVAMED EYE SURG CTR 11802-07 14LLME GANS BASIC PACK NOVAMED EYE SURG CTR 14429-07 14HPW3 DR SIEMINSKI CATARACT W NY CTR/AMB SVCS
FDA Enforcement
Class II
·Ongoing·Alcon Research, LLC·July 20, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·August 4, 2025
Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP 18392-03 14HDFF CATARACT SWAGEL WOOTTON EYE INSTITUTE 18527-03 14JM57 DOSS CATARACT ALLIANCE EYE SURG PARTNERS 11802-07 14KFAF GANS BASIC PACK NOVAMED EYE SURG CTR 11802-07 14LTRW GANS BASIC PACK NOVAMED EYE SURG CTR 11802-07 14LLME GANS BASIC PACK NOVAMED EYE SURG CTR 14429-07 14HPW3 DR SIEMINSKI CATARACT W NY CTR/AMB SVCS
FDA Recall
Open, Classified
·Alcon Research, LLC·Product code LRO·June 9, 2022
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011
PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE
FDA Adverse Event
Malfunction
·MEDELA, INC.·Product code HGX·June 13, 2013
ACCU-CHEK ADVANTAGE
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code NBW·September 29, 2008
ILET BIONIC PANCREAS
FDA Adverse Event
Injury
·BETA BIONICS INC.·Product code QFG·December 3, 2025
ELECTROSURGICAL GENERATOR "ESG-300"
FDA Adverse Event
Injury
·OLYMPUS WINTER & IBE GMBH·Product code GEI·September 29, 2021
ELECTROSURGICAL GENERATOR "ESG-300"
FDA Adverse Event
Injury
·OLYMPUS WINTER & IBE GMBH·Product code GEI·March 18, 2020
ELECTROSURGICAL GENERATOR "ESG-300"
FDA Adverse Event
Injury
·OLYMPUS WINTER & IBE GMBH·Product code GEI·September 30, 2020