17 results
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40ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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IPL Home Use Hair Removal Device (SJ15)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776181895·BRUNS CURETTE ANG OVAL SIZE
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257009826·30-40 DUAL LAYER CALF SINGLE M 10 PACK
COE TRAY PLASTIC™
FDA UDI
Gc America Inc.·D6582400931·COE TRAY PLASTIC™ Regular Set Liquid can 1 quar...
COE TRAY PLASTIC™
FDA UDI
Gc America Inc.·10386040006408·COE TRAY PLASTIC™ Regular Set Liquid can 1 quar...
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780187271·Integra® Jarit® Bruns Oval Cup Curette, 8", Ang...
TABLE
FDA 510(k)
FDA Class 2
·Radiology
Synthetic Nitrile Patient Exam Gloves, Powder Free, Blue, Tested for Use w/Chemotherapy Drug
FDA 510(k)
FDA Class 1
·General Hospital
BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·January 11, 2024
I-STAT EG7+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·April 9, 2024
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 10, 2014
TENDRIL SDX
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·September 9, 2011
2000CMS
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·July 11, 2013
I-STAT EC8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·April 23, 2024
GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code PRL·April 8, 2025
GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code NIP·March 26, 2025
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025