17 results · 40ms · Sources: EU EUDAMED, 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