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SHINING 3D®

FDA UDI
Shining 3D Tech Co., Ltd.·06970163087733·This is an intraoral scanner that works with th...

HM-272A-L-FB

FDA UDI
INTERNATIONAL MEDICAL LASERS, INC.·00851272007064·Surgical Laser Fiber 272/300/450 4m fiber, hard...

HM-365A-L-FB

FDA UDI
INTERNATIONAL MEDICAL LASERS, INC.·00851272007118·Surgical Laser Fiber 365/400/580 4m fiber, hard...

C-STEM AMT SZ4 HI OFFSET

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD - 8010379·Product code JDI·March 30, 2016

DEPUY ASR XL FEM IMP SIZE 45

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·April 1, 2016

TOTAL ASR ACET IMP SIZE 50

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·April 1, 2016

EDWARDS TRANSFEMORAL BALLOON CATHETER

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code NPT·March 22, 2013

TOTAL ASR ACET IMP SIZE 56

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD - 8010379·Product code KWA·March 3, 2016

INTERNAL NASAL SPLINT - SEPTAL BUTTON

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code LFB·April 21, 2021

NASAL SEPTAL BUTTON

FDA Adverse Event
Malfunction ·HOOD LABORATORIES·Product code LFB·November 6, 1996

BLOM-SINGER

FDA Adverse Event
Malfunction ·FREUDENBERG MEDICAL, LLC·Product code LFB·August 24, 2017

KOMED SILASTIC NS BUTTON

FDA Adverse Event
Injury ·KOMED SURGICAL PRODUCTS·Product code LFB·March 20, 1998

NA

FDA Adverse Event
Injury ·XOMED SURGICAL PRODUCTS, INC.·Product code LFB·April 29, 1998

BLOM-SINGER NASAL SEPTAL PERFORATION PROSTHESIS

FDA Adverse Event
Injury ·INHEALTH TECHNOLOGIES / FREUDENBERG MEDICAL, LLC·Product code LFB·August 26, 2019

BLOM-SINGER NASAL SEPTAL PERFORATION PROSTHESIS

FDA Adverse Event
Injury ·FREUDENBERG MEDICAL, LLC·Product code LFB·December 20, 2019

Sterile Procedural Trays, labeled as the following: a. ENDOSCOPY-LF b. SEPTO/ENDO

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code PPB·November 17, 2022

Sterile Procedural Tray, labeled as the following: a. PAIN SERVICE PACK-LF; b. LOCAL BASIC

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OFT·November 17, 2022

Sterile Procedural Trays, labeled as the following: a. MINOR/BREAST BIOPSY-LF b. BREAST BIOPSY-LF

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code FCH·November 17, 2022

Sterile Procedural Trays, labeled as the following: a. ENDOSCOPY-LF b. SEPTO/ENDO

FDA Enforcement
Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 15, 2023

Sterile Procedural Trays, labeled as the following: a. MINOR/BREAST BIOPSY-LF b. BREAST BIOPSY-LF

FDA Enforcement
Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 15, 2023