10 results · 24ms · Sources: EU EUDAMED, US FDA

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SIGNIFY BIOACTIVE

FDA 510(k)
FDA Class 2 ·Orthopedic

Ambler Value Line

FDA UDI
AMBLER SURGICAL CORP.·00190660056148·Heaney-Ballentine hysterectomy forceps, 14'', c...

PRE-POWDERED VINYL PATIENT EXAMINATION GLOVE, NON-STERILE

FDA 510(k)
FDA Class 1 ·General Hospital

DENTAURUM MIX TWO-PASTE BRACKET ADHESIVE

FDA 510(k)
FDA Class 2 ·Dental

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 28, 2025

DORMA 100

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·March 16, 2022

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·September 30, 2014

ATTAIN ABILITY

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·June 16, 2011

PINNACLE MTL INS NEUT36IDX52OD

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 20, 2008

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) 4.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE TRACH TUBE , Product Code/List Number/Item Code 60PFSS40; d) 4.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS45; e) 5.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS50; f) 5.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS55

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024