11 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SALTER LABS NEONATAL NASAL OXYGEN CANNULA
FDA 510(k)
FDA Class 1
·Anesthesiology
CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000)
FDA 510(k)
FDA Class 2
·Ophthalmic
AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·January 11, 2013
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·ANIMAS CORP.·Product code LZG·November 24, 2010
SUCTION APPARATUS, PATIENT CARE
FDA Adverse Event
EMG TECHNOLOGY CO. LTD·Product code DWM·July 3, 2014
SERIES A PAT STD 31 3 PEG
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·December 31, 2025
VANGUARD CR ILOK FEM-RT 62.5
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·December 31, 2025
BIOMET ILOK PRI TIB TRAY 67MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·December 31, 2025
BIOMET FINNED PRI STEM 40MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·December 31, 2025
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024