17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Sterile Latex Powder-Free Surgical Gloves
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Axcess Percutaneous Introducer
FDA UDI
ARGON MEDICAL DEVICES, INC.·00886333206957·Axcess Percutaneous Introducer with Multi-Purpo...
Oticon
FDA UDI
Oticon A/S·05707131339607·SIYA 1, KIT 312 2.4G NFM 90 PB R C001
BLOOD GLUCOSE MONITORING SYSTEM, MODEL FORA G90/TD-4234
FDA 510(k)
FDA Class 2
·Clinical Chemistry
R4 ACERT ULTRASOUND REPORTING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
KNIFE
FDA Adverse Event
Malfunction
·ALCON PRECISION DEVICE - SINKING SPRING·Product code HNN·July 22, 2011
VENTED AUTOFEED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·June 26, 2013
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
FDA Adverse Event
Malfunction
·COSTA RICA·Product code LTI·September 30, 2008
COOK COPE-LOOP CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code LJE·August 23, 2021
ULTRATHANE SUPRAPUBIC CATHETER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code KOB·August 23, 2022
COOK COPE-LOOP CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code LJE·March 17, 2022
COOK COPE-LOOP CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code LJE·March 17, 2022
COOK COPE-LOOP CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code LJE·March 17, 2022
COOK COPE-LOOP CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code LJE·March 17, 2022
COOK COPE-LOOP CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code LJE·August 23, 2021
COOK COPE-LOOP CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code LJE·July 21, 2021
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