20 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Dental Cone-beam Computed Tomography
FDA 510(k)
FDA Class 2
·Radiology
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668101186·GILL CORNEAL KNIFE CURVED
Tecomet
FDA UDI
TECOMET INC.·00841435121133·RONGEUR LARGE JAW STR
Vu a-POD™
FDA UDI
Seaspine Orthopedics Corporation·10889981041779·27x21mm Trial Rasp 10mm 8 deg
CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Disposable Medical Face Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IMP,TSV,4.1MM,DUAL SEL,HA
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·June 15, 2021
840 VENTILATOR
FDA Adverse Event
Malfunction
·PURITAN-BENNETT CORP.·Product code CBK·November 14, 2008
PINNACLE MTL INS NEUT28IDX48OD
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·August 18, 2011
ZEPHIR ANTERIOR CERVICAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·July 18, 2013
COMP LK SCR 3.5HEX 4.75X20 ST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·November 5, 2024
COMP RVRS 25MM BSPLT HA+ADPTR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·November 5, 2024
COMP RVS CNTRL 6.5X30MM ST/RST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·November 5, 2024
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
FDA Enforcement
Class II
·Ongoing·Abbott Point Of Care Inc.·September 24, 2025
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWS·January 14, 2025
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
FDA Recall
Open, Classified
·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025
IMP,TSV,4.1MM,DUAL SEL,HA
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·October 21, 2023
COMP NLK SCR 3.5HEX 4.75X30 ST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·November 5, 2024
COMP NLK SCR 3.5HEX 4.75X15 ST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·November 5, 2024
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025