17 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CATALYST II AND III
FDA 510(k)
FDA Class 2
·Cardiovascular
ArgenZ ST 98x12 ML A1B
FDA UDI
ARGEN CORPORATION, THE·D818130124·Dental porcelain/ceramic restoration kit
OsteoMed
FDA UDI
OSTEOMED LLC·00845694038898·1.6mm Right L plate 12mm, Rigid
Tecno
FDA UDI
TECNO INSTRUMENTS (PVT) LTD·08964003293536·Lateral Vaginal Retractor (1/2" Open)
SUTURE PLIER - RUSSIAN
FDA UDI
W.H. Holden, Inc.·D9281301240·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450189917·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450190005·
OLYMPUS FERRITIN REAGENT
FDA 510(k)
FDA Class 2
·Immunology
FASTX STERNAL INTRAOSSEOUS DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
ADULT INSPIRATORY HEATED BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·September 4, 2013
LEAVE ACTIVE PFC STB 15MM SZ4
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JWH·May 24, 2013
CAPSURE EPI
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DTB·June 16, 2011
ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL
FDA Adverse Event
Malfunction
·SANTO DOMINGO - USS·Product code GCJ·August 19, 2008
THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Death
·BIOSENSE WEBSTER INC·Product code LPB·May 10, 2023
VENTED AUTOFEED CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·August 2, 2013
TRUE METRIX AIR
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·June 8, 2022
Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·May 13, 2015