10 results
·
21ms
·
Sources: EU EUDAMED, US FDA
IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 )
FDA 510(k)
FDA Class 2
·Cardiovascular
NA
FDA UDI
DEPUY MITEK, LLC·10886705012237·RETRACTOR FRAME
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756030205·Needle Counter
CompuFlo Epidural Computer Controlled Anesthesia System
FDA 510(k)
FDA Class 2
·General Hospital
Reusable Full Silicone Cover
FDA 510(k)
FDA Class 2
·Cardiovascular
MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·December 2, 2008
ALARIS PUMP MODULE ADMINISTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION CORP.·Product code FPA·August 31, 2011
ABBOCATH-T 20G 1-1/4IN
FDA Adverse Event
Injury
·AMSINO MEDICAL CO., LTD, CONTRACT MFR FOR HOSPIRA, INC.·Product code FOZ·July 10, 2013
Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad¿ Avanta Injection System; Catalog number: AVA 500 MPAT (Part 2 of 2); Affected material numbers: 87629007, 60729458, 86566648;
FDA Enforcement
Class II
·Ongoing·Bayer Medical Care, Inc.·June 10, 2026
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