13 results
·
26ms
·
Sources: EU EUDAMED, US FDA
TUPPER TROLLEY
FDA 510(k)
FDA Class 1
·Orthopedic
GC Initial™
FDA UDI
Gc America Inc.·15400556701567·GC Initial™ MC Enamel Opal EOP2, 20g
GC Initial™
FDA UDI
Gc America Inc.·J0228701021·GC Initial™ MC Enamel Opal EOP2, 20g
Fresh Cells
FDA UDI
DIAGNOSTIC HYBRIDS, INC.·30014613334514·HS27 HFF SV/CS
Pekkton Ivory
FDA 510(k)
FDA Class 2
·Dental
SOPRO 162 CAMERA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Ready Cells
FDA UDI
DIAGNOSTIC HYBRIDS, INC.·30014613335818·RC HS27 SV FROZEN CULT
ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Injury
·STAAR SURGICAL CO.·Product code MTA·October 5, 2010
PK DISSECTING FORCEPS
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC.·Product code NAY·December 10, 2012
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·April 29, 2014
IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·August 20, 2014
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015