13 results
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18ms
·
Sources: EU EUDAMED, US FDA
LITHOTOMY HOLDERS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR88700981·Max. 2. Molar band W-Fit right 98
Trimline
FDA UDI
ORMCO CORPORATION·00889989052039·UPPER LEFT SECOND MOLAR TRIMLINE BAND SIZE 98
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR88700980501·Max. 2. Molar band W-Fit right 98
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR88700980101·Max. 2. Molar band W-Fit right 98
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR88700980051·Max. 2. Molar band W-Fit right 98
QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREENING TEST, MODEL 9317T; CUP MULTI DRUG SC
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ICONIX TT All Suture Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
ADVIA CENTAUR CP TROPONIN ULTRA ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·June 12, 2014
DUROM US ACETABULAR COMPONENT
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·October 11, 2010
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·December 12, 2012
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