10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BioFire Blood Culture Identification 2 (BCID2) Panel
FDA 510(k)
FDA Class 2
·Microbiology
CETRA
FDA UDI
Orthofix US LLC·18257200134649·4.0mm X 19mm PRIMARY CONSTRAINED SELF-TAPPING S...
MEDTRADE PRODUCTS CELOX VASCULAR TOPICAL HEMOSTATIC GRANULES ON SHEET
FDA 510(k)
FDA Unclassified
·Unknown
INVIVO DENTAL
FDA 510(k)
FDA Class 2
·Radiology
CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM
FDA Adverse Event
Malfunction
·STERILMED, INC.·Product code OWQ·August 24, 2023
NEXTAR INFRARED CAMERA
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code JWH·September 10, 2021
SIMPLEX P - JAPANESE TWIN PACK
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS LIMERICK·Product code LOD·October 8, 2008
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·July 13, 2011
M2A-MAGNUM MOD HD SZ 48MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·June 27, 2013
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014