71 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CAMPYLOBACTER GROWTH SUPPLEMENT
FDA 510(k)
FDA Class 1
·Microbiology
Preat
FDA UDI
Preat Corporation·00842092172650·1.8mm Retention Caps--White (6-Pack)
ACUMED
FDA UDI
Acumed LLC·10806378040764·2.0mm x 5 QR Drill, Marked 12-28mm
KORONA
FDA UDI
HNM TOTAL RECON LLC·00841742100678·KORONA Quad Staple - (L)12.5mm, 18mmx16mm
WELL-PEX
FDA 510(k)
FDA Class 2
·Dental
PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION
FDA 510(k)
FDA Class 2
·General Hospital
SMR GLENOID PEG TT SMALL-R #L
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code KWS·February 24, 2020
NOVASURE IMPEDANCE CONTROLLED EA SYSTEM
FDA Adverse Event
Injury
·HOLOGIC·Product code MNB·May 1, 2014
ADEL OBS
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code HDD·October 8, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·August 31, 2007
SMR HUMERAL HEAD Ø48 MM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code KWT·February 20, 2024
SMR HUMERAL EXTENSION + 9 MM
FDA Adverse Event
Injury
·LIMACORPORATE SPA·Product code KWS·January 9, 2019
SMR GLENOID BASEPLATE SMALL-R
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code KWS·October 21, 2022
SMR CEMENTLESS FINNED STEM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code HSD·June 18, 2019
SMR ECCENT. GLENOSPHERE Ø 36MM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code KWS·September 5, 2019
HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2-8C on receipt. Light Sensitive. In vitro diagnostic www.HardyDiagnostics.com
FDA Recall
Terminated
·Hardy Diagnostics·Product code JSO·July 9, 2015
Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus.
FDA Recall
Terminated
·Hardy Diagnostics·Product code JSJ·March 21, 2016
Hardy Diagnostics cat no. G327 HardyCHROM SS Agar (HardyCHROM Salmonella Shigella) Cat no: G327 Container type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2 to 8 degrees C. on receipt in dark A selective chromogenic medium for the primary screening isolation, and differentiation of Salmonella & Shigella spp.
FDA Recall
Terminated
·Hardy Diagnostics·Product code JSI·March 4, 2015
Hardy Diagnostics BEA Broth with Vancomycin container type: 13x100mm tube packaged: 20 tubes/box fill: 2ml Product Usage: BEA (Bile Esculin Azide) Broth with Vancomycin is for the surveillance of vancomycin resistant enterococci (VRE) not to be used for susceptibility reporting
FDA Recall
Terminated
·Hardy Diagnostics·Product code JSO·June 26, 2015
Hardy Diagnostics MDR Acinetobacter container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: MDR Acinetobacter is for the primary selective screening for detection and differentiation of multi-drug resistant (MDR) Acinetobacter baumannii.
FDA Recall
Terminated
·Hardy Diagnostics·Product code JSO·June 26, 2015