21 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115
FDA 510(k)
FDA Class 1
·Dental
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033558836·
InTess C Cervical Cage System
FDA UDI
Kalitec Direct LLC·B07309K01406T0·Cervical Rasp, 15 x 12, 6mm, 7 Degree, Tapered
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033575888·
InTess C Cervical Cage System
FDA UDI
Kalitec Direct LLC·B07309K01406N0·Cervical Rasp, 15 x 12, 6mm, 0 Degree, No Taper
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033575895·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033558805·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033558812·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033558843·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033558829·
RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L
FDA 510(k)
FDA Class 2
·Immunology
RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HEARTSINE SAMARITAN 300P AND PAD-PAK K014067
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·July 19, 2018
HEARTSINE SAMARITAN 300P AND PAD-PAK K014067
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·March 7, 2018
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013
ZEPHYR XL DR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWP·March 10, 2011
ACCU-CHEK ULTRAFLEX INFUSION SET
FDA Adverse Event
Malfunction
·DISETRONIC MEDICAL SYSTEMS·Product code FPA·March 13, 2008
Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin sensitivity.
FDA Enforcement
Class II
·Terminated·ITC-Nexus Dx·February 12, 2014
Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin sensitivity.
FDA Recall
Terminated
·ITC-Nexus Dx·Product code GFO·December 19, 2013
UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025