20 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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Z-SNAP OFF SCREW, Z-DOUBLE THREAD COMPRESSION SCREW, Z-GUIDE WIRE, Z-STAPLE
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772813872·GENUMEDI PRO SILVER SIZE VII
SURGISTAR
FDA UDI
SURGISTAR, INC.·00878799006684·
ArgenZ Anterior 95x18 #5
FDA UDI
ARGEN CORPORATION, THE·D818121277·Dental porcelain/ceramic restoration kit
CRYO.S
FDA UDI
Greiner Bio - One GmbH·14039943000030·
NOVO Health Services, LLC
FDA UDI
NOVO HEALTH SERVICES, LLC·00812564032072·Speer Pack
Ambler Surgical
FDA UDI
AMBLER SURGICAL CORP.·10190660198531·Anterior chamber rycroft cannula, 30 gauge x 7....
CRYO.S
FDA UDI
Greiner Bio - One GmbH·14039943001693·
ORION II (HEAVY DUTY 350 LBS AND 500 LBS)
FDA 510(k)
FDA Class 1
·Physical Medicine
BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B
FDA 510(k)
FDA Class 2
·Microbiology
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·April 12, 2024
ZEPHYR XL DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC CRMD·Product code DXY·January 13, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·June 13, 2011
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·April 24, 2024
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code PSZ·January 22, 2024
KIT FLU VERITOR SYSTEM 30 TEST JAPAN
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 1, 2022
KIT FLU VERITOR SYSTEM 30 TEST JAPAN
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 19, 2021
KIT FLU VERITOR SYSTEM 30 TEST JAPAN
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 25, 2021
Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262
FDA Enforcement
Class II
·Terminated·Isopure Corp·September 21, 2022