25 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HI-TORQUE CONNECT
FDA UDI
ABBOTT VASCULAR INC.·08717648175039·Hi-Torque Connect 250T Guide Wire .018" 145 cm
BODY GLOVE
FDA UDI
FGX INTERNATIONAL INC.·00193033427941·
BODY GLOVE
FDA UDI
FGX INTERNATIONAL INC.·00193033427965·
BODY GLOVE
FDA UDI
FGX INTERNATIONAL INC.·00193033427958·
POWDER FREE STERILE LATEX SURGICAL GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
UNKNOWN VERSASTEP
FDA Adverse Event
Malfunction
·COVIDIEN·Product code GCJ·June 11, 2015
CUFFLATOR ENDOTRACHEAL TUBE INFLATOR AND MANOMETER
FDA Adverse Event
Malfunction
·J. T. POSEY CO.·Product code BSK·February 20, 2013
ASR ACETABULAR CUPS 52
FDA Adverse Event
Injury
·DEPUY INTL., LTD.·Product code KWA·February 24, 2011
KENTROX SL-S 65/16
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.·Product code LWS·March 12, 2008
HT Connect Peripheral Guide Wire Part Number Description 1012587 018 HT CONNECT 145 CM 1012588 018 HT CONNECT 195 CM 1012589 018 HT CONNECT 300 CM 1012590 018 HT CONNECT FLEX 145 CM 1012591 018 HT CONNECT FLEX 195 CM 1012592 018 HT CONNECT FLEX 300 CM 1012593 018 HT CONNECT 250T 145 CM 1012594 018 HT CONNECT 250T 195 CM 1012595 018 HT CONNECT 250T 300 CM
FDA Enforcement
Class II
·Terminated·Abbott Vascular, Inc.·January 1, 2014
CADD EXTENSION SET WITH MALE/MALE LUER
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC·Product code FPA·January 6, 2025
UNK - SCREWS: MATRIXMANDIBLE
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HWC·August 20, 2020
UNK - PLATES: MANDIBLE LOCKING
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·August 20, 2020
UNK - SCREWS: MATRIXMANDIBLE
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HWC·August 20, 2020
UNK - PLATES: MATRIXMANDIBLE
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·August 20, 2020
CADD MEDICATION CASSETTE RESERVOIR
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC·Product code FPA·January 6, 2025
UNK - SCREWS: CMF
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HWC·August 20, 2020
UNK - SCREWS: CMF
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HWC·August 20, 2020