1,011 results
·
29ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Nexstim NBT system
FDA UDI
Nexstim Oyj·06430063200149·Nexstim NBT system
Nexstim NBT software
FDA UDI
Nexstim Oyj·06430063200156·NBT main software
SURGICAL INSTRUMENTATION
FDA UDI
HI-TEC IMPLANTS LTD.·07290110723644·BONE TAP
Stabilized NBT/BCIP CUBITAINER - 10L
FDA UDI
Lonza Verviers·05407010128710·
Nexstim NBT White Head Tracker
FDA UDI
Nexstim Oyj·06430063200163·Nexstim NBT White Head Tracker (box of 20) New ...
Nexstim Navigated Brain Therapy (NBT) System 2
FDA 510(k)
FDA Class 2
·Neurology
Nexstim Navigated Brain Therapy (NBT) System 2
FDA 510(k)
FDA Class 2
·Neurology
Trackit Sleepwalker
FDA UDI
LIFELINES LIMITED·05060275450691·
DIMENSION CLINICAL CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·DADE BEHRING, INC.·Product code JJE·September 27, 2006
DIMENSION CLINICAL CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·DADE BEHRING, INC.·Product code JJE·September 27, 2006
Stabilized NBT/BCIP 50ml bottle - sample
FDA UDI
Lonza Verviers·05407010128703·
BD VACUTAINER® K2E (EDTA) 10.8MG PLUS BLOOD COLLECTION TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·December 9, 2019
DERMAGRAFT
FDA Adverse Event
Injury
·ADVANCED TISSUE SCIENCES, INC.·Product code MGR·March 24, 1999
TRIATHLON CR FEM COMP #5 R-CEM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·October 2, 2013
UltraVision Detection System; Anti-Polyvalent, Alk-Phos/BCIP/NBT (Ready to Use) Manufactured by: Lab Vision Corporation 46360 Fremont Blvd, Fremont, CA 94538 Product Usage: These products detect specific antibodies bound to an antigen in tissue sections. The specific antibody is located by a biotin-conjugated secondary antibody. This step is followed by the addition of streptavidin-enzyme conjugate that binds to the biotin preset on the secondary antibody. The specific antibody, secondary antibody, and streptavidin-enzyme complex is then visualized with an appropriate substrate/chromogen.
FDA Recall
Terminated
·Lab Vision Corporation·Product code NJT·January 11, 2012
UltraVision Detection System; Anti-Rabbit, Alk-Phos/BCIP/NBT (Ready to Use) Manufactured by: Lab Vision Corporation 46360 Fremont Blvd, Fremont, CA 94538 Product Usage: These products detect specific antibodies bound to an antigen in tissue sections. The specific antibody is located by a biotin-conjugated secondary antibody. This step is followed by the addition of streptavidin-enzyme conjugate that binds to the biotin preset on the secondary antibody. The specific antibody, secondary antibody, and streptavidin-enzyme complex is then visualized with an appropriate substrate/chromogen.
FDA Recall
Terminated
·Lab Vision Corporation·Product code NJT·January 11, 2012
Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)
FDA classification
FDA Class 2
·Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)
Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A; 5) RMS010093CP.
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·May 21, 2025
Welch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002; 2) BT-20-0002A; 3) BT-20-0002AP; 4) BT200007; 5) BT-20-0007; 6) BT200011; 7) BT-20-0011; 8) RMS010118CP.
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·May 21, 2025
Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3) BT-20-0002AP, 4) BT-20-0007, 5) BT-20-0011, and 6) RMS010118CP
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·October 30, 2024