Medical Device Manufacturer · US , Franklin Lakes , NJ

Becton, Dickinson and Company - FDA 510(k) Cleared Devices

130 submissions · 130 cleared · Since 2010
130
Total
130
Cleared
0
Denied
55 devices
26-50 of 55
Cleared May 02, 2017
BD MAX Extended Enteric Bacterial Panel, BD MAX System
K170308 · PCH
Microbiology · 90d
Cleared Sep 06, 2016
BD MAX CT/GC/TV, BD MAX INSTRUMENT
K151589 · OUY
Microbiology · 452d
Cleared Feb 25, 2016
BD BACTEC Peds Plus/F Culture Vials (plastic)
K151866 · MDB
Microbiology · 231d
Cleared Jan 15, 2016
BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/ml
K151320 · LON
Microbiology · 242d
Cleared Oct 13, 2015
BD BBL Sensi-Disc Ceftazidime Avibactam (30/20ug), Antimicrobial...
K152516 · JTN
Microbiology · 40d
Cleared Aug 25, 2015
BD MAX Enteric Parasite Panel, BD MAX Instrument
K143648 · PCH
Microbiology · 246d
Cleared Jun 10, 2015
BD Veritor (TM) System for the Rapid Detection of Flu A+B
K151291 · PSZ
Microbiology · 26d
Cleared Jun 08, 2015
BD Veritor™ System Flu A+B Assay
K151301 · PSZ
Microbiology · 24d
Cleared Dec 10, 2014
BD BACTEC PLUS ANAEROBIC/F (PLASTIC)
K141810 · MDB
Microbiology · 156d
Cleared Oct 28, 2014
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTESM - TIGECYCLINE (0.313-4UG/ML) GP
K142170 · LON
Microbiology · 82d
Cleared Jun 02, 2014
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAROLINE (0.625-4 UG/ML)
K140468 · LON
Microbiology · 97d
Cleared May 20, 2014
BD VIPER LT SYSTEM
K140447 · OOI
Microbiology · 88d
Cleared May 06, 2014
BD MAX(TM) ENTERIC BACTERIAL PANEL
K140111 · PCI
Microbiology · 111d
Cleared Feb 14, 2014
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TIGECYCLINE (0.25-16 UG/ML)
K132909 · LON
Microbiology · 150d
Cleared Dec 27, 2013
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- MEROPENEM (0.125-32 UG/ML)
K132674 · LON
Microbiology · 122d
Cleared Nov 07, 2013
BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV
K132456 · GQG
Microbiology · 93d
Cleared Oct 02, 2013
BD Veritor™ System Flu A+B Assay
K132693 · PSZ
Microbiology · 34d
Cleared Sep 23, 2013
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
K132692 · PSZ
Microbiology · 25d
Cleared Aug 07, 2013
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
K132256 · PSZ
Microbiology · 19d
Cleared Aug 07, 2013
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
K132259 · PSZ
Microbiology · 19d
Cleared Jun 26, 2013
BD PHOENIX AUTOMATED MICROIOLOGY SYSTEM- ERTAPENEM 0.0625-8 UG/ML-GN
K123266 · LON
Microbiology · 250d
Cleared Feb 06, 2013
BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP
K122718 · GTY
Microbiology · 154d
Cleared Sep 18, 2012
BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV
K121633 · GQG
Microbiology · 106d
Cleared Sep 07, 2012
BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B
K121797 · PSZ
Microbiology · 80d
Cleared Aug 07, 2012
BD BACTEC Plus PRIME Aerobic/F Culture Vials
K120994 · MDB
Microbiology · 127d
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