Medical Device Manufacturer · US , Franklin Lakes , NJ

Becton, Dickinson & CO

190 submissions · 190 cleared · Since 2001
190
Total
190
Cleared
0
Denied

Becton, Dickinson & CO — FDA 510(k) Submissions

Becton, Dickinson & CO has submitted 190 FDA 510(k) premarket notifications since 2001, of which 190 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Test, Automated, Antimicrobial Susceptibility, Short Incubation, Needle, Hypodermic, Single Lumen, Dna-reagents, Neisseria, Tubes, Vials, Systems, Serum Separators, Blood Collection, Susceptibility Test Discs, Antimicrobial . Use the specialty filter in the sidebar to narrow results.

190 devices
1–25 of 190
BD Veritor System for Rapid Detection of Flu A + B Labratory Kit
K160164 · PSZ Devices Detecting... · Microbiology
Feb 2016 29d
BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit
K160161 · PSZ Devices Detecting... · Microbiology
Feb 2016 28d
BECTON DICKINSON INTELLIPORT SYSTEM
K141474 · PHC Infusion Safety... · General Hospital
Dec 2014 198d
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY
K140446 · MKZ Dna Probe, Nucleic Acid... · Microbiology
May 2014 88d
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
K140448 · LSL Dna-reagents, Neisseria · Microbiology
May 2014 88d
BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - INJECTOR
K140591 · ONB Closed Antineoplastic And... · General Hospital
May 2014 68d
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV
K133140 · GQG Antigen, Cf (including Cf... · Microbiology
Nov 2013 29d
BD Veritor? System Flu A+B Assay
K133138 · PSZ Devices Detecting... · Microbiology
Nov 2013 27d
BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY
K130268 · OUY Trichomonas Vaginalis... · Microbiology
Aug 2013 200d
BD FACS SAMPLE PREP ASSISTANT III
K131301 · PER Automated Pipetting,... · Immunology
Aug 2013 87d
BD PEN NEEDLE
K131358 · FMI Needle, Hypodermic,... · General Hospital
Jul 2013 67d
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN (0.5-32 UG/ML)
K131331 · LON System, Test, Automated,... · Microbiology
Jul 2013 62d
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- IMIPENEM (0.0625-32 UG/ML)
K123404 · LON System, Test, Automated,... · Microbiology
Jun 2013 234d
BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic)
K123903 · MDB System, Blood Culturing · Microbiology
May 2013 145d
BD ALCOHOL SWAB
K121655 · LKB Pad, Alcohol, Device... · General Hospital
Mar 2013 288d
0.9% SODIUM CHLORIDE INJECTION USP BD POSIFLUSH FLUSH SYRINGE, SF FLUSH SYRINGE
K121050 · NGT Saline, Vascular Access... · General Hospital
Feb 2013 307d
BD PEN NEEDLE
K123300 · FMI Needle, Hypodermic,... · General Hospital
Jan 2013 87d
BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE
K123213 · ONB Closed Antineoplastic And... · General Hospital
Jan 2013 86d
BD MAX GBS ASSAY, BD MAX INSTRUMENT
K111860 · NJR Nucleic Acid... · Microbiology
Feb 2012 231d
BD INSYTE AUTOGUARD BC
K110443 · FOZ Catheter, Intravascular,... · General Hospital
Jul 2011 153d
BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS
K103798 · OQO Herpes Simplex Virus... · Microbiology
Mar 2011 81d
BD FACS SAMPLE PREP ASSISTANT III (SPA III)
K102064 · GKZ Counter, Differential Cell · Hematology
Mar 2011 227d
BBL CHROMAGAR MRSA II
K092767 · JSO Culture Media,... · Microbiology
Aug 2010 345d
BD DIRECTIGEN EZ RSV
K101514 · GQG Antigen, Cf (including Cf... · Microbiology
Jul 2010 37d
BD VACUTAINER RAPID SERUM TUBE BLOOD COLLECTION TUBE, MODEL 368774
K101502 · JKA Tubes, Vials, Systems,... · Chemistry
Jun 2010 28d

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