BD Becton Dickinson Vacutainer Systems Preanalytic
Sparks, MD, US
Bd Becton Dickinson Vacutainer Systems Preanalytic appears in FDA device records in Sparks, MD. FDA records list 632 510(k) clearances between and , 24 PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 632
- PMA records
- 24
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 632FDA records hold 632 510(k) clearances for BD Becton Dickinson Vacutainer Systems Preanalytic between 1976 and 2001. The busiest year on record is 1987, with 45. The most recent is 2001, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 29 |
| 1977 | 35 |
| 1978 | 31 |
| 1979 | 7 |
| 1980 | 30 |
| 1981 | 32 |
| 1982 | 23 |
| 1983 | 30 |
| 1984 | 34 |
| 1985 | 33 |
| 1986 | 38 |
| 1987 | 45 |
| 1988 | 45 |
| 1989 | 37 |
| 1990 | 26 |
| 1991 | 21 |
| 1992 | 45 |
| 1993 | 19 |
| 1994 | 22 |
| 1995 | 17 |
| 1996 | 5 |
| 1997 | 5 |
| 1998 | 11 |
| 1999 | 5 |
| 2000 | 4 |
| 2001 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K003062 | BACTEC MGIT 960 SIR KITS | MJA | Substantially Equivalent | |
| K003553 | 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE | FOZ | Substantially Equivalent | |
| K003461 | BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE | FMI | Substantially Equivalent | |
| K002938 | B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 | FMI | Substantially Equivalent | |
| K001364 | BD DIRECTIGEN FLU A+B | PSZ | Substantially Equivalent | |
| K000762 | MOXIFLOXACIN, 5 UG, BBL SENSI-DISC | JTN | Substantially Equivalent | |
| K000829 | GATIFLOXACIN, 5 UG, BBL SENSI-DISC | JTN | Substantially Equivalent | |
| K993186 | SYNERCID, 15 UG, BBL SENSI-DISC | JTN | Substantially Equivalent | |
| K992734 | BECTON DICKINSON SYRINGE | MEG | Substantially Equivalent | |
| K992849 | QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM | GKZ | Substantially Equivalent | |
| K991551 | VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE | JKA | Substantially Equivalent | |
| K984059 | ANGIOCATH AUTOGUARD CATHETER, INSYTE AUTOGUARD CATHETER | FOZ | Substantially Equivalent | |
| K980185 | COLORPAC TOXIN A | LLH | Substantially Equivalent | |
| K972728 | STERILE WATER FOR INJECTION PREFILLED SYRING (SWFIPS) | FMF | Substantially Equivalent | |
| K980580 | BECTON DICKINSON SYRINGES | FMF | Substantially Equivalent | |
| K981797 | B-D PEN ULTRA | FMF | Substantially Equivalent | |
| K980987 | BECTON DICKINSON SYRINGE | FMF | Substantially Equivalent | |
| K974363 | BECTON DICKINSON BLUNT PLASTIC CANNULA | FMI | Substantially Equivalent | |
| K974678 | B-D AUTO-INJECTOR | KZH | Substantially Equivalent | |
| K974883 | BACTEC MGIT 960 SYSTEM | MDB | Substantially Equivalent | |
| K980755 | B-D E ML PEN | FMF | Substantially Equivalent | |
| K980414 | VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET MODEL MULTIPLE, VACUTAINER BRAND BLOOD COLLECTION SET | JKA | Substantially Equivalent | |
| K974006 | BECTON DICKINSON TWINPAK | FMI | Substantially Equivalent | |
| K972404 | VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE) | KJA | Substantially Equivalent | |
| K964654 | BECTON DICKINSON BLUNT PLASTIC CANNULA | FMI | Substantially Equivalent | |
| K970737 | B-D ULTRA-FINE II SHORT 31G X 5/16 PEN NEEDLE | FMI | Substantially Equivalent | |
| K965202 | VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET | JKA | Substantially Equivalent | |
| K961968 | BBLCRYSTAL GRAM-POSITIVE ID SYSTEM | LQL | Substantially Equivalent | |
| K952721 | RUBASCAN CARD TEST | LFX | Substantially Equivalent | |
| K952791 | DIRECTIGEN MENINGITIS COMBO TEST | GTJ | Substantially Equivalent | |
| K954953 | B-D DURASAFE COMBINED SPINAL EPIDURAL (CSE) TRAY | CAZ | Unknown | |
| K961188 | CEFEPIME, 30 MCG, SENSI-DISC | JTN | Substantially Equivalent | |
| K955235 | B-D ULTRA FINE II, MICRO FINE + SHORT NEEDLE INSULIN SYRINGE | FMI | Substantially Equivalent | |
| K953790 | BD PERISAFE EPIDURAL ANESTHESIA TRAY | CAZ | Substantially Equivalent | |
| K954064 | BECTON DICKINSON SYRINGSE | FMF | Substantially Equivalent | |
| K953467 | B-D SPINAL ANESTHESIA TRAY SPINAL | CAZ | Substantially Equivalent | |
| K951919 | B-D PEN ULTRA | FMF | Substantially Equivalent | |
| K951542 | DIRECTIGEN 1-2-3 GROUP A STREP TEST | GTZ | Substantially Equivalent | |
| K951254 | SAFETYGLIDE NEEDLE | FMI | Substantially Equivalent | |
| K944931 | BECTON DICKINSON BLUNT STEEL CANNULA | FMI | Substantially Equivalent | |
| K950995 | SENSICARE SYNTHETIC, SURGICAL GLOVE LINER | LYN | Substantially Equivalent | |
| K945427 | B-D DIGITAL THERMOMETER | LHD | Substantially Equivalent | |
| K950466 | B-D ULTRA-FINE II PEN NEEDLE | FMI | Substantially Equivalent | |
| K950432 | VACUTAINER BRAND SAFETY-LOK NEEDLE HOLDER | JKA | Substantially Equivalent | |
| K945497 | B-D DURASAFE)TM) VARIABLE EXTENSION COMBINED SPINAL EPIDURAL *CSE) NEEDLE SET/KIT | CAZ | Unknown | |
| K945813 | BECTON DICKINSON PRECISION CUT(TM) COAXIAL INTRODUCER NEEDLE WITH DEPTH STOP | FCG | Substantially Equivalent | |
| K945458 | VACUTAINER BRAND SAFETY-GARD PHLEBOTOMY SYSTEM | GIM | Substantially Equivalent | |
| K944183 | TRU-TOUCH MEDICAL GLOVES | LYZ | Substantially Equivalent | |
| K945952 | VACUTAINER(R) BRAND PLUS PST(TM) PLASMA SEPARATION TUBE | JKA | Substantially Equivalent | |
| K944757 | PISTON SYRINGES | FMI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CGNAcid, Folic, Radioimmunoassay
- CDHAcid, Uric, Phosphotungstate Reduction
- CDOAcid, Uric, Uricase (U.V.)
- DFBAlpha-1-Antitrypsin, Rhodamine, Antigen, Antiserum, Control
- CCJAnalyzer, Gas, Carbon-Monoxide, Gaseous-Phase
- CAZAnesthesia Conduction Kit
- CBTArterial Blood Sampling Kit
- CBOAttachment, Intermittent Mandatory Ventilation (Imv)
- DKDBacillus Subtilis, Microbiological Assay, Gentamicin
- CIXBromcresol Green Dye-Binding, Albumin
- DQOCatheter, Intravascular, Diagnostic
- DQYCatheter, Percutaneous
- BSYCatheters, Suction, Tracheobronchial
- BXJClip, Nose
- DQKComputer, Diagnostic, Programmable
- CICCresolphthalein Complexone, Calcium
- DSIDetector And Alarm, Arrhythmia
- CIGDiazo Colorimetry, Bilirubin
- CEMElectrode, Ion Specific, Potassium
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- DBFFerritin, Antigen, Antiserum, Control
- CAHFilter, Bacterial, Breathing-Circuit
- DOKFree Radical Assay, Morphine
- CGAGlucose Oxidase, Glucose
- CFRHexokinase, Glucose
- BTTHumidifier, Respiratory Gas, (Direct Patient Interface)
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- BSJMask, Gas, Anesthetic
- BYFMask, Oxygen, Low Concentration, Venturi
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CAFNebulizer (Direct Patient Interface)
- DQTOccluder, Catheter Tip
- CJKPhenolphthalein Phosphate, Alkaline Phosphatase Or Isoenzymes
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- CDDRadioassay, Vitamin B12
- CGRRadioimmunoassay, Cortisol
- CHORadioimmunoassay, Cyclic Amp
- DPORadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.
- DONRadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.
- CGIRadioimmunoassay, Estriol
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CECRadioimmunoassay, Free Thyroxine
- CGCRadioimmunoassay, Gastrin
- DJBRadioimmunoassay, Gentamicin (125-I), Second Antibody Sep.
- CFPRadioimmunoassay, Immunoreactive Insulin
- CEPRadioimmunoassay, Luteinizing Hormone
- DKPRadioimmunoassay, Phenobarbital
- CFTRadioimmunoassay, Prolactin (Lactogen)
- CDXRadioimmunoassay, Total Thyroxine
- CDPRadioimmunoassay, Total Triiodothyronine
- BZOSet, Tubing And Support, Ventilator (W Harness)
- BWFSpirometer, Therapeutic (Incentive)
- DHXSystem, Test, Carcinoembryonic Antigen
- DHRSystem, Test, Rheumatoid Factor
- CEJTetraphenyl Borate, Colorimetry, Potassium
- CFHTetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase
- DJCThin Layer Chromatography, Methamphetamine
- DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
- DQXWire, Guide, Catheter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets BD Becton Dickinson Vacutainer Systems Preanalytic edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for BD Becton Dickinson Vacutainer Systems Preanalytic. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain