AMERICAN DIAGNOSTIC CORP.

FDA Device Registration & Listing · HAUPPAUGE, NY, US · Registration 2434008

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2434008
FEI Number
2434008
Entity Name
AMERICAN DIAGNOSTIC CORP.
City/State/Country
HAUPPAUGE, NY, US
Establishment Address
55 COMMERCE DR., HAUPPAUGE, NY 11788, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
AMERICAN DIAGNOSTIC (Owner Number: 2434008)
Owner / Operator Contact Address
55 COMMERCE DR., --, Hauppauge, NY 11788, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Adtemp 417 Adtemp Ultra Diagnostix POCKET OTOSCOPE Diagnostix Advantage 6022N Diagnostix Advantage E-Sphyg 2 Advantage 424N Adtemp Tympanic Thermometer STETHOSCOPE CHESTPIECE Adscope Proscope Advantage 6023 Advantage 6022 Advantage 6023N Advantage 6017 ADTEMP Temple Touch Adtemp 419 Adtemp 415 Adtemp 422 Adcuff SPU 8450 Series 6021N 6021NSA Advantage Digital Blood Pressure Diagnostix Esphyg Adscope 657 Adsoft VELCRO(R) TOURNIQUET ADLITE Pro-Adlite Metalite Advantage 6015N Advantage Connect Advantage Adtemp NASAL DILATOR Diagnostix ADVIEW ORAL AIRWAY ADVIEW SATIN LARYNGOSCOPES 431 WARTENBURG PINWHEEL Adtemp Adtemp 424 FINGER RING CUTTER Patient Examination Glove Adtemp ADTEMP V E-Sphyg 3 429 Adtemp METAL TONGUE DEPRESSOR Diagnostix Adtemp Adtemp 433 Advantage Diagnostix Adtemp 418 Adimals 2150 Pro's Combo Adtoon Multikuf Prosphyg Diagnostix Adcuff 3693ST 3699BK 3695 3693 3697 3693RB 3600BK 3693DG 3691 3693BK ADC 2.5V DERMASCOPE Diagnostix Diagnostix Adstation EKG CALIPER Adtemp 415 Adtemp 413 Adtemp 412 ADC Pocket Ophthalmoscope ADC Standard Ophthalmoscope Diagnostix Adtemp™ 433 Adtemp Diagnostix

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2013-12-10
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2014-12-16
EPY Speculum, Ent General, Plastic Surgery Class 1 878.1800 2010-11-29
ERA Otoscope Ear, Nose, Throat Class 1 874.4770 1996-11-26
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2011-07-06
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2007-10-25
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2014-08-25
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2025-01-07
BZS Stethoscope Head Anesthesiology Class 1 868.1930 1996-11-26
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2007-10-25
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2009-12-11
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2007-11-06
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2016-02-24
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2009-12-11
LDE Stethoscope, Manual Cardiovascular Class 1 870.1875 2007-10-25
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2007-10-25
DQD Stethoscope, Electronic Cardiovascular Class 2 870.1875 2007-10-25
GAX Tourniquet, Nonpneumatic General, Plastic Surgery Class 1 878.5900 1996-11-26
KYT Light, Examination, Medical, Battery Powered General Hospital Class 1 880.6350 2006-04-21
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2014-04-01
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-09-02
SDV Clinical Electronic Thermometer General Hospital Class 2 880.2910 2025-07-03
LWF Dilator, Nasal Ear, Nose, Throat Class 1 874.3900 2004-07-12
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2010-08-13
CAE Airway, Oropharyngeal, Anesthesiology Anesthesiology Class 1 868.5110 1996-11-26
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2010-08-13
CCW Laryngoscope, Rigid Anesthesiology Class 1 868.5540 1996-11-26
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2011-07-06
GWY Pinwheel Neurology Class 1 882.1750 2004-06-15
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2007-10-25
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2009-12-11
FNS Ring Cutter General Hospital Class 1 880.6200 2004-06-15
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2009-05-13
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2007-10-25
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2008-02-04
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2019-09-04
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2015-06-12
KBL Depressor, Metal Tongue, Surgical Ear, Nose, Throat Class 1 874.4420 2004-07-12
DQA Oximeter Cardiovascular Class 2 870.2700 2025-05-29
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2007-10-25
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2020-06-22
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2021-11-24
LRW Scissors, General, Surgical General, Plastic Surgery Class 1 878.4800 2004-05-06
DQA Oximeter Cardiovascular Class 2 870.2700 2012-07-19
LHD Device, Fertility Diagnostic, Proceptive Unknown Class U N/A 2007-11-06
DQA Oximeter Cardiovascular Class 2 870.2700 2021-03-17
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2007-10-25
GWZ Percussor Neurology Class 1 882.1700 2004-06-15
IBJ Light, Microscope Pathology Class 1 864.3600 2004-01-13
FSP Loupe, Diagnostic/Surgical General, Plastic Surgery Class 1 878.4800 2014-06-20
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 1998-02-05
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2010-12-30
HLJ Ophthalmoscope, Battery-Powered Ophthalmic Class 2 886.1570 2010-11-24
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2023-08-31
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2024-07-26
KAI Mirror, Ent Ear, Nose, Throat Class 1 874.4420 2004-06-15

Official Correspondent

Michael Falco

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AMERICAN DIAGNOSTIC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K010462 Avita Corporation AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES) 2001-04-11
K760421 Arbrook Mfg. Corp. THERMOMETER, SURVALENT-ELECTRONIC 1976-08-23
K813409 Yellow Springs Instrument Co., Inc. MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER 1981-12-18
K830039 Science Development Corp. SDC RECTAL TEMP. PROBE PRODUCT #1020 1983-02-23
K842199 Sharp Electronics Corp. ELEC. DIGITAL THERMOMETER MT-20 & 30 1984-07-18

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0032-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
Z-0002-2014 King Systems Corp. 1
King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
Z-0144-2024 Covidien 1
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2434008. Last updated year: 2026. Please use registration number 2434008 when referencing this establishment in official correspondence.
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