AMERICAN DIAGNOSTIC CORP.

Registration Details

Registration Name: AMERICAN DIAGNOSTIC CORP.
Registration Number: 2434008
FEI Number: 2434008
Status: Active
Expiry Year: 2026
Initial Importer: Yes
Address: 55 COMMERCE DR.
City: HAUPPAUGE
State: NY
ZIP: 11788
Country: US

Regulatory Submissions

510(k) Number: K102508

Owner / Operator

Firm Name: AMERICAN DIAGNOSTIC
Operator Number: 2434008
Address: 55 COMMERCE DR., --
City: Hauppauge
State: NY
Postal Code: 11788
Country: US
Correspondent: Michael R Falco

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Continuous Measurement Thermometer	FLL	Class 2	General Hospital	No	2013-12-10
Speculum, Ent	EPY	Class 1	General, Plastic Surgery	No	2010-11-29
Otoscope	ERA	Class 1	Ear, Nose, Throat	No	1996-11-26
System, Measurement, Blood-Pressure, Non-Invasive	DXN	Class 2	Cardiovascular	No	2011-07-06
Stethoscope Head	BZS	Class 1	Anesthesiology	No	1996-11-26
Blood Pressure Cuff	DXQ	Class 2	Cardiovascular	No	2016-02-24
Stethoscope, Manual	LDE	Class 1	Cardiovascular	No	2007-10-25
Stethoscope, Electronic	DQD	Class 2	Cardiovascular	No	2007-10-25
Tourniquet, Nonpneumatic	GAX	Class 1	General, Plastic Surgery	No	1996-11-26
Light, Examination, Medical, Battery Powered	KYT	Class 1	General Hospital	No	2006-04-21
Clinical Electronic Thermometer	SDV	Class 2	General Hospital	No	2025-07-03
Dilator, Nasal	LWF	Class 1	Ear, Nose, Throat	No	2004-07-12
Airway, Oropharyngeal, Anesthesiology	CAE	Class 1	Anesthesiology	No	1996-11-26
Laryngoscope, Rigid	CCW	Class 1	Anesthesiology	No	1996-11-26
Pinwheel	GWY	Class 1	Neurology	No	2004-06-15
Ring Cutter	FNS	Class 1	General Hospital	No	2004-06-15
Polymer Patient Examination Glove	LZA	Class 1	General Hospital	No	2009-05-13
Depressor, Metal Tongue, Surgical	KBL	Class 1	Ear, Nose, Throat	No	2004-07-12
Oximeter	DQA	Class 2	Cardiovascular	No	2025-05-29
Scissors, General, Surgical	LRW	Class 1	General, Plastic Surgery	No	2004-05-06
Device, Fertility Diagnostic, Proceptive	LHD	Class U	Unknown	No	2007-11-06
Percussor	GWZ	Class 1	Neurology	No	2004-06-15
Light, Microscope	IBJ	Class 1	Pathology	No	2004-01-13
Loupe, Diagnostic/Surgical	FSP	Class 1	General, Plastic Surgery	No	2014-06-20
Tape, Measuring, Rulers And Calipers	FTY	Class 1	General, Plastic Surgery	No	1998-02-05
Ophthalmoscope, Battery-Powered	HLJ	Class 2	Ophthalmic	No	2010-11-24
Mirror, Ent	KAI	Class 1	Ear, Nose, Throat	No	2004-06-15
Flowmeter, Blood, Cardiovascular	DPW	Class 2	Cardiovascular	No	2007-10-25
Fork, Tuning	GWX	Class 1	Neurology	No	2004-06-15
Mask, Oxygen	BYG	Class 1	Anesthesiology	No	2005-07-29
Goniometer, Nonpowered	KQW	Class 1	Orthopedic	No	2020-04-08

Proprietary Names

Adtemp 417 Adtemp Ultra Diagnostix POCKET OTOSCOPE Advantage 6022N Advantage E-Sphyg 2 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 Esphyg Adscope 657 Adsoft VELCRO(R) TOURNIQUET ADLITE Pro-Adlite Metalite Advantage 6015N Advantage Connect NASAL DILATOR ADVIEW ORAL AIRWAY SATIN LARYNGOSCOPES 431 WARTENBURG PINWHEEL Adtemp 424 FINGER RING CUTTER Patient Examination Glove ADTEMP V E-Sphyg 3 429 Adtemp METAL TONGUE DEPRESSOR Adtemp 433 Adtemp 418 Adimals 2150 Pro's Combo Adtoon Multikuf Prosphyg Adcuff 3693ST 3699BK 3695 3693 3697 3693RB 3600BK 3693DG 3691 3693BK ADC 2.5V DERMASCOPE Adstation EKG CALIPER Adtemp 413 Adtemp 412 ADC Pocket Ophthalmoscope ADC Standard Ophthalmoscope Adtemp 433 Adview 2 Advantage 6012N Advantage 2200 504096 501024 502048 500128 500512 500256 ADSAFE CPR FACE SHIELD Adimals Adimal Adview 2.6 39708 39712

Establishment Types

Repack or Relabel Medical Device Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)