Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004552850

FEI Number

3004552850

Entity Name

AMERICAN MEDICALS

City/State/Country

Jacksonville, FL, US

Establishment Address

8900 Corporate Square Ct, Jacksonville, FL 32216, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Bihani Corporation (Owner Number: 9063049)

Owner / Operator Contact Address

8900 Corporate Square Ct., --, JAX, FL 32216, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AmericanMedicals AmericanMedicals AmericanMedicals AmericanMedicals AmericanMedicals AmericanMedicals AmericanMedicals AmericanMedicals AmericanMedicals AmericanMedicals AmericanMedicals AmericanMedicals AmericanMedicals AmericanMedicals AmericanMedicals AmericanMedicals AmericanMedicals ELEVATOR AmericanMedicals AmericanMedicals AmericanMedicals AmericanMedicals American Medicals American Medicals TUBE, EAR SUCTION AmericanMedicals AmericanMedicals American Medicals

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2004-07-13
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2005-10-12
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2004-07-13
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2004-07-13
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2004-07-13
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2004-07-13
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2004-07-13
EFL	Forceps, Dressing, Dental	Dental	Class 1	872.4565	2004-07-13
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	2004-07-13
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	2004-07-13
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2004-07-13
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2004-07-13
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2004-07-13
GAF	Spatula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2004-07-13
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2004-07-13
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	2004-07-13
EMH	Forceps, Rongeur, Surgical	Dental	Class 1	872.4565	2004-07-13
HTE	Elevator	General, Plastic Surgery	Class 1	878.4800	2020-12-14
GFJ	Mallet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2004-07-13
HNI	Retractor, Ophthalmic	Ophthalmic	Class 1	886.4350	2004-07-13
HTO	Reamer	Orthopedic	Class 1	888.4540	2005-08-09
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2004-07-13
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2017-01-19
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2017-02-14
JZF	Tube, Ear Suction	Ear, Nose, Throat	Class 1	874.4420	2021-10-07
GDN	Knife, Amputation	General, Plastic Surgery	Class 1	878.4800	2004-07-13
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2004-07-13
HRR	Scissors, Orthopedic, Surgical	Orthopedic	Class 1	888.4540	2017-01-19

Official Correspondent

B. G. BIHANI

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Bihani Corporation

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
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.
Z-0021-2015	Biomet, Inc.	1	Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
Z-0144-2024	Covidien	1	Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004552850. Last updated year: 2026. Please use registration number 3004552850 when referencing this establishment in official correspondence.