Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1313700

FEI Number

1313700

Entity Name

F.M. HOWELL & CO.

City/State/Country

ELMIRA, NY, US

Establishment Address

151 EAST FIFTH ST., P.O. BOX 286, ELMIRA, NY 14902, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

F.M. HOWELL & CO. (Owner Number: 1313700)

Owner / Operator Contact Address

151 EAST FIFTH ST., P.O. BOX 286, Elmira, NY 14902, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K891726

PMA Number

N/A

All Registered Proprietary Names

Scholl EXACTA-MED ORAL DISPENSER BD PRECISION GLIDE NEEDLE BIOJECT VIAL ADAPTER Conceptrol Clearblue Visual Pouched Preg Stick; Clearblue Rapid Detection Pregnancy Test Instant-View Histofreezer Device Ophthalmic Specula Ophthalmic Forceps OMNIPOD PUMP, INFUSION, INSULIN Sure Comfort Insulin Syringes Dollar General Preg One Step Cassette; First Signal Pregnancy Cassette; Walmart First Signal Preg Cassette EMERALD STERILE GAUZE PAD Examination Gloves

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2015-11-12
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2013-04-30
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2018-03-16
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2004-11-18
HGD	Applicator, Vaginal	Obstetrics/Gynecology	Class 1	884.4520	2018-08-29
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2020-03-30
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2013-02-01
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2017-05-12
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-01-22
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-01-22
LZG	Pump, Infusion, Insulin	General Hospital	Class 2	880.5725	2019-01-23
NDC	Calculator, Drug Dose	Anesthesiology	Class 2	868.1890	2019-01-23
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2013-01-22
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2020-03-30
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2018-03-16
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2013-01-22

Official Correspondent

KATHERINE ROEHLKE

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

F.M. HOWELL & CO.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007366413	F. M. HOWELL & CO.	Elmira, NY, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K190651	Erbe Elektromedizin GmbH	ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter	2020-01-07
K760953	Spembly Medical , Ltd.	DEEP FREEZE SYSTEM (DFS-30)	1976-11-16
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09
K964108	Direct Access Diagnostics	FACT PLUS PREGNANCY TEST	1996-11-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Z-0042-2024	Universal Meditech Inc.	2	One Step Pregnancy Test REF 100-01
Z-0006-05	Abbott Health Products, Inc.	2	AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21
Z-0005-2013	Animas Corporation	2	IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy.
Z-0010-05	Medtronic MiniMed	2	Medtronic MiniMed Paradigm Model 712

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1313700. Last updated year: 2026. Please use registration number 1313700 when referencing this establishment in official correspondence.