Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1025972

FEI Number

1030186

Entity Name

ACME UNITED CORP.

City/State/Country

Rocky Mount, NC, US

Establishment Address

2280 Tanner Rd, Rocky Mount, NC 27801, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

ACME UNITED CORP. (Owner Number: 1217843)

Owner / Operator Contact Address

1 Waterview Drive, Shelton, CT 06484, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Scissors Shoe Covers Pac-Kit First Aid Only Finger Cot Physicians Care First Aid Only Pac-Kit Physicians Care Physicians Care Pac-Kit First Aid Only First Aid Only Physicians Care Pac-Kit First Aid Only Pac-Kit Physicians Care First Aid Only Pac-Kit Physicians Care Pac-Kit First Aid Only Physicians Care First Aid Only Pac-Kit Physicans Care First Aid Only Pac-Kit Physicians Care First Aid Only Pac-Kit Physicians Care Tongue depressor and finger splint

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2019-01-23
FQZ	Thermometer, Clinical Color Change	General Hospital	Class 1	880.2900	2020-06-11
BWP	Shoe And Shoe Cover, Conductive	General, Plastic Surgery	Class 1	878.4040	2018-06-15
FPP	Stretcher, Hand-Carried	General Hospital	Class 1	880.6900	2023-07-07
LZB	Finger Cot	General Hospital	Class 1	880.6250	2017-01-27
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2011-11-05
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2016-04-11
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2018-06-15
FYH	Splint, Extremity, Noninflatable, External, Sterile	General, Plastic Surgery	Class 1	878.3910	2011-11-05
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2011-11-05
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2018-06-15
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	1992-07-30
CBP	Valve, Non-Rebreathing	Anesthesiology	Class 2	868.5870	2017-05-31
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2016-04-11
LRR	First Aid Kit With Drug	Unknown	Class N	N/A	2017-05-31
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2017-06-29
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2011-11-05
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2016-04-25
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2011-11-05
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2018-01-05

Official Correspondent

Roberta Bloom

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ACME UNITED CORP.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3015544945	Acme United Corporation - My Medic	North Salt Lake, UT, US
3017482874	LIVE SAFELY PRODUCTS, INC	Keene, NH, US
3023917	ACME UNITED CORP.	VANCOUVER, WA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K201622	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask	2020-11-24
K881618	3M Company	ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK	1988-05-09
K945177	Eagle Health Supplies	4-O2 JR. (CPR MOUTH BARRIER)	1994-11-01
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223

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8043496	REDA INSTRUMENTE GMBH	TUTTLINGEN Baden-Wurttemberg, DE
8040373	NADEEM SURGICAL CORP. PRIVATE LTD.	SIALKOT Punjab, PK
2531475	URAMIX, INC.	E Lansdowne, PA, US
1417592	MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1025972. Last updated year: 2026. Please use registration number 1025972 when referencing this establishment in official correspondence.