Acme United Corp.
Rocky Mount, NC, US
ACME UNITED CORP. appears in FDA device records in Rocky Mount, NC. FDA records list 27 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Acme United Corp. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- First Aid Only Increcall
510(k) clearance history
FDA records hold 27 510(k) clearances for Acme United Corp. between 1976 and 1996. The busiest year on record is 1986, with 4. The most recent is 1996, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 2 |
| 1977 | 3 |
| 1978 | 1 |
| 1979 | 2 |
| 1980 | 1 |
| 1981 | 2 |
| 1982 | 1 |
| 1983 | 3 |
| 1984 | 3 |
| 1986 | 4 |
| 1987 | 1 |
| 1990 | 1 |
| 1995 | 1 |
| 1996 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K961323 | LYOFOAM EXTRA C ODOR ABSORBING WOUND DRESSING | KMF | Substantially Equivalent | |
| K961452 | LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING | KMF | Substantially Equivalent | |
| K952565 | LYOFOAM EXTRA | KMF | Substantially Equivalent for Some Indications | |
| K895764 | MODIFIED LYOFOAM WOUND DRESSINGS | KMF | Substantially Equivalent for Some Indications | |
| K871740 | LYOSHEET SURGICAL SHEET FOR BURNS | FPY | Substantially Equivalent | |
| K864084 | LYOFOAM C ODOR-ABSORBING DRESSING | FRO | Substantially Equivalent for Some Indications | |
| K860085 | LYOFOAM WOUND DRESSINGS | NAD | Substantially Equivalent for Some Indications | |
| K860818 | ONE TIME ENTERAL FEEDING BAG | KNT | Substantially Equivalent | |
| K861015 | ONE TIME HYPERAL & CATHETER DRESSING CHANGE TRAYS | FOZ | Substantially Equivalent | |
| K842186 | ACU-DERM TRANSPARENT WOUND DRESSING | NAD | Substantially Equivalent | |
| K842064 | ACU-DERM TRANSPARENT IV DRESSING | KMK | Substantially Equivalent | |
| K841735 | ACU-DERM TRANSPARENT INCISE DRAPE | KKX | Substantially Equivalent | |
| K833120 | ONE TIME COMPOUND BENZOIN TINCTURE- | KGX | Substantially Equivalent | |
| K833141 | ONE TIME ACETONE/ALCOHOL;SWAB STICKS | LKB | Substantially Equivalent | |
| K830704 | ONE TIME DISPOSABLE SKIN STAPLER | FZQ | Substantially Equivalent | |
| K822865 | SURGI-SCRUB V | GEC | Substantially Equivalent | |
| K811625 | PREP-SITE PROTECTIVE DRESSING WIPE | KMF | Substantially Equivalent | |
| K811120 | SURGICAL STAPLE REMOVER | KDC | Substantially Equivalent | |
| K801884 | OP-SITE SKIN CLOSURE SUTURE ADHESIVE | FPX | Substantially Equivalent | |
| K791573 | JELONET PARAFFIN GAUZE DRESSINGS | FRO | Substantially Equivalent | |
| K791369 | AIRSTRIP THEATRE WARD DRESSING | NAD | Substantially Equivalent | |
| K780853 | OP-SITE ADHESIVE DRAPES | KKX | Substantially Equivalent | |
| K770481 | SHEAR, PLASTIC HANDLE UTILITY S-475-7 | JOK | Substantially Equivalent | |
| K770414 | PROBE RETRACTOR, PART #S-2L8-6 | GAD | Substantially Equivalent | |
| K770418 | RETRACTOR, SKIN HOOK | GAD | Substantially Equivalent | |
| K760507 | FORCEP, THUMB | GEN | Substantially Equivalent | |
| K760703 | SPONGE AND GAUZE FORCEP PART #S-417-9 | GEN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1025972 | 1030186 | ACME UNITED CORP. | 2280 Tanner Rd, Rocky Mount, NC 27801 US | 2026 | and 21 more, listed in full below |
| 3023917 | 3023917 | ACME UNITED CORP. | 11101 NE 37th Cir, VANCOUVER, WA 98682 US | 2026 | and 19 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LYUAccessory, Surgical Apparel
- KXFApplicator, Absorbent Tipped, Non-Sterile
- FQMBandage, Elastic
- KMFBandage, Liquid
- KMEBedding, Disposable, Medical
- GECBrush, Scrub, Operating-Room
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- FZQClip, Removable (Skin)
- FMADepressor, Tongue, Non-Surgical
- KMKDevice, Intravascular Catheter Securement
- KKXDrape, Surgical, Antimicrobial
- MHWDressing, Compression
- FRODressing, Wound, Drug
- NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic
- NACDressing, Wound, Hydrophilic
- NADDressing, Wound, Occlusive
- LZBFinger Cot
- LRRFirst Aid Kit With Drug
- OHOFirst Aid Kit Without Drug
- HTDForceps
- GENForceps, General & Plastic Surgery
- NABGauze / Sponge,Nonresorbable For External Use
- KDCInstrument, Surgical, Disposable
- FXXMask, Surgical
- BYPMouthpiece, Breathing
- IMDPack, Hot Or Cold, Disposable
- IMEPack, Hot Or Cold, Reusable
- LKBPad, Alcohol, Device Disinfectant
- HMPPad, Eye
- PXCPersonal Protection Kit
- LZAPolymer Patient Examination Glove
- GADRetractor
- LRWScissors, General, Surgical
- JOKScissors, Medical, Disposable
- FPYSheet, Burn
- BWPShoe And Shoe Cover, Conductive
- ILISling, Arm
- KYPSnake Bite Suction Kit
- FYHSplint, Extremity, Noninflatable, External, Sterile
- FPPStretcher, Hand-Carried
- FPXStrip, Adhesive, Closure, Skin
- KGXTape And Bandage, Adhesive
- FQZThermometer, Clinical Color Change
- GAXTourniquet, Nonpneumatic
- KNTTubes, Gastrointestinal (And Accessories)
- CBPValve, Non-Rebreathing
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0855-2008 | Ibuprofen tablet refills in cardboard boxes or clear plastic bags for first aid kits and cabinets First Aid Only, Inc., Vancouver, WA. Ibuprofen Tablets, Item A405-WIP, Item A405-10 Ibuprofen Tablets, Item FAE-7014;; Ibuprofen Tablets, Item H430; Ibuprofen Tablets, Item I431; Ibuprofen Tablets, item J432 and Ibuprofen Tablets, item Z6100 | Failed USP Impurity testing: the Ibuprofen supplied by its own manufacturer, used in these first aid kits, tablet refills, and cabinets, is being recalled for failing its USP limits for impurities during stability testing. | Terminated | ||
| Z-0854-2008 | First Aid Only brand cabinets (typically metal wall mount) containing ibuprofen tablets and a variety of other first aid supplies: Item 249-0/FAO Item 249-0/P Item 249-RK/P First Aid Exchange brand cabinet: Item 1300-FAE-0103 Item 1300-FAE-0108 and Item 1300-PAT-0109 | Failed USP Impurity testing: the Ibuprofen supplied by its own manufacturer, used in these first aid kits, tablet refills, and cabinets, is being recalled for failing its USP limits for impurities during stability testing. | Terminated | ||
| Z-0853-2008 | First Aid Kits, soft canvas, plastic, and metal containers holding various products to include ibuprofen and other first aid supplies, in various sizes. Kits include: Labeled with First Aid Only, Inc. Vancouver, WA: Recreational Sports First Aid, Item SM-134; Welder's First Aid Kit, Item 253-U; Vehicle First Aid Kit, Item 220-0; On-The-Road Auto First Aid, Item FAO-310; Auto First Aid Essentials, Item FAO-340; Auto First Aid Essentials, Item FDA-532; Auto First Aid Essentials, Item FDA-552; Vehicle First Aid Kit, Item 221-U; Outdoor First Aid Kit, Item FAO-410; Outdoor First Aid Kit, Item FAO-410 Outdoor First Aid Kit, Item FAO-420; Outdoor First Aid Kit, Item FAO-430; Outdoor First Aid Kit, Item FAO-440; First Aid & Survival Kit, Item FA-462; First Aid Kit, FAO-422-06; First Aid Kit, 403-PC; First Aid Response Kit, FA-504; All Purpose First Aid Kit, Item FAO-112; All Purpose First Aid Kit, Item FAO-122; All Purpose First Aid Kit, Item FAO-142; All Purpose First Aid Kit, Item FAO-432; All Purpose First Aid Kit, Item FAO-444; All Purpose First Aid Kit, Item FAO-452; First Aid Essentials, Item FAO-130; First Aid Essentials, Item FAO-132; First Aid Essentials, Item FAO-134; First Aid Essentials, Item FAO-422; First Aid Essentials, Item FAO-428; First Aid Essentials, Item FAO-432; First Aid Essentials, Item FAO-442; Refillable First Aid Kit, FAO-490C; Refillable First Aid Kit, FAO-490C; Brite Stock first aid kits (only labeled on shipping case as being manufactured by First Aid Only): Item FAO-130-BS; Item FAO-132-BS; Item FAO-134-BS; Manufactured by First Aid Only, Inc. Vancouver, WA. Distributed by Wholesale Merchandisers, Inc., Grand Rapids, MI 49544: Lake & Trail Outdoor First Aid Kit, Item MJR-420; Lake & Trail Outdoor First Aid Kit, Item MJR440; First aid kits labeled DIST. BY MEIJER DISTRIBUTION, INC. GRAND RAPIDS, MI 49544: meijer First Aid Kit, Item MJR-130; meijer First Aid Kit, Item MJR-442; First Aid Kits labeled FIRST AID Exchange: General Purpose Home First Aid Kit, Item 2800; Auto First Aid Kit, Item 2825 First Aid Kit labeled Distributed by Medicine Shoppe International St. Louis, MO: All purpose First Aid Kit, Item FAO-132-MS First Aid Kit labeled Mfg. by First Aid Only, Inc. Vancouver, WA Ready Solutions: First Aid Kit, Item 90030 First Aid Kit labeled NORTHERN Safety Co., Inc.: First Aid Kit, Item FAO-442-NS First Aid Kit labeled Manufactured for: Graham-Field Health Products, Atlanta, Georgia 30060: Grafco First Aid Kit, Item 1799-9133 and First Aid Kit labeled -Provided by MOTURIS LTD- Custom Kit, Item 9099 | Failed USP Impurity testing: the Ibuprofen supplied by its own manufacturer, used in these first aid kits, tablet refills, and cabinets, is being recalled for failing its USP limits for impurities during stability testing. | Terminated | ||
| Z-0147-2007 | First Aid Kit, Nexcare brand, all purpose first aid kit containing acetaminophen and a variety of first aid supplies. Made in U.S.A. for 3M 3M Consumer Health Care St. Paul, MN 55144-1000 | Kits contain acetaminophen tablets that were recalled due to being contaminated with mold. | Terminated | ||
| Z-0146-2007 | First Aid kits, Pharmacist''s Choice, containing acetaminophen and a variety of first aid items, all purpose first aid kit. | Kits contain acetaminophen tablets that were recalled due to being contaminated with mold. | Terminated | ||
| Z-0145-2007 | First Aid kits, First Aid Only brand, containing various products to include acetaminophen and other first aid supplies, various sizes, - travel size, all purpose, first aid response kit, on-the-road, recreational, outdoor. First Aid Only, Inc. Vancouver, WA | Kits contain acetaminophen tablets that were recalled due to being contaminated with mold. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain