Acme United Corp. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Acme United Corp. - FDA 510(k) Cleared Devices
27
Total
23
Cleared
0
Denied
Acme United Corp. is an American manufacturer of cutting, measuring, and safety products headquartered in McHenry, US. The company has operated globally since its incorporation in 1873.
Acme United has submitted 27 FDA 510(k) applications and received 23 clearances between 1976 and 1996. The company's regulatory focus centered on General & Plastic Surgery devices, which comprised 78% of submissions. Notable cleared products include wound dressings, surgical sheets, and enteral feeding systems. This company is inactive and represents a historical regulatory record only.
Explore the complete list of device names, product codes, and individual clearance dates in the database.
FDA 510(k) Regulatory Record - Acme United Corp.
27 devices
Cleared
Jun 19, 1996
LYOFOAM EXTRA C ODOR ABSORBING WOUND DRESSING
General & Plastic Surgery
75d
Cleared
May 31, 1996
LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING
General & Plastic Surgery
45d
Cleared
Nov 14, 1995
LYOFOAM EXTRA
General & Plastic Surgery
165d
Cleared
Sep 10, 1990
MODIFIED LYOFOAM WOUND DRESSINGS
General & Plastic Surgery
349d
Cleared
Jun 09, 1987
LYOSHEET SURGICAL SHEET FOR BURNS
General & Plastic Surgery
35d
Cleared
Nov 21, 1986
LYOFOAM C ODOR-ABSORBING DRESSING
General & Plastic Surgery
32d
Cleared
Jun 27, 1986
LYOFOAM WOUND DRESSINGS
General & Plastic Surgery
169d
Cleared
May 15, 1986
ONE TIME ENTERAL FEEDING BAG
Gastroenterology & Urology
72d
Cleared
Apr 22, 1986
ONE TIME HYPERAL & CATHETER DRESSING CHANGE TRAYS
General Hospital
35d
Cleared
Aug 24, 1984
ACU-DERM TRANSPARENT WOUND DRESSING
General & Plastic Surgery
84d
Cleared
Aug 15, 1984
ACU-DERM TRANSPARENT IV DRESSING
General & Plastic Surgery
86d
Cleared
Aug 02, 1984
ACU-DERM TRANSPARENT INCISE DRAPE
General Hospital
98d