Dacomed Corp.

Mchenry, IL, US

Dacomed Corp. appears in FDA device records in Mchenry, IL. FDA records list 20 510(k) clearances between 1981-06-26 and 1995-10-27, no PMA records and no registered establishments. As of 2026-09-10, FDA records show no recalls for this company.

510(k) clearances: 20
PMA records: 0
Recall records: 0
Registered establishments: 0

510(k) clearance history

FDA records hold 20 510(k) clearances for Dacomed Corp. between 1981 and 1995. The busiest year on record is 1982, with 2. The most recent is 1995, with 1.

Clearances by year, as a table

510(k) clearance decisions for Dacomed Corp., by decision year
Year	Clearances
1981	1
1982	2
1983	2
1984	2
1985	2
1986	1
1987	2
1988	1
1989	1
1990	1
1991	1
1992	2
1994	1
1995	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K953640	DUNA II PENILE PROSTHESIS	FAE	Substantially Equivalent	1995-10-27
K941781	RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEM	LIL	Substantially Equivalent	1994-08-25
K920409	DACOMED BATTERY OPERATED VACUUM ERECTION DEVICE	LKY	Substantially Equivalent	1992-05-11
K920420	DURA II PENILE PROSTHESIS	FAE	Substantially Equivalent	1992-04-16
K912344	MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS	FAE	Substantially Equivalent	1991-10-11
K900774	DACOMED NEGATIVE PRESSURE ERECTION DEVICE	LKY	Substantially Equivalent	1990-05-04
K885323	DACOMED EXTERNAL MALE CONTINENCE DEVICE	FHA	Substantially Equivalent	1989-02-08
K880391	DACOMED CYSTOMETER	EXQ	Substantially Equivalent	1988-04-27
K871653	DURAPHASE PENILE PROSTHESIS	FAE	Substantially Equivalent	1987-09-18
K870320	DACOMED PENILE PROSTHESIS SIZER	JLW	Substantially Equivalent	1987-03-17
K854118	DACOMED CORP. ESKA-HERRMAN VOICE PROSTHESIS	EWL	Substantially Equivalent	1986-03-17
K850019	OMNI PHASE PENILE PROSTHESIS	FAE	Substantially Equivalent	1985-04-09
K843186	ESKA MULTISTAGE ESOPHAGEAL BOUGIE	FAT	Substantially Equivalent	1985-01-18
K841202	DACOMED RIGISCAN SYSTEM	LIL	Substantially Equivalent	1984-07-06
K834504	ESKA JONAS SILICON-SILVER PENILE	FAE	Substantially Equivalent	1984-02-04
K830667	SILICONE-SILVER PENILE PROSTHESIS-ESK	FTQ	Substantially Equivalent	1983-10-20
K832121	DACOMED SNAP-GAUGE	LIL	Substantially Equivalent	1983-07-18
K820615	DACOMED SNAP-GAUGE	LIL	Substantially Equivalent	1982-04-21
K820081	ESKA JONAS SILICONE-SILVER PENILE PROST	FAE	Substantially Equivalent	1982-01-25
K811693	FORDER RETRACTOR	KOA	Substantially Equivalent	1981-06-26

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain