Ulti-Med Intl., Inc.

Minneapolis, MN, US

Ulti-Med Intl., Inc. appears in FDA device records in Minneapolis, MN. FDA records list 21 510(k) clearances between 1983-09-29 and 2011-02-02, no PMA records and no registered establishments. As of 2026-09-10, FDA records show no recalls for this company.

510(k) clearances: 21
PMA records: 0
Recall records: 0
Registered establishments: 0

510(k) clearance history

FDA records hold 21 510(k) clearances for Ulti-Med Intl., Inc. between 1983 and 2011. The busiest year on record is 1987, with 5. The most recent is 2011, with 1.

Clearances by year, as a table

510(k) clearance decisions for Ulti-Med Intl., Inc., by decision year
Year	Clearances
1983	1
1984	1
1986	1
1987	5
1988	1
1989	1
1990	2
1991	3
1992	3
1993	2
2011	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K103011	ULTICARE SAFETY INSULIN SYRINGE	MEG	Substantially Equivalent	2011-02-02
K923176	SURGICAL INSTRUMENT KIT, DISPOSABLE	KDD	Substantially Equivalent	1993-06-17
K923175	SURGICAL INSTRUMENT KIT, DISPOSABLE	FMC	Substantially Equivalent	1993-06-17
K920989	SURGICAL INSTRUMENT KIT, DISPOSABLE	KDD	Unknown	1992-10-19
K922828	ULCER WOUND TRAY	KKX	Unknown	1992-09-28
K914244	STERILE CUSTOM SURGICAL KITS	KDD	Unknown	1992-02-24
K914431	ABSORBENT FIBER	NAB	Substantially Equivalent	1991-12-04
K912693	POST OPERATIVE SPONGE	NAB	Substantially Equivalent	1991-10-04
K912692	CONFORMING BANDAGE	NAB	Substantially Equivalent	1991-10-04
K904896	EYE PAD	HMP	Substantially Equivalent	1990-12-05
K901465	ABSORBABLE GAUZE DRAPE	KKX	Substantially Equivalent	1990-06-12
K891717	PATIENT EXAMINATION GLOVES (VINYL)	LYZ	Substantially Equivalent	1989-05-11
K874296	INFECTION CONTROL GOGGLE (TSE FONG)/STER/NON-STER	FXX	Substantially Equivalent	1988-01-07
K874318	MAXIMUM CONTROL GOWN	FYC	Substantially Equivalent	1987-12-02
K873439	LACERATION TRAY	LRP	Substantially Equivalent	1987-09-11
K873175	CENTRAL SUPPLY ROOM WRAP	FRG	Substantially Equivalent	1987-09-09
K865023	COVER, SHOE OPERATING ROOM	FXP	Substantially Equivalent	1987-01-12
K865022	SURGICAL GARMENTS	FXO	Substantially Equivalent	1987-01-12
K860936	ABSORBENT, FIBER, OPERATING ROOM TOWELS	KKX	Substantially Equivalent	1986-04-04
K842572	GAUZE & LAB SPONGES STERILE & NON	GDY	Substantially Equivalent	1984-08-15
K832858	INTRADISCAL THERAPY TRAY	FMI	Substantially Equivalent	1983-09-29

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