McNeil Healthcare LLC

Fairfield, NJ, US

MCNEIL HEALTHCARE LLC appears in FDA device records in Fairfield, NJ. FDA records list 19 510(k) clearances between 1994-01-13 and 1994-02-03, no PMA records and one registered establishment. As of 2026-09-10, FDA records show no recalls for this company, and at least one establishment registration is current.

510(k) clearances: 19
PMA records: 0
Recall records: 0
Registered establishments: 1

510(k) clearance history

FDA records hold 19 510(k) clearances for McNeil Healthcare LLC in 1994.

Clearances by year, as a table

510(k) clearance decisions for McNeil Healthcare LLC, by decision year
Year	Clearances
1994	19

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K935930	NON ADHERENT DRESSING AND NON ADHERENT DRAIN DRESSING	EFQ	Substantially Equivalent	1994-02-03
K935883	NEUROLOGICAL SPONGES	GDY	Substantially Equivalent	1994-02-03
K935993	SURGICAL SPONGE X-RAY DETECTABLE	GDY	Substantially Equivalent	1994-02-02
K935934	NON ADHERANT BURN PADS	EFQ	Substantially Equivalent	1994-01-31
K935911	PACKING SPONGE	EFQ	Substantially Equivalent	1994-01-31
K935910	X-RAY PACKING SPONGE	GDY	Substantially Equivalent	1994-01-31
K935882	TONSIL SPONGES	GDY	Substantially Equivalent	1994-01-31
K935881	SPECIALTY SPONGES	GDY	Substantially Equivalent	1994-01-31
K935941	READY CUT GAUZE GAUZE BOLTS	EFQ	Substantially Equivalent	1994-01-14
K935940	GAUZE SPONGE; DRAIN SPONGE	EFQ	Substantially Equivalent	1994-01-14
K935939	GAUZE FLUFF	EFQ	Substantially Equivalent	1994-01-14
K935938	BANDAGE ROLLS, STRETCH GAUZE ROLLS, TEXTURED GAUZE ROLLS	EFQ	Substantially Equivalent	1994-01-14
K935937	POST OP SPONGE	EFQ	Substantially Equivalent	1994-01-14
K935936	CONFORMING ROLL	EFQ	Substantially Equivalent	1994-01-14
K935935	BURN GAUZE PADS	EFQ	Substantially Equivalent	1994-01-14
K935933	CUSTOM BURN DRESSING	EFQ	Substantially Equivalent	1994-01-14
K935932	BURN COMPRESS	EFQ	Substantially Equivalent	1994-01-14
K935931	NON-WOVEN SPONGE	EFQ	Substantially Equivalent	1994-01-14
K935942	SURGICAL LAPAROTOMY SPONGE X-RAY DETECTABLE	EFQ	Substantially Equivalent	1994-01-13

Registered establishments

FDA registered establishments for McNeil Healthcare LLC, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
1223924	1000305719	MCNEIL HEALTHCARE LLC	311 Rt 46 West, Fairfield, NJ 07004 US	2026	EFQ FRL GDY

Registration numbers link to the FDA registration and listing record for that establishment.

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