Company · US

Thantex Specialties, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 1997. Name variants (Inc, Corp, punctuation) are merged.

21510(k) clearances (0 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
GDY	Gauze/Sponge, Internal, X-Ray Detectable	7
EFQ	Gauze/Sponge, Internal	3
KKX	Drape, Surgical, Antimicrobial	3
FMI	Needle, Hypodermic, Single Lumen	2
FYA	Gown, Surgical	2
FXP	Cover, Shoe, Operating-Room	1
FYC	Gown, Isolation, Surgical	1
KME	Bedding, Disposable, Medical	1
LYU	Accessory, Surgical Apparel	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Jul 18, 1997	K970547	ISOLYSER SDS SHARPS CONTAINER Thantex Specialties, Inc.	FMI
Aug 23, 1996	K961083	OREX SURGEON'S VEST Thantex Specialties, Inc.	FYA
Aug 7, 1995	K942200	ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS Thantex Specialties, Inc.	LYU
Jun 16, 1995	K943626	ISOLYSER SHARPS MANAGEMENT SYSTEM SMS Thantex Specialties, Inc.	FMI
May 25, 1995	K945755	OREX(R) O.R EQUIPMENT DRAPES Thantex Specialties, Inc.	KKX
Apr 25, 1995	K945223	OREX ISOLATION GOWN Thantex Specialties, Inc.	FYC
Feb 28, 1995	K944859	OREX SURGICAL DRAPES Thantex Specialties, Inc.	KKX
Feb 28, 1995	K944827	OREX SURGEON'S GOWN Thantex Specialties, Inc.	FYA
Jan 2, 1995	K943034	OREX SHOE COVERS Thantex Specialties, Inc.	FXP
Dec 20, 1994	K942228	OREX O.R. TOWEL Thantex Specialties, Inc.	KKX
Dec 19, 1994	K940767	OREX (12X12 X-RAY DETECTABLE) Thantex Specialties, Inc.	GDY
Dec 19, 1994	K940766	OREX (18X18 X-RAY DETECTABLE) Thantex Specialties, Inc.	GDY
Dec 19, 1994	K940765	ISOLYSER Thantex Specialties, Inc.	EFQ
Dec 19, 1994	K940764	OREX Thantex Specialties, Inc.	GDY
Dec 19, 1994	K940716	OREX Thantex Specialties, Inc.	EFQ
Dec 2, 1994	K944953	OREX MEDICAL BEDDING Thantex Specialties, Inc.	KME
May 2, 1994	K940763	ISOLYSER (8X4 12 PLY X-RAY DETECTABLE) Thantex Specialties, Inc.	GDY
May 2, 1994	K940762	ISOLYSER (18X18 X-RAY DETECTABLE) Thantex Specialties, Inc.	GDY
May 2, 1994	K940757	ISOLYSER (4X18) X-RAY DETECTABLE Thantex Specialties, Inc.	GDY
May 2, 1994	K940756	ISOLYSER (X-RAY DETECTABLE) Thantex Specialties, Inc.	GDY
May 2, 1994	K940754	ISOLYER (4X4, 12 PLY) Thantex Specialties, Inc.	EFQ

Latest recalls

Date	Firm and product	Code	Linked 510(k)
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