Company · US

Customed, Inc

FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 2026. Name variants (Inc, Corp, punctuation) are merged.

37510(k) clearances (1 in 12 months)

699recalls (0 in 12 months)

108recalls that name a 510(k)

Product codes

Code	Device	Records
LRO	General Surgery Tray	238
OJH	Orthopedic Tray	78
FDE	Laparoscopy Kit	59
OKV	Obstetrical Kit	52
KKX	Drape, Surgical, Antimicrobial	36
OHM	Cesarean Section Tray	33
OEQ	Angiography/Angioplasty Kit	19
FWZ	Operating Room Accessories Table Tray	18
FYA	Gown, Surgical	18
OFA	Cardiovascular Surgical Instruments Tray	18
OJK	Eye Tray	18
OJG	Neurological Tray	17
MCY	Wound Dressing Kit	16
OGR	Ear, Nose, And Throat Surgical Tray	11
FHI	Ring, Laparotomy	10
HRX	Arthroscope	10
OHD	Gynecological Laparoscopic Kit	10
NWR		8
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	7
MCZ	Suture Removal Kit	6

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Jun 3, 2026	K260116	CustoMED Viewer CustoMED , Ltd., IL	LLZ
Jan 5, 1998	K974647	FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633 Customed, Inc.	KKX
Dec 4, 1997	K971920	GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522) Customed, Inc.	FYA
Nov 25, 1996	K964011	SUCTION CATHETER TRAY PRODUCT NO. 900277 Customed, Inc.	LRO
Oct 4, 1996	K962652	URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) Customed, Inc.	KNX
Sep 27, 1996	K962596	CUSTOMED BLOOD EXTRACTION KIT Customed, Inc.	GJE
May 9, 1996	K961442	UNIVERSAL DRAINAGE TRAY Customed, Inc.	FCM
Oct 2, 1995	K953678	STERIMED STERIZATION WRAPPER (NON-STERILE) Customed, Inc.	FRG
Apr 18, 1995	K950295	WOUND CLOSURE/LACERATION TRAY Customed, Inc.	LRO
Sep 8, 1994	K942177	FOLEY CATHETERIZATION TRAY Customed, Inc.	FCM
Aug 27, 1993	K925018	IV PREP KIT W/O DRESSING (NON-STERILE) Customed, Inc.	LRS
Aug 27, 1993	K925017	IV PREP KIT (NON-STERILE) Customed, Inc.	LRS
Jul 14, 1993	K930986	BLOOD GAS KIT (NON-STERILE) REORDER NO. 0560 Customed, Inc.	CBT
Jul 7, 1993	K925020	TRACHEOSTOMY CARE KIT (STERILE) Customed, Inc.	JOH
Jun 7, 1993	K925021	TPN TRAY (STERILE) Customed, Inc.	MCY
Jun 7, 1993	K925015	STERILE SUTURE REMOVAL KIT Customed, Inc.	MCZ
Jun 7, 1993	K924809	IRRIGATION TRAY W/ BULB SYRINGE Customed, Inc.	KYZ
Apr 26, 1993	K925022	SURGICAL TRAY (STERILE) Customed, Inc.	LRD
Apr 26, 1993	K925016	PREP SHAVE KIT (NON-STERILE) Customed, Inc.	LRO
Jan 2, 1991	K904694	CUSTOMED ANGIODRAPE PACK FEMORAL Customed, Inc.	KKX
Jan 2, 1991	K904693	CUSTOMED CARDIOVASCULAR PACK Customed, Inc.	KKX
Oct 31, 1990	K902191	CUSTOMED LAP PACK II Customed, Inc.	KKX
Oct 31, 1990	K901705	CUSTOMED CYSTO PACK II Customed, Inc.	KKX
Sep 28, 1990	K902032	O. B. PACK IV Customed, Inc.	HFC
Sep 20, 1990	K902274	CUSTOMED CYSTO PACK I Customed, Inc.	FAJ
Sep 19, 1990	K902886	CUSTOMED BASIC PACK III Customed, Inc.	KKX
Sep 19, 1990	K902885	CUSTOMED BASIC PACK II Customed, Inc.	KKX
Sep 19, 1990	K902884	CUSTOMED BASIC PACK I Customed, Inc.	KKX
Sep 10, 1990	K902888	CUSTOMED ORTHOPEDIC II Customed, Inc.	LRO
Sep 10, 1990	K902887	CUSTOMED ARTHROSCOPY PACK Customed, Inc.	LRO
Aug 29, 1990	K903336	CUSTOMED HIP PACT Customed, Inc.	LRO
Aug 21, 1990	K902273	O. B. PACK III Customed, Inc.	HHD
Aug 15, 1990	K902272	O. B. PACK II Customed, Inc.	HHD
Aug 15, 1990	K902271	O. B. PACK I Customed, Inc.	HHD
Jul 12, 1990	K902031	CUSTOMED LAP PACK IV Customed, Inc.	KKX
Jul 12, 1990	K902030	CUSTOMED LAP PACK III Customed, Inc.	KKX
Jul 12, 1990	K902029	CUSTOMED LAP PACK I Customed, Inc.	KKX

Latest recalls

Date	Firm and product	Code	Linked 510(k)
Apr 14, 2016	Customed, Inc Catalog Number: 900998 CESAREAN SECTION SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	OHM	None listed
Apr 14, 2016	Customed, Inc Catalog Number: 900997 PERI-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	OKV	None listed
Apr 14, 2016	Customed, Inc Catalog Number: 900996 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	LRO	K902029
Apr 14, 2016	Customed, Inc Catalog Number: 900982 ARTHROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	OJH	None listed
Apr 14, 2016	Customed, Inc Catalog Number: 900946 STRABISMUS SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	LRO	None listed
Apr 14, 2016	Customed, Inc Catalog Number: 900944 CATARACT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	OJK	None listed
Apr 14, 2016	Customed, Inc Catalog Number: 900921A C-SECTION SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	OHM	None listed
Apr 14, 2016	Customed, Inc Catalog Number: 900796 FEMORAL ANGIOGRAPHY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, et Terminated	OEQ	K902191
Apr 14, 2016	Customed, Inc Catalog Number: 900782 SKIN STAPLE REMOVER STERILE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	LRO	None listed
Apr 14, 2016	Customed, Inc Catalog Number: 900774 INCISION AND DRAINAGE TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	LRO	None listed
Apr 14, 2016	Customed, Inc Catalog Number: 900742A CARPAL TUNEL LARGE SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc Terminated	OJH	None listed
Apr 14, 2016	Customed, Inc Catalog Number: 900741A ORTHO-IMPLANT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	OJH	None listed
Apr 14, 2016	Customed, Inc Catalog Number: 900740A ARTHROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	OJH	None listed
Apr 14, 2016	Customed, Inc Catalog Number: 900633 FAN FOLD SHEET 44 X 58 Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	KKX	None listed
Apr 14, 2016	Customed, Inc Catalog Number: 900629 STERILE OR CLOTH TOWEL BLUE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	KKX	None listed
Apr 14, 2016	Customed, Inc Catalog Number: 900618A LAPAROSCOPY-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	LRO	None listed
Apr 14, 2016	Customed, Inc Catalog Number: 900582 UTILITY DRAPE WITH TAPE, SMS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	KKX	None listed
Apr 14, 2016	Customed, Inc Catalog Number: 900576A LAP-CHOLECYSTECTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, e Terminated	LRO	None listed
Apr 14, 2016	Customed, Inc Catalog Number: 900548A PERY-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	OKV	None listed
Apr 14, 2016	Customed, Inc Catalog Number: 900547 BASIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	LRO	K902029
Apr 14, 2016	Customed, Inc Catalog Number: 900540 WOUND MANAGEMENT TRAY III Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	LRO	None listed
Apr 14, 2016	Customed, Inc Catalog Number: 900522 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III, LARGE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, Terminated	FYA	K971920
Apr 14, 2016	Customed, Inc Catalog Number: 900521 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III, X-LARGE Used by medical staff to perform surgical procedures and patient care procedures such as wound healin Terminated	FYA	K971920
Apr 14, 2016	Customed, Inc Catalog Number: 900486 LAPAROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	OHD	None listed
Apr 14, 2016	Customed, Inc Catalog Number: 900484 LAPAROSCOPIC GYNECOLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds Terminated	OHD	None listed
Apr 14, 2016	Customed, Inc Catalog Number: 900474 LAPAROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	LRO	None listed
Apr 14, 2016	Customed, Inc Catalog Number: 900450 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	LRO	K902030
Apr 14, 2016	Customed, Inc Catalog Number: 900419 LABOR & DELIVERY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	OKV	None listed
Apr 14, 2016	Customed, Inc Catalog Number: 900410 CESAREAN SECTION SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	OHM	None listed
Apr 14, 2016	Customed, Inc Catalog Number: 900403 CESAREAN SECTION SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	OHM	None listed
Apr 14, 2016	Customed, Inc Catalog Number: 900345 BASIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	LRO	K902886
Apr 14, 2016	Customed, Inc Catalog Number: 9003190 SURG GOWN SMS AMMI IV FULL Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	LRO	K971920
Apr 14, 2016	Customed, Inc Catalog Number: 9002940 OBSTETRICAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	OKV	K902271
Apr 14, 2016	Customed, Inc Catalog Number: 9002899 CYSTO TUR SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	LRO	K902274
Apr 14, 2016	Customed, Inc Catalog Number: 9002830 ORTHOPEDIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	OJH	None listed
Apr 14, 2016	Customed, Inc Catalog Number: 9002829 BASIC SURG PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	LRO	None listed
Apr 14, 2016	Customed, Inc Catalog Number: 900281A LAPAROTOMY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	LRO	None listed
Apr 14, 2016	Customed, Inc Catalog Number: 900278 URETHRAL CATHETER TRAY 14FR Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	NWO	None listed
Apr 14, 2016	Customed, Inc Catalog Number: 900277 SUCTION CATHETER TRAY 14FR WITH SODIUM CHLORIDE 0.9% IRRIGATION Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture Terminated	JOL	None listed
Apr 14, 2016	Customed, Inc Catalog Number: 9002766 SHOULDER PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	OJH	None listed
Apr 14, 2016	Customed, Inc Catalog Number: 9002726 HIP AND KNEE REPLACEMENT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate woun Terminated	OJH	None listed
Apr 14, 2016	Customed, Inc Catalog Number: 9002618 OPEN HEART SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	OFA	K904693
Apr 14, 2016	Customed, Inc Catalog Number: 9002615 EXTREMITY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	OJH	None listed
Apr 14, 2016	Customed, Inc Catalog Number: 9002614 HIP AND KNEE REPLACEMENT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wound Terminated	OJH	None listed
Apr 14, 2016	Customed, Inc Catalog Number: 9002609 ARTHOSCOPY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	OJH	None listed
Apr 14, 2016	Customed, Inc Catalog Number: 9002516 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	LRO	K902031
Apr 14, 2016	Customed, Inc Catalog Number: 9002511 MINOR SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	LRO	None listed
Apr 14, 2016	Customed, Inc Catalog Number: 9002510 UROLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	LRO	None listed
Apr 14, 2016	Customed, Inc Catalog Number: 9002469 BASIC SURGICAL PACK IV Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	LRO	None listed
Apr 14, 2016	Customed, Inc Catalog Number: 9002259A LAPAROSCOPY-COLORECTAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds Terminated	LRO	None listed

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