Data / Medical devices / United States / Customed, Inc.
Customed, Inc.: FDA-registered device maker in Fajardo, PR, United States, 101 510(k) clearances
Customed, Inc. is registered with the FDA (registration 2648727) in Fajardo, PR, United States. It lists 111 device types. The FDA files 101 510(k) clearances under its listings, the newest dated August 21, 2017. 5 recall events name it as the recalling firm (2 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2648727
- Address
- CALLE IGUALDAD No. 7, Fajardo, PR, United States, 00738
- Owner or operator
- CUSTOMED, INC. (9000786)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- June 23, 1994
- Registered through
- 2026
- Brand names listed
- ANESTHESIA CUSTOM CIRCUIT HOS, ASPIRATOR, BLOOD GAS KIT WITH PROTECTOR, Biopsy kit, CUSTOMED, CUSTOMED INC, CUSTOMED INC., CUTOMED INC and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 101.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 21, 2017 | K171276 | Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs | KGO | Substantially Equivalent | Tg Medical Sdn. Bhd. | accessdata.fda.gov |
| June 12, 2012 | K120045 | EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV | FYA | Substantially Equivalent | Exact Medical Manufacturing, Inc. | accessdata.fda.gov |
| August 26, 2011 | K111535 | EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER | FYA | Substantially Equivalent | Exact Medical Manufacturing, Inc. | accessdata.fda.gov |
| May 27, 2011 | K092338 | MEDAX UNIPERSONALE SRL | KNW | Substantially Equivalent | Medax Unipersonale Srl | accessdata.fda.gov |
| January 13, 2011 | K102861 | SURGIPLUS SMS SURGICAL DRAPE (STERILE/NON-STERILE), SURGIPLUS SPP WITH PE LAMINATED SURGICAL DRAPE (STERILE/NON-STERILE) | KKX | Substantially Equivalent | A Plus International, Inc. | accessdata.fda.gov |
| January 3, 2011 | K103212 | ROUGHRIDER | IOR | Substantially Equivalent | Whirlwind Wheelchair International | accessdata.fda.gov |
| November 9, 2010 | K102666 | KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIM | KKX | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| October 4, 2010 | K101598 | EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS) | KKX | Substantially Equivalent | Exact Medical Manufacturing, Inc. | accessdata.fda.gov |
| September 20, 2010 | K101689 | EMM EQUIPMENT COVER-POLYTHYLENE | KKX | Substantially Equivalent | Exact Medical Manufacturing, Inc. | accessdata.fda.gov |
| September 20, 2010 | K101688 | EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004 | KKX | Substantially Equivalent | Exact Medical Manufacturing, Inc. | accessdata.fda.gov |
| September 3, 2010 | K101593 | EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL | FYA | Substantially Equivalent | Exact Medical Manufacturing, Inc. | accessdata.fda.gov |
| December 4, 2009 | K093570 | POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR | LYZ | Substantially Equivalent | Jiangsu Jaysun Glove Co., Ltd. | accessdata.fda.gov |
| November 12, 2009 | K093169 | SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED SURGICAL GOWN (STERILE) (NON STERILE) | FYA | Substantially Equivalent | A Plus International, Inc. | accessdata.fda.gov |
| November 10, 2009 | K091272 | BESMED JET NEBULIZER BOTTLE SET | CAF | Substantially Equivalent | Besmed Health Business Corp | accessdata.fda.gov |
| March 25, 2009 | K083234 | KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100 | KKX | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| October 8, 2008 | K082815 | WELL LEAD SILICONE AND LATEX FOLEY CATHETERS | EZL | Substantially Equivalent | Well Lead Medical Instruments | accessdata.fda.gov |
| August 11, 2008 | K081633 | PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS | FXX | Substantially Equivalent | Primed Medical Products, Inc. | accessdata.fda.gov |
| October 1, 2007 | K070411 | AMSURE NEBULIZER | CAF | Substantially Equivalent | Amsino International, Inc. | accessdata.fda.gov |
| July 11, 2005 | K050887 | GONGDONG DISPOSABLE VAGINAL SPECULUM | HIB | Substantially Equivalent | Zhejiang Gongdong Medical Plastic Factory | accessdata.fda.gov |
| May 19, 2005 | K050528 | POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET,PINK,GREEN,BLACK) | LZA | Substantially Equivalent | Spi Gloves Sdn. Bhd. | accessdata.fda.gov |
| April 14, 2005 | K050532 | CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WA | LYY | Substantially Equivalent | Spi Gloves Sdn. Bhd. | accessdata.fda.gov |
| February 18, 2005 | K042683 | WELL LEAD ENDOTRACHEAL TUBE | BTR | Substantially Equivalent | Well Lead Medical Instruments | accessdata.fda.gov |
| August 20, 2004 | K041436 | SYNTHETIC SURGICAL GLOVE-POWDERFREE NUZONE X2 | KGO | Substantially Equivalent | Terang Nusa Sdn Bhd | accessdata.fda.gov |
| May 25, 2004 | K041190 | A&I POWER WHEELCHAIR, PC-401 | ITI | Substantially Equivalent | Well Success Biotech, Inc. | accessdata.fda.gov |
| March 14, 2003 | K030228 | POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES | KGO | Substantially Equivalent | Pt. Medisafe Technologies | accessdata.fda.gov |
| November 29, 2001 | K013443 | POWDERED LATEX MEDICAL MEDICAL EXAMINATION GLOVES WITH 150 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER DM2 | LYY | Substantially Equivalent | Maxter Glove Manufacturing Sdn Bhd | accessdata.fda.gov |
| February 23, 2001 | K010198 | STERILE POWDERED LATEX SURGEON GLOVES | KGO | Substantially Equivalent | Supermax Glove Manufacturing Sdn Bhd | accessdata.fda.gov |
| September 8, 2000 | K001951 | PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP, PROCEDURE MASK PM4-306 | FXX | Substantially Equivalent | Primeline Medical Products, Inc. | accessdata.fda.gov |
| September 7, 2000 | K001872 | I.V. SET-LUER LOCK WITH LATEX FREE INJECTION SITE, MODEL B411 | FPA | Substantially Equivalent | Codan US Corp. | accessdata.fda.gov |
| August 17, 2000 | K001858 | OPERATING ROOM TOWEL, STERILE, COLORS BLUE OR WHITE | KKX | Substantially Equivalent | China Nantong Guangda Textile Co., Ltd. | accessdata.fda.gov |
| March 10, 2000 | K992821 | SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES | LYZ | Substantially Equivalent | Shijiazhuang Hongxiang Plastics Products Co., Ltd. | accessdata.fda.gov |
| October 27, 1999 | K993258 | SUPERGLOVES, POWDER FREE NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | Supermax Sdn Bhd | accessdata.fda.gov |
| July 30, 1999 | K992219 | POWDERED LATEX STERILE SURGICAL GLOVES | KGO | Substantially Equivalent | Tg Medical Sdn. Bhd. | accessdata.fda.gov |
| July 10, 1998 | K981393 | MICROCOOL SURGICAL GOWN | FYA | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| June 9, 1998 | K980494 | SUPERGLOVES | LYY | Substantially Equivalent | Supermax Sdn Bhd | accessdata.fda.gov |
| March 13, 1998 | K980071 | SUPERGLOVES LOW PROTEIN POWDER FREE LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | Supermax Latex Products Sdn. Bhd. | accessdata.fda.gov |
| January 5, 1998 | K974647 | FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633 | KKX | Substantially Equivalent | Customed, Inc. | accessdata.fda.gov |
| December 19, 1997 | K974042 | AMSURE CLEANSING ENEMA SET | FCE | Substantially Equivalent | Amsino Intl., Inc. | accessdata.fda.gov |
| December 4, 1997 | K971920 | GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522) | FYA | Substantially Equivalent | Customed, Inc. | accessdata.fda.gov |
| September 12, 1997 | K972306 | POWDERFREE COLORED AND FLAVORED NITRILE COPOLYMER PATIENT EXAMINATION GLOVES-MEDICAL DEVICE | LZA | Substantially Equivalent | P.T. Irama Dinamika Latex | accessdata.fda.gov |
| August 6, 1997 | K971929 | AMSINO URINARY LEG BAG | KNX | Substantially Equivalent | Amsino Intl., Inc. | accessdata.fda.gov |
| December 17, 1996 | K963749 | HIGH PRESSURE INJECTION LINES | DTL | Substantially Equivalent | Maxxim Medical | accessdata.fda.gov |
| October 4, 1996 | K962652 | URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) | KNX | Substantially Equivalent | Customed, Inc. | accessdata.fda.gov |
| September 27, 1996 | K962596 | CUSTOMED BLOOD EXTRACTION KIT | GJE | Substantially Equivalent | Customed, Inc. | accessdata.fda.gov |
| August 15, 1996 | K962161 | BAXTER NEBULIZER CAP MODEL 2D0868 | CAF | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| May 9, 1996 | K961442 | UNIVERSAL DRAINAGE TRAY | FCM | Substantially Equivalent | Customed, Inc. | accessdata.fda.gov |
| October 2, 1995 | K953678 | STERIMED STERIZATION WRAPPER (NON-STERILE) | FRG | Substantially Equivalent | Customed, Inc. | accessdata.fda.gov |
| May 11, 1995 | K951528 | AMSINO DISPOSABLE VIGINAL SPECULUM | HIB | Substantially Equivalent | Amsino Intl., Inc. | accessdata.fda.gov |
| April 18, 1995 | K950295 | WOUND CLOSURE/LACERATION TRAY | LRO | Substantially Equivalent | Customed, Inc. | accessdata.fda.gov |
| November 15, 1994 | K943954 | ASPEN SURGICAL SYSTEMS INSUFFLATION TUBING SET WITH FILTER | HIF | Substantially Equivalent | Conmedcorp | accessdata.fda.gov |
| August 1, 1994 | K935782 | DTX AND DTX PLUS DISPOSABLE PRESSURE TRANSDUCERS AND ACCESSORIES | DXN | Substantially Equivalent | Ohmeda Medical | accessdata.fda.gov |
| June 21, 1994 | K941900 | POWDERED LATEX EXAM GLOVES | LYY | Substantially Equivalent | Tg Medical Sdn. Bhd. | accessdata.fda.gov |
| December 14, 1993 | K934310 | BAGEASY(R) III ADULT DISPOSABLE MANUAL RESUSCITATOR | BTM | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| August 27, 1993 | K925018 | IV PREP KIT W/O DRESSING (NON-STERILE) | LRS | Unknown | Customed, Inc. | accessdata.fda.gov |
| July 14, 1993 | K930986 | BLOOD GAS KIT (NON-STERILE) REORDER NO. 0560 | CBT | Unknown | Customed, Inc. | accessdata.fda.gov |
| July 7, 1993 | K925020 | TRACHEOSTOMY CARE KIT (STERILE) | JOH | Unknown | Customed, Inc. | accessdata.fda.gov |
| June 7, 1993 | K925021 | TPN TRAY (STERILE) | MCY | Unknown | Customed, Inc. | accessdata.fda.gov |
| June 7, 1993 | K925015 | STERILE SUTURE REMOVAL KIT | MCZ | Unknown | Customed, Inc. | accessdata.fda.gov |
| June 7, 1993 | K924809 | IRRIGATION TRAY W/ BULB SYRINGE | KYZ | Unknown | Customed, Inc. | accessdata.fda.gov |
| April 26, 1993 | K925022 | SURGICAL TRAY (STERILE) | LRD | Substantially Equivalent | Customed, Inc. | accessdata.fda.gov |
| April 26, 1993 | K925016 | PREP SHAVE KIT (NON-STERILE) | LRO | Substantially Equivalent | Customed, Inc. | accessdata.fda.gov |
| March 31, 1993 | K930411 | UNIVERSAL WHEELCHAIR | IOR | Substantially Equivalent | Everest & Jennings, Inc. | accessdata.fda.gov |
| February 3, 1993 | K926055 | THE MILLER NEBULIZER SYSTEM | CAF | Substantially Equivalent | Warren C. Miller | accessdata.fda.gov |
| December 11, 1992 | K915301 | ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK | DTL | Substantially Equivalent | Advance Medical Designs, Inc. | accessdata.fda.gov |
| August 24, 1992 | K922492 | SPECIALTY PACKAGING PROD BACTERIAL/VIRAL FILTER | CAH | Substantially Equivalent | Specialty Packaging Producs, Inc. | accessdata.fda.gov |
| October 23, 1991 | K911710 | HEPARIN COATED THERMODILUTION CATH & ACCESSORIES | DQO | Substantially Equivalent | Sunscope Intl., Inc. | accessdata.fda.gov |
| October 21, 1991 | K912492 | EVACUATION/IRRIGATION/ELECROSURGICAL DEVICE | GCJ | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| September 16, 1991 | K911732 | ADVANCE DISPOSABLE CONTROL SYRINGE | IZI | Substantially Equivalent | Advance Medical Designs, Inc. | accessdata.fda.gov |
| January 2, 1991 | K904694 | CUSTOMED ANGIODRAPE PACK FEMORAL | KKX | Unknown | Customed, Inc. | accessdata.fda.gov |
| January 2, 1991 | K904693 | CUSTOMED CARDIOVASCULAR PACK | KKX | Unknown | Customed, Inc. | accessdata.fda.gov |
| October 31, 1990 | K902191 | CUSTOMED LAP PACK II | KKX | Substantially Equivalent | Customed, Inc. | accessdata.fda.gov |
| October 31, 1990 | K901705 | CUSTOMED CYSTO PACK II | KKX | Substantially Equivalent | Customed, Inc. | accessdata.fda.gov |
| September 28, 1990 | K902032 | O. B. PACK IV | HFC | Substantially Equivalent | Customed, Inc. | accessdata.fda.gov |
| September 20, 1990 | K902274 | CUSTOMED CYSTO PACK I | FAJ | Unknown | Customed, Inc. | accessdata.fda.gov |
| September 19, 1990 | K902886 | CUSTOMED BASIC PACK III | KKX | Substantially Equivalent | Customed, Inc. | accessdata.fda.gov |
| September 19, 1990 | K902884 | CUSTOMED BASIC PACK I | KKX | Substantially Equivalent | Customed, Inc. | accessdata.fda.gov |
| August 21, 1990 | K902273 | O. B. PACK III | HHD | Substantially Equivalent | Customed, Inc. | accessdata.fda.gov |
| August 15, 1990 | K902272 | O. B. PACK II | HHD | Substantially Equivalent | Customed, Inc. | accessdata.fda.gov |
| August 15, 1990 | K902271 | O. B. PACK I | HHD | Substantially Equivalent | Customed, Inc. | accessdata.fda.gov |
| July 12, 1990 | K902031 | CUSTOMED LAP PACK IV | KKX | Substantially Equivalent | Customed, Inc. | accessdata.fda.gov |
| July 12, 1990 | K902030 | CUSTOMED LAP PACK III | KKX | Substantially Equivalent | Customed, Inc. | accessdata.fda.gov |
| July 12, 1990 | K902029 | CUSTOMED LAP PACK I | KKX | Substantially Equivalent | Customed, Inc. | accessdata.fda.gov |
| October 3, 1989 | K894350 | SALTER LABS MODEL #4009 SAMPLE LINES | CCK | Substantially Equivalent | Salter Labs | accessdata.fda.gov |
| January 25, 1989 | K885235 | SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS. | DSK | Substantially Equivalent | Spectramed, Inc. | accessdata.fda.gov |
| June 23, 1988 | K882284 | SURGEONS CAP | FYF | Substantially Equivalent | A Plus International, Inc. | accessdata.fda.gov |
| June 23, 1988 | K882283 | BOUFFANT CAP | FYF | Substantially Equivalent | A Plus International, Inc. | accessdata.fda.gov |
| June 23, 1988 | K882280 | COVER, SHOE OPERATING ROOM | FXP | Substantially Equivalent | A Plus International, Inc. | accessdata.fda.gov |
| April 29, 1988 | K881396 | OPERATING ROOM TOWELS -STERILE & NON-STERILE | KKX | Substantially Equivalent | A Plus International, Inc. | accessdata.fda.gov |
| April 28, 1988 | K881395 | GAUZE AND LAP SPONGES -STERILE & NON-STERILE | EFQ | Substantially Equivalent | A Plus International, Inc. | accessdata.fda.gov |
| March 5, 1987 | K870417 | RCT-1, RCT-2, RCT-3 ARTHROGRAM TRAY | FSM | Substantially Equivalent | North Coast Medi-Tek | accessdata.fda.gov |
| August 7, 1986 | K862801 | SPUNGUARD PLUS SURGICAL DRAPE | KKX | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| February 26, 1986 | K855145 | MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATOR | DRS | Substantially Equivalent | Gould, Inc. | accessdata.fda.gov |
| November 25, 1985 | K854095 | BIOPSY TRAY I & II | LRO | Unknown | North Coast Medi-Tek | accessdata.fda.gov |
| June 11, 1984 | K842115 | SPUNGARD & SURG. DRAPES-GOWNS & PACKS | KKX | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| May 23, 1984 | K840824 | HEPARIN COATED THERMODILUTION CATHETERS | KRB | Substantially Equivalent | Gould, Inc. | accessdata.fda.gov |
| April 23, 1981 | K810637 | COBE DISPOSABLE PRESSURE TRANSDUCER | DRS | Substantially Equivalent | Cobe Laboratories, Inc. | accessdata.fda.gov |
| February 6, 1981 | K810126 | CURITY CURAD BANDAGES | KGX | Substantially Equivalent | The Kendal Co. | accessdata.fda.gov |
| March 25, 1980 | K800562 | DISPOSABLE HAND HELD NEBULIZER | CAF | Substantially Equivalent | Intec Medical, Inc. | accessdata.fda.gov |
| October 10, 1978 | K781558 | PRESSURE MONITORING INJECTION LINES | DQO | Substantially Equivalent | Cobe Laboratories, Inc. | accessdata.fda.gov |
| March 2, 1978 | K780271 | COBE STOPCOCK | DTL | Substantially Equivalent | Cobe Laboratories, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 7, 2016 | 72992 | Class II | Terminated | Catalog Number: 9001771 MAYO STAND COVER STERILE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. | accessdata.fda.gov |
| July 10, 2015 | 71721 | Class II | Terminated | ANGIODRAPE PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. | accessdata.fda.gov |
| October 8, 2014 | 69448 | Class I | Terminated | Surgical packs (includes trays, bags and kits) Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes (QSR) and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection. | accessdata.fda.gov |
| May 20, 2014 | 68536 | Class I | Terminated | Customed Angiodrape Pack convenience pack include multiple components: syringe 10cc and 30cc, gauze, denture cup, specimen container, band bag, glove, gown, needle hypodermic, absorbent towels, table cover, scalpel,cloth | Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. | accessdata.fda.gov |
| December 8, 2011 | 60753 | Not yet classified | Terminated | Suture removal kit, catalog# | The firm has determined that there is a possibility that packaging seals may be compromised. The issue could result in an injury to the patient due to product contamination or loss of sterility condition. | accessdata.fda.gov |
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Updated August 21, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.