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Customed, Inc.

FDA 510(k) & PMA Approved Devices — 36 products

Total Devices36
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K974647 FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633KKX1998-01-05 View
510(k) K971920 GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522)FYA1997-12-04 View
510(k) K964011 SUCTION CATHETER TRAY PRODUCT NO. 900277LRO1996-11-25 View
510(k) K962652 URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)KNX1996-10-04 View
510(k) K962596 CUSTOMED BLOOD EXTRACTION KITGJE1996-09-27 View
510(k) K961442 UNIVERSAL DRAINAGE TRAYFCM1996-05-09 View
510(k) K953678 STERIMED STERIZATION WRAPPER (NON-STERILE)FRG1995-10-02 View
510(k) K950295 WOUND CLOSURE/LACERATION TRAYLRO1995-04-18 View
510(k) K942177 FOLEY CATHETERIZATION TRAYFCM1994-09-08 View
510(k) K925017 IV PREP KIT (NON-STERILE)LRS1993-08-27 View
510(k) K925018 IV PREP KIT W/O DRESSING (NON-STERILE)LRS1993-08-27 View
510(k) K930986 BLOOD GAS KIT (NON-STERILE) REORDER NO. 0560CBT1993-07-14 View
510(k) K925020 TRACHEOSTOMY CARE KIT (STERILE)JOH1993-07-07 View
510(k) K925021 TPN TRAY (STERILE)MCY1993-06-07 View
510(k) K925015 STERILE SUTURE REMOVAL KITMCZ1993-06-07 View
510(k) K924809 IRRIGATION TRAY W/ BULB SYRINGEKYZ1993-06-07 View
510(k) K925022 SURGICAL TRAY (STERILE)LRD1993-04-26 View
510(k) K925016 PREP SHAVE KIT (NON-STERILE)LRO1993-04-26 View
510(k) K904694 CUSTOMED ANGIODRAPE PACK FEMORALKKX1991-01-02 View
510(k) K904693 CUSTOMED CARDIOVASCULAR PACKKKX1991-01-02 View
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