Customed, Inc
Fajardo, PR, US
CUSTOMED, INC. appears in FDA device records in Fajardo, PR. FDA records list 37 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 699 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 37 510(k) clearances for Customed, Inc between 1990 and 2026. The busiest year on record is 1990, with 16. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 16 |
| 1991 | 2 |
| 1993 | 9 |
| 1994 | 1 |
| 1995 | 2 |
| 1996 | 4 |
| 1997 | 1 |
| 1998 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260116 | CustoMED Viewer | LLZ | Substantially Equivalent | |
| K974647 | FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633 | KKX | Substantially Equivalent | |
| K971920 | GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522) | FYA | Substantially Equivalent | |
| K964011 | SUCTION CATHETER TRAY PRODUCT NO. 900277 | LRO | Unknown | |
| K962652 | URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) | KNX | Substantially Equivalent | |
| K962596 | CUSTOMED BLOOD EXTRACTION KIT | GJE | Substantially Equivalent | |
| K961442 | UNIVERSAL DRAINAGE TRAY | FCM | Substantially Equivalent | |
| K953678 | STERIMED STERIZATION WRAPPER (NON-STERILE) | FRG | Substantially Equivalent | |
| K950295 | WOUND CLOSURE/LACERATION TRAY | LRO | Substantially Equivalent | |
| K942177 | FOLEY CATHETERIZATION TRAY | FCM | Substantially Equivalent | |
| K925018 | IV PREP KIT W/O DRESSING (NON-STERILE) | LRS | Unknown | |
| K925017 | IV PREP KIT (NON-STERILE) | LRS | Substantially Equivalent | |
| K930986 | BLOOD GAS KIT (NON-STERILE) REORDER NO. 0560 | CBT | Unknown | |
| K925020 | TRACHEOSTOMY CARE KIT (STERILE) | JOH | Unknown | |
| K925021 | TPN TRAY (STERILE) | MCY | Unknown | |
| K925015 | STERILE SUTURE REMOVAL KIT | MCZ | Unknown | |
| K924809 | IRRIGATION TRAY W/ BULB SYRINGE | KYZ | Unknown | |
| K925022 | SURGICAL TRAY (STERILE) | LRD | Substantially Equivalent | |
| K925016 | PREP SHAVE KIT (NON-STERILE) | LRO | Substantially Equivalent | |
| K904694 | CUSTOMED ANGIODRAPE PACK FEMORAL | KKX | Unknown | |
| K904693 | CUSTOMED CARDIOVASCULAR PACK | KKX | Unknown | |
| K902191 | CUSTOMED LAP PACK II | KKX | Substantially Equivalent | |
| K901705 | CUSTOMED CYSTO PACK II | KKX | Substantially Equivalent | |
| K902032 | O. B. PACK IV | HFC | Substantially Equivalent | |
| K902274 | CUSTOMED CYSTO PACK I | FAJ | Unknown | |
| K902886 | CUSTOMED BASIC PACK III | KKX | Substantially Equivalent | |
| K902885 | CUSTOMED BASIC PACK II | KKX | Substantially Equivalent | |
| K902884 | CUSTOMED BASIC PACK I | KKX | Substantially Equivalent | |
| K902888 | CUSTOMED ORTHOPEDIC II | LRO | Substantially Equivalent | |
| K902887 | CUSTOMED ARTHROSCOPY PACK | LRO | Substantially Equivalent | |
| K903336 | CUSTOMED HIP PACT | LRO | Substantially Equivalent | |
| K902273 | O. B. PACK III | HHD | Substantially Equivalent | |
| K902272 | O. B. PACK II | HHD | Substantially Equivalent | |
| K902271 | O. B. PACK I | HHD | Substantially Equivalent | |
| K902031 | CUSTOMED LAP PACK IV | KKX | Substantially Equivalent | |
| K902030 | CUSTOMED LAP PACK III | KKX | Substantially Equivalent | |
| K902029 | CUSTOMED LAP PACK I | KKX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2648727 | 2648727 | CUSTOMED, INC. | CALLE IGUALDAD No. 7, Fajardo, PR 00738 US | 2026 | and 101 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered
- CBTArterial Blood Sampling Kit
- FAQBag, Urine Collection, Leg, For External Use, Sterile
- FQMBandage, Elastic
- FNYBasin, Emesis
- FNLBed, Ac-Powered Adjustable Hospital
- FOBBedpan
- GESBlade, Scalpel
- GECBrush, Scrub, Operating-Room
- CATCannula, Nasal, Oxygen
- FYFCap, Surgical
- BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)
- DQOCatheter, Intravascular, Diagnostic
- EZLCatheter, Retention Type, Balloon
- BSYCatheters, Suction, Tracheobronchial
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- DSKComputer, Blood-Pressure
- FMHContainer, Specimen, Sterile
- FXPCover, Shoe, Operating-Room
- FAJCystoscope And Accessories, Flexible/Rigid
- DREDilator, Vessel, For Percutaneous Catheterization
- FCEEnema Kit
- FRLFiber, Medical, Absorbent
- CAHFilter, Bacterial, Breathing-Circuit
- EYQGarment, Protective, For Incontinence
- EFQGauze/Sponge, Internal
- GDYGauze/Sponge, Internal, X-Ray Detectable
- FMEGown, Examination
- FYCGown, Isolation, Surgical
- FYAGown, Surgical
- GDFGuide, Needle, Surgical
- GDZHandle, Scalpel
- GCJLaparoscope, General & Plastic Surgery
- FXXMask, Surgical
- CAFNebulizer (Direct Patient Interface)
- GADRetractor
- FNSRing Cutter
- GDRSaw, Manual And Accessories
- GDXScalpel, One-Piece
- FPASet, Administration, Intravascular
- BZOSet, Tubing And Support, Ventilator (W Harness)
- EPYSpeculum, Ent
- HDFSpeculum, Vaginal, Metal
- GDTStaple, Removable (Skin)
- FXOSuit, Surgical
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- GAXTourniquet, Nonpneumatic
- DRSTransducer, Blood-Pressure, Extravascular
- BYZTrap, Sterile Specimen
- GJETray, Blood Collection
- FCMTray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
- FSMTray, Surgical, Instrument
- BYYTube, Aspirating, Flexible, Connecting
- BTRTube, Tracheal (W/Wo Connector)
- BYXTubing, Pressure And Accessories
- FNPUrinal
- BTMVentilator, Emergency, Manual (Resuscitator)
- FRGWrap, Sterilization
Recall records
Showing 25 of 699| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1496-2016 | 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. | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. | Class II | Terminated | |
| Z-1495-2016 | 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. | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. | Class II | Terminated | |
| Z-1494-2016 | 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. | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. | Class II | Terminated | |
| Z-1493-2016 | 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. | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. | Class II | Terminated | |
| Z-1492-2016 | 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. | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. | Class II | Terminated | |
| Z-1491-2016 | 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. | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. | Class II | Terminated | |
| Z-1490-2016 | 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. | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. | Class II | Terminated | |
| Z-1489-2016 | 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, etc. | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. | Class II | Terminated | |
| Z-1488-2016 | 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. | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. | Class II | Terminated | |
| Z-1487-2016 | 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. | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. | Class II | Terminated | |
| Z-1486-2016 | 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. | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. | Class II | Terminated | |
| Z-1485-2016 | 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. | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. | Class II | Terminated | |
| Z-1484-2016 | 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. | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. | Class II | Terminated | |
| Z-1483-2016 | 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. | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. | Class II | Terminated | |
| Z-1482-2016 | 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. | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. | Class II | Terminated | |
| Z-1481-2016 | 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. | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. | Class II | Terminated | |
| Z-1480-2016 | 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. | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. | Class II | Terminated | |
| Z-1479-2016 | 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, etc. | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. | Class II | Terminated | |
| Z-1478-2016 | 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. | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. | Class II | Terminated | |
| Z-1477-2016 | 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. | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. | Class II | Terminated | |
| Z-1476-2016 | 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. | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. | Class II | Terminated | |
| Z-1475-2016 | 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, 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. | Class II | Terminated | |
| Z-1474-2016 | 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 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. | Class II | Terminated | |
| Z-1473-2016 | 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. | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. | Class II | Terminated | |
| Z-1472-2016 | 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, etc. | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain