CUSTOMED, INC.

FDA Device Registration & Listing · Fajardo, PR, US · Registration 2648727

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2648727
FEI Number
2648727
Entity Name
CUSTOMED, INC.
City/State/Country
Fajardo, PR, US
Establishment Address
CALLE IGUALDAD No. 7, Fajardo, PR 00738, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
CUSTOMED, INC. (Owner Number: 9000786)
Owner / Operator Contact Address
CALLE IGUALDAD #7, --, Fajardo, PR 00738, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K911710
PMA Number
N/A

All Registered Proprietary Names

Customed Customed Customed Inc Customed Inc Customed Inc Customed Customed Customed Inc Customed Inc Customed Customed Inc Customed Inc Customed Customed Inc Customed Inc Customed Inc Customed Inc Customed Inc Customed Inc Customed Inc customed Customed Inc Customed Inc Customed Inc Customed Inc Customed Customed Inc Customed Customed Inc CUSTOMED INC. Customed Suture removal kit Customed Customed Inc CUSTOMED Customed Customed Inc Customed Inc customed Customed Customed Inc CUSTOMED INC Customed Inc surgical tray Customed Inc Customed Inc Customed Inc Customed Customed catheter kit Customed Customed Inc Customed Inc Customed Inc Customed Inc Customed Inc CUTOMED INC Customed Inc BLOOD GAS KIT WITH PROTECTOR Customed Inc Customed Inc customed Customed Inc Customed Inc Customed Inc surgical drape wound dressing kit Customed Inc Customed Inc Customed Inc SYRINGE, IRRIGATING Customed Cystoscope and accessories Customed Inc ANESTHESIA CUSTOM CIRCUIT HOS Trach Tube and Cuff surgical gown Customed Inc Customed Inc Customed Customed Inc MALE AMBULATORY KIT Customed Inc Customed Inc Customed Inc Customed Inc Customed Inc Customed Inc SURGICAL TRAY Customed Inc Customed Inc Customed Inc ASPIRATOR Customed Inc Customed Inc Surgical Tray Customed Customed Inc Customed Customed Inc Customed Inc Customed catheter kit Customed Inc Customed Inc Customed Customed Customed Inc Customed Inc Customed Inc Customed Inc Customed Inc CUSTOMED INC. Customed Inc Customed Inc Customed Inc Customed Inc Customed Inc

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2015-03-17
NAB Gauze / Sponge,Nonresorbable For External Use General, Plastic Surgery Class 1 878.4014 2018-04-05
FYF Cap, Surgical General, Plastic Surgery Class 1 878.4040 2015-01-22
IOR Wheelchair, Mechanical Physical Medicine Class 1 890.3850 2015-01-08
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2015-01-08
FRL Fiber, Medical, Absorbent General Hospital Class 1 880.5300 2018-04-05
HIF Insufflator, Laparoscopic Obstetrics/Gynecology Class 2 884.1730 2015-03-05
FQM Bandage, Elastic General Hospital Class 1 880.5075 2015-01-12
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2015-01-08
GDR Saw, Manual And Accessories General, Plastic Surgery Class 1 878.4800 2015-07-30
GDT Staple, Removable (Skin) General, Plastic Surgery Class 1 878.4760 2015-01-13
HHD Pad, Menstrual, Unscented Obstetrics/Gynecology Class 1 884.5435 2015-01-08
GDY Gauze/Sponge, Internal, X-Ray Detectable General, Plastic Surgery Class 1 878.4450 2018-04-05
HRQ Hemostat General, Plastic Surgery Class 1 878.4800 2015-01-08
NKC Tubing/Tubing With Filter, Insufflation, Laparoscopic Obstetrics/Gynecology Class 1 884.1730 2015-01-09
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2015-01-23
GDX Scalpel, One-Piece General, Plastic Surgery Class 1 878.4800 2015-01-09
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2015-01-08
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2015-01-30
FYF Cap, Surgical General, Plastic Surgery Class 1 878.4040 2015-01-22
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2016-08-08
FXO Suit, Surgical General, Plastic Surgery Class 1 878.4040 2015-01-13
ITG Bandage, Cast Physical Medicine Class 1 890.3025 2015-01-12
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2015-01-13
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2015-01-08
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2018-04-05
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2015-01-08
FNL Bed, Ac-Powered Adjustable Hospital General Hospital Class 2 880.5100 2016-02-03
HIB Speculum, Vaginal, Nonmetal Obstetrics/Gynecology Class 2 884.4530 2015-01-23
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2014-12-30
FCE Enema Kit Gastroenterology, Urology Class 1 876.5210 2018-04-05
MCZ Suture Removal Kit General, Plastic Surgery Class 1 878.4800 2007-12-07
JOL Catheter And Tip, Suction General Hospital Class 2 880.6740 2015-07-30
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2015-01-08
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2016-09-22
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2018-04-05
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2015-01-22
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2015-01-08
IOR Wheelchair, Mechanical Physical Medicine Class 1 890.3850 2016-03-18
KNX Collector, Urine, (And Accessories) For Indwelling Catheter Gastroenterology, Urology Class 2 876.5250 2018-04-05
BYY Tube, Aspirating, Flexible, Connecting General Hospital Class 2 880.6740 2015-01-13
FME Gown, Examination General Hospital Class 1 880.6265 2014-12-30
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2015-01-08
GJE Tray, Blood Collection Clinical Chemistry Class 2 862.1675 2007-12-14
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2007-12-14
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2015-01-09
EPY Speculum, Ent General, Plastic Surgery Class 1 878.1800 2015-01-08
ILS Adaptor, Hygiene Physical Medicine Class 1 890.5050 2015-01-08
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2015-03-17
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2015-11-06
KNX Collector, Urine, (And Accessories) For Indwelling Catheter Gastroenterology, Urology Class 2 876.5250 2007-12-14
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2018-04-05
BZN Cart, Emergency, Cardiopulmonary (Excluding Equipment) Anesthesiology Class 1 868.6175 2015-01-08
HTF Curette General, Plastic Surgery Class 1 878.4800 2015-01-08
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2015-01-13
CBT Arterial Blood Sampling Kit Anesthesiology Class 1 868.1100 2015-01-30
HDF Speculum, Vaginal, Metal Obstetrics/Gynecology Class 1 884.4520 2015-01-08
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2014-12-30
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2015-01-13
CBT Arterial Blood Sampling Kit Anesthesiology Class 1 868.1100 1994-06-23
IKX Aid, Transfer Physical Medicine Class 1 890.5050 2015-01-08
BYX Tubing, Pressure And Accessories Anesthesiology Class 1 868.5860 2015-01-09
INP Tips And Pads, Cane, Crutch And Walker Physical Medicine Class 1 890.3790 2016-03-18
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2015-01-08
KGZ Accessories, Catheter General, Plastic Surgery Class 1 878.4200 2015-01-09
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2015-01-13
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2007-12-07
MCY Wound Dressing Kit General Hospital Class 2 880.5075 2007-11-26
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2015-01-08
HHD Pad, Menstrual, Unscented Obstetrics/Gynecology Class 1 884.5435 2015-01-08
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2015-01-08
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2007-12-14
CAT Cannula, Nasal, Oxygen Anesthesiology Class 1 868.5340 2018-04-05
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2007-12-14
GDF Guide, Needle, Surgical General, Plastic Surgery Class 1 878.4800 2015-01-13
CAI Circuit, Breathing (W Connector, Adaptor, Y Piece) Anesthesiology Class 1 868.5240 1996-03-14
JOH Tube Tracheostomy And Tube Cuff Anesthesiology Class 2 868.5800 2007-12-14
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2007-12-07
GAD Retractor General, Plastic Surgery Class 1 878.4800 2015-01-08
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2015-01-13
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2015-03-17
FYC Gown, Isolation, Surgical General, Plastic Surgery Class 2 878.4040 2015-03-17
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2015-01-08
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 1996-03-14
KYX Dispenser, Liquid Medication General Hospital Class 1 880.6430 2015-01-08
EYQ Garment, Protective, For Incontinence Gastroenterology, Urology Class 1 876.5920 2015-01-13
LRD Applicator, Ent Drug Ear, Nose, Throat Class 1 874.5220 2015-01-30
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2015-01-30
HHM Sound, Uterine Obstetrics/Gynecology Class 1 884.4530 2015-01-08
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2015-01-30
LRD Applicator, Ent Drug Ear, Nose, Throat Class 1 874.5220 1994-06-23
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2015-01-08
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2015-01-16
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2015-01-08
HFC Aspirator, Endocervical Obstetrics/Gynecology Class 2 884.1050 2007-12-14
KRB Probe, Thermodilution Cardiovascular Class 2 870.1915 2015-01-13
CAH Filter, Bacterial, Breathing-Circuit Anesthesiology Class 2 868.5260 2015-01-09
LRO General Surgery Tray General, Plastic Surgery Class 2 878.4370 2007-12-07
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2018-04-05
EFQ Gauze/Sponge, Internal Unknown Class U N/A 2015-01-22
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2016-02-03
NNI Container, Specimen, Non-Sterile Pathology Class 1 864.3250 2015-01-08
LRW Scissors, General, Surgical General, Plastic Surgery Class 1 878.4800 2015-01-08
EZL Catheter, Retention Type, Balloon Gastroenterology, Urology Class 2 876.5130 2018-04-05
FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) Gastroenterology, Urology Class 2 876.5130 2007-12-07
FOB Bedpan General Hospital Class 1 880.6730 2015-01-08
LRO General Surgery Tray General, Plastic Surgery Class 2 878.4370 2015-01-30
HTE Elevator General, Plastic Surgery Class 1 878.4800 2018-04-05
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2018-04-05
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2015-01-08
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2015-01-13
KNX Collector, Urine, (And Accessories) For Indwelling Catheter Gastroenterology, Urology Class 2 876.5250 2015-01-23
FAQ Bag, Urine Collection, Leg, For External Use, Sterile Gastroenterology, Urology Class 1 876.5250 2015-01-23
KYR Bag, Ice General Hospital Class 1 880.6050 2015-01-13
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2015-01-13
OEA Non-Surgical Gown General, Plastic Surgery Class 1 878.4040 2014-12-30
FCE Enema Kit Gastroenterology, Urology Class 1 876.5210 2015-01-23
ITJ Walker, Mechanical Physical Medicine Class 1 890.3825 2015-01-08
KTC Bath, Sitz, Nonpowered Physical Medicine Class 1 890.5125 2015-01-08
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2015-01-08
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2015-01-13

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CUSTOMED, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K914369 Deroyal Industries, Inc. QUALTEX MAGNETIC INSTRUMENT DRAPE 1991-12-02
K812809 Abco Dealers, Inc. STERILE ADHERENT DRAPES 1981-11-06
K910084 Biocor Medical, Inc. SURGICAL DRAPE 1991-03-19
K935211 Brookefield Hunter, Inc. WALK N CHAIR 1994-02-02
K832685 Health America WHEELCHAIR-VARIOUS MODELS 1983-09-20

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0021-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Z-0024-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
Z-0025-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02
Z-0026-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01
Z-0027-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2648727. Last updated year: 2026. Please use registration number 2648727 when referencing this establishment in official correspondence.
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