ACTIVE MEDICAL, INC.

FDA Device Registration & Listing · HARRISBURG, PA, US · Registration 2529647

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
2529647
FEI Number
1000121298
Entity Name
ACTIVE MEDICAL, INC.
City/State/Country
HARRISBURG, PA, US
Establishment Address
2200B HUMMINGBIRD LANE, HARRISBURG, PA 17112, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
ACTIVE MEDICAL, INC. (Owner Number: 9009036)
Owner / Operator Contact Address
2200 B Hummingbird Lane, --, Harrisburg, PA 17112, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

MEDIONICS INTERNATIONAL MEDIONICS INTERNATIONAL NEOMEDIC INTERNATIONAL NEOMEDIC INTERNATIONAL MEDIONICS INTERNATIONAL MEDIONICS INTERNATIONAL

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FJS Catheter, Peritoneal, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2017-04-06
FJS Catheter, Peritoneal, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2017-04-06
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2024-12-17
OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed Obstetrics/Gynecology Class 3 884.5980 2017-04-06
OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator General, Plastic Surgery Class 2 878.3300 2017-04-06
HWT Template Orthopedic Class 1 888.4800 2017-04-06
GBW Catheter, Peritoneal General, Plastic Surgery Class 1 878.4200 2017-04-06

Official Correspondent

JAMES DELANEY

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ACTIVE MEDICAL, 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
K914997 Conmedcorp ASP-IRRATOR 1992-01-07
K153773 Olympus Medical Systems Corp. Disposal Lens Cleaning Sheath 2016-11-22
K940141 Micro-Medical Devices, Inc. LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH 1994-05-19
K933812 Advanced Surgical, Inc. ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES 1993-12-13
K254228 Karl Storz SE & CO. KG KARL STORZ Trocars with Valve Seals 2026-05-11

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0027-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2529647. Last updated year: 2026. Please use registration number 2529647 when referencing this establishment in official correspondence.
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