Data / Medical devices / United States / Active Medical, Inc.
Active Medical, Inc.: FDA-registered device maker in Harrisburg, PA, United States, 8 510(k) clearances
Active Medical, Inc. is registered with the FDA (registration 2529647) in Harrisburg, PA, United States. It lists 8 device types. The FDA files 8 510(k) clearances under its listings, the newest dated November 13, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2529647
- FEI number
- 1000121298
- Address
- 2200B Hummingbird Lane, Harrisburg, PA, United States, 17112
- Owner or operator
- ACTIVE MEDICAL, INC. (9009036)
- Roles
- Repackager or relabeler
- First device listed
- April 6, 2017
- Registered through
- 2026
- Brand names listed
- MEDIONICS INTERNATIONAL, NEOMEDIC INTERNATIONAL
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Peritoneal | GBW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Catheter, Peritoneal, Long-Term Indwelling | FJS | 2 | Repackager or relabeler | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Mesh, Surgical, For Stress Urinary Incontinence, Male | OTM | 2 | Repackager or relabeler | accessdata.fda.gov |
| Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed | OTP | 3 | Repackager or relabeler | accessdata.fda.gov |
| Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling | PAH | 2 | Repackager or relabeler | accessdata.fda.gov |
| Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | OTN | 2 | Repackager or relabeler | accessdata.fda.gov |
| Template | HWT | 1 | Repackager or relabeler | accessdata.fda.gov |
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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 13, 2014 | K141593 | UNIMICRO DISPOSABLE RETRIEVAL ENDO-POUCH | GCJ | Substantially Equivalent | Unimicro Medical Systems (Shenzhen) Co., Ltd. | accessdata.fda.gov |
| April 19, 2013 | K130441 | FALLER STYLET | FJS | Substantially Equivalent | Medionics International, Inc. | accessdata.fda.gov |
| December 20, 2011 | K103022 | KIM | OTN | Substantially Equivalent | Neomedic International S.L. | accessdata.fda.gov |
| July 7, 2011 | K102815 | SURELIFT PROLAPSE SYSTEM | OTP | Substantially Equivalent | Neomedic International | accessdata.fda.gov |
| December 19, 2006 | K063136 | NEEDLELESS SLING | PAH | Substantially Equivalent | Specialities Remeex International, S.L. | accessdata.fda.gov |
| November 2, 2006 | K062341 | MALE REMEEX SYSTEM | OTM | Substantially Equivalent | Specialities Remeex International, S.L. | accessdata.fda.gov |
| January 15, 2004 | K033310 | REMEEX SYSTEM FOR URINARY INCONTINENCE | OTN | Substantially Equivalent | Specialities Remeex International, S.L. | accessdata.fda.gov |
| April 28, 2000 | K993149 | PERITONEAL DIALYSIS CATHETERS AND ADAPTERS | FJS | Substantially Equivalent | Medionics International, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Laparoscope, General & Plastic Surgery
- All makers of Mesh, Surgical, For Stress Urinary Incontinence, Male
- All makers of Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
- All makers of Catheter, Peritoneal, Long-Term Indwelling
- All makers of Catheter, Peritoneal
Updated November 13, 2014. 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.