Endymed Medical Inc.
Caesarea Northern, IL
ENDYMED MEDICAL INC. appears in FDA device records in Caesarea Northern, IL. FDA records list 8 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no 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 8 510(k) clearances for Endymed Medical Inc. between 2011 and 2025. The busiest year on record is 2011, with 1. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2011 | 1 |
| 2012 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2022 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K242996 | EndyMed PRO MAX | GEI | Substantially Equivalent | |
| K222369 | PURE Laser | GEX | Substantially Equivalent | |
| K161715 | EndyGel | GYB | Substantially Equivalent | |
| K161199 | EndyMed Contour Handpiece | PBX | Substantially Equivalent | |
| DEN150005 | Newa Skin Therapy System | PAY | Unknown | |
| K130501 | INTENSIF | OUH | Substantially Equivalent | |
| K120513 | GLOW BY ENDYMED | OUH | Substantially Equivalent | |
| K101510 | FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR | OUH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010761224 | 3010761224 | ENDYMED MEDICAL INC. | 4400 Route 9 South, East Freehold, NJ 07728 US | 2026 | No device listings on this registration |
| 3008085016 | 3008085016 | ENDYMED MEDICAL LTD | 12 Leshem Street, Caesarea Northern 3088900 IL | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain