Ellman Intl., Inc.
Hewlett, NY, US
Ellman Intl., Inc. appears in FDA device records in Hewlett, NY. FDA records list 21 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 21
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 21 510(k) clearances for Ellman Intl., Inc. between 1996 and 2011. The busiest year on record is 1996, with 5. The most recent is 2011, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 5 |
| 1997 | 1 |
| 1998 | 2 |
| 1999 | 2 |
| 2000 | 3 |
| 2001 | 2 |
| 2005 | 1 |
| 2006 | 1 |
| 2009 | 1 |
| 2010 | 2 |
| 2011 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K102698 | PELLEVE GLIDESAFE NON-ABLATIVE WRINKLE TREATMENT SYSTEM MODEL PELLEVE GLIDESAFE | GEI | Substantially Equivalent | |
| K102368 | NON-ABLATIVE WRINKLE TREATMENT HANDPIECE | GEI | Substantially Equivalent | |
| K101967 | NON-ABLATIVE WRINKLE TREATENT HANDPIECE MODLE PELLEVE' | GEI | Substantially Equivalent | |
| K082834 | ELLMAN INTERNATIONAL NON-ABLATIVE TECHNIQUE FOR SURGITRON IEC | GEI | Substantially Equivalent | |
| K061174 | SURGI-MAX | GEI | Substantially Equivalent | |
| K042710 | SURGITRON RADIOLASE II | GEI | Substantially Equivalent | |
| K013255 | SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF | GEI | Substantially Equivalent | |
| K003126 | BIPOLAR TRIGGER-FLEX PROBE | GEI | Substantially Equivalent | |
| K001986 | SURGITRON IEC II | GEI | Substantially Equivalent | |
| K001407 | SURGITRON IEC II | GEI | Substantially Equivalent | |
| K001253 | SURGITRON IEC II | GEI | Substantially Equivalent | |
| K992382 | SURGITRON RADIOLASE | GEI | Substantially Equivalent | |
| K990146 | SURGITRON | GEI | Substantially Equivalent | |
| K980177 | SUGITRON MODEL: IEC | GEI | Substantially Equivalent | |
| K980170 | SURGITRON | GEI | Substantially Equivalent | |
| K972072 | SURGITRON MODEL FFPF-EMC | GEI | Substantially Equivalent | |
| K955176 | DENTO-SURGE | EKZ | Substantially Equivalent | |
| K954718 | ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE | HEE | Substantially Equivalent | |
| K955158 | SURGITRON | HQR | Substantially Equivalent | |
| K955167 | SURGITRON | GEI | Substantially Equivalent | |
| K954703 | MEDI-FRIG | GEH | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain