Elmed, Inc.
Addison, IL, US
Elmed, Inc. appears in FDA device records in Addison, IL. FDA records list 15 510(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
- 15
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 15 510(k) clearances for Elmed, Inc. between 1986 and 2001. The busiest year on record is 1986, with 3. The most recent is 2001, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 3 |
| 1988 | 2 |
| 1990 | 1 |
| 1991 | 1 |
| 1992 | 1 |
| 1993 | 1 |
| 1994 | 2 |
| 1995 | 1 |
| 1996 | 1 |
| 1998 | 1 |
| 2001 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K010465 | DENSTAT | GEI | Substantially Equivalent | |
| K974793 | ELMED ESU 120 M/M DIGITAL | GEI | Substantially Equivalent | |
| K953271 | ELMED RF-ALERT | GEI | Substantially Equivalent | |
| K952110 | ELMED THERMO-FLUX | GEI | Substantially Equivalent | |
| K926517 | ELMED LBC 50-P | HIN | Substantially Equivalent | |
| K932938 | ELMED ESU 300 M/M AND DIGITAL | GEI | Substantially Equivalent | |
| K921770 | ELECTROSURGICAL UNITS ESU 100L, 100 L M/M & E M/M | GEI | Substantially Equivalent | |
| K915731 | ELECTROSURGICAL UNITS ESU 30, 70, 70 B, 70 DIGITAL | GEI | Substantially Equivalent | |
| K905417 | ELMED PNEUMOMAT DIGITAL | HIF | Substantially Equivalent | |
| K881431 | SIEMENS STEREODYNATOR 828 | IPF | Substantially Equivalent | |
| K875238 | SIEMENS NEUROTON 826 AND 827 | IPF | Substantially Equivalent | |
| K872909 | SIEMENS SONODYNATOR 834, ULTRASOUND/STIMULATION | IMG | Substantially Equivalent | |
| K862589 | ULTRATHERM 808 I | IMJ | Substantially Equivalent | |
| K862029 | SIEMENS RADIOTHERM 706, MICROWAVE THERAPY UNIT | IOA | Substantially Equivalent | |
| K852034 | VITATRON M | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- HINCoagulator-Cutter, Endoscopic, Bipolar (And Accessories)
- IOADiathermy, Microwave, For Use In Applying Therapeutic Deep Heat
- IMJDiathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- HIFInsufflator, Laparoscopic
- IPFStimulator, Muscle, Powered
- IMGStimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
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