Company ยท US
Elmed, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 2019. Name variants (Inc, Corp, punctuation) are merged.
28510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 7 |
| IPF | Stimulator, Muscle, Powered | 3 |
| IMJ | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | 2 |
| DPS | Electrocardiograph | 1 |
| DYC | Vectorcardiograph | 1 |
| FFK | Lithotriptor, Electro-Hydraulic | 1 |
| FLL | Continuous Measurement Thermometer | 1 |
| FSO | Microscope, Surgical, General & Plastic Surgery | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 |
| GWK | Conditioner, Signal, Physiological | 1 |
| HEX | Colposcope (And Colpomicroscope) | 1 |
| HIF | Insufflator, Laparoscopic | 1 |
| HIN | Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) | 1 |
| IMG | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat | 1 |
| IOA | Diathermy, Microwave, For Use In Applying Therapeutic Deep Heat | 1 |
| LIH | Interferential Current Therapy | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 22, 2019 | K181173 | ELMED Laparoscopic Instruments and Accessories Elmed Incorporated | GCJ |
| Apr 30, 2010 | K092033 | VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR Elmed USA | FFK |
| May 14, 2001 | K010465 | DENSTAT Elmed, Inc. | GEI |
| Mar 19, 1998 | K974793 | ELMED ESU 120 M/M DIGITAL Elmed, Inc. | GEI |
| Jan 18, 1996 | K953271 | ELMED RF-ALERT Elmed, Inc. | GEI |
| Aug 14, 1995 | K952110 | ELMED THERMO-FLUX Elmed, Inc. | GEI |
| Nov 15, 1994 | K926517 | ELMED LBC 50-P Elmed, Inc. | HIN |
| May 2, 1994 | K932938 | ELMED ESU 300 M/M AND DIGITAL Elmed, Inc. | GEI |
| May 17, 1993 | K921770 | ELECTROSURGICAL UNITS ESU 100L, 100 L M/M & E M/M Elmed, Inc. | GEI |
| Nov 5, 1992 | K915731 | ELECTROSURGICAL UNITS ESU 30, 70, 70 B, 70 DIGITAL Elmed, Inc. | GEI |
| Jan 31, 1991 | K905417 | ELMED PNEUMOMAT DIGITAL Elmed, Inc. | HIF |
| Apr 16, 1990 | K881431 | SIEMENS STEREODYNATOR 828 Elmed, Inc. | IPF |
| Mar 10, 1988 | K875238 | SIEMENS NEUROTON 826 AND 827 Elmed, Inc. | IPF |
| Jan 13, 1988 | K872909 | SIEMENS SONODYNATOR 834, ULTRASOUND/STIMULATION Elmed, Inc. | IMG |
| Aug 1, 1986 | K862589 | ULTRATHERM 808 I Elmed, Inc. | IMJ |
| Jul 16, 1986 | K862029 | SIEMENS RADIOTHERM 706, MICROWAVE THERAPY UNIT Elmed, Inc. | IOA |
| Jan 3, 1986 | K852034 | VITATRON M Elmed, Inc. | |
| Apr 23, 1984 | K832589 | ELMED WMC 10 AND BC 50 M/M Elmed, Inc. | |
| Mar 16, 1984 | K840321 | ENDODYNE DUAL Elmed, Inc. | LIH |
| Nov 14, 1983 | K832393 | ENCODYNE 4 & VACUFIX 4 Elmed, Inc. | |
| Apr 23, 1981 | K810529 | DIRECT WRITING VECTORCARDIOGRAPH Elmed, Inc. | DYC |
| Sep 17, 1979 | K791279 | KOLPOSKOP KP20005 Elmed, Inc. | HEX |
| Jul 24, 1979 | K791280 | OPERATION MICROSCOPE SOM 1 Elmed, Inc. | FSO |
| May 31, 1979 | K790794 | SIEMENS CARDIOSTAT 701 Elmed, Inc. | DPS |
| Feb 9, 1979 | K790033 | HVG-100 Elmed, Inc. | IPF |
| Dec 7, 1978 | K781455 | SIEMENS ULTRATHERM 708 Elmed, Inc. | IMJ |
| May 6, 1977 | K770782 | FIBERSCOPIC SCOPE RECORDER SYSTEM Elmed, Inc. | GWK |
| May 3, 1977 | K770777 | THERMOMETER, ELECTRONIC, DIGIMED HOL Elmed, Inc. | FLL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||