Company ยท US
Instromedix, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 2001. Name variants (Inc, Corp, punctuation) are merged.
33510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 17 |
| DTC | Analyzer, Pacemaker Generator Function | 3 |
| DPS | Electrocardiograph | 2 |
| KRE | Analyzer, Pacemaker Generator Function, Indirect | 2 |
| DQO | Catheter, Intravascular, Diagnostic | 1 |
| DRS | Transducer, Blood-Pressure, Extravascular | 1 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 |
| DWS | Instruments, Surgical, Cardiovascular | 1 |
| DXC | Clamp, Vascular | 1 |
| DXM | Densitometer | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 |
| DXY | Implantable Pacemaker Pulse-Generator | 1 |
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 12, 2001 | K010945 | HEARTCARD, MODEL 5258 Instromedix | DXH |
| Jul 23, 1997 | K964408 | POSEIDON CARDIAC MONITORING SYSTEM (PCMS) Instromedix, Inc. | DPS |
| Jul 18, 1997 | K964036 | CARDIOMAGIC 2000 SOFTWARE Instromedix, Inc. | DXH |
| Apr 8, 1996 | K955060 | ACCELERATED TRANSMISSION PROTOCOL Instromedix, Inc. | DXH |
| Jan 16, 1996 | K951096 | LIFESIGNS RECEIVING CENER 2000 TRANSTELEPHONIC RECEIVER Instromedix, Inc. | DXH |
| Nov 9, 1995 | K945476 | HEARTHWATCH III(TM) Instromedix, Inc. | DXH |
| Oct 31, 1995 | K950003 | CARDIOMAGIC(R) SOFTWARE ENHANCEMENTS Instromedix, Inc. | DXH |
| Sep 7, 1995 | K944362 | HEARTCARD CARDIAC EVENT MONITOR Instromedix, Inc. | DXH |
| Apr 4, 1995 | K943931 | CARRYALL ENHANCEMENTS Instromedix, Inc. | DXH |
| Nov 8, 1994 | K935586 | PRINCE Instromedix, Inc. | DXH |
| Jun 22, 1993 | K925639 | CARDIOMAGIC SOFTWARE Instromedix, Inc. | DXH |
| Mar 8, 1993 | K923221 | KING OF HEARTS SCEPTER Instromedix, Inc. | DPS |
| Feb 22, 1993 | K925809 | COMPRESSAR UNIVERSAL (TM) SYSTEM Instromedix, Inc. | DXC |
| Oct 14, 1992 | K920984 | KING OF HEARTS EXPRESS (E.X.) MONITOR Instromedix, Inc. | DXH |
| May 15, 1990 | K896040 | KING OF HEARTS CDM Instromedix, Inc. | DXH |
| Feb 28, 1990 | K896039 | KING OF HEARTS 1200 MONITOR Instromedix, Inc. | DXH |
| Jan 19, 1990 | K896002 | CARRY-ALL EKG TRANSTELEPHONIC TRANSMITTER Instromedix, Inc. | DXH |
| May 19, 1989 | K891000 | MODIFIED EXTERNAL PAD Instromedix, Inc. | DWS |
| Sep 16, 1988 | K881297 | BARO-GRAF 24 Instromedix, Inc. | DRS |
| Apr 11, 1988 | K880626 | KING OF HEARTS Instromedix, Inc. | DXH |
| Apr 18, 1985 | K844310 | BLOOD-PRESSURE ECG TRANSMITTER Instromedix, Inc. | DXN |
| Mar 1, 1985 | K842051 | EKG TRANSMITTER MODEL 5134 Instromedix, Inc. | DXY |
| Oct 26, 1984 | K840587 | INSTANT REPLAY Instromedix, Inc. | DXH |
| Dec 1, 1983 | K833809 | NEURAL STIMULATOR MONITOR Instromedix, Inc. | GZB |
| Jul 19, 1983 | K831337 | COMPRESSAR DISPOSABLE DISC Instromedix, Inc. | DQO |
| May 9, 1983 | K830477 | CARDIOMEMO III Instromedix, Inc. | DXH |
| Mar 17, 1981 | K803286 | CARDIOMEMO Instromedix, Inc. | KRE |
| Aug 14, 1980 | K800696 | ELECTRONIC PACEMAKER WAVEFORM ANALYZER Instromedix, Inc. | KRE |
| Jul 21, 1980 | K800405 | A-V MINI CLINIC Instromedix, Inc. | DRT |
| Nov 5, 1979 | K791892 | TAPE-A-TRACE Instromedix, Inc. | DXM |
| Sep 21, 1979 | K791762 | SELF CHECK Instromedix, Inc. | DTC |
| Aug 31, 1978 | K781349 | PACER-TRACER PULSE WIDTH Instromedix, Inc. | DTC |
| Nov 2, 1977 | K771922 | MINICLINIC TM Instromedix, Inc. | DTC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||