Company ยท US
Intermedics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 1996. Name variants (Inc, Corp, punctuation) are merged.
211510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DTB | Permanent Pacemaker Electrode | 105 |
| DXY | Implantable Pacemaker Pulse-Generator | 52 |
| DTD | Pacemaker Lead Adaptor | 14 |
| FRN | Pump, Infusion | 7 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 5 |
| KRG | Programmer, Pacemaker | 4 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 3 |
| DTE | Pulse-Generator, Pacemaker, External | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 |
| BXN | Stimulator, Nerve, Battery-Powered | 1 |
| DBT | Factor Xiii A, S, Antigen, Antiserum, Control | 1 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 1 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 1 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 1 |
| DYB | Introducer, Catheter | 1 |
| ETN | Stimulator, Nerve | 1 |
| GDX | Scalpel, One-Piece | 1 |
| HLM | Instrument, Measuring, Lens, Ac-Powered | 1 |
| HPS | Unit, Cryophthalmic | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 16, 1996 | K954610 | MODEL 430-07 ENDOCARDIAL PACING LEAD Intermedics, Inc. | DTB |
| Nov 4, 1996 | K955122 | INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD Intermedics, Inc. | DTB |
| Aug 21, 1996 | K962174 | BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07) Intermedics, Inc. | DTB |
| Jun 19, 1996 | K955550 | CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD Intermedics, Inc. | DTB |
| Jun 18, 1996 | K960281 | IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY Intermedics, Inc. | DTB |
| Feb 27, 1996 | K954719 | INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD Intermedics, Inc. | DTB |
| Mar 15, 1995 | K933278 | INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04 Intermedics, Inc. | KRG |
| Apr 29, 1993 | K922042 | CARDIFIX ENDOCARDIAL PACING LEAD Intermedics, Inc. | DTB |
| Jan 22, 1993 | K922972 | MODELS 438-05 AND 435-05 IMPLANTABLE PACING LEAD Intermedics, Inc. | DTB |
| Mar 17, 1992 | K920530 | INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG Intermedics, Inc. | DXY |
| Sep 18, 1991 | K912235 | MODELS 432-03 & 433-03 IMPLANT ENDOCARD PAC LEAD Intermedics, Inc. | DTB |
| May 16, 1991 | K911122 | 8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS Intermedics, Inc. | DXY |
| Apr 22, 1991 | K903948 | INTERMEDICS MODEL 431-11 IMPLANT ENDOCARD PAC LEAD Intermedics, Inc. | DTB |
| Mar 1, 1991 | K902672 | INTERMEDICS 430-07 BIPOL IMPLANT ENDOCARD PAC LEAD Intermedics, Inc. | DTB |
| Sep 5, 1989 | K894718 | ADAPTAID(TM) ADAPTER SLEEVE MODEL 366-33 Intermedics, Inc. | DTD |
| Mar 28, 1989 | K890412 | MODELS 430-07 & 431-07 IMPLANTABLE PACING LEADS Intermedics, Inc. | DTB |
| Mar 28, 1989 | K890411 | MODELS 432-03 & 433-03 IMPLANTABLE PACING LEADS Intermedics, Inc. | DTB |
| Sep 6, 1988 | K883602 | BIOPORE VS.1 ENDOCARDIAL INTER IMPLANT PACING LEAD Intermedics, Inc. | DTB |
| May 25, 1988 | K875178 | MODEL 435-04 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD Intermedics, Inc. | DTB |
| May 24, 1988 | K875100 | MODEL 438-03 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD Intermedics, Inc. | DTB |
| Mar 22, 1988 | K872126 | MODEL 438-02 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD Intermedics, Inc. | DTB |
| Mar 7, 1988 | K880551 | MODEL 439-07 AND 439-09 LIFELINE MYOCARDIAL LEAD Intermedics, Inc. | DTB |
| Jan 7, 1988 | K874531 | POLYFLEX(R) EPICARDIAL 439-04 IMPLANT PACING LEAD Intermedics, Inc. | DTB |
| Jan 6, 1988 | K874930 | MODEL 366-12 ADAPTAID(TM) STEP-DOWN ADAPTER Intermedics, Inc. | DTB |
| Dec 3, 1987 | K873921 | MODEL 366-30 ADAPTAID(TM) ADAPTER SLEEVE Intermedics, Inc. | DTB |
| Nov 23, 1987 | K874394 | QUANTUM(R) MODELS 253-19V & 254-20V PULSE GENERA. Intermedics, Inc. | DXY |
| Oct 9, 1987 | K873528 | MODIFIED MODELS 253-19 & 254-20 QUANTUM GENERATORS Intermedics, Inc. | DXY |
| Sep 15, 1987 | K872230 | MODEL 366-29 ADAPTAID(TM) ADAPTER SLEEVE Intermedics, Inc. | DBT |
| May 22, 1987 | K871580 | IMPLANTABLE PACING LEAD MODELS 487-06 TO 430-01 Intermedics, Inc. | DTB |
| May 21, 1987 | K871625 | MODEL 366-12 ADAPTAID (TM) STEP-DOWN ADAPTER Intermedics, Inc. | DTB |
| May 21, 1987 | K870357 | ELECTRODE, PACEMAKER, PERMANENT & TEMPORARY Intermedics, Inc. | DTB |
| Apr 10, 1987 | K870948 | MODEL 435-03 SIDE HOOK IMPLANTABLE PACING LEAD Intermedics, Inc. | DTB |
| Jan 16, 1987 | K864326 | MODEL 366-13 ADAPTAID STEP DOWN ADAPTER Intermedics, Inc. | DTB |
| Jan 6, 1987 | K864738 | MODEL 366-14 INTERMEDICS LEAD CONNECTOR CAP Intermedics, Inc. | DTB |
| Jan 6, 1987 | K862051 | MODEL 436-01 BIOPORE IMPLANTABLE PACING LEAD Intermedics, Inc. | DTB |
| Dec 5, 1986 | K864564 | MODEL 486-05 POLYFLEX(R) IMPLANTABLE PACING LEAD Intermedics, Inc. | DTB |
| Dec 5, 1986 | K864428 | MODEL 366-23 ADAPTAID(TM) STEP-DOWN ADAPTER Intermedics, Inc. | DTB |
| Nov 20, 1986 | K864287 | MODEL 430-05 POLYFLEX IMPLANTABLE PACING LEAD Intermedics, Inc. | DTB |
| Nov 20, 1986 | K864002 | MODEL 431-06 POLYFLEX IMPLANTABLE PACING LEAD Intermedics, Inc. | DTB |
| Nov 3, 1986 | K864048 | MODEL 366-27 ADAPTAID(TM) STEP-DOWN ADAPTER Intermedics, Inc. | DTB |
| Nov 3, 1986 | K864047 | MODEL 366-28 ADAPTAID(TM) STEP-DOWN ADAPTER Intermedics, Inc. | DTB |
| Nov 3, 1986 | K863781 | MODEL 493-08 POLYFLEX ENDOCARDIAL LEAD Intermedics, Inc. | DTB |
| Sep 24, 1986 | K863418 | MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE Intermedics, Inc. | DXY |
| Sep 19, 1986 | K862054 | MODEL 430-01 BIOPORE IMPLANTABLE PACING LEAD Intermedics, Inc. | DTB |
| Sep 19, 1986 | K862053 | MODEL 432-01 BIOPORE IMPLANTABLE PACING LEAD Intermedics, Inc. | DTB |
| Jul 10, 1986 | K862259 | MODEL 433-01 BIOPORE IMPLANTABLE PACING LEAD Intermedics, Inc. | DTB |
| Jul 10, 1986 | K862258 | MODEL 437-01 BIOPORE IMPLANTABLE PACING LEAD Intermedics, Inc. | DTB |
| Jul 10, 1986 | K862257 | MODEL 431-02 BIOPORE IMPLANTABLE PACING LEAD Intermedics, Inc. | DTB |
| Jul 3, 1986 | K862052 | MODEL 438-01 CARDIFIX IMPLANTABLE PACING LEAD Intermedics, Inc. | DTB |
| Jul 2, 1986 | K862276 | MODEL 435-02 CARDIFIX IMPLANTABLE PACING LEAD Intermedics, Inc. | DTB |
Newest 50 of 211.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||