Medical device manufacturer
Intermedics, Inc.
Intermedics, Inc. holds 211 FDA 510(k) clearances across 23 product codes. Median elapsed review time is 55 days. openFDA lists no recall records naming the company.
Updated · ingest status · JSON
- 510(k) clearances
- 211
- Product codes
- 23
- Median review
- 55 days
- Recall records
- 0
How does FDA spell Intermedics, Inc.?
FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.
Which product codes does Intermedics, Inc. file in?
23 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| DTB | Permanent Pacemaker Electrode | 105 | 73 days | |
| DXY | Implantable Pacemaker Pulse-Generator | 52 | 39 days | |
| DTD | Pacemaker Lead Adaptor | 14 | 42 days | |
| FRN | Pump, Infusion | 7 | 51 days | |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 5 | 69 days | |
| KRG | Programmer, Pacemaker | 4 | 77 days | |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 3 | 80 days | |
| DTE | Pulse-Generator, Pacemaker, External | 2 | 132 days | |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 13 days | |
| BXN | Stimulator, Nerve, Battery-Powered | 1 | 14 days | |
| DBT | Factor Xiii A, S, Antigen, Antiserum, Control | 1 | 98 days | |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 1 | 139 days | |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 | 55 days | |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 1 | 52 days | |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 1 | 59 days | |
| DYB | Introducer, Catheter | 1 | 42 days | |
| ETN | Stimulator, Nerve | 1 | 84 days | |
| GDX | Scalpel, One-Piece | 1 | 7 days | |
| HLM | Instrument, Measuring, Lens, Ac-Powered | 1 | 81 days | |
| HPS | Unit, Cryophthalmic | 1 | 27 days | |
| IPF | Stimulator, Muscle, Powered | 1 | 74 days | |
| JOS | Electrode, Electrosurgical | 1 | 25 days | |
| KFJ | Materials, Repair Or Replacement, Pacemaker | 1 | 27 days |
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Intermedics, Inc. had a recall?
openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Intermedics, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K954610 | MODEL 430-07 ENDOCARDIAL PACING LEAD | DTB | 439 | |
| K955122 | INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD | DTB | 361 | |
| K962174 | BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07) | DTB | 77 | |
| K955550 | CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD | DTB | 197 | |
| K960281 | IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY | DTB | 151 | |
| K954719 | INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD | DTB | 137 | |
| K933278 | INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04 | KRG | 624 | |
| K922042 | CARDIFIX ENDOCARDIAL PACING LEAD | DTB | 363 | |
| K922972 | MODELS 438-05 AND 435-05 IMPLANTABLE PACING LEAD | DTB | 217 | |
| K920530 | INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG | DXY | 41 |
Source: openFDA device/510k · retrieved
Watch what Intermedics, Inc. files next
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.