Medical device manufacturer
Jedmed Instrument Company
Jedmed Instrument Company holds 93 FDA 510(k) clearances across 48 product codes. Median elapsed review time is 59 days. openFDA lists no recall records naming the company. FDA publishes it under 3 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 93
- Product codes
- 48
- Median review
- 59 days
- Recall records
- 0
How does FDA spell Jedmed Instrument Company?
FDA publishes this company under 3 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| JEDMED Instrument Company | device/registrationlisting | normalised |
| Jedmed Instrument Co. | device/510k | normalised |
| Jedmed Instrument Company | device/510k | normalised |
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Jedmed Instrument Company file in?
48 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| ETF | Unit, Examining/Treatment, Ent | 17 | 33 days | |
| DZI | Drill, Bone, Powered | 4 | 29 days | |
| ERA | Otoscope | 4 | 87 days | |
| ETP | Stimulator, Caloric-Water | 4 | 11 days | |
| FSO | Microscope, Surgical, General & Plastic Surgery | 4 | 21 days | |
| FWD | Camera, Television, Microsurgical, Without Audio | 4 | 11 days | |
| EQH | Source, Carrier, Fiberoptic Light | 3 | 68 days | |
| HOZ | Sponge, Ophthalmic | 3 | 94 days | |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 3 | 164 days | |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 2 | 38 days | |
| DSP | System, Balloon, Intra-Aortic And Control | 2 | 78 days | |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | 88 days | |
| EPT | Microscope, Surgical | 2 | 79 days | |
| EQN | Laryngoscope, Nasopharyngoscope | 2 | 170 days | |
| KYG | Device, Irrigation, Ocular Surgery | 2 | 67 days | |
| BXQ | Rhinoanemometer (Measurement Of Nasal Decongestion) | 1 | 167 days | |
| ENZ | Telescope, Laryngeal-Bronchial | 1 | 394 days | |
| EOQ | Bronchoscope (Flexible Or Rigid) | 1 | 163 days | |
| EQL | Laryngostroboscope | 1 | 79 days | |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 1 | 29 days | |
| FEA | Attachment, Teaching, For Endoscope | 1 | 109 days | |
| FRK | Chair, Examination And Treatment | 1 | 49 days | |
| GBC | Lamp, Surgical, Incandescent | 1 | 69 days | |
| GBQ | Catheter, Continuous Irrigation | 1 | 59 days | |
| GNJ | Antigens, Ha, Echovirus 1-34 | 1 | 127 days |
Showing the 25 they file in most, of 48.
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 Jedmed Instrument Company 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 Jedmed Instrument Company cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K150248 | ORL Video NasoPharyngo-Larngoscope | EQN | 170 | |
| K132039 | ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM | EQN | 234 | |
| K021750 | LID CHAIN EYELID WEIGHTS | MML | 244 | |
| K954184 | JED-LIGHT FIBEROPTIC LIGHT SOURCE | EQH | 68 | |
| K944032 | VIDEO SCOPE SYSTEM (LARYNGOSCOPE) | ENZ | 394 | |
| K953457 | JEDMED SPECTRUM ENT CABINET | ETF | 21 | |
| K950925 | JEDMED LARYNGEAL SCOPE | EOQ | 163 | |
| K950785 | HORTMANN AIRMATIC AIR CALORIC STIMULATOR | KHH | 127 | |
| K950078 | MICROFLOW IRRIGATION SYSTEM | KMA | 162 | |
| K944671 | VIDEO SCOPE SYSTEM (NASOPHARYNGOSCOPE {FLEXIBLE OR RIGID}) | EOB | 138 |
Source: openFDA device/510k · retrieved
Where is Jedmed Instrument Company registered?
FDA lists 1 registered establishment for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Jedmed Instrument Company 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.