Medical device manufacturer
Terumo Medical Corporation
Terumo Medical Corporation holds 157 FDA 510(k) clearances across 58 product codes. Median elapsed review time is 64 days. openFDA lists 43 recall records naming the company. FDA publishes it under 7 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 157
- Product codes
- 58
- Median review
- 64 days
- Recall records
- 43
How does FDA spell Terumo Medical Corporation?
FDA publishes this company under 7 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 |
|---|---|---|
| TERUMO MEDICAL CORP. | device/registrationlisting | normalised |
| Terumo Medical Corp | device/recall | normalised |
| Terumo Medical Corp | device/enforcement | normalised |
| Terumo Medical Corp. | device/510k | normalised |
| Terumo Medical Corporation | device/recall | normalised |
| Terumo Medical Corporation | device/enforcement | normalised |
| Terumo Medical Corporation | 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 Terumo Medical Corporation file in?
58 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| DYB | Introducer, Catheter | 27 | 56 days | |
| DQX | Wire, Guide, Catheter | 11 | 95 days | |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 10 | 90 days | |
| FMF | Syringe, Piston | 10 | 29 days | |
| DQO | Catheter, Intravascular, Diagnostic | 6 | 31 days | |
| FJI | Dialyzer, Capillary, Hollow Fiber | 6 | 96 days | |
| FPA | Set, Administration, Intravascular | 6 | 62 days | |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 5 | 79 days | |
| DQY | Catheter, Percutaneous | 4 | 77 days | |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 4 | 78 days | |
| FMI | Needle, Hypodermic, Single Lumen | 4 | 22 days | |
| KOC | Accessories, Blood Circuit, Hemodialysis | 4 | 29 days | |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 3 | 87 days | |
| DXC | Clamp, Vascular | 3 | 45 days | |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 3 | 90 days | |
| FLL | Continuous Measurement Thermometer | 2 | 45 days | |
| FMG | Stopcock, I.V. Set | 2 | 38 days | |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 2 | 50 days | |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 2 | 52 days | |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 2 | 32 days | |
| KRA | Catheter, Continuous Flush | 2 | 24 days | |
| MEG | Syringe, Antistick | 2 | 60 days | |
| OCY | Endoscopic Guidewire, Gastroenterology-Urology | 2 | 80 days | |
| BSO | Catheter, Conduction, Anesthetic | 1 | 28 days | |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 1 | 28 days |
Showing the 25 they file in most, of 58.
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 Terumo Medical Corporation had a recall?
openFDA lists 43 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.
Z-1374-2019Class ITerminatedDYB
There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath.
Z-1375-2019Class ITerminatedDYB
There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath.
Z-1376-2019Class ITerminatedDYB
There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath.
Z-1998-2019Class IITerminatedFMI
There is a potential for a loss of package integrity that may compromise the sterility of the product.
Z-1999-2019Class IITerminatedFMI
There is a potential for a loss of package integrity that may compromise the sterility of the product.
Showing the 5 most recently initiated of 43.
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 Terumo Medical Corporation cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K231044 | R2P Navicross | DQY | 106 | |
| K213531 | TR BAND Radial Compression Device | DXC | 45 | |
| K193125 | R2P Destination Slender Guiding Sheath | DYB | 55 | |
| K181237 | Glidesheath Slender Tibial Pedal Kit | DYB | 85 | |
| K173831 | Glidesheath Slender | DYB | 141 | |
| K172995 | Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath | DYB | 55 | |
| K171491 | R2P Destination Slender Guiding Sheath | DYB | 136 | |
| K152173 | Glidesheath | DYB | 119 | |
| K152525 | TR BAND Radial Compression Device | DXC | 68 | |
| K151471 | Radifocus Glidewire Endoscopic Wire | OCY | 108 |
Source: openFDA device/510k · retrieved
Where is Terumo Medical Corporation registered?
FDA lists 2 registered establishments 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 Terumo Medical Corporation 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.