Medical device manufacturer
Medos International Sarl
Medos International Sarl holds 101 FDA 510(k) clearances across 25 product codes. Median elapsed review time is 90 days. openFDA lists 1 recall record naming the company. FDA publishes it under 6 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 101
- Product codes
- 25
- Median review
- 90 days
- Recall records
- 1
How does FDA spell Medos International Sarl?
FDA publishes this company under 6 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 |
|---|---|---|
| MEDOS INTERNATIONAL SARL | device/registrationlisting | normalised |
| Medos International SARL | device/510k | normalised |
| Medos International Sarl | device/recall | normalised |
| Medos International Sarl | device/enforcement | normalised |
| Medos International Sàrl | device/510k | normalised |
| Medos-International Sarl | 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 Medos International Sarl file in?
25 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 16 | 69 days | |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 12 | 89 days | |
| OLO | Orthopedic Stereotaxic Instrument | 12 | 126 days | |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 11 | 59 days | |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 8 | 105 days | |
| NKG | Posterior Cervical Screw System | 6 | 85 days | |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 5 | 127 days | |
| JXG | Shunt, Central Nervous System And Components | 4 | 82 days | |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 4 | 63 days | |
| HRX | Arthroscope | 3 | 266 days | |
| PDQ | Neurosurgical Nerve Locator | 3 | 142 days | |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 24 days | |
| HCG | Device, Neurovascular Embolization | 2 | 25 days | |
| KRA | Catheter, Continuous Flush | 2 | 111 days | |
| GWM | Device, Monitoring, Intracranial Pressure | 1 | 127 days | |
| KWP | Appliance, Fixation, Spinal Interlaminal | 1 | 27 days | |
| LXT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | 1 | 77 days | |
| MQP | Spinal Vertebral Body Replacement Device | 1 | 179 days | |
| MRW | System, Facet Screw Spinal Device | 1 | 90 days | |
| NDN | Cement, Bone, Vertebroplasty | 1 | 80 days | |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 | 65 days | |
| PGM | Growing Rod System | 1 | 141 days | |
| PLR | Spinal Vertebral Body Replacement Device - Cervical | 1 | 312 days | |
| PML | Bone Cement, Posterior Screw Augmentation | 1 | 265 days | |
| QJP | Catheter, Percutaneous, Neurovasculature | 1 | 149 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 Medos International Sarl had a recall?
openFDA lists 1 recall record naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.
Z-1284-2024Class IOpen, ClassifiedQJP
Medos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractures at the distal end, which may result in surgical procedural delay, vascular injury and in extreme rare occasions it may result in embolism.
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 Medos International Sarl cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K254157 | CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody | OLO | 155 | |
| K260240 | SYMPHONY Navigation Ready Instruments | OLO | 60 | |
| K253249 | TriALTIS Spine System | NKB | 22 | |
| K243249 | TriALTIS Spine System | NKB | 98 | |
| K241893 | CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays | OLO | 80 | |
| K242042 | TriALTIS Spine System | NKB | 59 | |
| K233684 | TriALTIS Spine System | NKB | 26 | |
| K233366 | SYMPHONY OCT System | NKG | 38 | |
| K232492 | 2.7 mm GRYPHON Flex Knotless PEEK Anchor; 2.7 mm GRYPHON Flex Knotless Biocomposite Anchor | MBI | 50 | |
| K231527 | TriALTIS Navigation Enabled Instruments | OLO | 126 |
Source: openFDA device/510k · retrieved
Where is Medos International Sarl 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 Medos International Sarl 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.