Medical device manufacturer
Medrad Inc dba Bayer R&I
Medrad Inc dba Bayer R&I holds 105 FDA 510(k) clearances across 23 product codes. Median elapsed review time is 75 days. openFDA lists 30 recall records naming the company. FDA publishes it under 5 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 105
- Product codes
- 23
- Median review
- 75 days
- Recall records
- 30
How does FDA spell Medrad Inc dba Bayer R&I?
FDA publishes this company under 5 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 |
|---|---|---|
| Medrad Inc | device/enforcement | normalised |
| Medrad Inc | device/recall | normalised |
| Medrad Inc dba Bayer R&I | device/recall | normalised |
| Medrad Inc dba Bayer R&I | device/enforcement | normalised |
| Medrad, Inc. | 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 Medrad Inc dba Bayer R&I file in?
23 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| DXT | Injector And Syringe, Angiographic | 32 | 81 days | |
| MOS | Coil, Magnetic Resonance, Specialty | 18 | 70 days | |
| LNH | System, Nuclear Magnetic Resonance Imaging | 16 | 90 days | |
| FRN | Pump, Infusion | 6 | 72 days | |
| DQO | Catheter, Intravascular, Diagnostic | 3 | 80 days | |
| DQX | Wire, Guide, Catheter | 3 | 39 days | |
| LLZ | System, Image Processing, Radiological | 3 | 83 days | |
| MCW | Catheter, Peripheral, Atherectomy | 3 | 30 days | |
| QEZ | Aspiration Thrombectomy Catheter | 3 | 27 days | |
| DOY | Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep. | 2 | 27 days | |
| FPK | Tubing, Fluid Delivery | 2 | 29 days | |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 2 | 68 days | |
| JAK | System, X-Ray, Tomography, Computed | 2 | 49 days | |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 1 | 27 days | |
| DWE | Tubing, Pump, Cardiopulmonary Bypass | 1 | 11 days | |
| EAG | Cephalometer | 1 | 34 days | |
| FOX | Stand, Infusion | 1 | 90 days | |
| GDM | Needle, Aspiration And Injection, Reusable | 1 | 28 days | |
| IXO | Synchronizer, Ecg / Respirator, Radiographic | 1 | 100 days | |
| IZP | Programmer, Changer, Film/Cassette, Radiographic | 1 | 106 days | |
| IZQ | Injector, Contrast Medium, Automatic | 1 | 168 days | |
| KPR | System, X-Ray, Stationary | 1 | 56 days | |
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | 1 | 165 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 Medrad Inc dba Bayer R&I had a recall?
openFDA lists 30 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-1686-2015Class IITerminatedDXT
The root cause investigation showed that the under-volume hazard can occur when the unit has been configured to prime with contrast, but instead primes with saline due to the configuration data not being sent to the injector head. This may create a non-optimal priming condition that could lead to under-infusion.
Z-1586-2013Class IITerminatedMWI
The firm is recalling these power cables due to a latent design reliability issue and the potential for shorting which can result in heating/melting of the cable jacket.
Z-0870-2013Class IITerminatedDXT
The seal between the white polyethylene and the clear plastic may be missing on the Hand Controller Sheath package, resulting in a potential breach of the sterility of this accessory.
Z-0595-2013Class IITerminatedFRN
Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating this recall because this tubing exhibits a variation that, when used in conjunction with any Continuum pump, may result in flow rate accuracy performance issues.
Z-0596-2013Class IITerminatedFPA
Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating this recall because this tubing exhibits a variation that, when used in conjunction with any Continuum pump, may result in flow rate accuracy performance issues.
Showing the 5 most recently initiated of 30.
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 Medrad Inc dba Bayer R&I cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K133023 | JETSTREAM XC 2.4/3.4; JETSTREAM XC 2.1/3.0; JETSTREAM SC 1.85; JETSTREAM SC 1.6 | MCW | 335 | |
| K130381 | ANGIOJET ULTRA POWER PULSE KIT | QEW | 165 | |
| K130637 | JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEM | MCW | 30 | |
| K122916 | JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM | MCW | 28 | |
| K113363 | ANGIOJET SOLENT DISTA THROMBECTOMY SET | QEZ | 204 | |
| K113133 | MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE | DXT | 52 | |
| K113428 | ANGIOJET ULTRA DVX THROMBECTOMY SET | QEZ | 11 | |
| K112086 | MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE | DXT | 85 | |
| K111182 | ANGIOJET SOLENT OMNI THROMBECTOMY SET | QEZ | 27 | |
| K100798 | MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C | FRN | 93 |
Source: openFDA device/510k · retrieved
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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.