Domico Med-Device, LLC
Fenton, MI, US
Domico Med-Device, LLC appears in FDA device records in Fenton, MI. FDA records list 8 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Domico Med-Device, LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Contour Fabricators, Inc.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 8 510(k) clearances for Domico Med-Device, LLC between 1979 and 2009. The busiest year on record is 1997, with 4. The most recent is 2009, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1982 | 1 |
| 1996 | 1 |
| 1997 | 4 |
| 2009 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K090773 | CFI ULTRASOUND PROBE DRAPE | IYO | Substantially Equivalent | |
| K970900 | INSTRUMENT HOLDER | GCJ | Substantially Equivalent | |
| K971040 | CABLE HOLDER, SUCTION TUBE HOLDER | GEI | Substantially Equivalent | |
| K970185 | STERILE DISPOSABLE EQUIPMENT MAGNET COVER | KKX | Substantially Equivalent | |
| K964141 | GE STERILE DISPOSABLE EQUIPMENT COIL COVER | MOS | Substantially Equivalent | |
| K963453 | CFI RESTRAINT BELT (CFI-168) / CFI RESTRAINT BELT (CFI-4046) | FMQ | Substantially Equivalent | |
| K820692 | BANDBAG, WRAP, STERILE | MMP | Substantially Equivalent | |
| K782155 | GENERAL EQUIPMENT COVER | IZL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3014680784 | 1825560 | Domico Med-Device, LLC | 14241 N. Fenton RD, Fenton, MI 48430 US | 2026 | and 15 more, listed in full below |
| 3042941605 | 3042941605 | Domico Med-Device, LLC | Celaya Salvatierra road KM 17, Las palomas Guanajuato 38150 MX | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NBHAccessories, Arthroscopic
- HSTApparatus, Traction, Non-Powered
- EAJApron, Leaded
- IXACassette, Radiographic Film
- MOSCoil, Magnetic Resonance, Specialty
- MMPCover, Barrier, Protective
- FMWCover, Mattress (Medical Purposes)
- FMRDevice, Transfer, Patient, Manual
- KKXDrape, Surgical, Antimicrobial
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- IWYHolder, Head, Radiographic
- ILYLamp, Infrared, Therapeutic Heating
- GCJLaparoscope, General & Plastic Surgery
- IKYMattress, Flotation Therapy, Non-Powered
- FWZOperating Room Accessories Table Tray
- IRTPad, Heating, Powered
- PRNPediatric Position Holder
- FMQRestraint, Protective
- FZFSplint, Extremity, Inflatable, External
- FPPStretcher, Hand-Carried
- CCXSupport, Patient Position
- LWGSurgical Table Cushion
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- EYZSystem, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
- IZLSystem, X-Ray, Mobile
- BWNTable And Attachments, Operating-Room
- GDCTable, Operating-Room, Electrical
- KXJTable, Radiologic
- JEBTable, Surgical With Orthopedic Accessories, Manual
- QCITranscranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
- OBPTranscranial Magnetic Stimulator
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0080-2017 | Zero-Gravity Radiation Protection System Radiology Personnel protective shield. | Two customer complaints suggest that excessive rotation of the cable in one direction (clockwise or counter-clockwise) without allowing the cable to unwind to its normal condition may cause the cable to break suddenly and the body shield to fall. While no injuries or deaths occurred in either failure, the Zero-GravityTM body shield weighs 55 pounds, and in the event of a cable failure, the body shield will fall immediately. A fall of this nature places the user, associated staff and the patient at risk for a potential injury. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain