North Coast Medical Inc
Morgan Hill, CA, US
NORTH COAST MEDICAL, INC. appears in FDA device records in Morgan Hill, CA. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for North Coast Medical Inc in 2005.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2939821 | 1000124207 | NORTH COAST MEDICAL, INC. | 135 E Main Ave Ste. 110, Morgan Hill, CA 95037 US | 2026 | and 41 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KNOAccessories, Wheelchair
- ILDAdaptor, Dressing
- ILTAdaptor, Recreational
- IKXAid, Transfer
- HSTApparatus, Traction, Non-Powered
- FQMBandage, Elastic
- IODComponents, Exercise
- MMKContainer, Sharps
- EGJDevice, Iontophoresis, Other Uses
- GWIDiscriminator, Two-Point
- MHWDressing, Compression
- HRWDynamometer, Nonpowered
- MDAElastomer, Silicone, For Scar Management
- GXYElectrode, Cutaneous
- GXBEsthesiometer
- IONExerciser, Non-Measuring
- QKRFace Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua
- QDOFentanyl And Other Opioid Protection Glove
- KEOFormulations, Paraffin, All
- HTJGauge, Depth
- KQWGoniometer, Nonpowered
- KYSInsoles, Medical
- MDMInstrument, Manual, Surgical, General Use
- ITWJoint, Ankle, External Brace
- ITQJoint, Knee, External Brace
- LYGMassager, Therapeutic, Manual
- LZCMedical Glove, Specialty
- OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- MQXNeedle, Acupuncture, Single Use
- KNPOrthosis, Corrective Shoe
- IQIOrthosis, Limb Brace
- DQAOximeter
- IMEPack, Hot Or Cold, Reusable
- OHYPill Crusher/Cutter
- LZAPolymer Patient Examination Glove
- FMPProtector, Skin Pressure
- ILISling, Arm
- ILHSplint, Hand, And Components
- BWKStimulator, Electro-Acupuncture
- NGXStimulator, Muscle, Powered, For Muscle Conditioning
- NUHStimulator, Nerve, Transcutaneous, Over-The-Counter
- ITCStirrup, External Brace Component
- ILGStocking, Elastic
- IOYSupport, Arm
- INWTable, Mechanical
- INQTable, Powered
- HXTTape, Orthopedic
- ISZUnit, Wrist, External Limb Component, Mechanical
- ILCUtensil, Eating
- IKWUtensil, Homemaking
- IROVibrator, Therapeutic
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0125-2024 | Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC86651 (Small/Right), NC86652 (Medium/Left), NC86653 (Medium/Right), NC86654 (Large/Left), NC86655 (Large/Right), NC86656 (X-Large/Left), and NC86657 (X-Large/Right) | The thumb strap of the wrist and thumb orthosis may contain latex that is not declared in the product labeling. | Class II | Open, Classified | |
| Z-2583-2021 | EcoLotion Transmission Lotion, used in ultrasound procedures. Item/Description: NC70481/Eco Lotion 5 liters, NC70482/Eco Lotion with Aloe 5 liters, NC70482C/Eco Lotion with Aloe 5 liters (4); Myossage Lotion, 1 Gallon, Item: NC31208 | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health | Class I | Open, Classified | |
| Z-2582-2021 | Norco Ultrasound Gel, Item/Description: NC70479/Norco Ultrasound Gel, 250 mL; NC70479/North Coast Ultrasound Gel, 250 mL; NC70479-5/Norco Ultrasound Gel, 5 liters; NC70479-5/North Coast Ultrasound Gel, 5 liters; NC70479-5C/Norco Ultrasound Gel, 5 liters (4); NC70479-5C/North Coast Ultrasound Gel, 5 liters (4); NC70479C/Norco Ultrasound Gel, 250 mL (24); NC70479C/North Coast Ultrasound Gel, 250 mL (24) | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health | Class I | Open, Classified | |
| Z-1429-2012 | Norco Folding Shower Bench; Features a nonskid surface and handholds for added security. holes allow excess water to drain away easily. Sturdy legs have non-skid rubber feet. Supports up to 200 lbs. North Coast Medical Inc. 8100 Camino Arroyo Gilroy, CA 95020 Comfort and safety in shower | Due to a consumer complaint, North Coast Medical determined that due to a design flaw, there was not enough plastic support material to retain bracket bolts when subjected to a force greater than 150 lbs. | Terminated | ||
| Z-1542-2012 | Norco Shoulder Pulley Distributed by North Coast Medical, Gilroy, CA. Used to improve range of shoulder movement and coordination following a stroke, shoulder injury or surgery. | Potential for plastic D-ring to break during use and cause injury. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain