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Sign in to claim this brandKlarity Medical Products, LLC
US
Last updated September 17, 2026
What Klarity Medical Products, LLC makes
Klarity Medical Products, LLC manufactures patient positioning solutions, including thermoplastic mould materials, vacuum-mould systems, and foam mould kits for custom immobilization. Their portfolio also includes indexed-immobilization systems and specialized head/neck positioners designed for procedural stability.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. Klarity Medical Products, LLC is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Klarity Medical Products, LLC specialize in?
Klarity Medical Products, LLC focuses on patient positioning solutions. Their portfolio includes thermoplastic mould materials for custom immobilization, vacuum-mould patient positioning systems, foam mould kits, indexed-immobilization systems, and specialized head/neck procedure positioners. These devices are designed to enhance procedural stability and comfort for patients.
Where is Klarity Medical Products, LLC based?
Klarity Medical Products, LLC is headquartered in the United States. The company’s location is relevant for regulatory compliance and distribution, as it operates within the FDA’s jurisdiction.
Which regulatory registries or databases list Klarity Medical Products, LLC’s devices?
Klarity Medical Products, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for healthcare providers and regulators, allowing them to verify device details and compliance information.
How are Klarity Medical Products, LLC’s devices classified under FDA regulations?
Klarity Medical Products, LLC’s devices fall under FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and require less regulatory oversight, while Class II devices involve moderate risk and may require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway for each device.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 600 Industrial Pkwy, Heath, OH, 43056
- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
- —
- FDA FEI Number
- 3001236129
- DUNS Number
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Catalogue (681)
Page 4 of 14| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Klarity Medical | R501-2 | FDA UDI | Class II | Active |
| Klarity Medical | RNE-100PL | FDA UDI | Class II | Active |
| Klarity Medical | R7504-40C | FDA UDI | Class II | Active |
| Klarity Medical | R550-U | FDA UDI | Class II | Active |
| Klarity Medical | R461-5SHT | FDA UDI | Class II | Active |
| Klarity Medical | R7505-30BC | FDA UDI | Class II | Active |
| Klarity Medical | RB461-6STEM | FDA UDI | Class II | Active |
| Klarity Medical | R550-CSL | FDA UDI | Class II | Active |
| Klarity Medical | R550-PS47 | FDA UDI | Class II | Active |
| Klarity Medical | S-2004 | FDA UDI | Class II | Active |
| Klarity Medical | R550-LB1 | FDA UDI | Class II | Active |
| Klarity Medical | R550-CVM4 | FDA UDI | Class II | Active |
| Klarity Medical | R550-CVL | FDA UDI | Class II | Active |
| Klarity Medical | RG460ST | FDA UDI | Class II | Active |
| Klarity Medical | R630-OHCF | FDA UDI | Class II | Active |
| Klarity Medical | R7504-30C | FDA UDI | Class II | Active |
| Klarity Medical | R7504-35BC | FDA UDI | Class II | Active |
| Klarity Medical | RE-630EA | FDA UDI | Class II | Unknown |
| Klarity Medical | R550-PS27 | FDA UDI | Class II | Active |
| Klarity Medical | R550-M | FDA UDI | Class II | Active |
| Klarity Medical | RC7215-35BC | FDA UDI | Class II | Active |
| Klarity Medical | R550-CVP | FDA UDI | Class II | Active |
| Klarity Medical | RLG322-S424C1-R | FDA UDI | Class II | Active |
| Klarity Medical | P-2400A | FDA UDI | Class II | Active |
| Klarity Medical | RE-7E2 | FDA UDI | Class II | Active |
| Klarity Medical | R-4000CL | FDA UDI | Class II | Active |
| Klarity Medical | RB461-3210SHT | FDA UDI | Class II | Active |
| Klarity Medical | RDLG104-2412C | FDA UDI | Class II | Active |
| Klarity Medical | RE-7 | FDA UDI | Class II | Unknown |
| Klarity Medical | R550-CELC1 | FDA UDI | Class II | Active |
| Klarity Medical | R550-P | FDA UDI | Class II | Active |
| Klarity Medical | P-2412 | FDA UDI | Class II | Active |
| Klarity Medical | R7503-13C | FDA UDI | Class II | Active |
| Klarity Medical | R7200-05C | FDA UDI | Class II | Active |
| Klarity Medical | R550-BOS3 | FDA UDI | Class II | Active |
| Klarity Medical | R7506-20 | FDA UDI | Class II | Active |
| Klarity Medical | R7644-32.5C | FDA UDI | Class II | Active |
| Klarity Medical | R461ST | FDA UDI | Class II | Active |
| Klarity Medical | R7540-60 | FDA UDI | Class II | Active |
| Klarity Medical | R461-8SHTF | FDA UDI | Class II | Active |
| Klarity Medical | R471SH | FDA UDI | Class II | Active |
| Klarity Medical | R550-CAEP2 | FDA UDI | Class II | Active |
| Klarity Medical | R461SHT | FDA UDI | Class II | Active |
| Klarity Medical | RE-7BGF | FDA UDI | Class II | Active |
| Klarity Medical | R550N-L2 | FDA UDI | Class II | Active |
| Klarity Medical | RE-7E | FDA UDI | Class II | Active |
| Klarity Medical | R7509-60C | FDA UDI | Class II | Active |
| Klarity Medical | RG460-4ST | FDA UDI | Class II | Active |
| Klarity Medical | R612-BE4-E | FDA UDI | Class II | Active |
| Klarity Medical | RNB-100L | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
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Importers
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Notified Bodies
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Authorities
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Klarity Medical Products, LLC has one FDA recall record initiated on 2020-07-31, which is recorded as terminated. The reason stated is that vacuum bags may not maintain their vacuum adequately for the required duration of patient treatment.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jul 31, 2020 | Z-2881-2020 | — | terminated | Vacuum bags potentially may not hold their vacuum adequately for needed patient treatment times. |