BETA
Israeli manufacturer of HemaClear surgical tourniquets, HemaShock emergency auto-transfusion devices, Hema-T tourniquets and PrepSleeve limb-preparation devices.
Oneg HaKarmel, also presented as OHK Medical Devices, is an Israeli medical-device manufacturer founded in 1999 and based in Tirat Carmel. Its corporate site identifies product lines covering surgical blood management, emergency care and preoperative limb preparation.
HemaClear combines limb exsanguination and arterial occlusion in a sterile single-use surgical tourniquet. HemaShock is marketed for emergency displacement of blood from limbs toward central circulation; Hema-T addresses external limb bleeding. PrepSleeve is designed for preoperative disinfection of a limb.
The HemaClear and HemaShock websites also identify OHK Medical Devices, Inc. in the United States. This profile covers the Israeli manufacturer. Upright Medical Solutions advertises HemaClear, with no independently confirmed contractual territory.
Device records identify Oneg HaKarmel as the HemaClear labeler and list the reviewed sterile tourniquet under FDA product code GAX, exempt from premarket submission. That supports an exemption description for the documented device, not a 510(k) clearance or PMA approval. [2]
Published FDA UDI records also identify HemaShock EMS and Hema-T as Oneg HaKarmel devices, report commercial distribution and mark them exempt from premarket submission under product code GAX (Class I). These are device-identification and exemption records, not FDA clearances or proof of every clinical claim. PrepSleeve’s Class I exemption statement remains manufacturer-reported because an independent product-specific record was not established. [3][1][19]
The product lines have different surgical and emergency uses. Instructions, contraindications and use limits apply; international marketing and performance claims do not establish every jurisdiction’s authorization or universal clinical benefit. [4][7][17]
Published FDA searches under the company and selected product names found no relevant original PMA approvals, De Novo grants or recall events. Unrelated name matches are excluded. [15][13][14][16]
Latest recorded source review: 2026-10-27.
Documented commercial product families.
Elastic ring with stockinette and pull handles to displace blood from a limb and maintain a bloodless surgical field. Color-coded models address different limb sizes. [11][4][2]
Exemption documentedCommercially marketed through the HemaClear website and U.S. sales channel.
Roll-on compression device marketed to shift blood from limbs toward central circulation and restrict re-entry in selected emergency situations. [11][6][7][3]
FDA-listed Class I, premarket-exempt deviceMarketed by the manufacturer; FDA UDI record reports commercial distribution.
Enclosed sleeve for bathing and scrubbing a limb with disinfectant before surgery. [11][19]
Manufacturer reports Class I exemption; independently unconfirmedMarketed through the manufacturer’s PrepSleeve website.
The corporate portfolio spans surgery, emergency care and preoperative preparation. Reviewed primary sources do not establish open employee-role counts or a quantified expansion rate. The U.S. contact and Upright’s HemaClear listing do not establish nationwide or exclusive distribution rights. [11][4]
Publicly documented relationships; coverage may be incomplete.
| Partner | Territory / scope | Products |
|---|---|---|
| Upright Medical Solutions (distributor-reported) [12] | U.S. provider-facing offering; product-specific territory and active contract not independently confirmed | HemaClear surgical exsanguination tourniquets |
Sources checked October 26, 2026.
Accessed 10/27/2026
Last substantive review: 10/27/2026