Company Product Description Indication Status
3nt Medical Ltd., of Rosh Ha'ayin, Israel Colibri Micro ENT Scope Single-use endoscope  For visualization and illumination during otologic surgery Received 510(k) clearance from the U.S. FDA
Abiomed Inc., of Danvers, Mass. Impella RP  Temporary heart pump Provides circulatory support for patients who develop right side ventricular failure Received emergency use authorization from the U.S. FDA to include patients with COVID-19 related right heart failure or decompensation, including pulmonary embolism
Healgen Scientific LLC, of Houston, Texas COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Serological test For the qualitative detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in human venous whole blood, plasma (Li+-heparin, K2-EDTA and sodium-citrate), and serum Received emergency use authorization from the U.S. FDA
Meditech Spine LLC, of Atlanta Cure Opel-L (S) system Interbody/plate assembly  For anterior lumbar spinal procedures Received 510(k) clearance from the U.S. FDA
Rhaeos Inc., of Evanston, Ill. Flowsense A wireless, noninvasive flow sensor Monitors ventricular shunt function in patients with excess cerebrospinal fluid caused by hydrocephalus Received breakthrough device designation by the U.S. FDA
Siemens Healthineers AG, of Erlangen, Germany Atellica IM SARS-CoV-2 Total (COV2T) Total antibody test For the qualitative detection of antibodies against SARS-CoV-2 in human serum and plasma (potassium EDTA and lithium heparin) using the Atellica IM Analyzer Received emergency use authorization from the U.S. FDA
Tissue Regenix Group plc Orthopure XT Decellularised xenograft ligament that enables tissue regeneration For revision of the anterior cruciate ligament  following re-rupture; also permits use for the reconstruction of other knee ligaments, including multiligament procedures following trauma Received the CE mark

Notes

For more information about individual companies and/or products, see Cortellis.

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