Devices

Name Classification Manufacturer Risk Class Country Source
Vapotherm" Respiratory Gas Humidifier, Model 2000i, labeled in part ***Vapotherm Inc., Annapolis, MD 21401***. Anesthesiology Devices Vapotherm, Inc. 2 United States
Product is a CALYSTO Series IV Physio-monitoring & Information System model # M-S0053. Cardiovascular Devices Witt Biomedical Corporation 2 United States
Osteofil RT, ICM Allograft Paste Orthopedic Devices Regeneration Technologies, Inc. 2 United States
Osteofil ICM Moldable Strip Orthopedic Devices Regeneration Technologies, Inc. 2 United States
Osteofil IC Syringeable Orthopedic Devices Regeneration Technologies, Inc. 2 United States
Osteofil Allograft Paste (Bio) Orthopedic Devices Regeneration Technologies, Inc. 2 United States
Osteofil Allograft Orthopedic Devices Regeneration Technologies, Inc. 2 United States
Osteofil RT Allograft Paste Orthopedic Devices Regeneration Technologies, Inc. 2 United States
Product is 2.0 cc Opteform¿ RT. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. Orthopedic Devices Regeneration Technologies, Inc. 2 United States
Product is OPTEFORM¿ Allograft Full Disc, 5 x 90mm, 32cc, Frozen. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. Orthopedic Devices Regeneration Technologies, Inc. 2 United States
Product is OPTEFIL Allograft Paste, Syringe of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. Orthopedic Devices Regeneration Technologies, Inc. 2 United States
Product is OPTEFIL Allograft Paste of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. Orthopedic Devices Regeneration Technologies, Inc. 2 United States
Product is 1.0cc flowable paste from donor approved for distribution in Italy. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. Orthopedic Devices Regeneration Technologies, Inc. 2 United States
Product is REGENAFIL¿ Allograft Paste, Syringe, 0.5cc. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. Orthopedic Devices Regeneration Technologies, Inc. 2 United States
Product is RTI Allograft Paste of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. Orthopedic Devices Regeneration Technologies, Inc. 2 United States
Product is REGENAFORM¿ Allograft Moldable Blocks, of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. Orthopedic Devices Regeneration Technologies, Inc. 2 United States
Product is REGENAFORM RT Allograft Paste, 1cc. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. Orthopedic Devices Regeneration Technologies, Inc. 2 United States
Product is Regenafil IC. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. Orthopedic Devices Regeneration Technologies, Inc. 2 United States
OsteoPack 3 FZ 22cc. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. Orthopedic Devices Regeneration Technologies, Inc. 2 United States
OSTEOFIL¿ DBM Paste of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. Orthopedic Devices Regeneration Technologies, Inc. 2 United States
Osteofil RT, ICM Allograft Paste of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. Orthopedic Devices Regeneration Technologies, Inc. 2 United States
Osteofil ICM Moldable Strip of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. Orthopedic Devices Regeneration Technologies, Inc. 2 United States
Osteofil IC Syringeable of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. Orthopedic Devices Regeneration Technologies, Inc. 2 United States
Osteofil Allograft Paste (Bio) of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. Orthopedic Devices Regeneration Technologies, Inc. 2 United States
Osteofil + RT Allograft Paste in varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. Orthopedic Devices Regeneration Technologies, Inc. 2 United States