FDA 510(k) Applications Submitted by Dan ny

FDA 510(k) Number Submission Date Device Name Applicant
K160675 03/10/2016 Powder free vinyl patient examination glove, colored (yellow) KAIXING PLASTIC PRODUCTS CO., LITD.
K210344 02/05/2021 inVisionOS PrecisionOS Technology Inc.
K954838 10/20/1995 EZ FIX BIODYNAMIC TECHNOLOGIES, INC.
K980102 01/12/1998 BTI HUMERAL INTRAMEDULLARY ROD SYSTEM BIODYNAMIC TECHNOLOGIES, INC.
K990436 02/11/1999 ULTIMAX TROCHANTERIC INTRAMEDULLARY ROD SYSTEM BIODYNAMIC TECHNOLOGIES, INC.
K990481 02/16/1999 ULTIMAX DISTAL RADIAL (VOLAR) LOCKING PLATE SYSTEM BIODYNAMIC TECHNOLOGIES, INC.
K990513 02/18/1999 ULTIMAX CORTICAL BONE SCREWS BIODYNAMIC TECHNOLOGIES, INC.
K970897 03/11/1997 BTI DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM BIODYNAMIC TECHNOLOGIES, INC.
K981230 04/03/1998 ULTIMAX DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM BIODYNAMIC TECHNOLOGIES, INC.
K972403 06/26/1997 BTI CORTICAL BONE SCREWS BIODYNAMIC TECHNOLOGIES, INC.
K962552 07/01/1996 EZ-6 PROXIMAL HUMERAL INTERAMEDULLARY ROD SYSTEM BIODYNAMIC TECHNOLOGIES, INC.
K962553 07/01/1996 EZ-FIX MIDSHAFT HUMERAL INTRAMEDULLARY ROD SYSTEM BIODYNAMIC TECHNOLOGIES, INC.
K962706 07/12/1996 EZ-FIX CANNULATED SCREW SYSTEM BIODYNAMIC TECHNOLOGIES, INC.
K962846 07/22/1996 EZ-FIX COMPRESSION HIP/SUPRACONDYLAR SCREW (CHS) SYSTEM BIODYNAMIC TECHNOLOGIES, INC.
K962987 08/01/1996 EZ-FIX SMALL CANNULATED SCREW SYSTEM BIODYNAMIC TECHNOLOGIES, INC.
K974756 12/19/1997 BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS BIODYNAMIC TECHNOLOGIES, INC.
K973254 08/29/1997 J-TIP INJECTOR NATIONAL MEDICAL PRODUCTS, INC.
K220656 03/07/2022 iovera System Pacira Biosciences, Inc.
K952941 06/26/1995 SUN MODEL OA 3000 OXYGEN ANALYZER SUN MEDICAL EQUIPMENT, INC.
K990081 01/11/1999 DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDERED SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC.
K990117 01/13/1999 DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC.
K030148 01/15/2003 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC.
K990267 01/28/1999 POWDERED BLUE NITRILE MEDICAL EXAMINATION GLOVES SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC.
K990299 02/01/1999 POWDER FREE BLUE COPOLYMER NITRILE MEDICAL EXAMINATION GLOVES SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC.
K991457 04/26/1999 DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC.
K992100 06/21/1999 PVC (POLYVINYL CHLORIDE) SYNTHETIC EXAMINATION GLOVES, POWDERED SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC.
K061760 06/22/2006 ARM BLOOD PRESSURE MONITOR, MODEL KP-7600 K-JUMP HEALTH CO., LTD.
K212550 08/13/2021 Hura CTP v1.0 Hura Imaging, Inc.
K031142 09/04/2003 DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC.
K023343 10/07/2002 ENVIRON-NP DISPOSABLE SYNTHETIC VINYL EXAM GLOVES, POWDERED SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC.
K023560 10/23/2002 ENVIRON-NP DISPOSABLE VINYL EXAM GLOVES, POWDERED SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC.
K103498 11/29/2010 LAKONG ULTRASONIC SCALER LAKONG MEDICAL DEVICE COMPANY, LTD
K190275 02/08/2019 GenePOC Carba GenePOC Inc.
K183366 12/04/2018 GenePOC Strep A GenePOC Inc.
K223927 12/30/2022 360CAS Kico Knee Innovation Company Pty Limited


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