FDA 510(k) Applications Submitted by D Preston Smith

FDA 510(k) Number Submission Date Device Name Applicant
K221356 05/10/2022 Wee Bell wee MEDICAL
K980716 01/07/1998 ADVANTAGE CHEMILUMINESCENCE PROSTATE SPECIFIC ANTIGEN (PSA) IMMUNOASSAY NICHOLS INSTITUTE DIAGNOSTICS
K000471 02/14/2000 FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT FUTURE DIAGNOSTICS B.V.
K961650 04/30/1996 NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID STIMULATING HORMONE THIRD GENERATION KIT NICHOLS INSTITUTE DIAGNOSTICS
K961678 05/01/1996 HUMAN GROWTH HORMONE IMMUNOASSAY KIT NICHOLS INSTITUTE DIAGNOSTICS
K962033 05/24/1996 CHEMILUMINESCENCE INTRA-OPERATIVE INTACT PTH KIT NICHOLS INSTITUTE DIAGNOSTICS
K952559 06/02/1995 ERYTHROPOIETIN IMMUNOASSAY KIT NICHOLS INSTITUTE
K972070 06/03/1997 NICHOLS ADVANTAGE CHEMILUMINESCENCE TRI-LEVEL SPECIALTY CONTROLS NICHOLS INSTITUTE DIAGNOSTICS
K962208 06/10/1996 NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL KIT NICHOLS INSTITUTE DIAGNOSTICS
K962408 06/21/1996 NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T4- ESTIMATE KIT NICHOLS INSTITUTE DIAGNOSTICS
K962598 07/02/1996 NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE KIT NICHOLS INSTITUTE DIAGNOSTICS
K962601 07/02/1996 NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE NICHOLS INSTITUTE DIAGNOSTICS
K962687 07/11/1996 GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM NICHOLS INSTITUTE DIAGNOSTICS
K002638 08/24/2000 FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT FUTURE DIAGNOSTICS B.V.
K964635 11/19/1996 NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT NICHOLS INSTITUTE DIAGNOSTICS
K965058 12/18/1996 NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T3 KIT NICHOLS INSTITUTE DIAGNOSTICS
K202300 08/13/2020 Optellum Virtual Nodule Clinic, Optellum software, Optellum platform Optellum Ltd
K051102 04/29/2005 OMNIPICC PI RITA MEDICAL SYSTEMS, INC.
K062414 08/17/2006 VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET RITA MEDICAL SYSTEMS, INC.
K062579 08/31/2006 OMNIPICC P.I. RITA MEDICAL SYSTEMS, INC.
K083218 10/31/2008 TC ENDO PORT TRANSCARDIAC THERAPEUTICS, INC.
K961142 03/21/1996 STRATEC LIA II ANALYZER NICHOLS INSTITUTE DIAGNOSTICS
K242042 07/12/2024 TriALTISÖ Spine System Medos International SARL
K222473 08/16/2022 EXPEDIUM« Spine System, EXPEDIUM VERSE« Spine System: ALTALYNEÖ Ultra Rods Medos-International, SARL
K233684 11/16/2023 TriALTISÖ Spine System Medos International SARL
K941567 04/01/1994 DIATHERMY DEVICE-MICROFOCUS CHEUNG LABORATORIES, INC.
K040130 01/21/2004 ANTERIOR LUMBAR BUTTRESS SYSTEM SEASPINE
K090161 01/22/2009 EPIPHANY INJECTION SYSTEM STAAR SURGICAL CO.
K011028 04/05/2001 SCREW-VENT DENTAL IMPLANT SYSTEM SULZER DENTAL, INC.
K011038 04/05/2001 TAPER-LOCK DENTAL IMPLANT SYSTEM SULZER DENTAL, INC.
K061342 04/15/2006 MALIBU SPINAL SYSTEM SEASPINE, INC.
K031381 05/01/2003 UCR SPINAL SYSTEM, LAMINAR HOOKS, PEDICLE HOOKS, AND INSTRUMENTS SEASPINE
K051663 06/22/2005 MALIBU SPINAL SYSTEM SEASPINE, INC.
K051942 07/15/2005 MALIBU SPINAL SYSTEM SEASPINE, INC.
K032368 08/01/2003 SONOMA ANTERIOR CERVICAL PLATE SYSTEM SEASPINE
K052170 08/09/2005 SEASPINE VBR SYSTEM SEASPINE, INC.
K032739 09/04/2003 UCR SPINAL SYSTEM SEASPINE
K062934 09/28/2006 SIERRA SEASPINE, INC.
K043232 11/22/2004 UCR SPINAL SYSTEM SEASPINE
K073586 12/20/2007 MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM STAAR SURGICAL CO.
K073591 12/20/2007 MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM STAAR SURGICAL CO.
K120563 02/24/2012 KEYPATH MRSA/MSSA BLOOD CULTURE TEST-BT MICROPHAGE, INC.
K102342 08/18/2010 KEYPATH(TM) MRSA/MSSA BLOOD CULTURE TEST- BT MICROPHAGE, INC.


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