| 780 nm SPY Portable Handheld Imaging (SPY-PHI) System (K261037) | Stryker Endoscopy | 2026-05-28 |
| SURGIMAGE SIM 1000H Fluorescence Imaging Platform (K253181) | Surgimage Corporation | 2026-05-13 |
| IC-Flow™ Imaging System 2.0 (K243645) | Diagnostic Green GmbH | 2025-09-22 |
| Affirm 800 (K243077) | Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) | 2025-06-27 |
| Modus IR (K231986) | Synaptive Medical, Inc. | 2024-03-25 |
| EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004) (K234090) | Surgvision GmbH | 2024-03-20 |
| Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) (K231075) | Carl Zeiss Meditec, Inc. | 2023-06-20 |
| SPY Portable Handheld Imaging (SPY-PHI) System (K230727) | Novadaq Technologies Ulc (A Part of Stryker) | 2023-06-05 |
| EXPLORER AIR® II (K222240) | Surgvision GmbH | 2023-02-28 |
| Explorer Air II (K214097) | Surgvision GmbH | 2022-02-25 |
| DIR 800 (K202391) | Aesculap, Inc. | 2021-01-21 |
| Asimov-MKS Imaging System (K192761) | Onlume, Inc. | 2020-01-17 |
| SURGICAL MICROSCOPE SYSTEM ORBEYE with IR (K190772) | Olympus Medical Systems Corp. | 2019-10-10 |
| SPY Elite Intraoperative Perfusion Assessment System (K182907) | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2019-01-23 |
| GLOW800 (K181537) | Leica Microsystems (Schweiz) AG | 2018-09-07 |
| CAAS Workstation (K180019) | Pie Medical Imaging BV | 2018-05-03 |
| YELLOW 560 Fluorescence Module (K162991) | Carl Zeiss Meditec, AG | 2017-07-24 |
| Leica FL560 (K170239) | Leica Microsystems (Schweiz) AG | 2017-07-05 |
| CAAS Workstation (K151780) | Pie Medical Imaging BV | 2016-03-11 |
| LEICA FL800 (K141136) | Leica Biosystems Richmond | 2014-08-19 |
| PDE-NEO (K133719) | Hamamatsu Photonics K.K. | 2014-03-27 |
| CAAS WORKSTATION (K133993) | Pie Medical Imaging | 2014-03-25 |
| XIRALITE FLOURESCENCE IMAGING SYSTEM X4 (K130003) | Mivenion GmbH | 2014-01-31 |
| ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES (K130842) | Philips Medical Systems Nederland B.V. | 2013-05-21 |
| C-THV SYSTEM (K113594) | Paieon, Inc. | 2012-03-02 |
| GE INNOVA SOLID STATE XRAY IMAGER FLUROSOPIC X RAY SYSTEM (K113034) | GE Healthcare | 2011-12-13 |
| INTEGRATED INNOVA - S5I SYSTEM OPTION (K111209) | GE Healthcare | 2011-07-26 |
| THE IC-PRO SYSTEM (K110256) | Paieon, Inc. | 2011-05-27 |
| SPY INTRA-OPERATIVE IMAGING SYSTEM (K100371) | Novadaq Technologies, Inc. | 2011-02-04 |
| SYNC-RX SYSTEM, MODEL AS00010 (K100849) | Sync-Rx, Ltd. | 2010-05-21 |
| ZEISS INFRARED 800 WITH FLOW 800 OPTION (K100468) | Carl Zeiss Surgical GmbH | 2010-03-03 |
| ARTIS ZEE / ZEEGOS WITH SW VC14 (K090745) | Siemens Medical Solutions USA, Inc. | 2009-06-18 |
| THE IC-PRO SYSTEM, MODEL VERSION 3.2 (K083745) | Paieon, Inc. | 2009-02-17 |
| IC-PRO SYSTEM, VERSION 3.1.0.4 (K082907) | Paieon, Inc. | 2008-11-18 |
| CARDIOP-B SYSTEM, VERSION 2.1 WITH LVA (K073328) | Paieon, Inc. | 2008-09-09 |
| LEICA FL800 (K080612) | Leica Microsystems (Schweiz) AG | 2008-05-09 |
| ARTIS ZEE AND ZEEGO (K073290) | Siemens Medical Solutions USA, Inc. | 2008-02-11 |
| SPY FLUORESCENT IMAGING SYSTEM (K073130) | Novadaq Technologies, Inc. | 2008-01-10 |
| SPY FLUORESCENT IMAGING SYSTEM (K073088) | Novadaq Technologies, Inc. | 2008-01-10 |
| SPY FLUORESCENT IMAGING SYSTEM (K071619) | Novadaq Technologies, Inc. | 2007-11-09 |
| CARDIOP-B SYSTEM, VERSION 2.1 (K072591) | Paieon, Inc. | 2007-10-10 |
| SPY FLUORESCENT IMAGING SYSTEM (K072222) | Novadaq Technologies, Inc. | 2007-09-07 |
| DAR-9400F (K072006) | Shimadzu Corp. | 2007-08-31 |
| GE OEC ALTITUDE (K071717) | Shimadzu Corp. | 2007-07-05 |
| SPY INTRA-OPERATIVE IMAGING SYSTEM, MODEL SP2000 (K071037) | Novadaq Technologies, Inc. | 2007-05-10 |
| SPY IMAGING SYSTEM (K063345) | Novadaq Technologies, Inc. | 2007-01-12 |
| BRANSIST SAFIRE (K062360) | Shimadzu Corp. | 2006-10-05 |
| LEICA MODEL FL800 (K061871) | Leica Microsystems, Inc. | 2006-09-20 |
| SPY INTRAOPERATIVE IMAGING SYSTEM (K060867) | Novadaq Technologies, Inc. | 2006-05-03 |
| XPERCT (K060749) | Philips Medical Systems North America Co. | 2006-04-04 |
| DAR-8000F (K052500) | Shimadzu Medical Systems | 2005-10-17 |
| DAR-8000I (K052076) | Shimadzu Medical Systems | 2005-09-02 |
| GE OEC ALTITUDE (K052039) | Ge Oec Medical Systems | 2005-08-11 |
| SPY INTRA-OPERATIVE IMAGING SYSTEM: SP2000 (K042961) | Novadaq Technologies, Inc. | 2005-01-19 |
| DYNACT (K042646) | Siemens Medical Systems, Inc. | 2004-10-19 |
| ALLURA XPER FD10 (K041949) | Philips Medical Systems North America Co. | 2004-07-30 |
| DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR, MODEL DFP8000D (K041027) | Toshibamedical Systems Corporation | 2004-05-14 |
| THE CARDIOP-B SYSTEM (K030139) | Paieon, Inc. | 2004-04-02 |
| DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIRE (K032443) | Shimadzu Corp. | 2004-02-20 |
| LATERAL ANGIOGRAPHIC C-ARM SUPPORT MH-400 (K033184) | Shimadzu Corp. | 2003-12-09 |
| PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2 (K031333) | Philips Medical Systems North America, Inc. | 2003-05-13 |
| QUANTITATIVE VASCULAR ANGIOGRAPHY - CMS (K023970) | Medis Medical Imaging Systems BV | 2003-01-24 |
| PHILIPS MULTIDIAGNOST ELEVA (K023441) | Philips Medical Systems | 2002-10-30 |
| AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM (K010721) | Siemens Medical Corp. | 2001-03-30 |
| ATLAS MULTI-PURPOSE DSA SYSTEM (K010391) | Cares Built, Inc. | 2001-03-12 |
| MARKS REFERENCE PHANTOM, MEASURE REFERENCE PHANTOM (K002840) | The Phantom Laboratory, Inc. | 2000-11-17 |
| KOORDINANT ANGIOGRAPHIC AND OPERATING ROOM MODEL X-RAY TABLE FAMILY (K993947) | Siemens Corp. | 1999-12-21 |
| QUANTITATIVE ANALYSIS OF LEFT VENTRICULAR ANGIOGRAMS (QLV) (K993765) | Medis Medical Imaging Systems BV | 1999-11-26 |
| QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA) (K993763) | Medis Medical Imaging Systems BV | 1999-11-26 |
| DIGITAL IMAGING SYSTEM (BSR) (K991922) | Siemens Medical Solutions USA, Inc. | 1999-09-01 |
| HITACHI VERSIFLEX (K991231) | Hitachi Medical Systems America, Inc. | 1999-05-24 |
| RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000) SYSTEMS (K984545) | Philips Medical Systems North America, Inc. | 1999-02-25 |
| PHILIPS INTEGRIS 3D RA OPTION (K983877) | Philips Medical Systems North America, Inc. | 1998-12-21 |
| CAAS II LVA BIPLANE OPTION (K982203) | Pie Medical Equipment B.V. | 1998-07-14 |
| THE TCS-MEDCON'S TELECARDIOLOGY SYSTEM (K974679) | Medcon , Ltd. | 1998-03-23 |
| ADVANTX LCN, ADVANTX LCLP (K974367) | GE Medical Systems | 1998-02-13 |
| LEG'MAP OPTION (K973270) | Ge Medical Systems, Inc. | 1997-11-25 |
| PHILIPS INTEGRIS V5000 AND BV5000 (K973482) | Philips Medical Systems North America, Inc. | 1997-11-10 |
| CONTROL SYRINGE (K972655) | Medical Specialties Intl., Inc. | 1997-11-04 |
| STRAIT'MAP OPTION (K973368) | Ge Medical Systems, Inc. | 1997-10-17 |
| IMAGEVIEW CORONARY ANGIOGRAPHY DISPLAY AND REVIEW SYSTEM (K972229) | Heartware, Inc. | 1997-10-16 |
| DAR-3000B (K973342) | Shimadzu Corp. | 1997-10-08 |
| VIEW ARCHIVING STATION (K971176) | Electromed Intl., Ltd. | 1997-09-03 |
| THE MIDVIEW-MEDCON'S DICOM VIEWER (K971181) | Medcon , Ltd. | 1997-07-29 |
| RATATIONAL ANGIOGRAPHY OPTION FOR PHILIPS MULTIDIAGNOST 4 (K971489) | Philips Medical Systems North America, Inc. | 1997-07-03 |
| TV MONITOR (P12/17) (K972136) | Perkins Mfg. Co. | 1997-06-26 |
| PHILIPS INTEGRIS H5000 (K971365) | Philips Medical Systems North America, Inc. | 1997-05-14 |
| KODAK DIGITAL SCIENCE CARDIAC DIGITAL ACQUISITION UNIT (K970738) | Jamieson Film Co. | 1997-05-07 |
| STATNET (K970525) | Gorca Systems, Inc. | 1997-04-16 |
| CONTRAST MEDIA SET (K955179) | B.Braun Medical, Inc. | 1997-03-12 |
| DICOMNET (K961451) | Lockheed Martin Communications Systems | 1996-07-03 |
| ANALYTICAL REVIEW STATION (K955519) | Camtronics, Ltd. | 1996-05-09 |
| ADVANTX LCV+ (K960575) | GE Medical Systems | 1996-05-07 |
| ARC SERIES (K954581) | Continental X-Ray Corp. | 1995-12-21 |
| DAR-2400-15B/30B (K955395) | Shimadzu Medical Systems | 1995-12-11 |
| HITACHI DYNAMIC 3D IMAGING SYSTEM,SF-VA100 (K945400) | Hitachi Medical Corp. of America | 1995-11-20 |
| ANGIOREX (K954309) | Toshiba Medical Systems | 1995-10-06 |
| VANGUARD XR-350 CINEANGIOGRAM PROJECTOR (K953563) | Jamieson Film Co. | 1995-10-05 |
| PHILIPS EASYVISION (K952704) | Philips Medical Systems, Inc. | 1995-07-03 |
| CAAS II (K945540) | Pie Medical Equipment B.V. | 1995-06-28 |