| ENSITE VELOCITY SYSTEM (K110549) | St Jude Medical | 2011-05-05 |
| REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL DX INSERTABLE CARDIAC MONITOR, MODEL 9528 (K103764) | Medtronic, Inc. | 2011-05-04 |
| SENSILASE PAD-IQ (K110438) | Vasamed, Inc. | 2011-05-04 |
| WEBSTER DUO-DECAPOLAR CATHETER (K101991) | Biosense Webster, Inc. | 2011-05-02 |
| TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER;TRANSTEK GLASS BODY ANALYZER (K102191) | Zhongshan Transtek Electronics Co., Ltd. | 2011-05-02 |
| EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM, BAREWIRE FILTER DELIVERY WIRE-WORKHORSE-190CM / 315CM, BAREWIRE FILTER DEL.. (K110909) | Abbott Laboratories | 2011-04-29 |
| MAC 5500 HD, MAC 3500 (K110266) | Ge Medical Systems Information Technologies, Inc. | 2011-04-29 |
| PTS-X SIZING BALLOON CATHETER (K110903) | NuMED, Inc. | 2011-04-29 |
| IMPELLA CONTROLLER WITH FLOW CONTROL (K110845) | Abiomed, Inc. | 2011-04-27 |
| JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L SYSTEM (K110626) | Pathway Medical Technologies, Inc. | 2011-04-20 |
| SELECTRA CS LEAD INTRODUCER SYSTEM (K110461) | Biotronik, Inc. | 2011-04-20 |
| SPACELABS SMART DISCLOSURE SYSTEM (K110779) | Spacelabs Healthcare | 2011-04-19 |
| WEXLER VASCULAR CLAMP SERIES (K110148) | Microsurgical Laboratories,Inc.Dba Wexler Surgical | 2011-04-19 |
| EVERON CENTRAL DISPLAY STATION (CDS) (K110521) | Earlysense, Ltd. | 2011-04-19 |
| MODEL MC-180MA MULTI-FREQUENCY BODY COMPOSITION ANALYZER (K100183) | Tanita Corp. | 2011-04-15 |
| ANGIOSCULPT PTA SCORING BALLOON CATHETER (K110767) | Angioscore, Inc. | 2011-04-15 |
| REVERSE MEDICAL REPORT GUIDE CATHETER SYSTEM (K102418) | Reverse Medical Corporation | 2011-04-15 |
| VICOR PD2I ANALYZER (K101867) | Vicor Technologies, Inc. | 2011-04-14 |
| EVERCROSS 0.035 OTW PTA DILATATION CATHETER (K110319) | Ev3, Inc. | 2011-04-14 |
| ONESTEP ADULT MULTI-FUNCTION ELECTRODE (K110742) | ZOLL Medical Corporation | 2011-04-13 |
| MPS450 MULTIPARAMETER SIMULATOR (K103336) | Fluke Biomedical | 2011-04-13 |
| WALDO PATIENT MONITOR (K110334) | Waldo Health | 2011-04-12 |
| AGILIS ES STEERABLE INTRODUCER (K103083) | St Jude Medical | 2011-04-08 |
| ACUITY WHISPER VIEW GUIDE WIRES (K110479) | Boston Scientific Corp | 2011-04-08 |
| HYDROFIX VASO SHIELD (K101805) | Mimedx Group, Inc. | 2011-04-08 |
| COMBITRANS MONITORING SETS AND ACCESSORIES (K102033) | B.Braun Melsungen AG | 2011-04-07 |
| CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR (K110499) | Card Guard Scientific Survival , Ltd. | 2011-04-06 |
| REVERSE MEDICAL REFLEX GUIDE CATHETER (K110055) | Reverse Medical Corporation | 2011-04-05 |
| CARDIOHELP SYSTEM (K102726) | Maquet Cardiopulmonary, AG | 2011-04-04 |
| MODIFIED HD GUIDE CATHETER (K110483) | Concentric Medical, Inc. | 2011-04-04 |
| TORFLEX TRANSSEPTAL GUIDING SHEATH (K102948) | Baylis Medical Co., Inc. | 2011-04-01 |
| INTELLIVUE PATIENT MONITOR (K110622) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2011-03-31 |
| A SCOPE (K103499) | Active Signal Technologies, Inc. | 2011-03-31 |
| ELECTRO SENSOR -BODY COMPOSITION (K103026) | Ld Technology, LLC | 2011-03-29 |
| ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE (K110526) | ZOLL Medical Corporation | 2011-03-25 |
| MOBILEECG SYSTEM (K103427) | Memtec Corp. | 2011-03-24 |
| MUSTANG BALLOON DILATATION CATHETERS (K103751) | Boston Scientific | 2011-03-22 |
| THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER (K101422) | Access Scientific, Inc. | 2011-03-22 |
| LIFEPAK 15 MONITOR/DEFIBRILLATOR (K103567) | Physio-Control, Inc. | 2011-03-22 |
| MIDMARK IQECG (K103640) | Brentwood Medical Technology Corp. | 2011-03-22 |
| DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM10 SERIES (K110299) | Grandway Technology (Shenzhen) Limited | 2011-03-21 |
| DANMEDICAL ANALYSIS SYSTEM, MODEL D-MAS (K100424) | Danmedical Limited | 2011-03-21 |
| HEM-4030 (K110501) | Omron Healthcare, Inc. | 2011-03-21 |
| ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE (K102588) | Medtronic Ablation Frontiers, LLC | 2011-03-18 |
| ASAHI TREASURE FLOPPY PERIPHERAL GUIDE WIRE (K110553) | Asahi Intecc USA, Inc. | 2011-03-18 |
| MASIMO RADICAL Y PULSE CO-OXIMETER (K110028) | Masimo Corporation | 2011-03-17 |
| DOPPLER MONITOR (K110347) | Cook Vascular, Inc. | 2011-03-16 |
| ESSENTIAL MRI PATIENT MONITOR (K103700) | Invivo Corporation | 2011-03-15 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K110018) | Andon Health Co, Ltd. | 2011-03-15 |
| STAR 50 N (K103686) | Larsen & Toubro Limited | 2011-03-15 |
| STEALTH 360 ORBITAL PAD SYSTEM (K110389) | Cardiovascular Systems, Inc. | 2011-03-11 |
| MERIT EMBOLECTOMY CATHETER MODEL ASAP100 (K100569) | Merit Medical Systems, Inc. | 2011-03-11 |
| FUKUDA DENSHI (K103134) | Fukuda Denshi USA, Inc. | 2011-03-11 |
| NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE (K102919) | Maquet Cardiopulmonary, AG | 2011-03-11 |
| STELLAR 300 (K103763) | Larsen & Toubro Limited | 2011-03-11 |
| AIRSTRIP REMOTE PATIENT MONITORING (RPM) (K110503) | Airstrip Technologies, LP | 2011-03-10 |
| ZOLL R SERIES WITH 2010 AHA GUIDELINES SOFTWARE UPDATE (K110361) | Zoll Medical Corporation, World Wide Headquarters | 2011-03-08 |
| QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE / BIOLINE COATING (K103191) | Maquet Cardiopulmonary, AG | 2011-03-08 |
| ASAHI GUIDE WIRE EXTENSION 165CM (K101985) | Asahi Intecc Co., Ltd. | 2011-03-07 |
| QUADROX-I NEONATAL MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE/BIOLINE COATING (K102464) | Maquet Cardiopulmonary, AG | 2011-03-04 |
| MEDLINE ANGIOGRAPHIC CONTROL SYRINGE (K093830) | Medline Industries, Inc. | 2011-03-03 |
| INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM (K110295) | Boston Scientific Corp | 2011-03-03 |
| SPACELABS MULTI-PARAMETER MODULE (K103142) | Spacelabs Healthcare, Inc. | 2011-03-03 |
| INTERLOCK FIBERED IDC OCCLUSION SYSTEM (K102912) | Boston Scientific | 2011-03-03 |
| SPAULDING IQ ELECTROCARDIOGRAPH (K110065) | Spaulding Clinical Research, LLC | 2011-03-02 |
| INPECTRA STO2 SPOT CHECK (K103613) | Hutchinson Technology, Inc. | 2011-03-02 |
| BLOOD PRESSURE CUFF (K102825) | APK Technology Co., Ltd. | 2011-03-02 |
| V-TRUST MODEL TD-2202 PORTABLE ECG RECORDER (K101569) | Taidoc Technology Corporation | 2011-03-01 |
| DIGITAL ELECTROCARDIOGRAPH, MODELS ECG-1210, ECG-1230, ECG-3010, ECG-6010 (K101876) | Shenzhen Biocare Electronics Co., Ltd. | 2011-03-01 |
| FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815 (K100799) | Contract Medical Intl. GmbH | 2011-02-25 |
| APPROACH PRO ST WIRE GUIDE (K110163) | Cook Incorporated | 2011-02-25 |
| ENDOLOGIX GUIDEWIRE (K110241) | Techdevice Corporation | 2011-02-25 |
| HLS CANNULA NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING (K102532) | Maquet Cardiopulmonary, AG | 2011-02-25 |
| FLASH PTA BALLOON DILATATION CATHETER 5MM X 19MM X 135CM; FLASH PTA BALLOON DILATATION CATHETER 6MM X 19MM X 135CM (K102482) | Ostial Corporation | 2011-02-25 |
| FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH; FEMOSTOP II PLUS SET; FEMOSTOP II PLUS ARCH, BILATERAL ADAPTER; F (K110193) | St. Jude Medical Systems AB | 2011-02-24 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-931 (K102939) | Andon Health Co, Ltd. | 2011-02-23 |
| ASCOM CLINICALCONNEX CARDIOMAX (K103634) | Ascom (Us), Inc. | 2011-02-23 |
| EBONY PTA .035 PERIPHERAL DILATATION CATHETER (K103354) | Natec Medical , Ltd. | 2011-02-23 |
| ENVITEC REUSABLE SPO2 SENSORS TYPE NIHON-KOHDEN (K102270) | Envitec-Wismar GmbH | 2011-02-22 |
| ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10 (K102206) | Mortara Instrument, Inc. | 2011-02-18 |
| VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE (K103260) | Vasonova, Inc. | 2011-02-18 |
| INFINITY CNAP SMARTPOD (K102968) | Draeger Medical Systems, Inc. | 2011-02-18 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K110330) | Andon Health Co, Ltd. | 2011-02-18 |
| VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET (K103255) | Vasonova, Inc. | 2011-02-18 |
| PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN) (K110167) | Edwards Lifesciences, LLC | 2011-02-18 |
| SYNTHES SCOUT VESSEL GUARD (K103558) | Synthes Spine | 2011-02-18 |
| REPROCESSED PULSE OXIMETER SENSORS (K102560) | Sterilmed, Inc. | 2011-02-18 |
| ZOLL AED PLUS WITH 2010 AHA GUIDLINES SOFTWARE UPDATE (K110154) | Zoll Medical Corporation, World Wide Headquarters | 2011-02-17 |
| MODIFIED RETRIEVER (MODIFIED, LINE EXTENSION), MODELS 90152, 90153 (K093610) | Concentric Medical, Inc. | 2011-02-17 |
| ZOLL E SERIES WITH 2010 AHA GUIDLINES SOFTWARE UPDATE (K110168) | Zoll Medical Corporation, World Wide Headquarters | 2011-02-17 |
| CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM (K103678) | Ge Medical Systems Information Technologies GmbH | 2011-02-16 |
| VANTAGE ABI (K103693) | Summit Doppler Systems, Inc. | 2011-02-15 |
| PHILIPS ECG LEADWIRE SET (K110287) | Philips Medical Systems | 2011-02-15 |
| ADVANCED MEMBRANE GAS EXCHANGE (AMG), AMG OXYGENALING MODULE, AMG VENOUS CARDIOTOMY RESEVOIR 4500 MODEL EU5011, EU5012 (K102109) | Eurosets S.R.L | 2011-02-15 |
| FUSTAR STEERABLE INTRODUCERS (K100184) | Lifetech Scientific (Shenzhen) Co., Ltd. | 2011-02-14 |
| MEDTRONIC VASCULAR - HUB MATERIAL MODIFICATION TO THE 5F AND 8F LAUNCHER(R) GUIDE CATHETERS (K103386) | Medtronic, Inc. | 2011-02-11 |
| COMPLEX HELICAL 18, MULTI-LOOP 18, FIGURE 8-18, STRAIGHT 18 FIBERED PLATINUM COILS, VORTX -18, VORTX 35 & 2D HELICAL (K102714) | Boston Scientific Corp | 2011-02-11 |
| NC TREK RX CORONARY DILATATION CATHETER (K110134) | Abbott Vascular-Cardiac Therapies | 2011-02-11 |
| EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER (K110103) | Edwards Lifesciences, LLC | 2011-02-11 |
| HI-TORQUE BALANCE MIDDLEWEIGHT ELITE (K103101) | Abbott Vascular-Cardiac Therapies | 2011-02-10 |