| NELLCOR OXIMAX PULSE OXIMETRY SENSONS (MAX-A, MAX-AL, MAX-N, MAX-I, MAX-P (K052186) | Nellcor Puritan Bennett, Inc. | 2005-11-10 |
| JOSTRA HLM TUBING SET (K053025) | Maquet Cardiopulmonary, AG | 2005-11-10 |
| ANGIOJET XPEEDIOR 120 CATHETER (K052256) | Possis Medical, Inc. | 2005-11-10 |
| WRISTOX MODEL 3100 PULSE OXIMETER (K052829) | Nonin Medical, Inc. | 2005-11-10 |
| CG FUTURE ANNULOPLASTY BAND (K052860) | Medtronic Heart Valves | 2005-11-10 |
| FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (K052280) | Boston Scientific Corp | 2005-11-07 |
| SWIRLGRAFT BYPASS AND VASCULAR ACCESS GRAFTS (K051312) | Veryan Medical Limited | 2005-11-04 |
| INVOS SYSTEM (K051274) | Somanetics Corp. | 2005-11-04 |
| MODIFICATION TO: AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER (K052791) | Invatec Innovative Technologies, S.R.L. | 2005-11-04 |
| ASAHI ANGIOGRAPHIC CATHETER (K051561) | Asahi Intecc Co., Ltd. | 2005-11-02 |
| INTELLIVUE PATIENT MONITORS WITH RELEASE C.02, MODELS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 (K052801) | Philips Medizin Systeme Boeblingen GmbH | 2005-11-02 |
| DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORS (K051799) | Coeur, Inc. | 2005-11-02 |
| DATEX-OHMEDA S/5 MEMORY MODULE, E-MEM (K052756) | GE Healthcare | 2005-11-01 |
| CARDIOSERVER (K052883) | Datrix | 2005-11-01 |
| SLIMMANAGER, MODEL SM-X, SM-E (K051589) | Aiia Communication, Inc. | 2005-10-31 |
| VP SHEATH (K051580) | Flowcardia, Inc. | 2005-10-31 |
| CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM (DEN050006) | Cardiomems, Inc. | 2005-10-28 |
| PHERON PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER (K052757) | Biotronik AG | 2005-10-28 |
| OMRON NON-INVASIVE BLOOD PRESSURE MONITOR WITH AUGMENTATION INDEX, MODEL HEM-9000AI (K050233) | Omron Healthcare, Inc. | 2005-10-28 |
| MODIFICATION TO: IQ GUIDE WIRE, MODELS 38950-XX. 38951-XX (K052783) | Boston Scientific Corp | 2005-10-27 |
| VYGON MICRO-ACCESS SAFETY INTRODUCER KIT (K051248) | Vygon Corp. | 2005-10-27 |
| PERIPRO PATCH (K052416) | Hancock/Jaffe Laboratories | 2005-10-25 |
| POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A) (K052161) | Cardiac Science, Inc. | 2005-10-21 |
| M3046B COMPACT PORTABLE PATIENT MONITORS (K052707) | Philips Medical Systems | 2005-10-20 |
| D732 MICRO 27 PH.I.S.I.O. ADULT ARTERIAL FILTER (K052717) | Dideco S.R.L. | 2005-10-20 |
| CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL 1002 (K052240) | Cardionet, Inc. | 2005-10-19 |
| CLIRPATH TURBO PLUS EXCIMER LASER CATHETERS, MODELS 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-001 (K052514) | Spectranetics Corp. | 2005-10-19 |
| BLOOD PRESSURE METER, MODEL CH-432 (K052046) | Citizen Watch Co., Ltd. | 2005-10-19 |
| ICY CATHETER, MODEL IC-3893A (K052443) | Alsius Corp. | 2005-10-17 |
| DUAL SHOT - CONTRAST DELIVERY SYSTEM (K052633) | Nemoto Kyorindo Co., Ltd. | 2005-10-17 |
| KENDALL SCD SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE THIGH), KENDALL SCD LEXPRES SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE (K051805) | Tyco Healthcare/Kendall | 2005-10-13 |
| DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, E-NSAT (K052755) | GE Healthcare | 2005-10-13 |
| COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A; ICY CATHETER KIT, MODEL IC-3585A; FORTIUS CATHETER KIT, MOD. FR-5093B (K051912) | Alsius Corp. | 2005-10-11 |
| VITALCAREGIVING SYSTEM (K051544) | Advanced Monitoring Caregiving, Inc. | 2005-10-07 |
| PLEURX PLEURAL CATHETER KIT, MODEL 50-7000 (K052436) | Denver Biomedical, Inc. | 2005-10-06 |
| PHILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR, MODELS M3860A, M3861A, M3840A, M3841A (K051632) | Philips Medical Systems | 2005-10-05 |
| CARDIOLINE AR 600, AR 1200, AR 2100 (K051534) | Et Medical Devices Spa | 2005-10-05 |
| TECHNO-SCOPE VISUAL STETHOSCOPE (K050097) | Techtrade, LLC | 2005-09-30 |
| CARTO RMT EP NAVIGATION SYSTEM (K042681) | Biosense Webster, Inc. | 2005-09-29 |
| NAVISTAR RMT STEERABLE TIP DIAGNOSTIC CATHETER (K052083) | Biosense Webster, Inc. | 2005-09-29 |
| ADVANTA T-GRAFT (K051332) | Atrium Medical Corp. | 2005-09-29 |
| REFSTAR RMT EXTERNAL REFERENCE PATCH (K042998) | Biosense Webster, Inc. | 2005-09-29 |
| VASCULAR SOLUTIONS PRONTO V3 EXTRACTION CATHETER (K052232) | Vascular Solutions, Inc. | 2005-09-28 |
| MATRIX HOLTER SYSTEM, MODEL M12 (K051730) | Global Instrumentation, LLC | 2005-09-26 |
| ASAHI TORNUS SUPPORT CATHETER (K051772) | Asahi Intecc Co., Ltd. | 2005-09-26 |
| MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C (K052372) | Medtronic Perfusion Systems | 2005-09-22 |
| VENAFLO II VASCULAR GRAFT (K052282) | Bard Peripheral Vascular, Inc. | 2005-09-20 |
| CAPIOX RX15 HOLLOW, FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR (K051997) | Terumo Cardiovascular Systems Corp. | 2005-09-15 |
| PICONIBP OEM MODULE (K051366) | Philips Medizin Systeme Boeblingen GmbH | 2005-09-14 |
| THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM (K052454) | Abbott Vascular Devices | 2005-09-14 |
| CAPIOX AF125X ARTERIAL FILTER (K052205) | Terumo Cardiovascular Systems Corp. | 2005-09-12 |
| PROTON DIGITAL BLOOD PRESSURE MONITOR, MODELS PH168A, PH168E, PH168W, PHC888JA, PH888HA (K051565) | Proton Healthcare , Ltd. | 2005-09-12 |
| ANGIODYNAMICS, INC., MICRO ACCESS KITS (K051655) | AngioDynamics, Inc. | 2005-09-12 |
| HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION (K052302) | Boston Scientific Corp | 2005-09-12 |
| ALL PURPOSE CUFF, MODEL 222APC (K051904) | Suntech Medical, Inc. | 2005-09-09 |
| OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-711AC (K052154) | Omron Healthcare, Inc. | 2005-09-08 |
| HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A (K051134) | Philips Medical Systems | 2005-09-08 |
| OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-741CREL (K052153) | Omron Healthcare, Inc. | 2005-09-08 |
| LEVITRONIX CENTRIMAG BACK-UP CONSOLE (K051209) | Levitronix, LLC | 2005-09-08 |
| DESTINATION CAROTID GUIDING SHEATH (K052185) | Terumo Medical Corp. | 2005-09-06 |
| VCS DOPPLER TRANSCEIVER, MODEL 09-0023-01 (K052209) | Vascular Control Systems, Inc. | 2005-09-06 |
| IMAGER II ANGIOGRAPHIC CATHETER (K050863) | Boston Scientific Corp | 2005-09-02 |
| ACCU-LEAD (K050443) | Kentec Medical, Inc. | 2005-09-02 |
| CLIRPATH TURBO EXCIMER LASER CATHETERS (K052296) | Spectranetics Corp. | 2005-09-02 |
| ANGIOSCULPT SCORING BALLOON CATHETER (K050629) | Angioscore, Inc. | 2005-09-02 |
| EDWARDS PERIPHERAL DILATION CATHETER (K052149) | Edwards Lifesciences, LLC | 2005-09-02 |
| SEER MC (K042782) | Ge Medical Systems Information Technologies | 2005-09-02 |
| MODIFIED CONCENTRIC RETRIEVER, MODEL 90039 (K051838) | Concentric Medical, Inc. | 2005-09-01 |
| MODIFIED ACUMEN SHEATH, MODEL TTW 10-65 (K051515) | Acumen Medical, Inc. | 2005-09-01 |
| REGENSIS PERICARDIAL PATCH (K051405) | Cormatrix Cardiovascular, Inc. | 2005-08-31 |
| MODIFICATION TO: RECOVERY FILTER SYSTEM, MODEL RF-210F (K050558) | C.R. Bard, Inc. | 2005-08-29 |
| PHILIPS 12-LEAD ALGORITHM (K052049) | Philips Medical Systems | 2005-08-26 |
| MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 3160 (K050399) | Invivo Research, Inc. | 2005-08-26 |
| ATB ADVANCE PTA DILATATION CATHETER (K052036) | Cook, Inc. | 2005-08-25 |
| ASAHI PTCA GUIDE WIRE FIELDER (K052022) | Asahi Intecc Co., Ltd. | 2005-08-25 |
| H12+ HOLTER RECORDER (K050896) | Mortara Instrument, Inc. | 2005-08-24 |
| BARD ATLAS PTA BALLOON DILATATION CATHETER (K052236) | Bard Peripheral Vascular, Inc. | 2005-08-23 |
| PC COMPATIBLE BLOOD PRESSURE MONITOR, MODEL AK-4000TU, BP-410U, BP-410R; AUTOMATIC DIGITAL WRIST BLOOD PRESS. MONITOR. (K051862) | Ya Horng Electronic Co., Ltd. | 2005-08-23 |
| AMLUCK, YA HORNG (K051863) | Ya Horng Electronic Co., Ltd. | 2005-08-19 |
| CARDIONAVIGATOR + (K051960) | Del Mar Reynolds Medical, Ltd. | 2005-08-19 |
| MODIFICATION TO: RX ACCUNET EMBOLIC PROTECTION SYSTEM (K052166) | Guidant Corporation | 2005-08-18 |
| EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900/859XX; VOLCANO VH-IVUS SYSTEM, MODEL 8049XX-001 (K051337) | Volcano Corporation | 2005-08-18 |
| 2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011 (K043465) | Spectranetics Corp. | 2005-08-18 |
| PERIPHERAL CUTTING BALLOON SMALL MONORAIL OR OVER-THE-WIRE DELIVERY SYSTEM (K052038) | Boston Scientific Corporation | 2005-08-16 |
| RX ACCUNET EMBOLIC PROTECTION SYSTEM (K052165) | Guidant Corporation | 2005-08-16 |
| LYSUS INFUSION SYSTEM (K052071) | Ekos Corp. | 2005-08-16 |
| GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING (K051606) | Gish Biomedical, Inc. | 2005-08-12 |
| TRIO MONITOR (K051897) | Datascope Corp. | 2005-08-12 |
| CLEVER TD-3018A BLOOD PRESSURE MONITOR (K051703) | Taidoc Technology Corporation | 2005-08-12 |
| 506 PATIENT MONITOR (K051038) | Ciriticare Systems, Inc. | 2005-08-12 |
| OXIMAX NPB-40 HANDHELD PULSE OXIMETER (K051352) | Nellcor Puritan Bennett, Inc. | 2005-08-11 |
| BR 102 PLUS BLOOD PRESSURE HOLTER SYSTEM (K051368) | Schiller AG | 2005-08-09 |
| VASCULAR SOLUTIONS PRONTO SHORT EXTRACTION CATHETER (K051193) | Vascular Solutions, Inc. | 2005-08-08 |
| DIVER C.E. CATHETER (K051917) | Invatec Innovative Technologies, S.R.L. | 2005-08-08 |
| 7F SHERPA NX GUIDE CATHETER (K051846) | Medtronic Vascular | 2005-08-05 |
| POLAR CATH PERIPHERAL DILATATION SYSTEM (K051916) | Cryo Vascular Systems, Inc. | 2005-08-05 |
| TRICOT BLOOD PRESSURE CUFF (K051539) | Ya Horng Electronic Co., Ltd. | 2005-08-05 |
| METRICATH GEMINI-P BALLOON CATHETER, MODELS RX2515S-P, RX3015S-P, RX3515S-P, RX4015S-P, METRICATH CONSOLE, MODEL 1000 (K051042) | Angiometrx, Inc. | 2005-08-05 |
| PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH (K051601) | Terumo Medical Corp. | 2005-08-04 |
| INNER-LOCK INTRODUCER SHEATH (K051468) | Rex Medical | 2005-08-04 |