| TRILOGY 100 VENTILATOR (K083526) | Respironics Inc., Sleep & Home Respiratory Group | 2009-03-13 |
| VARELISA RECOMBI ANA SCREEN, MODEL 12 596 (K083188) | Phadia US, Inc. | 2009-03-13 |
| STONE GRASPING BASKET, MODEL PD-T1 2115 (K082735) | Sialo Technology, Ltd. | 2009-03-13 |
| EASYQC - CHEMISTRY WITH ELECTROLYTES; CHEMISTRY; ELECTROLYTES KIT; CHEMISTRY CALIBRATOR, CREA-U CLAIBRATOR (K080404) | Medica Corp. | 2009-03-13 |
| DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM 2-5MHZ CURVED LINEAR ARRAY, 5-10MHZ LINEAR ARRAY, 2-4MHZ PHASE ARRAY, 4-8MHZ TRANSV (K090229) | Chang Gung Medical Supplies & Equipment Corp. | 2009-03-13 |
| REVELATION STEM, MODEL 427-21/42-080/180 (K083651) | Encore Medical L.P. | 2009-03-13 |
| SYMCARE DIABETES MANAGEMENT PROGRAM (K083263) | Symcare Personalized Health Solutions, Inc. | 2009-03-13 |
| 3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM (K083316) | Topcon Medical Systems, Inc. | 2009-03-13 |
| VERATHON INC. BLADDERSCAN BVM 9500 ULTRASOUND (K090214) | Verathon Incorporated | 2009-03-13 |
| ACL ACUSTAR, HEMOSIL ACUSTAR D-DIMER, HEMOSIL ACUSTAR D-DIMER CONTROLS (K083518) | Instrumentation Laboratory CO | 2009-03-13 |
| DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M (K083463) | Siemens Healthcare Diagnostics | 2009-03-13 |
| THEKEN ATOLL CERVICO-THORACIC SYSTEM (K083073) | Theken Spine, LLC | 2009-03-13 |
| HOSPIRA VITAL SIGNS WIRELESS MONITORING SYSTEM (K090610) | Hospira, Inc. | 2009-03-13 |
| ROOT CANAL XR (K083062) | S & C Polymer GmbH | 2009-03-12 |
| HEMOBAND, MODELS HB-NS AND HB-NSXL (K081740) | Innovations For Access, Inc. | 2009-03-12 |
| SUPERCATH 5 (K081953) | Togo Medikit Co., Ltd. | 2009-03-12 |
| ORBITAL RECONSTRUCTIVE IMPLANT II (K083342) | Evera Medical, Inc. | 2009-03-12 |
| SYNTHES MATRIXORTHOGNATHIS FIXATION SYSTEM (K083388) | Synthes (Usa) | 2009-03-12 |
| AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415 (K090168) | MicroVention, Inc. | 2009-03-12 |
| UNIVERSAL COMPRESSION FRACTURE REPAIR SYSTEM (K081813) | U.S. Implant Solutions, LLC | 2009-03-12 |
| SOFTSEAL-STF (K090100) | Chitogen, Inc. | 2009-03-11 |
| IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT (K083314) | Siemens Healthcare Diagnostics | 2009-03-11 |
| U-RIGHT TD-4249/U-RIGHT TD-4250 BLOOD GLUCOSE MONITORING SYSTEM (K083570) | Taidoc Technology Corporation | 2009-03-11 |
| GRYPHON P BR DS ANCHOR W/ORTHOCORD,GRYPHON P BR ANCHOR W/ORTHOCORD, MODEL 210813,210814 (K090124) | Depuy Mitek, A Johnson & Johnson Company | 2009-03-11 |
| BAXOLVE XP CONDUCTIVE GARMENT ACCESSORY & LUMBAR SUPPORT KIT, MODELS 297, 298 (K082190) | Bio-Medical Research, Ltd. | 2009-03-11 |
| PEDINAIL INTRAMEDULLARY NAILING SYSTEM (K083726) | OrthoPediatrics Corp. | 2009-03-11 |
| LIFEPAK 15 MONITOR/DEFIBRILLATOR (K082937) | Physio-Control, Inc. | 2009-03-11 |
| ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR, MODELS P/N 04851534, P/N 10376487 (K083906) | Siemens Healthcare Diagnostics | 2009-03-11 |
| AERO DV TRACHEOBRONCHIAL STENT SYSTEM (K083625) | Alveolus, Inc. | 2009-03-11 |
| SEDECAL, MILLENNIUM PLUS (K090279) | Sedecal., Sa. | 2009-03-11 |
| JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE) (K090325) | Pathway Medical Technologies, Inc. | 2009-03-11 |
| HI-TORQUE FLEX-T GUIDE WIRE, MODELS 1012067-01, 02, 03, 04 AND 05 (K083738) | Abbott Vascular | 2009-03-11 |
| BIOCLEAN CHEMO SHIELD (K081970) | Nitritex (M) Sdn. Bhd. | 2009-03-11 |
| BIOLOX DELTA CERAMIC FEMORAL HEADS (K083762) | Smith & Nephew, Inc. | 2009-03-11 |
| CADI SMARTSENSE VITAL SIGNS AND WIRELESS TEMPERATURE MONITORI NG SYSTEM, MODEL S1 (K083185) | Cadi Scientific Pte.Ltd | 2009-03-11 |
| STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S (K090374) | DePuy Orthopaedics, Inc. | 2009-03-11 |
| PIGALILEO TKR BASE V2.3 AND CAS V4.1 (K090313) | Smith & Nephew, Inc. | 2009-03-11 |
| LOUSEBUSTER (K083206) | Larada Sciences | 2009-03-10 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K083015) | Zibo Goldenline Plastic Product Co., Ltd. | 2009-03-10 |
| ADX4000-L, DX3000-L (K083532) | Dexcowin Co., Ltd. | 2009-03-10 |
| FORA IR20B EAR THERMOMETER, MODEL TD-1261F, FORA IR21B EAR THERMOMETER, MODEL TD-1261E (K090395) | Taidoc Technology Corporation | 2009-03-10 |
| CARDIOVIEW32 REVIEW MODULE (K083749) | Qrs Diagnostic, LLC | 2009-03-10 |
| DYNAMIPEAK PEAK FLOW METER (K082899) | Dynamitech Medical, Inc. | 2009-03-10 |
| PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1 (K083677) | Commwell , Ltd. | 2009-03-10 |
| NOVA SAFE SCALP VEIN BLOOD COLLECTION SET (K090502) | U.S. Safety Syringes Co., Inc. | 2009-03-10 |
| ZQUIET MOUTHPIECE (K090503) | Sleeping Well, LLC | 2009-03-10 |
| PRISM ACQUIRE (VERSION 1.5), PRISM PROCESS (VERSION 1.5), PRISM VIEW (VERSION 2.5) (K082964) | Prism Clinical Imaging, Inc. | 2009-03-09 |
| MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT (K083796) | Miltex, Inc. | 2009-03-09 |
| ZOLL E SERIES WITH BLUETOOTH DIAL UP NETWORKING (K081081) | Zoll Medical Corporation, World Wide Headquarters | 2009-03-09 |
| WELCH ALLYN CARDIOPERFECT WORKSTATION SOFTWARE (CPWS) V 1.62 (K082478) | Welch Allyn, Inc. | 2009-03-09 |
| SILS STITCH ENDOSCOPIC SUTURING DEVICE (K090419) | Covidien Lp, Formerly Registered AS United States | 2009-03-09 |
| CARDIUS 3 X-ACT (K083649) | Digirad Corp. | 2009-03-09 |
| N-600X WITH SPD, OXIMAX N-600X (K083325) | Covidien | 2009-03-09 |
| DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS) (K083339) | Siemens Healthcare Diagnostics, Inc. | 2009-03-09 |
| PATHFAST HSCRP (K083412) | Mitsubishi Kagaku Iatron | 2009-03-09 |
| CLEARVUE PRONE BREAST TREATMENT TABLE (K090349) | Orbital Therapy, LLC | 2009-03-09 |
| BLACK NITRILE EXAMINATION GLOVES (K083908) | Innovative Gloves Co;, Ltd. | 2009-03-06 |
| DENOVISMED DENTAL IMPLANT SYSTEMS (K083543) | Denovis Medical, LLC | 2009-03-06 |
| SYNTHES (USA) 2.4 MM VA-LCP TWO COLUMN VOLAR DISTAL RADIUS PLATES (K083694) | Synthes (Usa) | 2009-03-06 |
| DYNASTY POROUS ACETABULAR SHELL, DYNASTY POLYETHYLENE ACETABULAR LINER, DYNASTY METAL ACETABULAR LINER (K082924) | Wrightmedicaltechnologyinc | 2009-03-06 |
| DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE (K083320) | Dukal Corp. | 2009-03-06 |
| PARCUS TINTANIUM INTERFERENCE SCREW, MODELS: 10001-10012, 10014-10016, 10018-10020 (K083619) | Parcus Medical, LLC | 2009-03-06 |
| EVOX ELECTRO DIAGNOSTIC DEVICE (K082614) | Laborie Medical Technologies, Inc. | 2009-03-06 |
| KFX PEEK BONE ANCHOR WITH PRE-ATTACHED SUTURES AND INSERTER HANDLE (K083609) | Kfx Medical | 2009-03-06 |
| TC ENDO PORT (K083218) | Transcardiac Therapeutics, Inc. | 2009-03-06 |
| SOMNOLYZER 24X7 (K083620) | The Siesta Group North America | 2009-03-06 |
| SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS (K081063) | Trek Diagnostic Systems, Inc. | 2009-03-06 |
| ELATION ENDOVENOUS LASER PROCEDURE KIT UNIVERSAL FLUID DISPENSING SYRINGE (K090084) | Merit Medical Systems, Inc. | 2009-03-06 |
| CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR) (K081330) | O-Two Medical Technologies, Inc. | 2009-03-06 |
| DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS (K083642) | DePuy Orthopaedics, Inc. | 2009-03-06 |
| EXPEDIUM SPINE SYSTEM (K090230) | Depuy Spine, Inc. | 2009-03-06 |
| PARCUS V-LOX TITANIUM SUTURE ANCHOR,MODELS: 10251, 10252, 10257, 10258 (K090075) | Parcus Medical, LLC | 2009-03-06 |
| D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT (K090073) | Diagnostic Hybrids, Inc. | 2009-03-06 |
| MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA C (K083558) | Medacta International S.A. | 2009-03-06 |
| SNOR-SCOPE PLUS OR SNOR-SCOPE + ELECTRONIC STETHOSCOPE SYSTEM (K082528) | Noble Anesthesia-Air, Inc. | 2009-03-06 |
| MERCURY MEDICAL PEEP VALVE (K081266) | Mercury Enterprizes Dba Mercury Medical | 2009-03-05 |
| BIOPSY SCIENCES HYDROMARK BREAST BIOPSY SITE MARKER, MODELS 4005-02-15-T1, 4005-02-15-S1, 4005-03-15-T1, 4005-03-15-S1 (K090501) | Biopsy Sciences, LLC | 2009-03-05 |
| EMU-GRAPH 4 EMULATOR, MODEL CI 144 (K083650) | Steritec Products, Inc. | 2009-03-05 |
| CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1030AIV-LB-S (K083776) | Corpak Medsystems | 2009-03-05 |
| V-GRIP PLUS DETACHMENT CONTROLLER, MODEL VG503 (K090001) | MicroVention, Inc. | 2009-03-05 |
| QUANTA PULSE OXIMETER, MODEL: PULSE LINK 1000 OR QH100 (K083079) | Quanta Computer, Inc. | 2009-03-05 |
| GE DATEX-OHMEDA AISYS (K090233) | Datex-Ohmeda, Inc. | 2009-03-05 |
| TRACH-ASSIST (K083702) | Mergenet Medical | 2009-03-05 |
| CSBP-001A BODY PERFUSION SYSTEM (K090504) | Toshibamedical Systems Corporation | 2009-03-05 |
| NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, LAVENDER BLUE COLOR, POLYMER COATED, TEXTED WITH CHEMOTHERAPY DRUGS (K083755) | Siam Sempermed Corp., Ltd. | 2009-03-05 |
| INCLUSIVE TITANIUM ABUTMENT BLANKS (K083192) | Inclusive Dental Solutions | 2009-03-04 |
| BIPAP AUTOSV (K090248) | Respironics Inc., Sleep & Home Respiratory Group | 2009-03-04 |
| M-50 SERIES SPO2 SENSOR (K082487) | Beijing Choice Electronic Technololgy Co., Ltd. | 2009-03-04 |
| APERFIX FEMORAL IMPLANT WITH INSERTER, 9,10,11 MM X 35MM AND X 29MM (K083612) | Cayenne Medical, Inc. | 2009-03-04 |
| SYNTHES (USA) 3.5MM LOCKING ATTACHMENT PLATES (K083573) | Synthes (Usa) | 2009-03-04 |
| AESCULAP CESPACE PEEK INTERVERTEBRAL BODY FUSION SYSTEM (K083311) | Aesculap Implant Systems, Inc. | 2009-03-04 |
| HOSPITAL FULL FACE MASK NON VENTED, MODEL: RT041 (K083122) | Fisher & Paykel Healthcare, Ltd. | 2009-03-04 |
| ACCUTECH FAMILY OF POWERFLEX LASER DELIVERY DEVICES (K090281) | Accutech Medical Technologies, Inc. | 2009-03-04 |
| MODIFICATION TO SECURACATH, MODEL: SPK01 (K083081) | Interrad Medical, Inc. | 2009-03-04 |
| CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1060AIV-S (K083791) | Corpak Medsystems | 2009-03-04 |
| BODYVIZ, MODEL 100 (K090295) | Visual Medical Solutions, LLC | 2009-03-04 |
| PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS (K083451) | Smiths Medical Asd, Inc. | 2009-03-04 |
| LABORPRO SYSTEM (K081984) | Trig Medical, Ltd. | 2009-03-04 |
| DATACOM DC PACS (K083182) | Datacom Technology Corp. | 2009-03-04 |
| MESA SPINAL SYSTEM (K080611) | K2m, Inc. | 2009-03-04 |