| FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000 (K093065) | Calibra Medical, Inc. | 2010-01-20 |
| ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM (K093713) | Civco Medical Instruments | 2010-01-19 |
| KEELER APPLANATION TONOMETER; T-TYPE KAT, K-TYPE KAT, (KAT) (K093445) | Keeler, Ltd. | 2010-01-19 |
| 3DI (K093703) | Shina Systems , Ltd. | 2010-01-19 |
| IMMUNOCAP RAPID READER, MODEL 12-3600-10 (K092978) | Phadia US, Inc. | 2010-01-19 |
| SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061 (K092754) | Small Bone Innovations, Inc. | 2010-01-19 |
| BLADE ANTERIOR CERVICAL PLATE SYSTEM (K091936) | Nexxt Medical, Inc. | 2010-01-19 |
| C. ALBICANS PNA FISH (K092655) | Advandx, Inc. | 2010-01-19 |
| EBCARRYON BLOOD GLUCOSE MONITORING SYSTEM (K091765) | Visgeneer, Inc. | 2010-01-19 |
| LIFE SPINE LUMBAR PLATE SYSTEM (K093200) | Life Spine | 2010-01-19 |
| ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM (K093849) | Medison Co., Ltd. | 2010-01-19 |
| POWDER FREE NITRILE EXAMINATION GLOVES, WHITE (NON-COLORED) OR BLUE (COLORED), NON-STERILE (K093500) | Wear Safe (Malaysia) Sdn. Bhd. | 2010-01-19 |
| CEROX MODEL 3210 (K093923) | Or-Nim Medical , Ltd. | 2010-01-19 |
| NORAS OR HEAD HOLDER S17000-MQ/ NORAS OR HEAD COIL 3T 7230-PH MODEL S1700-MQ/ 7230-PH (K093693) | Noras Mri Products GmbH | 2010-01-19 |
| PRUTECT TOPICAL OINTMENT, MODELS 45 GRAM TUBE, 90 GRAM TUBE (K092878) | Prugen IP Holdings, Inc. | 2010-01-15 |
| ETHICON ENDO-SURGERY FLEXIBLE BIPOLAR HEMOSTASIS FORCEPS (K091259) | Ethicon Endo-Surgery, Inc. | 2010-01-15 |
| SORIN C5 SYSTEM MODEL 58-00-00 (K093882) | Sorin Group Deutschland GmbH | 2010-01-15 |
| SMART-WELL EZTEST INCUBATOR (K091950) | Sgm Biotech, Inc. | 2010-01-15 |
| COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG (K093223) | Compumedics Limited | 2010-01-15 |
| PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM (K091052) | Abaxis, Inc. | 2010-01-15 |
| HALO 360 & SIZING BALLOON, MODEL 3441C (K093855) | Barrx Medical, Incorporated | 2010-01-15 |
| PICA CATHETER (K093970) | Penumbra, Inc. | 2010-01-15 |
| NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOS (K091547) | Nova Biomedical Corp. | 2010-01-15 |
| MICROPLEX COIL SYSTEM-COSMOS, MODELS 81451CS-V, 181555CS-V, 16=81652CS-V (K093358) | MicroVention, Inc. | 2010-01-15 |
| ARTHROCARE COBLATOR IQ SYSTEM (K091674) | Arthrocare Corp. | 2010-01-15 |
| MODERN MEDICAL RESECTOSCOPE ELECTRODES (K091511) | Modern Medical Equipment Mfg., Ltd. | 2010-01-15 |
| THE LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM (K092743) | Stryker Craniomaxillofacial | 2010-01-15 |
| ADAGIO RETRACTING ECG LEAD WIRES (K093657) | Acist Medical Systems, Inc. | 2010-01-15 |
| MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD (K093308) | Nidek Medical Products, Inc. | 2010-01-14 |
| HYDROCOAT MESH (K090271) | Promethean Surgical Devices, Inc. | 2010-01-14 |
| MEDTRADE PRODUCTS CELOX VASCULAR TOPICAL HEMOSTATIC GRANULES ON SHEET (K093519) | Medtrade Products , Ltd. | 2010-01-14 |
| SAF (SELF ADJUSTING FILE) (K092933) | Redent-Nova , Ltd. | 2010-01-14 |
| TYTAN AUTOMATIC ANEROID SPHYGMOMANOMETER, MODEL A730 AND MANUAL DIGITAL LCD SPHYGMOMANOMETER, MODEL A830 SERIES (K092893) | Tytan Medical Corp. | 2010-01-14 |
| ECLIPSE FILTER SYSTEM-FEMORAL DELIVERY KIT, ECLIPSE FILTER SYSTEM-JUGULAR/SUBCLAVIAN DELIVERY KIT MODEL RF500F MODEL RF5 (K093659) | C.R. Bard, Inc. | 2010-01-14 |
| ASCENSION METAL GREAT TOE SYSTEM (K092047) | Ascension Orthopedics, Inc. | 2010-01-14 |
| CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONITOR & BLOOD GLUCOSE MONITOR, MODEL IGM-0023 (K082275) | Infopia Co, Ltd. | 2010-01-14 |
| RENU MEDICAL VASOPRESS CALF , THIGH GARMENTS- ALL SIZESD, RENU MEDICAL VASOPRESS FOOT GARMENTS (K093658) | Renu Medical, Inc. | 2010-01-14 |
| W&H HANDPIECE ANESTO, MODEL: RA-5 (K083811) | W&H Dentalwerk Buermoos GmbH | 2010-01-14 |
| ADVIA CENTAUR SHBG READYPACK, LOW AND HIGH CALIBRATORS AND MASTER CURVE MATERIAL, MODELS 06520781, 04819274 AND 06520773 (K091867) | Siemens Healthcare Diagnostics | 2010-01-14 |
| DISPOSABLE HYPODERMIC NEEDLE (K092831) | Feel Tech | 2010-01-14 |
| CT2011 SONICSTIMU PAIN RELIEF DEVICE (K092627) | Shenzhen Dongdixin Technology Co., Ltd. | 2010-01-14 |
| REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS (K092158) | Sterilmed, Inc. | 2010-01-14 |
| ACE SURGICAL SECURE LOCATOR 3.25 IMPLANT SYSTEM (K093518) | Ace Surgical Supply Co., Inc. | 2010-01-14 |
| ALBOGRAFT VASCULAR PROSTHESIS (K093231) | LeMaitre Vascular, Inc. | 2010-01-14 |
| PORT ACCESS SYSTEMS ENDODIRECT ARTERIAL CANNULA MODEL ED24 (OLD CODE WAS-DFK24) (K093730) | Edwards Lifesciences, LLC | 2010-01-14 |
| LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLES (K093832) | Levitronix, LLC | 2010-01-13 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7035B, KD-7921, KD-7903 (K092811) | Andon Health Co, Ltd. | 2010-01-13 |
| SOPROLIFE (K092583) | Sopro | 2010-01-13 |
| VITAL SLEEP (K092942) | The Snore Reliever Company, LLC | 2010-01-13 |
| AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE (K093825) | Ambu A/S | 2010-01-13 |
| ANGIOGRAPHIC CATHETER, MODEL ANGIOS (K092118) | Oscor, Inc. | 2010-01-13 |
| ASTHMA MONITOR AM3 (K092890) | Carefusion Germany 234 GmbH | 2010-01-13 |
| EVALVE STEERABLE GUIDE CATHETER (K093866) | Evalve, Inc. | 2010-01-13 |
| MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DUAL LIGHT SOURCE STERILE (K092739) | C-Link Micro Imaging, Inc. | 2010-01-12 |
| AESPIRE 7900, AESPIRE VIEW (K092864) | Datex-Ohmeda Inc., A Division of Instrumentarium C | 2010-01-12 |
| LUMOS, MODEL R 72B (K093596) | Lumos, Inc. | 2010-01-12 |
| LIFENET SYSTEM (K093925) | Physio-Control, Inc. | 2010-01-12 |
| SYNTHES 7.3 MM CANNULATED SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREWS (SCFE) (K092909) | Synthes (Usa) | 2010-01-11 |
| EXPLORER 4D TREATMENT PLANNING SYSTEM (K093588) | American Radiosurgery, Inc. | 2010-01-11 |
| OPTETRAK LOGIC TOTAL KNEE SYSTEM TRAPEZOIDAL TIBIAL TRAY, SIZES 2.5F/1.5T-3.5F/4.5T (K093360) | Exactech, Inc. | 2010-01-11 |
| SDX-SPIRODYNR'X RADIOTHERAPY BREATHING CONTROL (K092479) | Dyn'R | 2010-01-11 |
| HARDYDISK AST TELAVANCIN,30UG (K093807) | Hardy Diagnostics | 2010-01-08 |
| XELERIS 3 PROCESSING AND REVIEW WORKSTATION (K093982) | Ge Medical Systems F.I. Haifa | 2010-01-08 |
| DURASPAN HEMODIALYSIS LONG-TERM CATHETER, MODELS 62152420, 621512820, 62153220, 62153620, 62154020, 62155520 (K091506) | R4 Vascular, Inc. | 2010-01-08 |
| CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER, MODEL: MULTIPLE, PREFIX C-PTBS (K093469) | Cook, Inc. | 2010-01-08 |
| DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE (K082097) | Demetech Corp. | 2010-01-08 |
| MATRIX RF APPLICATOR (K090025) | Syneron Medical, Ltd. | 2010-01-08 |
| PCR ELEVA 1.2 (K093355) | Philips Medical Systems, Inc. | 2010-01-08 |
| FINGERTIP PULSE OXIMETER, MODEL MD300CA ND300CA (K092652) | Beijing Choice Electronic Technololgy Co., Ltd. | 2010-01-08 |
| MICRO-STICK SET (K091954) | Medcomp | 2010-01-08 |
| HALO ABLATION CATHETER, MODEL 90-9100 (K093008) | Barrx Medical, Incorporated | 2010-01-08 |
| DIMELA OBSTERICAL FORCEPS, MODEL 72.1 XX XX (K092827) | Dimeda Instrumente GmbH | 2010-01-08 |
| DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3D (K090467) | VATECH Co., Ltd. | 2010-01-08 |
| ORTHOSS (K090401) | Ed. Geistlich Soehne AG Fur Chemische Industrie | 2010-01-08 |
| OC-SENSOR DIANA IFOB TEST (K092330) | Polymedco Cancer Diagnostics, LLC | 2010-01-08 |
| BLOOD PRESSURE MONITOR, MODEL MD200A (K093013) | Beijing Choice Electronic Technololgy Co., Ltd. | 2010-01-08 |
| MENDASIL TWG GEL ANTIMICROBIAL SKIN AND WOUND GEL (K090345) | Conseal International, Inc. | 2010-01-07 |
| ENDOMAX CORDLESS ENDODONTIC HANDPIECE (K092833) | Dentamerica | 2010-01-07 |
| MOUNTAINEER LAMINOPLASTY SYSTEM (K091994) | Depuy Spine, Inc. | 2010-01-07 |
| INF 4160 PLUS, MODEL D-FJ31F (K092780) | Fuji Dynamics Limited | 2010-01-07 |
| EXACTECH EQUINOXE PLATFORM FRACTURE STEM AND REVISION PLATFORM FRACTURE STEM (K092900) | Exactech, Inc. | 2010-01-07 |
| GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS (K093817) | Vascutek, Ltd. | 2010-01-07 |
| CARDIO-WRAP (K090637) | Mast Biosurgery USA, Inc. | 2010-01-07 |
| MEDLINE CURAD WOUND DRESSINGS (K093349) | Medline Industries, Inc. | 2010-01-07 |
| VIDAR DENTAL FILM DIGITIZER (K093809) | Vidar Systems Corp. | 2010-01-07 |
| VARI-LASE ENDOVENOUS LASER CONSOLE (K093502) | Vascular Solutions, Inc. | 2010-01-07 |
| DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER), DT SERIES (K092447) | Hangzhou Hua'An Medical & Health Instruments Co., | 2010-01-07 |
| SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171 (K092346) | Serim Research Corp. | 2010-01-07 |
| MINI RAIL EXTERNAL FIXATOR SYSTEM (K093550) | Small Bone Innovations, Inc. | 2010-01-07 |
| POGS, MODEL 65/130 (K092636) | On Site Gas Systems, Inc. | 2010-01-07 |
| CHAMPIONS IMPLANTS GMBH MIMI 1-PIECE PRECISION IMPLANT, MODEL 1000 UP TO 6000 (K091182) | Champions Implants GmbH | 2010-01-07 |
| INTRAX FILM PROCESSOR (K093503) | Velopex International, Inc. | 2010-01-06 |
| CYTORI PUREGRAFT 250/PURE SYSTEM (K092923) | Cytori Therapeutics, Inc. | 2010-01-06 |
| 3D ASL (K092925) | Ge Medical Systems, LLC | 2010-01-06 |
| MICHIGAN CRANIAL RESHAPING ORTHOSIS (K090341) | Danmar Products, Inc. | 2010-01-06 |
| 4CIS PEEK, PLIF AND TLIF CAGE SYSTEM (K092162) | Solco Biomedical Co., Ltd. | 2010-01-06 |
| PORTABLE X-RAY SYSTEM, MODEL HAND-RAY (K092772) | Hanjin Digi-X Co., Ltd. | 2010-01-06 |
| THERMODILUTION CATHETER (K083384) | Biosensors Intl. Pte. , Ltd. | 2010-01-05 |
| MIKRO-CATH, MODEL 825-0101 (K093111) | Millar Instruments, Inc. | 2010-01-05 |
| VIVOSIGHT TOPICAL OCT SYSTEM (K093520) | Michelson Diagnostics, Ltd. | 2010-01-05 |