| BNX FINE NEEDLE ASPIRATION SYSTEM (K103668) | Boston Endoscopic Engineering | 2010-12-30 |
| G-CINCH SUTURE GRASPER (K102931) | Usgi Medical | 2010-12-30 |
| IRRIGATION SYSTEM (K103239) | United States Endoscopy Group, Inc. | 2010-12-30 |
| CANTATA MICROCATHETER (K101450) | Cook, Inc. | 2010-12-30 |
| LUPOTEK KCT (K090105) | R2 Diagnostics, Inc. | 2010-12-30 |
| NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE (K102616) | Smart Medical Systems , Ltd. | 2010-12-30 |
| AXIOM FASCIAL CLOSURE SYSTEM (K103412) | Axiom Technology Partners, LLC | 2010-12-30 |
| AED RESECTOSCOPE (K102663) | National Advanced Endoscopy Devices, Inc. | 2010-12-30 |
| VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETER (K103153) | Abbott Vascular-Cardiac Therapies | 2010-12-30 |
| C-MAX, C-MAX U1, C-MAX U1 160KG, C-MAX U2, C-MAX U2 160KG, S-MAX, S-MAX AVIATION, S-MAX SELLA, S-MAX SELLA 160KG (K103122) | Aat Alber Antriebstechnik GmbH | 2010-12-30 |
| ZENIUS SPINAL SYSTEM (K103272) | Medyssey Co, Ltd. | 2010-12-29 |
| INFRARED EAR THERMOMETER (K103097) | Radiant Innovation, Inc. | 2010-12-29 |
| INCU I (K102279) | Atom Medical Corporation | 2010-12-29 |
| SAPPHIRE ST PORTABLE DIODE LASER (K103667) | Den-Mat Holdings, LLC | 2010-12-29 |
| INCLUSIVE TITANIUM ABUTMENTS FOR ASTRA TECH OSSEOSPEED IMPLANTS (K100993) | Prismatik Dentalcraft, Inc. | 2010-12-28 |
| ACL TIGHTROPE DOUBLE BUNDLE (K101837) | Arthrex, Inc. | 2010-12-28 |
| MIRAGE FX (K102746) | Resmed, Ltd. | 2010-12-28 |
| LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPHETAMINES 500 CALIBRATORS; LZI AMPHETAMINES 500 CONTROLS (K102210) | Lin-Zhi International, Inc. | 2010-12-28 |
| I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND (K103608) | Ellex, Inc. | 2010-12-27 |
| DC-7 DIAGNOSTIC ULTRASOUND SYSTEM (K103583) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010-12-27 |
| IYUNNI 3ID SUPRAPUBIC CYSTOSTOMY TUBE KIT (K102572) | Sainath Intellectual Properties, LLC | 2010-12-27 |
| OSTEOPHIL BETA-TCP (K102937) | Cytophil, Inc. | 2010-12-27 |
| FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK) (K103359) | C.R. Bard, Inc. | 2010-12-27 |
| PT2 VARIAN PROTON THERAPY SYSTEM (K101294) | Varian Medical Systems, Oncology Systems | 2010-12-27 |
| DOSEVIEW 3D (K103193) | Standard Imaging, Inc. | 2010-12-27 |
| VITAL SIGNS MONITOR (K102835) | Edan Instruments, Inc. | 2010-12-27 |
| DIGITAL DIAGNOSTIC X-RAY SYSTEM (K102408) | DRGEM Corporation | 2010-12-27 |
| INCLUSIVE MINI IMPLANT (K100932) | Prismatik Dentalcraft, Inc. | 2010-12-27 |
| MEDISTIM VERIQC SYSTEM (K102595) | Medi-Stim Asa | 2010-12-27 |
| LIFEBRIDGE (K103357) | Lifebridge Medizintechnik AG | 2010-12-27 |
| CROSSTEX SURGICAL EARLOOP MASK- WHITE, CROSSTEX SURGICAL EARLOOP NO FOG MASK-WHITE, NO FOG MASK WITH SPLASH VISOR-WHITE (K103303) | Crosstex International, Inc. | 2010-12-23 |
| COMPACT WHEELCHAIR PLATFORM (K101723) | Design Specific Fletcher | 2010-12-23 |
| NYDIAG 200 (K102364) | Interacoustics A/S | 2010-12-23 |
| DEFOGGING AND CLEANING SOLUTION- FLO-X (K102452) | Minimally Invasive Devices, LLC | 2010-12-23 |
| MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS (K103406) | Kimberly-Clark Corp. | 2010-12-23 |
| MODEL LUNA MANUAL WHEELCHAIR (K102910) | P.D.G., Inc. | 2010-12-23 |
| MODEL LA-1200 MULTI-CHANNEL LASER THERAPY SYSTEM (K102134) | United Integrated Services Co., Ltd. | 2010-12-23 |
| ERBEFLO 2 DISPOSABLE TUBING SYSTEM (K103235) | Erbe USA, Inc. | 2010-12-23 |
| AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5 (K100715) | Aalto Scientific, Ltd. | 2010-12-23 |
| ULTRA SEAL STERILE LUBRICATING JELLY (K101522) | Ultra Seal Corporation | 2010-12-23 |
| US ENDOSCOPY CYTOLOGY BRUSH (K103437) | United States Endoscopy Group, Inc. | 2010-12-23 |
| FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 SERIES, MODELS MC2000, MC2010, MC2020, MC2030 (K094030) | Cas Medical Systems, Inc. | 2010-12-23 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K102817) | Hebei Hongtai Plastic Products Co., Ltd. | 2010-12-23 |
| ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5 (K103221) | Roche Diagnostics | 2010-12-23 |
| AUDIT MICROCV HS-CRP LINEARITY SET (K101427) | Aalto Scientific, Ltd. | 2010-12-23 |
| 3.0T METAFLEXCOIL (K103342) | Neocoil, LLC | 2010-12-23 |
| TSRH SPINAL SYSTEM (K103049) | Medtronic Sofamor Danek | 2010-12-23 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K102819) | Hebei Hongtai Plastic Products Co., Ltd. | 2010-12-23 |
| HIROLLER ELEVATING WHEELCHAIR (K102837) | Max Mobility, LLC | 2010-12-23 |
| MI VARNISH (K102808) | GC America, Inc. | 2010-12-22 |
| REAVILLMED PRESSURE MONITORING SYSTEM AND PICC (K101189) | Reavillmed | 2010-12-22 |
| T2 RECON NAIL, R1500, LEFT/RIGHT 125 DEGREES / 120 DEGREES / 130 DEGREES (K102992) | Howmedica Osteonics Corp. | 2010-12-22 |
| PACIFIC XTREME PTCA BALLOON DILATATION CATHETER (K103464) | Medtronic, Inc. | 2010-12-22 |
| HINSON & HALE MEDICAL TECHNOLOGIES INFUSED (R) POLYESTER WRAPPERS (K102783) | Hinson and Hale Medical Technologies, Inc. | 2010-12-22 |
| MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER (K102605) | Covidien, LLC, Formerly Registered AS Tyco Healthca | 2010-12-22 |
| V200 VENTILATOR (K102054) | Respironics California, Inc. | 2010-12-22 |
| EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE (K093715) | Magnatone Hearing Aid Corp. Dba Persona Medical | 2010-12-22 |
| 31P/1H DUAL TUNED SURFACE COIL 3T; 23NA/ 1H DUAL TURNED SURFACE COIL 3T; 13C /1H DUAL TURNED SURFACE COIL 3T (K102348) | Rapid Biomedical GmbH | 2010-12-22 |
| TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM (K101861) | Truevision Systems, Incorporated | 2010-12-22 |
| PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC, (K102007) | Life-Tech, Inc. | 2010-12-22 |
| LIFEPAK 12 (K102972) | Physio-Control, Inc. | 2010-12-22 |
| THERMAL MASSAGE BED, MODEL 2D-GX (K102281) | Inarex Corporation | 2010-12-22 |
| PULSE OXIMETER (K102350) | Nonin Medical, Inc. | 2010-12-22 |
| PRONTO V4 EXTRACTION CATHETER 5.5F; PRONTO V4 EXTRACTION CATHETER 6F; PRONTO V4 EXTRACTION 7F; PRONTO V4 EXTRACTION CATH (K103405) | Vascular Solutions, Inc. | 2010-12-22 |
| ANTERIOR APPROACH HIP SURGERY INSTRUMENTS (K102565) | Wrightmedicaltechnologyinc | 2010-12-22 |
| PONSKY* NON-BALLOON REPLACEMENT GASTROSTOMY TUBE (K103109) | C.R. Bard, Inc. | 2010-12-22 |
| AXIS NANO OPTHALMIC BIOMETER ULTRASOUND SYSTEM (K102027) | Quantel Medical S.A. | 2010-12-22 |
| RESOLUTION II CLIP (K102764) | Boston Scientific Corporation | 2010-12-22 |
| NEO-SERVO I (K102710) | Atom Medical Corporation | 2010-12-22 |
| BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM (K102391) | C.R. Bard, Inc. | 2010-12-22 |
| GOLIFE NASAL MASK (K102502) | Respironics, Inc. | 2010-12-22 |
| MICROSTAAR MSI INJECTOR SYSTEM CARTRIDGE (K101782) | Staar Japan | 2010-12-22 |
| MICROFUSE PUTTY AND MICROFUSE ST MIS (K102392) | Globus Medical, Inc. | 2010-12-22 |
| SIMPLYGO BREAST PUMP (K102600) | Evenflo Company, Inc. | 2010-12-22 |
| RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH (K103568) | Coloplast A/S | 2010-12-22 |
| ARTHREX UNIVERS II SHOULDER PROSTHESIS (K103466) | Arthrex, Inc. | 2010-12-22 |
| COULTER LIN-X LINEARITY CONTROL, MODEL A81196 (K100790) | Beckman Coulter, Inc. | 2010-12-21 |
| OSOM C. DIFFICILE TOXIN A/B TEST (K102242) | Genzyme Corporation | 2010-12-21 |
| TARGON FN SYSTEM (K102057) | Aesculap Implant Systems, LLC | 2010-12-21 |
| SONIXTABLET ULTRASOUND SCANNER (K102997) | Ultrasonix Medical Corporation | 2010-12-21 |
| MATRYX INTERFERENCE SCREW (5.0-6.5MM) (K102410) | Conmed Linvatec | 2010-12-21 |
| MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180 (K101982) | St Jude Medical, Crmd | 2010-12-21 |
| GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132 (K100451) | Gambro Renal Products, Inc. | 2010-12-21 |
| PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE (K100937) | I-Sens, Inc. | 2010-12-21 |
| LEKSELL GAMMAPLAN (K103093) | Elekta Instrument AB | 2010-12-21 |
| FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCAN MEDIUM FLOW (K102770) | Heraeus Kulzer, LLC | 2010-12-21 |
| FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573 (K101715) | Fresenius Medical Care North America, Design Cente | 2010-12-21 |
| GEOSOURCE (K092844) | Electrical Geodesics, Inc. | 2010-12-21 |
| THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY (K102549) | Ascension Orthopedics, Inc. | 2010-12-21 |
| CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001 (K103502) | Veridex, LLC | 2010-12-21 |
| LIPID CONTROLS; MULTI- ANALYTE CONTROL; MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALS (K102700) | Alere, San Diego, Dba Biosite INcorporated, Dba IN | 2010-12-21 |
| STATIONARY X-RAY SYSTEM (DETECTOR) MODEL: ALTAS (K100703) | Comed Co., Ltd. | 2010-12-21 |
| HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS (K103223) | Encore Medical L.P. | 2010-12-21 |
| NEUROVISION SE (NERVEANA) (K102862) | Neurovision Medical Products, Inc. | 2010-12-21 |
| CARRIGEN (K100883) | Etex Corp. | 2010-12-21 |
| 2.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICC (K102966) | Medcomp | 2010-12-21 |
| SYNTHETIC, POWDER-FREE NITRILE EXAMINATION (K102593) | Zibo Yinghao Medical Products Co., Ltd. | 2010-12-20 |
| SUNMAX VIETNAM CO. LTD POWDER FREE WHITE NITRILE EXAMINATION GLOVE (K101870) | Sunmax Vietnam Co., Ltd. | 2010-12-20 |
| ULTRASIGHT HD DIGITAL COLPOSCOPY WITH IMAGESENSE TECHNOLOGY (K090324) | Sti Medical Systems | 2010-12-20 |
| ENDURO KNEE SYSTEM (K101815) | Aesculap Implant Systems | 2010-12-20 |