| CENTROS CHRONIC HEMODIALYSIS CATHETER SET (K092597) | Ash Access Technology, Inc. | 2009-11-12 |
| SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED SURGICAL GOWN (STERILE) (NON STERILE) (K093169) | A Plus International, Inc. | 2009-11-12 |
| ASAP ANTIMICROBIAL SILVER WOUND DRESSING GEL (K092826) | American Biotech Labs | 2009-11-12 |
| VIZTEK WL (K091752) | Viztek, Inc. | 2009-11-12 |
| SAFERSONIC SONOGRAPHY COVER (K092858) | Safersonic Medizinprodukte GmbH | 2009-11-10 |
| COLOR LCD MONITOR, MODEL RADIFORCE MX241W (K092741) | Eizo Nanao Corporation | 2009-11-10 |
| BARD SACROCOLPOPEXY GRAFT (K090739) | C.R. Bard, Inc. | 2009-11-10 |
| ELECSYS TOXO IGG CALCHECK 5 (K092888) | Roche Diagnostics Corp. | 2009-11-10 |
| ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6 (K092997) | Edan Instruments, Inc. | 2009-11-10 |
| BESMED JET NEBULIZER BOTTLE SET (K091272) | Besmed Health Business Corp | 2009-11-10 |
| FINESSE ULTRA BREAST BIOSPY SYSTEM DRIVER - BLUE, PINK, PROBE FO1BLU, FOIPNK, F14105US (K093068) | C.R. Bard, Inc. | 2009-11-10 |
| OPER SERIES OPEN TYPE PERMANENT-MAGNET MRI SYSTEM, MODEL: OPER-0.3, -0.35, -0.4 (K092899) | Ningbo Xingaoyi Magnetism Co., Ltd. | 2009-11-10 |
| ETHICON ENDO-SURGERYOPTICAL DILATOR (K093236) | Ethicon Endo-Surgery, Inc. | 2009-11-10 |
| STERNGOLD 2.2MM ANGLES MICRO ERA DENTAL IMPLANT SYSTEM (K092434) | Sterngold | 2009-11-10 |
| HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230A (K092487) | Barrx Medical, Incorporated | 2009-11-10 |
| SPINEOLOGY FACET SCREW (K092464) | Spineology, Inc. | 2009-11-09 |
| DENSICHECK PLUS (K093224) | bioMerieux, Inc. | 2009-11-09 |
| GREENLIGHT XPS LASER SYSTEM (K092735) | American Medical Systems, Inc. | 2009-11-09 |
| PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549) (K091725) | U&I Corp. | 2009-11-09 |
| DX-D IMAGING PACKAGE (K092669) | Agfa Healthcare N.V. | 2009-11-06 |
| MODIFICATION TO: LEVEEN SUPERSLIM NEEDLE ELECTRODES, MODELS M001262260, M001262270, M001262280, M001262290 (K092009) | Boston Scientific Corporation | 2009-11-06 |
| CADSTREAM VERSION 5 (K092954) | Confirma, Inc. | 2009-11-06 |
| TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM (K093301) | Ev3, Inc. | 2009-11-06 |
| SHIMADZU COLLIMATOR R-30H (K090578) | Shimadzu Corp. | 2009-11-06 |
| MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER; RAD 87 PULSE CO-OXIMETER (K091241) | Masimo Corporation | 2009-11-06 |
| CLAMPFIX (K090605) | Synthes (Usa) | 2009-11-06 |
| ENVOY GUIDING CATHETERS (K093184) | Codman & Shurtleff, Inc. | 2009-11-06 |
| VIGILANT EEG MONITOR, VIGILANT 2.0 (K091963) | Infinite Biomedical Technologies, LLC | 2009-11-06 |
| OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION (K091914) | Bionostics, Inc. | 2009-11-06 |
| ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, MODEL 2.7.5 (K092400) | Endogastric Solutions, Inc. | 2009-11-06 |
| CASPIAN SPINAL SYSTEM (K092640) | K2m, Inc. | 2009-11-06 |
| ASEPT PLEURAL DRAINAGE SYSTEM (K093307) | Pfm Medical, Inc. | 2009-11-06 |
| SURGIQUEST AIRSEAL OPTICAL TROCAR AND CANNULA SYSTEM (K092504) | Surgiquest, Inc. | 2009-11-05 |
| SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM (K092463) | Sorin Group Deutschland GmbH | 2009-11-05 |
| ASCENSION CANNULATED SCREW SYSTEM (K092440) | Ascension Orthopedics, Inc. | 2009-11-05 |
| LH-75 PHOTOTHERAPY SYSTEM (K091568) | Lerner Medical Devices, Inc. | 2009-11-05 |
| ALEXIS LAPAROSCOPIC SYSTEM (K093296) | Applied Medical Resources Corp. | 2009-11-05 |
| REVOLUTION FEMORAL INTRAMEDULLARY NAIL SYSTEM, MODEL DGOOXX (K091309) | Dgimed Ortho, Inc. | 2009-11-05 |
| IRRIGATION PUMP, IRRIGATION BIOPSY VALVE, ,MODEL 00711520, 00711139, 00711140 (K092461) | United States Endoscopy Group, Inc. | 2009-11-05 |
| MODIFICATION TO MODIFIED HD GUIDE CATHETER (K092298) | Concentric Medical, Inc. | 2009-11-05 |
| HEADWAY 21 MICROCATHETER, MODEL: MC212150S (K093160) | MicroVention, Inc. | 2009-11-05 |
| PECTUS STRUT (K082399) | Koros USA, Inc. | 2009-11-05 |
| ARTHROCARE TITANIUM SUTURE ANCHOR, MODEL 22-9055,22-9055N, 22-9065, 22-9065N (K092133) | Arthrocare Corp. | 2009-11-05 |
| NASAL AIRE II PEDIATRIC, MODEL 5 SIZES, MODEL TBD (K090804) | Innomed Technologies, Inc./Respcare, Inc. | 2009-11-05 |
| MODIFICATION TO THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM (K093187) | Avantis Medical Systems, Inc. | 2009-11-05 |
| GDS-DCS (K091367) | Guided Delivery Systems | 2009-11-05 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K093276) | Tangshan Kangyuan Glove Co., Ltd. | 2009-11-04 |
| EPIFUSE CATHETER CONNECTOR, MODEL: 4909E (K092657) | Smiths Medical Asd, Inc. | 2009-11-04 |
| PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM (K092313) | B.Braun Medical, Inc. | 2009-11-04 |
| ABG II MODULAR HIP STEM (K092406) | Howmedica Osteonics Corp. | 2009-11-04 |
| ENGAGE TR INTRODUCER (K093130) | St Jude Medical | 2009-11-04 |
| AMSCO EVOLUTION SERIES STEAM STERILIZER, MODEL: HC-2000 AND HC-3000 (K092490) | STERIS Corporation | 2009-11-04 |
| GATOR CLIPSEAL PLUG (K092563) | Vascular Solutions, Inc. | 2009-11-04 |
| GUIDELINER CATHETER, MODELS 5571, 5572, 5573 (K091750) | Vascular Solutions, Inc. | 2009-11-04 |
| LIQUICORD (K092384) | Centrix, Inc. | 2009-11-04 |
| POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED, BLUE (K092072) | Gx Corporation Sdn Bhd | 2009-11-04 |
| ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM (K093170) | Spineart | 2009-11-04 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K093270) | Tangshan Excellence Glove Co., Ltd. | 2009-11-04 |
| PLASTIC TEMPORARY ABUTMENTS, MODELS: PT341S, PT344S, PT341A, PT344A, PT451S, PT454S, PT451A, PT454A, PT561S, PT564S (K092377) | Zimmer Dental, Inc. | 2009-11-03 |
| EPICARE-DUO LASER SYSTEM (K091625) | Light Age, Inc. | 2009-11-03 |
| R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS (K092386) | Smith & Nephew, Inc. | 2009-11-03 |
| INTELLIVUE PATIENT MONITORS ,MODELS MP40, MP50, MP60, MP70, MP80, MP90 (K091927) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2009-11-03 |
| CAPRI APPLICATOR (K092822) | Vivaray, Inc. | 2009-11-03 |
| MODEL 220 PATIENT MAGNET (K092364) | Cyberonics, Inc. | 2009-11-03 |
| ELECSYS PRECICONTROL THYROAB (K092320) | Roche Diagnostics | 2009-11-03 |
| INTRA LUX HEAD 3 LDSY (K092446) | Kaltenbach & Voigt GmbH & Co. | 2009-11-03 |
| REPROCESSED PULSE OXIMETER SENSORS (K092368) | Sterilmed, Inc. | 2009-11-03 |
| SEC VBR (K091743) | Innvotec Surgical, Inc. | 2009-11-02 |
| KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500, KC600 (K092167) | Kimberly-Clark Corp. | 2009-11-02 |
| DEROYAL NON-STERILE LOCKING COMPRESSION PLATE SYSTEM (K092317) | Deroyal Industries, Inc. | 2009-11-02 |
| ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE (K091607) | Etex Corp. | 2009-11-02 |
| ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A (K092359) | Cook Ireland, Ltd. | 2009-11-02 |
| ETEST VORICONAZOLE 0.002-32 UG/ML (K082534) | Ab Biomerieux | 2009-11-02 |
| SLEEPWEAVER NASAL CPAP MASK (K092362) | Circadiance, LLC | 2009-11-02 |
| KENSEY NASH P1076 COLLAGEN DENTAL MEMBRANE, MODEL 20655-XX (K091192) | Kensey Nash Corp. | 2009-11-02 |
| SPECTRANETICS VISISHEATH DILATOR SHEATH (K092378) | Spectranetics Corp. | 2009-11-02 |
| CHOICE SPINE CERVICAL INTERBODY SPACER SYSTEM CHOICE SPINE CERVICAL INTERBODY SPACER (K091531) | Choice Spine, Llp | 2009-11-02 |
| POWDER FREE LATEX EXAMINATION GLOVES, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (K091643) | Gx Corporation Sdn Bhd | 2009-11-02 |
| ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00 (K091653) | Ark Diagnostics, Inc. | 2009-11-02 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K092790) | Zibo Boxiang Plastic & Rubber Co., Ltd. | 2009-11-02 |
| BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICE (K092318) | Baxter Healthcare Corporation | 2009-10-30 |
| ELECSYS RUBELLA IGGA CALCHECK 5 (K092585) | Roche Diagnostics | 2009-10-30 |
| HI TECH IMPLANT, HT PHYSIO IMPLANT (K091913) | By Dental Srl | 2009-10-30 |
| SILVERI: COFLEX AFD, COFLEX AFD FIRST AID, AFD PAD FOAM DRESSING, POWERFLEX AFD FOAM DRESSINGS (K083133) | Andover Healthcare, Inc. | 2009-10-30 |
| DENTIMAX DIGITAL X-RAY IMAGING SYSTEM SENSOR SIZE 1, 2, DENTIMAX USB CONTROL BOX (K092547) | Dentimax | 2009-10-30 |
| BUILD-IT LIGHT CURE (K091512) | Pentron Clinical Technologies | 2009-10-30 |
| ECO2 LASER SYSTEM (K091115) | Lutronic Corporation | 2009-10-30 |
| SINGLE USE ELECTROSURGICAL KNIFE SERIES, MODEL KD-610L, KD-611L, KD-620LR, KD-630L, KF-640L (K092309) | Olympus Medical Systems Corporation | 2009-10-30 |
| SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET (K091441) | Synergetics, Inc. | 2009-10-30 |
| SHARPSMART DISPOSABLE SHARPS CONTAINER, MODEL S2 (K091736) | Daniels Corporation Pty, Inc. | 2009-10-30 |
| BIPAP AUTOSV ADVANCED (K090539) | Respironics Inc., Sleep & Home Respiratory Group | 2009-10-30 |
| TI PREPABLE ABUTMENT, MODEL 1618, 1619, 1620 (K092403) | Zimmer Dental, Inc. | 2009-10-30 |
| INTEGRATED REGISTRATION (K093234) | GE Medical Systems SCS | 2009-10-30 |
| MITS DICOM GATEWAY AND IMAGE MANAGER (K092581) | Mitsmed Medical Instrument Technology Co., Ltd. | 2009-10-30 |
| BIODENTINE (K092251) | Septodont | 2009-10-30 |
| PALINDROME P HEMODIALYSIS CATHETER (K092205) | Covidien Lp, Formerly Registered AS Kendall | 2009-10-30 |
| SPINAL FIXATION SYSTEM (K092536) | Lanx, Inc. | 2009-10-30 |
| DIRECT DIGITIZER, REGIUS MODEL 210 (K092717) | Konica Minolta Medical & Graphic, Inc. | 2009-10-30 |
| PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II (K093221) | Dentsply Intl., Inc. | 2009-10-30 |
| ORIO-C CERVICAL, ORIO-TL TLIF, ORIO-PL PLIF, ORIO-AL ALIF INTERVEDRTEBRAL BODY FUSION CAGES (K090887) | SpineCraft | 2009-10-30 |