| PRACTICAL COMPRESSION DEVICE (PCD) 901A&901B (K121962) | Mego Afek AC , Ltd. | 2012-10-19 |
| DIGITAL FLAT PLANEL X-RAY DETECTOR / 1717SCC (K122173) | Rayence Co., Ltd. | 2012-10-19 |
| 3M ATTEST(TM) SUPER RAPID READOUT BIOLOGICAL INDICATOR, 3M ATTEST(TM) AUTO-READER (K121484) | 3M Company | 2012-10-19 |
| VERTECEM II CEMENT KIT (K121876) | Aap Biomaterials GmbH | 2012-10-19 |
| SYSMEX XN-SERIES (K112605) | Sysmex America, Inc. | 2012-10-19 |
| SMITH & NEPHEW, INC. INTRAMEDULLARY NAIL SYSTEM INSTRUMENTATION (K122170) | Smith & Nephew, Inc. | 2012-10-19 |
| ZFX DENTAL CAD SYSTEM (K121709) | Zimmer Dental, Inc. | 2012-10-19 |
| XN CHECK (K120742) | Streck | 2012-10-19 |
| ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM (K113219) | Ellipse Technologies, Inc. | 2012-10-19 |
| SDX SYSTEM (K121845) | Dyn'R Sas | 2012-10-19 |
| JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM (K122916) | Medrad, Inc. | 2012-10-19 |
| NONDISPOSABLE STIMULATING INSTRUMENTS (K121931) | Neurovision Medical Products, Inc. | 2012-10-19 |
| VERSAFITCUP CC TRIO EXTENSION (K122911) | Medacta International | 2012-10-19 |
| XN CAL (K120745) | Streck | 2012-10-19 |
| NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE (K113469) | Nipro Medical Corporation | 2012-10-18 |
| DOMAIN SURGICAL SYSTEM (K121881) | Domain Surgical, Inc. | 2012-10-18 |
| NMI HPICC III (K122882) | Navilyst Medical, Inc. | 2012-10-18 |
| 4-WEB CERVICAL STS (SPINAL TRUSS SYSTEM) (K121741) | 4-Web, Inc. | 2012-10-18 |
| PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSERTION STYLET, PLEURX INTEGRAL VALVED PEE (K121849) | Care Fusion | 2012-10-18 |
| AIRCAST VENAFLOW ELITE SYSTEM (K122499) | Djo, LLC | 2012-10-18 |
| IPS E.MAX PRESS - ABUTMENT SOLUTIONS (K120053) | Ivoclar Vivadent, AG | 2012-10-18 |
| NIPRO HUBER INFUSION SET, EXCEL HUBER INFUSION SET (K113471) | Nipro Medical Corporation | 2012-10-18 |
| VIRULITE COLD SORE MACHINE (DEN090012) | Virulite, LLC | 2012-10-18 |
| STERILE BLUNT FOR SINGLE USE (K120420) | Shanghai Double Dove Industrial Co., Ltd. | 2012-10-18 |
| COUGAR LS 15 LATERAL CAGE SYSTEM (K122896) | Medos International SARL | 2012-10-18 |
| SMITH & NEPHEW ULTRA FAST-FIX MENISCAL REPAIR SYSTEM, SMITH & NEPHEW ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEM, SMITH & N (K121861) | Smith & Nephew, Inc. | 2012-10-18 |
| NIPRO SAFE TOUCH HUBER INFUSION SET (K113470) | Nipro Medical Corporation | 2012-10-17 |
| GLOBAL MEDI PRODUCTS RETRACTABLE SAFETY SYRINGE (K120641) | Global Medi Products | 2012-10-17 |
| INSPIRE 8F DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL RESERVOIR (K122844) | Sorin Group Italia S.R.L. | 2012-10-17 |
| BOX PEEK VBR SYSTEM, (K121581) | Innovasis, Inc. | 2012-10-17 |
| CHARTER GUIDEWIRE (K122856) | Brivant, Ltd. | 2012-10-17 |
| NU SLEEP (K121344) | Rh Associates, LLC | 2012-10-17 |
| POWDER FREE NITRILE EXAMINATION GLOVE-BLUE (CHEMOTHERAPY) (K122131) | Matang Mfg. Sdn. Bhd. | 2012-10-17 |
| STINGRAY CERVICAL CAGE (K122085) | Omni Surgical, LP Dba Spine360 | 2012-10-17 |
| QBTES (K122149) | Qbtech AB | 2012-10-17 |
| ENDOWRIST STAPLER SYSTEM (K113706) | Intuitive Surgical, Inc. | 2012-10-17 |
| THS INSTRUMENT TRAY (K120947) | Hologic, Inc. | 2012-10-17 |
| LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY PLUS CONTROL, LEVEL 2 MODEL 268, LIQUICHEK (K122838) | Bio-Rad Laboratories | 2012-10-17 |
| DISPOSABLE SURGICAL GOWNS (K120192) | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | 2012-10-16 |
| POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR (K121992) | Xinwei (Shandong) Plastic and Rubber Products Co., | 2012-10-16 |
| TOWERLOX PEDICLE SCREW SYSTEM (K122332) | Captiva Spine | 2012-10-16 |
| ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 (K121564) | Olympus Medical Systems Corp. | 2012-10-16 |
| AMS LARGE PORE POLYPROPHLENE MESH (K121805) | American Medical Systems | 2012-10-16 |
| ACCUMESH DEPLOYMENT SYSTEM (K123066) | Covidien, LLC | 2012-10-16 |
| SMITH & NEPHEW R3 CONSTRAINED LINERS (K122139) | Smith & Nephew, Inc. | 2012-10-16 |
| MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, PINK (K122465) | Industrial Clothings, Ltd. | 2012-10-16 |
| ME AGAIN(R) LONG LASTING VAGINAL MOISTURIZER, VH ESSENTIALS (R) LONG LASTING VAGINAL MOISTURIZER (K112217) | Polichem S.A | 2012-10-16 |
| QUARTZ SPLINT SYSTEM (UD, WOVEN, ROPE, MESH) QUARTZ SPINT RESIN QS FLOW (K122348) | Recherches Techniques Dentaires (R.T.D.) | 2012-10-15 |
| AESKUSLIDES ANA HEP-2 (K120889) | Aesku Diagnostics | 2012-10-15 |
| GRAM POSTITVE CLINDAMYCIN (K122547) | bioMerieux, Inc. | 2012-10-15 |
| LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE) (K121721) | Abbott Medical Optics, Inc. | 2012-10-15 |
| SMITH & NEPHEW REDAPT REVISION FEMORAL SYSTEM (K121627) | Smith & Nephew, Inc. | 2012-10-15 |
| TYVEK SELF-SEAL POUCHES ,TYVEK HEAT-SEAL ROLLS (K112087) | Advanced Sterilization Products | 2012-10-15 |
| ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 14MM ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 16MM (K122497) | Medical Design, LLC | 2012-10-15 |
| REUSABLE CUTANEOUS ELECTRODE (K121483) | Ampcare, LLC | 2012-10-15 |
| CAVITY VARNISH (K122331) | Dentsply International, Inc. | 2012-10-15 |
| FINGERTIP PULSE OXIMETER (K121697) | Andon Health Co, Ltd. | 2012-10-15 |
| PROTECH DENT (K121272) | Akervall Technologies, Inc. | 2012-10-15 |
| AUTOJECT 2 FOR GLASSY SYRINGE (K122837) | Owen Mumford, Ltd. | 2012-10-15 |
| IFUSE IMPLANT SYSTEM (K122074) | SI-BONE, Inc. | 2012-10-12 |
| MULTI-UNIT ABUTMENTS WITH ANGULATIONS 17 AND 30 FOR TAPERED IMPLANT SYSTEM (K121688) | Prismatik Dentalcraft, Inc. | 2012-10-12 |
| PIONEER STERNAL CABLE PLATE SYSTEM (K122293) | Pioneer Surgical Technology, Inc. | 2012-10-12 |
| BIOMET MICROFIXATION NEURO PLATING SYSTEM (K121624) | Biomet Microfixation | 2012-10-12 |
| RAPICIDE OPA-28 TEST STRIP (K120652) | Serim Research Corp. | 2012-10-12 |
| ORTHOLOC 3DI MIDFOOT/FLATFOOT SYSTEM (K121651) | Wrightmedicaltechnologyinc | 2012-10-12 |
| CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE (K122811) | Medtronic, Inc. | 2012-10-12 |
| ETEST CEFTAROLINE (K121002) | bioMerieux, Inc. | 2012-10-12 |
| AESPIRE 7900, AESPIRE VIEW (K122445) | Datex-Ohmeda | 2012-10-12 |
| ANCHORSURE (K120831) | Neomedic International S.L. | 2012-10-12 |
| DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL D3 AND D6 (K122574) | Edan Instruments, Inc. | 2012-10-12 |
| RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS (K122398) | Siemens Healthcare Diagnostics, Inc. | 2012-10-12 |
| ME HAIR2GO (K121598) | Syneron Medical, Ltd. | 2012-10-12 |
| GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY (K120199) | Beckman Coulter, Inc. | 2012-10-12 |
| TREGOR DUAL MOBILITY ACETABULAR SYSTEM (K111981) | Aston Medical | 2012-10-12 |
| COCHLEAR BAHA IMPLANT SYSTEM (K121317) | Cochlear Americas | 2012-10-12 |
| UNISYN PLUS HIP STEM (K120595) | Consensus Orthopedics, Inc. | 2012-10-12 |
| INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELL (K122798) | Exactech, Inc. | 2012-10-11 |
| ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, BASE PLATES & HUMERAL STEMS (K121543) | Zimmer, Inc. | 2012-10-11 |
| PNEUTON MINI VENTILATOR PNEUTON MINI NON-INVASIVE VENTILATION (NIV) KIT ACCESSORY (K121379) | Airon Corporation | 2012-10-11 |
| FLAVORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (VANLLA, GRAPE AND STRAWBERRY) (K121591) | Tekmedic (M) Sdn Bhd | 2012-10-11 |
| LIFEPAK 1000 DEFIBRILLATOR (K122600) | Physio-Control, Inc. | 2012-10-11 |
| CAPSURE(R) PS SYSTEM (K122233) | Spine Wave, Inc. | 2012-10-11 |
| CXI SUPPORT CATHETER (K122796) | Cook, Inc. | 2012-10-11 |
| WIRELESS THERMOMETER (K121696) | Raling Medical Company | 2012-10-11 |
| FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 19MM X 1 (K122178) | Ostial Corporation | 2012-10-11 |
| WECK REUSABLE OBTURATOR (K121796) | Teleflexmedical, Inc. | 2012-10-11 |
| PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KIT (K121883) | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2012-10-11 |
| ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM (K121679) | Roche Diagnostics | 2012-10-11 |
| TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA (K121083) | Loma Vista Medical | 2012-10-11 |
| PROFEMUR Z REVISION HIP STEM (K122778) | Wrightmedicaltechnologyinc | 2012-10-11 |
| APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 10X24 APERFIX FEMORAL IMPLANT W (K122463) | Cayenne Medical, Inc. | 2012-10-11 |
| ARCHON ANTERIOR CERVICAL PLATE SYSTE, (K122910) | Nu Vasive, Incorporated | 2012-10-11 |
| VISUALIF CHALLENGING ACCESS PLATE (K122168) | Spine Smith Partners L.P. | 2012-10-11 |
| ESA620 ELECTRICAL SAFETY ANALYZER (K121722) | Fluke Biomedical | 2012-10-11 |
| BLUE SUI SLING (K121754) | Boston Scientific Corp | 2012-10-10 |
| FEMORAL HEADS, 2.5 AND 7.5 MM NECK LENGTH (K122504) | United Orthopedic Corporation | 2012-10-10 |
| NOORVMS-OXY TISSUE OXYGEN AND TEMPERTURE MONITOR (K112826) | Moor Instruments, Ltd. | 2012-10-10 |
| CROSS-OVER ACETABULAR SHELL & LINER (K122773) | Stelkast Company | 2012-10-09 |
| AXCESS SOFT TIP WIRE GUIDE (K122816) | Wilson-Cook Medical, Inc. | 2012-10-09 |
| ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE (K121076) | Toshiba America Medical Systems, In.C | 2012-10-09 |