| ATHEROEDGE (K122022) | Atheropoint, LLC | 2012-09-26 |
| DURABLUE STERILIZATION WRAP, MODEL NUMBERS CH100, CH200, CH300, CH400, CH500 AND CH600, STERRAD NX STERILIZATION (K122507) | Cardinal Health200, LLC | 2012-09-26 |
| COOLRAIL LINEAR PEN MODEL MCRI (K122611) | AtriCure, Inc. | 2012-09-26 |
| SHORT LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT MODEL 3017-000 (LEFT) AND 3018-000 (RIGHT); 6 HOLE MEDIUM MIDSHAFT (K122623) | Advanced Orthopaedic Solutions, Inc. | 2012-09-26 |
| EMBRYOGEN (K120136) | Origio A/S | 2012-09-26 |
| ITERATIVE RECONSTRUCTION TECHNIQUE SOFTWARE APPLICATION (K113483) | Philips Healthcare (Cleveland) | 2012-09-26 |
| EXSPIRON (K120087) | Respiratory Motion, Inc. | 2012-09-26 |
| STERRAD (R) 100NX DUO CYCLE TEST PACK (K111391) | Advanced Sterilization Products | 2012-09-26 |
| ELECTRONIC STETHOSCOPE (K121144) | Sharp Corporation | 2012-09-26 |
| PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37 (K122341) | Hitachi Aloka Medical, Ltd. | 2012-09-26 |
| ORACLE LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM (K121567) | Accel Spine | 2012-09-26 |
| BENCOX FORET & BENCOX DELTA (K121665) | Corentec Co., Ltd. | 2012-09-25 |
| ATTAIN CLARITY 6225 VENOGRAM BALLOON CATHETER (K121219) | Medtronic, Inc. | 2012-09-25 |
| FAXITRON SPECIEN RADIOGRAPHY SYSTEM (K122428) | Faxitron Bioptics, LLC | 2012-09-25 |
| CUSTOM CRANIOFACIAL IMPLANT (CCI) (K121755) | Kelyniam Global, Inc. | 2012-09-25 |
| DMRC NANOFLOW DMRC NANOCOMPOSITE EBOND SURE ETCH GEL SURE ETCH LIQUID (K121880) | Danville Materials, Inc. | 2012-09-25 |
| SURELASE CO2 LASER SYSTEM (K121580) | Clinicon Corp. | 2012-09-25 |
| STERLING MEDICAL IMPULSE 3 STIMULATOR (K121305) | Armstrong Industries, Inc. Dha Mediquip Int. Dha S | 2012-09-25 |
| ARTHREX SUTURE (UHMWPE) (K122374) | Arthrex, Inc. | 2012-09-25 |
| CHF-Y0005 (K113120) | Olympus Medical Systems Corp. | 2012-09-25 |
| TOSHIBA 3T 32CH HEAD SPEEDER COIL, (K122638) | Quality Electrodynamics | 2012-09-25 |
| ZOLL R SERIES (K120907) | Zoll Medical Corporation, World Wide Headquarters | 2012-09-25 |
| BLOOD PRESSURE MONITOR WITH STETHOSCOPE (K122259) | Hangzhou Reli-On Co., Ltd. | 2012-09-24 |
| LEW MDI O-BALL COLLARED IMPLANT, (K121707) | Park Dental Research Corp. | 2012-09-24 |
| QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST (K112449) | Tianjin New Bay Bioresearch Co., Ltd. | 2012-09-24 |
| THE PL-1064 LASER SYSTEM (K120938) | Sheaumann Laser, Inc. | 2012-09-24 |
| INOMAX DS (DELIVERY SYSTEM) (K121021) | Ino Therapeutics | 2012-09-24 |
| GEMINI LITHOTRIPTER (K121656) | Dornier Medtech America, Inc. | 2012-09-24 |
| BENEHOLD CHG TRANSPARENT FILM DRESSING (10X12CM) (8.5X12CM) (6.5X7 CM) (K113836) | Avery Dennison Belgie Bvba | 2012-09-24 |
| PRISM ACQUIRE PRISM PROCESS PRISM VIEW (K122026) | Prism Clinical Imaging, Inc. | 2012-09-21 |
| ADIPREP ADIPOSE TRANSFER SYSTEM (K121005) | Harvest Technologies, Corp. | 2012-09-21 |
| ALMA LASERS FAMILY OF PIXEL RF TIPS (K121150) | Alma Lasers, Inc. | 2012-09-21 |
| DALI SPINAL FIXATION SYSTEM (K121568) | Accel Spine | 2012-09-21 |
| TROOPER OXYGEN CONCENTRATOR (K121260) | Vbox, Inc. | 2012-09-21 |
| ECHOSOFT(TM) (K111142) | Echometrix, LLC | 2012-09-21 |
| HUMID-VENT HEPA (K112958) | Teleflex Medical | 2012-09-21 |
| DIAZYME HSCRP POC TEST KIT (K121558) | Diazyme Laboratories | 2012-09-21 |
| NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODE (K121773) | Biomerics | 2012-09-21 |
| OSTIAL PRO STENT POSITIONING SYSTEM (K122089) | Merit Medical Systems, Inc. | 2012-09-21 |
| BIOMET MICROFIXATION FACIAL PLATING SYSTEM (K121589) | Biomet Microfixation | 2012-09-21 |
| SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM (K121848) | Medical Components, Inc. | 2012-09-21 |
| SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT SPEEDLOCK HIP DRILL SPEEDLOCK HIP GUIDE CROWN TIP SPEEDLOCK HIP PATHFINDER (K120943) | ArthroCare Corporation | 2012-09-21 |
| AQUILION ONE VISION, V4.90 (K122109) | Toshiba America Medical Systems, In.C | 2012-09-21 |
| ASPIRE HD PLUS, ASPIRE HD-S (K121674) | Fujifilm Medical System U.S.A., Inc. | 2012-09-21 |
| VOLUSON E6/E8/E8EXPERT/E10 (K122327) | GE Healthcare | 2012-09-21 |
| RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3 (K113720) | Randox Laboratories, Ltd. | 2012-09-20 |
| ULTRASAFE PASSIVE NEEDLE GUARD (K122558) | Safety Syringes, Inc. | 2012-09-20 |
| AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION) (K120462) | Inovise Medical, Inc. | 2012-09-20 |
| VIPER AND EXPEDIUM NAVIGATED INSTRUMENTS (K120867) | Medos International SARL | 2012-09-20 |
| NEXTGEN ALTIUS OCT SYSTEM (K122378) | Biomet Spine (Aka Ebi, LLC) | 2012-09-20 |
| STERISPINE LC CAGE (K122021) | Safe Orthopaedics | 2012-09-20 |
| E-CUBE 7 (K121729) | Alpinion Medical Systems Co., Ltd. | 2012-09-20 |
| NEOMED ORAL/ENTERAL SYRINGE (K122373) | Neomed, Inc. | 2012-09-20 |
| 1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT (K121676) | Ge Medical Systems, LLC | 2012-09-20 |
| CERASORB DENTAL,CERADORB M DENTAL, CERASORB PERIO (K113282) | Riemser Arzeimittel AG | 2012-09-20 |
| ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2 (K121724) | Richard Wolf Medical Instruments Corp. | 2012-09-20 |
| CHAMP CHAMP TRANSIT (K120501) | Convaid Products, Inc. | 2012-09-20 |
| VESTIBULAR ANALYSIS APPARATUS (K121590) | Capacity Sports, LLC | 2012-09-20 |
| BLUE, LATEX POWDER FREE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH PROTEIN LABLING CLAIM (50UG/DM (K121926) | Northstar Healthcare Holdings | 2012-09-20 |
| CG+ ARROW PICC POWERED BY ARROW VPS STYLET (K122545) | Arrow International (Subsidiary of Teleflex Inc.) | 2012-09-20 |
| Typhoon(TM) Facet Screw Fixation System (K121850) | Choicespine, LP | 2012-09-20 |
| MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY (K121262) | Medefil, Inc. | 2012-09-20 |
| METS MODULAR PROXIMAL FEMUR (K121056) | Stanmore Implants Worldwide , Ltd. | 2012-09-20 |
| ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP) (K122541) | Orthofix Srl | 2012-09-20 |
| QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS (K113863) | Inova Diagnostics, Inc. | 2012-09-20 |
| MASIMO SET AND MASIMO RAINBOW SET PULSE OXIMETERS AND SENSORS (K120657) | Masimo Corporation | 2012-09-19 |
| SLEEP PROFILER (K120450) | Advanced Brain Monitoring, Inc. | 2012-09-19 |
| MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM (K120397) | Nihon Kohden Corp. | 2012-09-19 |
| BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM (K121302) | Biomet Microfixation | 2012-09-19 |
| METS MODULAR DISTAL FEMUR (K121029) | Stanmore Implants Worldwide , Ltd. | 2012-09-19 |
| GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM (K121224) | Taidoc Technology Corporation | 2012-09-19 |
| MINDCHILD MERIDIAN FETAL HEART RATE MONITOR (K120018) | Mindchild Medical | 2012-09-19 |
| METS MODULAR TOTAL FEMUR (K121055) | Stanmore Implants Worldwide , Ltd. | 2012-09-19 |
| WALK ON WHEELS HS-3500 ELECTRIC AISLE WHEELCHAIR (K120405) | Walk on Wheels Australia Pty, Ltd. | 2012-09-19 |
| POWER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED) (K120968) | Tangshan Zhonghong Pulin Plastic Co.,Ltd | 2012-09-19 |
| ORTHOCAD SOFTWARE OPTION (K120288) | Esaote, S.p.A. | 2012-09-19 |
| ENDURAMESH (K122622) | Lucero Medical, LLC | 2012-09-19 |
| VITASCAN LT SCANMASTER (K121689) | Vitacon Medical, Inc. | 2012-09-19 |
| MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL (K122563) | Hologic, Inc. | 2012-09-19 |
| MERIT HYDROPHILIC GUIDE WIRE (K120644) | Merit Medical Systems, Inc. | 2012-09-19 |
| VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST (K122514) | Nanosphere, Inc. | 2012-09-19 |
| PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM (K121917) | Penumbra, Inc. | 2012-09-19 |
| ISIGHT (K121519) | C&E GP Specialists, Inc. | 2012-09-18 |
| NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER (K121614) | Boston Scientific Corp | 2012-09-18 |
| BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV (K121633) | Becton, Dickinson and Company | 2012-09-18 |
| SCKOONCUP (K120107) | Sckoon, Inc. | 2012-09-18 |
| BICERA (TM) RESORBABLE BONE SUBSTITUTE (K110949) | Wiltrom Corporation Limited | 2012-09-18 |
| CLYDESDALE SPINAL SYSTEM (K122591) | Medtronic Sofamor Danek, Inc. | 2012-09-18 |
| MODEL FAMILY OF AEROLASE ND:YAG LASERS: FRIENDLYLIGHT ND: YAG LASERS, FRIENDLYLIGHT NEO, LIGHTPOD ND: YAG LASERS, LIGHTP (K120235) | Aerolase Medical Lasers, LLC | 2012-09-17 |
| KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES (K121187) | Katalyst Surgical, LLC | 2012-09-17 |
| AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIV (K121022) | Ameriwater | 2012-09-17 |
| TIGRAN PERIBRUSH (K121114) | Tigran Technologies AB | 2012-09-17 |
| DIGNITY POWER INJECTABLE TITANIUM PORT (K120281) | Medical Components, Inc. | 2012-09-17 |
| ORIGINS LIPOHARVESTING SYSTEM (K120328) | Sound Surgical Technologies, LLC | 2012-09-17 |
| KMC KYPHOPLASTY SYSTEM (K113742) | Shanghai Kinetic Medical Co., Ltd. | 2012-09-17 |
| BIOFIBER SYTURE (K122487) | Tornier, Inc. | 2012-09-17 |
| SUREFIRE HIGH FLOW ANGIOGRAPHIC CATHETER, ACCESS (K122506) | Surefire Medical, Inc. | 2012-09-17 |
| IMAGER II ANGIOGRAPHIC CATHETER (K121694) | Boston Scientific Corp | 2012-09-14 |
| STERRAD (R) CYCLESURE (R) 24 BIOLOGICAL INDICATOR (K111375) | Advanced Sterilization Products | 2012-09-14 |
| ZMR HIP SYSTEM KWZ-PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER (K113296) | Zimmer, Inc. | 2012-09-14 |