| ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER (K121006) | St Jude Medical | 2012-05-03 |
| APTIMA COMBO 2 ASSAY (K111409) | Gen-Probe, Inc. | 2012-05-03 |
| FORCE MEDICAL IM NAIL SYSTEM (K102577) | Force Medical, Inc. | 2012-05-03 |
| COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL (K113660) | Cryotherapy Products, Inc. | 2012-05-03 |
| JIAJIAN TENS (K112288) | Wuxi Jiajian Medical Instrument Co., Ltd. | 2012-05-02 |
| 2.6F X 20CM VASCU-PICC 2.6F X 50CM VASCU-PICC (K120981) | Medical Components, Inc. | 2012-05-02 |
| CAIRE COMPANION 5 OXYGEN CONCENTRATOR (K121167) | Caire, Inc. | 2012-05-02 |
| LULLABY LED PHOTTHERAPY SYSTEM (K120168) | Wipro GE Healthcare Private, Ltd. | 2012-05-02 |
| ZELTIQ COOLSCULPTING (K120023) | Zeltiq Aesthetics, Inc. | 2012-05-02 |
| ECHOSTAR SPICA 1.5T MR SYSTEM (K113511) | Alltech Medical Systems America, Inc. | 2012-05-02 |
| FLASH (DIFFERENT MATERIALS) (K120438) | 3M Deutschland GmbH | 2012-05-02 |
| MICROWARE BONE PLATES AND BONE SCREW (K111008) | Microware Precision Co., Ltd. | 2012-05-02 |
| ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM (K120983) | Boston Scientific Corporation | 2012-05-02 |
| HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY) (K113088) | Innerspace, Inc. | 2012-05-02 |
| 1.9F X 20CM VASCU-PICC 1.9F X 50CM VASCU-PICC (K120980) | Medical Components, Inc. | 2012-05-02 |
| RS SAFE BLACK NITRILE MEDICAL EXAMINATION GLOVES POWDER OR OTHER PROPRIETARY NAME (K112924) | Riverstone Resources Sdn Bhd | 2012-05-02 |
| PPS PI PRESSURE INJECTABLE SAFETY HUBER NEEDLE WITHOUT LATERAL INJECTION SITE, PPS PI PRESSURE INJECTABLE SAFETY HUBER (K120261) | Perouse Medical | 2012-05-02 |
| POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLORED, BLACK COLORED AND WHITE COLORED (K120184) | Encompass Medical Supplies Inc Limited | 2012-05-02 |
| POSEY BED (K113355) | J. T. Posey Co. | 2012-05-02 |
| ACCUMESH DEPLOYMENT SYSTEM (K121139) | Covidien, LLC | 2012-05-02 |
| OSTEOBRIDGE IKA KNEE ARTHODESIS NAIL WITH COLLAR (K120978) | Merete Medical GmbH | 2012-05-02 |
| PSYCHEMEDICS PHENCYCLIDINE EIA (K111928) | Psychemedics Corp. | 2012-05-01 |
| PSYCHEMEDICS METHAMPHETAMINE EIA (K111927) | Psychemedics Corp. | 2012-05-01 |
| ECHELON OVAL MRI SYSTEM (K113145) | Hitachi Medical Systems America, Inc. | 2012-05-01 |
| PSYCHEMEDICS COCAINE EIA (K111925) | Psychemedics Corp. | 2012-05-01 |
| ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM (K121044) | Meridian Bioscience, Inc. | 2012-05-01 |
| SPEEDUP SOFTWARE OPTION (K120748) | Esaote, S.p.A. | 2012-05-01 |
| STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM (K112593) | Stryker Corporation | 2012-05-01 |
| VITAL SIGNS MONITOR (K113833) | Guangdong Biolight Meditech Co., Ltd. | 2012-05-01 |
| PSYCHEMEDICS CANNABINOIDS EIA (K111929) | Psychemedics Corp. | 2012-05-01 |
| MONT BLANC PEDICLE SCREW SYSTEMS (K112684) | Qualgenix | 2012-05-01 |
| AYERS ROCK CERVICAL CAGE (K112801) | Qualgenix | 2012-05-01 |
| INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP (K110212) | Alere San Diego, Inc (Formally Biosite Incorporate | 2012-05-01 |
| EXTERNAL FIXATOR ST.A R 90 F4 (K113384) | Citieffe | 2012-05-01 |
| PSYCHEMEDICS OPIATES EIA (K111926) | Psychemedics Corp. | 2012-05-01 |
| LATERAL FUSION DEVICE (K112986) | Integra Spine (Integra Lifesciences) | 2012-05-01 |
| OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION (K112909) | Bausch & Lomb, Inc. | 2012-04-30 |
| PERCUTANEOUS SURGICAL SET WITH 5MM OR 10MM ATTACHMENTS (DEN110016) | Ethicon Endo-Surgery | 2012-04-30 |
| K2 MEDICAL VASCULAR CLAMPS (K120492) | K2 Medical GmbH & Co. KG | 2012-04-30 |
| ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL (K110530) | HORIBA ABX SAS | 2012-04-30 |
| EQUINOX RELIEVE (K113687) | O-Two Medical Technologies, Inc. | 2012-04-30 |
| SINGLE-SITE MEDIUM-LARGE CLIP APPLIER, SINGLE-SITE CADIERE GRASPER, SINGLE-SITE FUNDUS GRASPER, SINGLE-SITE CROCODILE (K120215) | Intuitive Surgical, Inc. | 2012-04-30 |
| PORTRAIT ANALYZER (DEN120013) | Great Basin Scientific | 2012-04-30 |
| POWERED MUSCLE STIMULATOR (K112148) | Valmed, SA | 2012-04-30 |
| GENESIS REUSABLE RIGID CONTAINER SYSTEM (K112535) | Carefusion 2200, Inc. | 2012-04-27 |
| VOLUSON S6, VOLUSON S8 (K120741) | GE Healthcare | 2012-04-27 |
| NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER (K112314) | Nephros, Inc. | 2012-04-27 |
| EPIFLO(R) (K120764) | Neogenix, LLC | 2012-04-27 |
| STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING (K113707) | Cardinal Health-Medical Products and Services | 2012-04-27 |
| RESMART CPAP, RESMART AUTO-CPAP AND RESMART HUMIDIFIER (K110629) | 3B Products, Inc. | 2012-04-27 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES (K113837) | Hebei Changsheng Plastic Products Co., Ltd. | 2012-04-27 |
| ACCUDXA2 (K113616) | Lone Oak Medical Technologies, LLC | 2012-04-27 |
| DRY MOUTH MOUTHWASH (K111250) | Dr. Fresh, Inc. | 2012-04-27 |
| TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLET (K121106) | Surgical Appliance Industries, Inc. | 2012-04-27 |
| R3 XLPE LINERS (K113848) | Smith & Nephew, Inc. | 2012-04-27 |
| SURGICASE CONNECT (K113599) | Materialise NV | 2012-04-27 |
| ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERS (K113286) | Ge Medical Systems Lunar | 2012-04-27 |
| PATHASSIST LIGHT FIBER (K120962) | Entellus Medical, Inc. | 2012-04-27 |
| ENDOGATOR ADVANTAGE IRRIGATION PUMP (K113119) | Byrne Medical, Inc. | 2012-04-27 |
| CSM INTERNAL-R IMPLANT SYSTEM (K120043) | Csm Implant | 2012-04-27 |
| APTUS PROXIMAL HUMERUS SYSTEM (K120108) | Medartis AG | 2012-04-27 |
| ECHOTIP(R) ULTRA FIDUCIAL NEEDLE (K111895) | Wilson-Cook Medical Inc./Cook Endoscopy | 2012-04-27 |
| DISPOSABLE POWDER FREE VINYL EXAM GLOVES (K120746) | Canopus Medical Supply Co., Ltd. | 2012-04-27 |
| PLASTIC NEEDLE WITH MANDRIN 2.0 DIAMETER LENGTH 113MM (K120341) | Varian Medical Systems, Inc. | 2012-04-27 |
| PROSTATE MECHANICAL IMAGER (DEN100016) | Artann Laboratories, Inc. | 2012-04-27 |
| SECURACATH (K120935) | Interrad Medical, Inc. | 2012-04-27 |
| NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (K113221) | North American Science Assoc., Inc. | 2012-04-27 |
| IROOT 100 MINI (K112153) | S-Denti Co., Ltd. | 2012-04-26 |
| AERONEB PRO (K120939) | Aerogen, Ltd. | 2012-04-26 |
| TWISTER SIDE-FIRE FIBER OPTIC DELIVERY SYSTEM (K120437) | Biolitec Sia (Latvia) | 2012-04-26 |
| DEPUY PULSE CERVICAL CAGE SYSTEM (K120517) | Medos International SARL | 2012-04-26 |
| FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM (K112342) | Convatec, Inc. | 2012-04-26 |
| C-QUR RPM MESH (K121070) | Atrium Medical Corp. | 2012-04-26 |
| SOLITAIRE-C CERVICAL SPACER SYSTEM (K113796) | Ebi, LLC | 2012-04-26 |
| GEO MAGIC COLOR (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS (K110835) | GEO MEDICAL CO., LTD. | 2012-04-26 |
| SHARPS TANK REUSABLE SHARPS CONTAINER (K111085) | Rehrig Pacific Company | 2012-04-25 |
| SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS (K112611) | Sintea Plastek, LLC | 2012-04-25 |
| ELECTROCARDIOGRAPH (K113485) | Shenzhen Carewell Electronics Co., Ltd. | 2012-04-25 |
| NASAL/EPISTAXIS PACK (K113585) | Cogent Therapeutics, LLC | 2012-04-25 |
| ZOLL PROPAQ MD (K112761) | Zoll Medical Corporation, World Wide Headquarters | 2012-04-25 |
| HYDROCOIL EMBOLIC SYSTEM (HES) (K120908) | MicroVention, Inc. | 2012-04-25 |
| VARIAX SUPERIOR AND ANTERIOR, LATERAL AND MIDSHAFT CLAVICLE PLATES VARIAX AIMING BLOCKS & JOYSTICK (K113760) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2012-04-25 |
| CAREFUSION NICOLET EDX (K120979) | Carefusion 209, Inc. | 2012-04-25 |
| MILAGRO INTERFERENCE SCREWS (K120589) | Depuy Mitek, A Johnson & Johnson Company | 2012-04-24 |
| APLAN A.V. FISTULA NEEDLE SET (K112734) | Aplan Well Enterprise Co., Ltd. | 2012-04-24 |
| EVOLVE HPD 980/ 1470NM MULTIWAVELENGTH DIODE LASER (EVOLVE DUAL) (K120231) | Biolitec Medical Devices, Inc. | 2012-04-24 |
| HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOS (K120055) | Hamilton Thorne, Inc. | 2012-04-24 |
| SLEEPWEAVER ELAN NASAL CPAP MASK (K120757) | Circadiance, LLC | 2012-04-24 |
| APEX KIRSCHNER WIRES AND STEINMANN PINS (K121004) | Apex Tools & Orthopedics Co. | 2012-04-24 |
| BRAIN BIOPSY NEEDLE (K112094) | Ad-Tech Medical Instrument Corp | 2012-04-24 |
| PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM (K120664) | Abaxis, Inc. | 2012-04-24 |
| CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER 80CM (K120086) | Cardiosolutions | 2012-04-24 |
| PRO-TOE(TM) VO HAMERTOE IMPLANT SYSTEM-LINE SDDITION (K120645) | Wrightmedicaltechnologyinc | 2012-04-24 |
| PICCOLO HDL-CAPILLARY TEST SYSTEM (K120662) | Abaxis, Inc. | 2012-04-24 |
| OSTEOMED WRIST PLATING SYSTEM (K120015) | Osteomed LP | 2012-04-24 |
| AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION (K103230) | Bestgen Biotech Corp. | 2012-04-24 |
| FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM (K120452) | Flexible Stenting Solutions, Inc. | 2012-04-24 |
| FLAT PANEL DETECTOR (K111824) | Canon Inc. -Medical Equipment Group | 2012-04-23 |
| VISIA (K120207) | MeVis Medical Solutions AG | 2012-04-23 |
| SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE (K113857) | Synergetics, Inc. | 2012-04-23 |