| GYNECOLOGY STERILIZATION TRAY (K121904) | Smith & Nephew Inc., Endoscopy Division | 2013-03-11 |
| GSO GS1 CANNULATED SCREW SYSTEM (K123487) | Gold Standard Orthopaedics, LLC | 2013-03-11 |
| ORAVAN OSA (K121285) | New Jersey Snoring Solutions | 2013-03-08 |
| BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE) (K113636) | Philosys Co., Ltd. | 2013-03-08 |
| QUIDEL MOLECULAR RSV + HMPV ASSAY (K122189) | Quidel Corp. | 2013-03-08 |
| QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY (K123998) | Quidel Corp. | 2013-03-08 |
| POLARIS 100/200 (K123776) | Drager Medical GmbH | 2013-03-08 |
| UNI-PICC (K130034) | Health Line International Corporation | 2013-03-08 |
| TRINITY ACETABULAR SYSTEM (K130128) | Corin Medical | 2013-03-08 |
| FASTPACK CONTROL KIT (K123725) | Qualigen, Inc. | 2013-03-08 |
| ENDOSEE MODEL 8000 U-SCOPE (K123151) | Endosee Corp | 2013-03-08 |
| REVOIS IMPLANT SYSTEM (K113042) | Riemser Arzneimittel AG | 2013-03-08 |
| IMAGE WORKS PANOURA (K122806) | Mic International | 2013-03-08 |
| INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B) (K123228) | Biospace Corporation Limited | 2013-03-08 |
| SYNOVIS COLLAGEN MATRIX (TBD) (K122306) | Synovis Surgical Innovations | 2013-03-08 |
| QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT (K123955) | Life Technologies Corporation | 2013-03-08 |
| ASAHI PTCA GUIDE WIRE ASAHI SION 180CMJ ASAHI PTCA GUIDE WIRE ASAHI SION 300CMJ (K122469) | Asahi Intecc Co., Ltd. | 2013-03-08 |
| ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS (K123212) | Ethicon Endo-Surgery, LLC | 2013-03-08 |
| ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 180CM ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 3300CM ASAHI PTCA GUIDE WIRE ASAHI SIO (K122468) | Asahi Intecc Co., Ltd. | 2013-03-08 |
| ECLIPSE SOFT TISSUE FASTENER (K123350) | MedShape, Inc. | 2013-03-07 |
| LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANT (K122476) | Ansell Healthcare Products, LLC | 2013-03-07 |
| MACLIN POWER INTRAVASCULAR ADMINISTRATION SET (K121511) | Maclin Power, Inc. | 2013-03-07 |
| SAM JUNCTIONAL TOURNIQUET (K123694) | Sam Medical Products | 2013-03-07 |
| SHUNTCHECK (K123554) | Neurodx Development, LLC | 2013-03-07 |
| GENESIS HEALTH RECORD SYSTEM, (GHRS) (K123136) | Genesis Health Technologies | 2013-03-07 |
| NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS (K123395) | Nxstage Medical, Inc. | 2013-03-07 |
| BONOS R GENTA 1X20 MODEL 01-0228; BONOS R GENTA 2X20 MODEL 01-0229; BONOS R GENTA 1X40 MODEL 01-0217; BONOS R GENTA 2X40 (K123081) | Aap Biomaterials GmbH & Co. KG | 2013-03-07 |
| HERO GRAFT (K124039) | Hemoshpere, Inc., A Cryolife Company | 2013-03-07 |
| K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS) (K123344) | Kawasumi Laboratories, Inc. | 2013-03-07 |
| DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL) (K123677) | Siemens Healthcare Diagnostics | 2013-03-07 |
| EVRF SYSTEM (K130283) | F Care Systems NV | 2013-03-07 |
| LITTLE ANGELS SWADDLING BLANKET (K123411) | Bionix Development Corp. | 2013-03-07 |
| SILVERSPEED HYDROPHILIC GUIDEWIRE, X-CELERATOR HYDROPHILIC EXCHANGE GUIDEWIRE, X-PEDION HYDROPHILIC GUIDEWIRE, MIRAGE HY (K124007) | Micro Therapeutics, Inc. D/B/A: Ev3, Inc. | 2013-03-07 |
| NAUTILUS SPINAL SYSTEM (K123373) | Life Spine | 2013-03-06 |
| INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE (K120815) | Philips Medical Systems | 2013-03-06 |
| CLEARED UNDER GRAFTON II EDBM (K122513) | Medtronic Sofamor Danek, Inc. | 2013-03-06 |
| KANGAROO NASAL MASK (K122847) | Respironics, Inc. | 2013-03-06 |
| SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES (K123980) | Misonix, Inc. | 2013-03-05 |
| MULTIPLE NAME (K123819) | Top Calibre Sdn Bhd | 2013-03-05 |
| VIDAS LYME IGG (K122986) | Biomerieux S.A. | 2013-03-05 |
| ULTRASONIC SCALER (K113717) | Nakanishi, Inc. | 2013-03-05 |
| COLS® FIXATION SYSTEM (K120740) | Fournitures Hospitalieres Industrie | 2013-03-05 |
| DENTOCORE / DENTOCORE BODY (K121769) | Itena Clinical | 2013-03-05 |
| CALLISTO EYE (K123464) | Carl Zeiss Meditec, AG | 2013-03-05 |
| SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM (K123993) | Alphatec Spine, Inc. | 2013-03-05 |
| SUPERIOR LATERAL VARIAX CLAVICLE PLATE (K130116) | Stryker Trauma AG | 2013-03-05 |
| BIOMONDE LARVAE (K123449) | Biomonde (A Trading Name of Zoobiotic Limited) | 2013-03-05 |
| PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER (K123837) | Biosense Webster, Inc. | 2013-03-05 |
| CIMVA UNIVERSAL (K123472) | Therapeutic Monitoring Systems (Tms), Inc. | 2013-03-05 |
| RESTORELLE Y CONTOUR (K123914) | Coloplast A/S | 2013-03-05 |
| JMS SAFE WING CATH (SWC) (K121488) | JMS North America Corporation | 2013-03-05 |
| FORTIVA PORCINE DERMIS (K123356) | Rti Biologics, Inc. | 2013-03-05 |
| ONCOZENE MICROSPHERES 40UM, 2ML, ONCOZENE MICROSPHERES 75UM, 2ML, ONCOZENE MICROSPHERES 100UM, 2ML, ONCOZENE MICROSPHERE (K130307) | Celonova Biosciences, Inc. | 2013-03-04 |
| CURA COLLIMATOR (K123893) | Cura Medical Technologies, LLC | 2013-03-04 |
| INBONE ( I AND II) TOTAL ANKLE SYSTEMS (K123059) | Wrightmedicaltechnologyinc | 2013-03-04 |
| ACLEARA, THERACLEAR (K123889) | Theravant Corporation | 2013-03-04 |
| URSA ANGIOGRAPHIC CATHETER (K123818) | Curative Medical Technology, Inc. | 2013-03-04 |
| DORNOCH DUO SUCTION CART WITH DL2800 LID MODEL UL-DU2800, DORNOCH DUO SUCTION CART WITH CL500 LID MODEL UL-DU500, DORNOC (K123188) | Dornoch Medical Systems, Inc. | 2013-03-04 |
| AVENIR MULLER STEM (K123392) | Zimmer GmbH | 2013-03-04 |
| UCENTUM (K123717) | Ulrich GmbH & Co. KG | 2013-03-04 |
| RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE (K122590) | Terumo Medical Corporation | 2013-03-01 |
| UNIGOLD GIARDIA (K120001) | Trinity Biotech | 2013-03-01 |
| DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM (K122955) | Wright Health Group , Ltd. | 2013-03-01 |
| COHERENCE RT THERAPIST CONNECT WORKSPACE, V2.3, ARIA CONNECTIVITY OPTION FOR SIEMENS NON-IMAGING SYSTEMS, ARIA CONNECTIV (K123812) | Siemens Medical Solutions USA, Inc. | 2013-03-01 |
| MEDICVOD, MEDICAST, MEDISHOW, MEDISEARCH, CENTRAL STORAGE SYSTEM - CSS (K123426) | Orpheus Medical , Ltd. | 2013-03-01 |
| VITA ENAMIC STAINS (K123761) | Innovation Meditech GmbH | 2013-03-01 |
| VERTEX THERMOSENS RIGID (K123220) | Vertex-Dental B.V. | 2013-03-01 |
| OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190 (K123365) | Olympus Medical Systems Corp. | 2013-03-01 |
| MAGNETOM ESSENZA WITH SYNGO MR D14 (K130262) | Siemens Medical Solutions USA, Inc. | 2013-03-01 |
| RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS SHEATH, 12/14 CH-FR, LENGTH 35CM, UR (K123675) | Coloplast A/S | 2013-03-01 |
| EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT (K123802) | Medica Corp. | 2013-03-01 |
| CASSI II ROTATIONAL CORE BIOPSY SYSTEM; CASSI QUADPOINT DISPOSABLE (K123606) | Scion Medical Technologies, LLC | 2013-03-01 |
| LIQUID ASSAYED MULTIQUAL PREMIUM (K130162) | Bio-Rad Laboratories | 2013-03-01 |
| LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO (K130245) | Baxter Healthcare Corp | 2013-03-01 |
| TRANSTEK BLOOD PRESSURE MONITOR (K123780) | Zhongshan Transtek Electronics Co., Ltd. | 2013-03-01 |
| DEPUY GRIPTION TF 5.5MM STERILE LOCKING SCREWS (K123924) | Depuy Orthopaedics | 2013-03-01 |
| ILAB ULTRASOUND IMAGING SYSTEM (K130243) | Boston Scientific Corp | 2013-03-01 |
| POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, GREEN, NON-STERILE (K123749) | Kossan Latex Industries(M)Sdn Bhd | 2013-03-01 |
| MUSE CARDIOLOGY INFORMATION SYSTEM (K130155) | Ge Medical Systems Information Technologies, Inc. | 2013-03-01 |
| TM ARDIS INTERBODY SYSTEM INSERTER (K123602) | Zimmer Trabecular Metal Technology | 2013-03-01 |
| EVOLUTION BILIARY STENT SYSTEM (K121430) | Cook Ireland, Ltd. | 2013-03-01 |
| REXTAR, REXTAR LCD (K122016) | Meta Biomed, Inc. | 2013-03-01 |
| LOFRIC SENSE (K123751) | Wellspect Healthcare | 2013-02-28 |
| U-RIGHT COMPRESSOR NEBULIZER (K121969) | Taidoc Technology Corporation | 2013-02-28 |
| EDRAIN CHEST DRAINAGE SYSTEM (K130131) | Atrium Medical Corp. | 2013-02-28 |
| ANKLE TRAUMA SYSTEM (K122936) | Orthopro, LLC | 2013-02-28 |
| POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES (K123869) | Dehai (Shandong) Medical Gloves, Co., Ltd. | 2013-02-28 |
| COBAS INTEGRA BILIRUBIN DIRECT GEN.2 (K123965) | Roche Diagnostics | 2013-02-28 |
| TI-MAX Z45 (K121901) | Nakanishi, Inc. | 2013-02-28 |
| CLEAR ALIGNER ADHESIVE (K123348) | Reliance Orthodontic Products, Inc. | 2013-02-28 |
| GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE (K121999) | Draeger Medical GmbH | 2013-02-28 |
| QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN (K130078) | Surgical Specialties Corp. Dba Angiotech | 2013-02-28 |
| 3M TEGADERM CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSING (K123679) | 3M Company | 2013-02-28 |
| FACET SCREW SYSTEM (K123497) | Facet-Link, Inc. | 2013-02-28 |
| DURABLUE STERILIZATION WRAP (K123289) | Cardinal Health-Medical Products and Services | 2013-02-28 |
| CIRCUFLOW 5150 (K123959) | Devon Medical, Inc. | 2013-02-28 |
| CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES (K123195) | GE Healthcare Finland Oy | 2013-02-28 |
| SYNTHES PATIENT SPECIFIC PLATE (K122647) | Synthes, Inc. | 2013-02-28 |
| ALIGHT 16 SUPERSELECTIVE MICROWIRE GUIDE (K123707) | Cook, Inc. | 2013-02-28 |
| INTERVERTEBRAL BODY FUSION DEVICE (K122872) | Dio Medical Co., Ltd. | 2013-02-28 |