| INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE (K122008) | Incite Innovation, LLC | 2012-11-16 |
| SPHYGMOCOR XCEL (K122129) | Atcor Medical | 2012-11-16 |
| VARISOURSE IX BRAHYTHERAPY AFTERLOADER VARISOURCE IX (T) BRACHYTHERAPY AFTERLOADER (K122236) | Varian Medical Systems, Inc. | 2012-11-16 |
| NEUVIZ 64 MULTI-SLICE CT SCANNER SYSTEM (K121792) | Neusoft Medical Systems Co., Ltd. | 2012-11-16 |
| 360 GAS ASSISTED ENDOSCOPIC APPLICATOR (K122526) | Micromedics, Inc. | 2012-11-16 |
| STEREOS WORKSTATION (K113344) | Eos Imaging | 2012-11-16 |
| MS SA IMPLANT SYSTEM (K122171) | Osstem Implant Co., Ltd. | 2012-11-16 |
| WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU; (K122904) | Guangzhou Wondfo Biotech Co., Ltd. | 2012-11-15 |
| POWERPORT CLEARVUE SLIM IMPLANTABLE PORT (K122899) | C.R. Bard, Inc. | 2012-11-15 |
| SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (K122090) | St. Jude Medical, Cardiac Rhythm Management Divisi | 2012-11-15 |
| SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY (K113728) | Hans Biomed Corp. | 2012-11-15 |
| PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATOR (K113380) | Medtronic, Inc. | 2012-11-15 |
| MAMMOTOME REOLVE DUAL VACUUM ASSISTED BIOPSY (VAB) SYSTEM (K123259) | Devicor Medical Products, Inc. | 2012-11-15 |
| NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING (K122886) | Hemostasis, LLC | 2012-11-15 |
| NAVIGATION SOFTWARE HIP-UNIVERSAL; NAVIGATION SOFTWARE HIP THR-AESCULAP (K122011) | Brainlab AG | 2012-11-15 |
| FEMMYCYCLE (K121857) | Femcap Incorporated | 2012-11-15 |
| KLS MARTIN RECON TALON (K122860) | KLS Martin L.P. | 2012-11-14 |
| EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX (K120857) | Ncontact Surgical, Inc. | 2012-11-13 |
| ZOEFLUID STATUS MONITOR (MODEL ZOE 2B) (K112830) | Noninvasive Medical Technologies, Inc. | 2012-11-13 |
| OPTIMA MR 430S (K123068) | Ge Medical Systems, LLC | 2012-11-13 |
| PASCAL LASER INDIRECT OPHTHALMOSCOPE (K123056) | Topcon Medical Laser Systems, Inc. (Tmls) | 2012-11-13 |
| HIGH FLOW INSUFFLANTION UNIT (K122180) | Olympus Medical Systems Corporation | 2012-11-13 |
| ENCORE 26 ADVANTAGE KIT (K123214) | Boston Scientific Corp | 2012-11-13 |
| VERTIFLEX DIRECT DECOMPRESSION SYSTEM (K122662) | Vertiflex, Inc. | 2012-11-13 |
| VPAP S-A (K122324) | Resmed, Ltd. | 2012-11-13 |
| MICRO/MINI N-PK(H) BONE ANCHOR (K121356) | Anulex Technologies, Inc. | 2012-11-09 |
| PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM (K113314) | Hmd Biomedical, Inc. | 2012-11-09 |
| AIR-BAND RADIAL COMPRESSION DEVICE (K122405) | Datascope Corp., Cardiac Assist Division | 2012-11-09 |
| PSG-1100 SLEEP DIAGNOSTIC SYSTEM (K120888) | Nihon Kohden Corp. | 2012-11-09 |
| ALN OPTIONAL VANA CAVA FILTER (K113124) | Aln Implants Chirurgicaux | 2012-11-09 |
| NEWPORT AURA VENTILATOR (K121891) | Newport Medical Instruments, Inc. | 2012-11-09 |
| VOLTERA POWERED SUCTION PUMP (K112853) | Suzric Enterprise Co., Ltd. | 2012-11-09 |
| REGEN SPRAY APPLICATOR, (K122122) | Regen Lab SA | 2012-11-09 |
| H-MAX S FEMORAL STEMS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS (K112091) | Lima Corporate S.P.A. | 2012-11-09 |
| CRIT-LINE CLIP (CLIC) (K121599) | Fresenius Medical Care-North America | 2012-11-09 |
| MICRO/MINI N-PK(F) BONE ANCHOR (K121354) | Anulex Technologies, Inc. | 2012-11-09 |
| AEM DISPOSABLE SUCTION IRRIGATION HANDSET MODEL ES1700; AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES MODEL ES077X SERIES (K122580) | Encision, Inc. | 2012-11-09 |
| PERSONA NATURAL TIBIA BASEPLATES (K122765) | Zimmer, Inc. | 2012-11-09 |
| MTF FASCIA (K120479) | Musculoskeletal Transplant Foundation | 2012-11-08 |
| AAP LOQTEQ DISTAL MEDIAL TIBIA PLATE 3.5 SYSTEM (K113601) | Aap Implantate AG | 2012-11-08 |
| DCS LACRIMAL STENT (K113316) | Dcs Surgical, Inc. | 2012-11-08 |
| TERUMO(R) NEEDLE (K121607) | Terumo (Philippines) Corporation | 2012-11-08 |
| CORVIS ST (K113066) | Oculus Optikgerate GmbH | 2012-11-08 |
| ZIMMER ZFX ABUTMENT FOR NOBEL REPLACE IMPLANT SYSTEM (K120873) | Zimmer Dental, Inc. | 2012-11-08 |
| STINGRAY GUIDEWIRES (K122795) | Bridgepoint Medical | 2012-11-08 |
| ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM (K121771) | Zimmer, Inc. | 2012-11-07 |
| HAMMER TOE IMPLANT (K122959) | Trilliant Surgical, Ltd. | 2012-11-07 |
| GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SET (K122738) | Solana Surgical, LLC | 2012-11-07 |
| CLEARLUMEN THROMBECTOMY SYSTEM (K120508) | Walk Vascular, LLC | 2012-11-07 |
| Z-SNAP OFF SCREW, Z-DOUBLE THREAD COMPRESSION SCREW, Z-GUIDE WIRE, Z-STAPLE (K121277) | Z-Medical GmbH & Co. KG | 2012-11-07 |
| OCELOT SYSTEM (K122380) | Avinger, Inc. | 2012-11-07 |
| SMARTSTITCH PERFECTPASSER SYSTEM (K123268) | Arthocare Corporation | 2012-11-07 |
| BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATOR (K122278) | Baylis Medical Company, Inc. | 2012-11-07 |
| INOBLENDER (K122689) | Ino Therapeutics | 2012-11-07 |
| DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER) (K122912) | Hangzhou Hua'An Medical & Health Instruments Co., | 2012-11-07 |
| HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100 (K122857) | Pegasus Research Corp. | 2012-11-07 |
| ENCORE TONGUE SUSPENSION SYSTEM (K121814) | Siesta Medical, Inc. | 2012-11-07 |
| PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM (K121725) | Pioneer Surgical Technology, Inc. | 2012-11-07 |
| COMEN MULTI-PARAMETER PATIENT MONITOR (K112877) | Goldway (Us), Inc. | 2012-11-07 |
| BLUE POWDERED NITRILE EXAMINATION GLOVE (K122998) | Northstar Healthcare Holdings | 2012-11-06 |
| TRINITY WRINKLE REMOVER (K120560) | Carol Cole Company | 2012-11-06 |
| VERIGENE CYP2C19 NUCLEIC ACID TES (2C19) (K120466) | Nanosphere, Inc. | 2012-11-06 |
| NYLUS PICC (K113225) | Semprus Biosciences | 2012-11-06 |
| VRESELECT CULTURE MEDIUM (K122187) | Bio-Rad | 2012-11-06 |
| HU-FRIEDY DENTAL CARTRIDGE SYRINGE (K120659) | Hu-Friedy Mfg. Co., LLC | 2012-11-06 |
| INSURGICAL SINGLE USE POWER EQUIPMENT (K112599) | Insurgical, LLC | 2012-11-06 |
| MINIME 2 NASAL MASK (K121692) | Sleepnet Corporation | 2012-11-05 |
| ALTIS SINGLE INCISION CLING SYSTEM (K121562) | Coloplast A/S | 2012-11-05 |
| RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM (K120280) | Acclarent, Inc. | 2012-11-05 |
| THE ABLATION SYSTEM (K121858) | Halt Medical, Inc. | 2012-11-05 |
| OSOM INFLUENZA A&B TEST MODEL 190 (K123182) | SEKISUI Diagnostics, LLC | 2012-11-05 |
| CS2 HIP SYSTEM (K122512) | Consensus Orthopedics, Inc. | 2012-11-05 |
| TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT (K121509) | Tgm Medical, Inc. | 2012-11-05 |
| SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO (K121434) | Siemens Medi Cal Solutions, Inc. | 2012-11-05 |
| VAPR P50 SUCTION ELECTRODE VAPR S90 SUCTION ELECTRODE VAPR P50 SUCTION ELECTRODE WITH HANDCONTROLS VAPRS90 SUCTION ELECT (K122425) | Depuy Mitek, A Johnson & Johnson Company | 2012-11-05 |
| DYMAXEON SPINE SYSTEM (K121786) | B2b Spine Pty, Ltd. | 2012-11-05 |
| FLEXIPORT ECOCUFF (K122058) | Welch Allyn, Inc. | 2012-11-05 |
| TAMARIN BLUE PTCA RX DILATATION CATHETER (K112735) | Natec Medical , Ltd. | 2012-11-02 |
| RESUSCITAIRE WITH AUTOBREATH (K120642) | Draeger Medical Systems, Inc. | 2012-11-02 |
| SURFFLASH(R) PLUS SAFETY I.V. CATHETER (K123267) | Kofu Factory of Terumo Corp. | 2012-11-02 |
| NC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RN TEMPORARY ABUTMENT, CAD-TEMP, PMMA WN TEM (K122192) | Straumann USA, LLC | 2012-11-02 |
| TRUSCULPT (K122389) | Cutera, Inc. | 2012-11-02 |
| FLO-GUARD BREATHING FILTER (K121026) | Intersurgical, Inc. | 2012-11-02 |
| EC 2.7 ENDOSCOPIC CUTTER (K120909) | Medtronic Advanced Energy, LLC | 2012-11-02 |
| FLIGHTPLAN FOR LIVER (K121200) | GE Healthcare | 2012-11-02 |
| LATEX MALE CONDOM (SMOOTH SURFACE) LATEX MALE CONDOM (TEXTURED SURFACE) (K120555) | Medical-Latex (Dua) Sdn. Bhd | 2012-11-02 |
| VITREAADVANCED (K121213) | Vital Images, Inc. | 2012-11-02 |
| CARDIOBLATE CRYOFLEX SURGICAL ABLATION PROBES (K121878) | Medtronic, Inc. | 2012-11-02 |
| XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX) (K121539) | Cepheid | 2012-11-02 |
| FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCH (K122938) | Carl Zeiss Meditec, AG | 2012-11-02 |
| REVELATION POROUS COATED HIP STEM, SIZE 8 (K122636) | Encore Medical L.P. | 2012-11-02 |
| DC-8/DC-8 PRO/DC-8, CV/DC-8, EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM (K123185) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2012-11-02 |
| IUI CATHETERS (K112396) | Kitazato Medical Co., Ltd. | 2012-11-02 |
| TANGO M2 BLOOD PRESSURE MONITOR (K122401) | Suntech Medical, Inc. | 2012-11-02 |
| DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0T (K122646) | Invivo Corporation | 2012-11-02 |
| AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING (K123179) | C.R. Bard, Inc. | 2012-11-02 |
| BIOPLEX 2200 EBV IGM KIT (K123021) | Bio-Rad Laboratories | 2012-11-02 |
| COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM (K122436) | C.R. Bard, Inc. | 2012-11-02 |
| BARD PTV DILATATION CATHETER (K122367) | C.R. Bard, Inc. | 2012-11-02 |
| LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999 (K122637) | Stryker Spine | 2012-11-01 |