| C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE (K121320) | Medyssey Co, Ltd. | 2012-08-10 |
| ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY FEMORAL NAIL - ASIA SHORT (K120715) | Zimmer GmbH | 2012-08-10 |
| ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT (K113389) | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-08-10 |
| NITRILE EXAMINATION GLOVE, POWDER FREE (BLUE, BLACK OR WHITE) (K121368) | Matang Mfg. Sdn. Bhd. | 2012-08-10 |
| ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR (K120554) | Sejoy Electronics & Instruments Co., Ltd. | 2012-08-10 |
| ET/SS IMPLANT SYSTEM (K120847) | Osstem Implant Co., Ltd. | 2012-08-10 |
| POWDER FREE LATEX EXAMINATION GLOVES (K113685) | Khai Hoan Joint Stock Company | 2012-08-10 |
| BIOPSY DIGIT S BIOPSY SL (K113607) | Giotto USA, LLC | 2012-08-10 |
| CRAWFORD BIOCANALICULUS INTUBATION (K121142) | Fci Sas (France Chirurgie Instrumentation) | 2012-08-09 |
| CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH (K120781) | Fuji Systems Corp. | 2012-08-09 |
| XENX (K113692) | Xenolith Medical | 2012-08-09 |
| RENOIR POSTERIOR CERVIAL FIXATION SYSTEM (K121136) | Accel Spine | 2012-08-09 |
| PROFEMUR Z REVISION HIP STEM (K121221) | Wrightmedicaltechnologyinc | 2012-08-09 |
| INSIGNIA (K121524) | Ormco Corp. | 2012-08-09 |
| ESPIN (K120553) | Nlt Spine, Ltd. | 2012-08-09 |
| PICASSO MIS SPINAL FIXATION SYSTEM (K120714) | Accel Spine | 2012-08-09 |
| REFORM PEDICLE SCREW SYSTEM (K121172) | Spinal USA | 2012-08-08 |
| FLASHPAK (K113776) | Symmetry Medical | 2012-08-08 |
| KERATOR (K112787) | Kj Meditech Co., Ltd. | 2012-08-08 |
| CONICAL CONNECTION IMPLANTS (K112162) | Mis Implants Technologies , Ltd. | 2012-08-08 |
| NEUTROPHASE ANTIMICROBIAL WOUND CLEANSER (K113820) | Novabay Pharmaceuticals | 2012-08-08 |
| OSTEOSYMBIONICS PEEK CRANIAL IMPLANT (K121102) | Osteosymbionics, LLC | 2012-08-08 |
| CONVEY GUIDING CATHETER (K120585) | Pendracare International, B.V. | 2012-08-08 |
| UNBALLOON NON-OCCLUSIVE MODELING CATHETER (K121839) | LeMaitre Vascular, Inc. | 2012-08-08 |
| APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH (K121168) | Aptus Endosystems, Inc. | 2012-08-08 |
| KENT CAMERA (K113507) | Kent Imaging, Inc. | 2012-08-08 |
| IDS-ISYS IGF-I CALIBRATION VERIFIERS (K122141) | Immunodiagnostic Systems , Ltd. | 2012-08-07 |
| SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION (K121393) | Smith & Nephew, Inc. | 2012-08-07 |
| NAUTILUS SPINAL SYSTEM (K111953) | Life Spine | 2012-08-07 |
| SUCTION LIPOLASTY ACCESSORIES (K113795) | Norman M. Black Iii | 2012-08-07 |
| SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM (K121059) | Zimmer Medizinsystems GmbH | 2012-08-07 |
| BD BACTEC Plus PRIME Aerobic/F Culture Vials (K120994) | Becton, Dickinson and Company | 2012-08-07 |
| VITEK 2 AST- GRAM POSTIVE PENICILLIN FOR STREPTOCOCCUS PNEUMONIAE (K113783) | bioMerieux, Inc. | 2012-08-07 |
| ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT (K113437) | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-08-06 |
| HEART SYNC PEDIATRIC PHYSIO AED PAD (K120536) | Heart Sync, Inc. | 2012-08-06 |
| ET II BIO-SA FIXTURE SYSTEM (K112532) | Hiossen, Inc. | 2012-08-06 |
| NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN (K121698) | Dentsply International, Inc. | 2012-08-06 |
| REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS (K121158) | Sterilmed, Inc. | 2012-08-06 |
| G-SCAN BRIO (K122006) | Esaote, S.p.A. | 2012-08-06 |
| TREVO RETRIEVER (K120961) | Concentric Medical, Inc. | 2012-08-03 |
| NITRILE EXAMINATION GLOVES (WHITE, BLUE AND BLACK) (K121192) | Tekmedic (M) Sdn Bhd | 2012-08-03 |
| LTM-LABAROSCOPIC SURGICAL MESH (K121289) | Lifecell Corp. | 2012-08-03 |
| BE PLUS LTM AMPLIFIER GWI AMPLIFIER (K121996) | Eb Neuro S.P.A. | 2012-08-03 |
| BIOLAND G-423 GLOOD GLUCOSE MONITORING SYSTEM (K113077) | Taidoc Technology Corporation | 2012-08-03 |
| BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650 (K120423) | Bionime Corporation | 2012-08-03 |
| UROPLASTY RIGID ENDOSCPIC NEEDLES (K121337) | Uroplasty, Inc. | 2012-08-03 |
| 8MP COLOR LCD MONITOR, REDIFORCE RX840 (K120451) | Eizo Nanao Corporation | 2012-08-03 |
| HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM (K122118) | Codman & Shurtleff, Inc. | 2012-08-03 |
| IDENTIFY (K112692) | Humediq GmbH | 2012-08-03 |
| SHANGRING (K121789) | Wuhu Snna Medical Treatment Appliance Technology C | 2012-08-03 |
| KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA (K120898) | Richard Wolf Medical Instruments Corp. | 2012-08-03 |
| MASTERKA 40 MASTERKA 35 MASTERKA 30 (K113536) | Fci Sas (France Chirurgie Instrumentation) | 2012-08-03 |
| ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED (K121048) | Boston Scientific Corp | 2012-08-03 |
| POWER-FREE NITRILE PATIENT EXAMINATION GLOVES (K121526) | Shandong Junchi Medical Products Co., Ltd. | 2012-08-03 |
| PICC CONVENIENCE KIT (K121990) | Navilyst Medical, Inc. | 2012-08-03 |
| MYSAFETY SYRINGE (K113673) | Medicalchain Internartional Corporation | 2012-08-03 |
| PERIFUSE CATHETER (K121525) | Smiths Medical Asd, Inc. | 2012-08-02 |
| BT-200V VASCULAR DOPPLER (K121267) | Bistos Co., Ltd. | 2012-08-02 |
| DISITAL BLOOD PRESSURE MONITOR (K112620) | Nihon Seimitsu Sokki Co., Ltd. | 2012-08-02 |
| SONOTOUCH SERIES DIAGNOSTIC ULTRASOUND SYSTEMS (K121867) | Chison Medical Imaging Co., Ltd. | 2012-08-02 |
| ABACUS 3CP (K111534) | Diatron U.S., Inc. | 2012-08-02 |
| ELI 280 ELECTROCARDIOGRAPH (K122073) | Mortara Instrument, Inc. | 2012-08-02 |
| SOFTSEAL-C (K112864) | Chitogen, Inc. | 2012-08-02 |
| SENSUS (K121184) | Neurometrix, Inc. | 2012-08-02 |
| MICROSOFT AMALGA UIS IMAGE PROCESSING MODULE (K120734) | Microsoft Corp. | 2012-08-02 |
| DRAGON LW (K121410) | Sedecal., Sa. | 2012-08-02 |
| MICROLIFE WRIST WATCH BLOOD PREEURE MONITOR, BP3MO1-3P (K120430) | Microlife Intellectual Property GmbH | 2012-08-02 |
| POWDER-FREE VIVYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K121157) | Shijazhuang Jiuyuan Plastic Co., Ltd. | 2012-08-02 |
| LANX SPINAL FIXATION SYSTEM (K121940) | Lanx, Inc. | 2012-08-02 |
| HEADWAY DUO MICROCATHETER (K120917) | MicroVention, Inc. | 2012-08-02 |
| PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE (K122121) | Pulsion Medical Systems SE | 2012-08-02 |
| CELOX GAUZE PRO (K113560) | Medtrade Products , Ltd. | 2012-08-01 |
| MEDILAS H RFID LASER FIBER (K121938) | Dornier Medtech America, Inc. | 2012-08-01 |
| ORION MICRO CATHETER (K113289) | Micro Therapeutics, Inc. | 2012-08-01 |
| WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO BENZODIAZEPINES URINE TEST (K121987) | Guangzhou Wondfo Biotech Co., Ltd. | 2012-08-01 |
| SOLAR GI (K121014) | Medical Measurement Systems B.V. | 2012-08-01 |
| DIAZYME HOMOCYSTEINE POC TEST KIT (K121053) | Diazyme Laboratories | 2012-07-31 |
| OSSEOSPEED PLUS (K120414) | Astra Tech AB | 2012-07-31 |
| HQS INTRODUCER (K113849) | Alseal | 2012-07-31 |
| SYNTHES MATRIX SYSTEM (K120838) | Synthes Spine | 2012-07-31 |
| ATOM 1 (MODEL: BRC 2200) (K121578) | Bioelectric Research Corporation | 2012-07-31 |
| VICTUS LASER PLATFORM (K120426) | Technolas Perfect Vision GmbH | 2012-07-31 |
| DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT (K120283) | Novocol, Inc. | 2012-07-31 |
| QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM (K112545) | Inova Diagnostics, Inc. | 2012-07-31 |
| STENTUBE LACRIMAL INTUBATION SET (K113118) | Quest Medical, Inc. | 2012-07-31 |
| VIDAS D-DIMER EXCLUSION II (DEX2) (K112818) | bioMerieux, Inc. | 2012-07-31 |
| PLATO MICROCATH 27 MICROCATHETER (K121734) | Scientia Vascular, LLC | 2012-07-30 |
| SPINAL ELEMENTS POSTERIOR CERVICAL/THORACIC SPINAL SYSTEM (K120467) | Spinal Elements, Inc. | 2012-07-30 |
| HIP SYSTEMS (K121308) | Howmedica Osteonics Corp. | 2012-07-30 |
| XPRESSWAY RX CATHETER (6F LD-VERISON) (K121301) | Kaneka Pharma America, LLC | 2012-07-30 |
| IND DRUG HOME MULTI-PANEL TEST (2-5) IND MORPHINE HOME TEST (K121231) | Ind Ndiagnostic, Inc. | 2012-07-30 |
| DYNAPBV BODY SOFTWARE (K121292) | Siemens Medical Solutions USA, Inc. | 2012-07-30 |
| KEVO NPWT-AHEMO30 AND A HEMO45 FOAM DRESSING KIT (K113199) | Kevo Medical Supplies | 2012-07-30 |
| AGELESS WONDER FACIAL MUSCLE STIMULATION SYSTEM (K120511) | Leto Enterprise , Ltd. | 2012-07-30 |
| STERISPINEPS PEDICLE SCREW, STERISPINEPS ROD (K121299) | Safe Orthopaedics | 2012-07-30 |
| SENTINEL (K120668) | C-Rad Positioning AB | 2012-07-30 |
| DYNASTY BIOFOAM SHELL (K121544) | Wrightmedicaltechnologyinc | 2012-07-30 |
| EON CHOLESTEROL REAGENT (K120202) | Vital Diagnostics Pty., Ltd. | 2012-07-27 |
| SENSICARDIAC (K121617) | Diacoustic Medical (Pty) | 2012-07-27 |
| MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEM (K121569) | Accel Spine | 2012-07-27 |