| DYNAMIC DU SERIES PORTABLE DENTAL UNIT (K111907) | Shanghai Dynamic Industry Co., Ltd. | 2011-12-02 |
| VANTAGE TITAN HSR (K112003) | Toshibamedical Systems Corporation | 2011-12-02 |
| PRESTIGE 24I; BIOLIS 24I; MGC 240 (K103531) | Tokyo Boeki Medisys, Inc. | 2011-12-01 |
| ACCULIF TL-PEEK IBF CAGE (K112095) | Coalign Innovations, Inc. | 2011-12-01 |
| MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES (K112782) | Misonix, Inc. | 2011-12-01 |
| ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321 (K111335) | Tosoh Bioscience, Inc. | 2011-12-01 |
| LATERAL BUTTON (K112296) | T.A.G. Medical Products Corporation, Ltd. | 2011-12-01 |
| HYDROCOIL(R) EMBOLIC SYSTEM (HES) (K112181) | MicroVention, Inc. | 2011-12-01 |
| RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVEL (K112337) | Randox Laboratories, Ltd. | 2011-12-01 |
| AMSCO V-PRO (K112813) | Steris Corp | 2011-12-01 |
| GENUINE FIRST AID CPR MASK (K112126) | Genuine First Aid, LLC | 2011-12-01 |
| NARVAL CC (K113201) | Resmed Sas | 2011-12-01 |
| NEWPORT HT70 VENTILATOR (K111146) | Newport Medical Instruments, Inc. | 2011-12-01 |
| ASAHI CHIKAI 10 NEUROVASCULAR GUIDE WIRE (K112979) | Asahi Intecc Co., Ltd. | 2011-12-01 |
| SNAP WOUND CARE SYSTEM (K113032) | Spiracur, Inc. | 2011-12-01 |
| RENAISSANCE SYSTEM (K113228) | Mazor Robotics , Ltd. | 2011-12-01 |
| JENSEN ZIRCONIA (K112806) | Jensen Industries, Inc. | 2011-12-01 |
| ATLANTIS ABUTMENT IN ZIRCONIA FOR ASTRA TECH OSSEOSPEED PLUS IMPLANT (K112138) | Astra Tech, Inc. | 2011-12-01 |
| NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVES (ORIGINAL BLUE, COBALT BLUE) (K111248) | Yty Industry (Manjung) Sdn Bhd | 2011-12-01 |
| GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS (K111458) | Gri Medical & Electronic Technology Co., Ltd. | 2011-12-01 |
| ADVANCED TRAUMA DRESSING (ATD) (K101257) | Nanosys, Inc. | 2011-12-01 |
| GUIDELINER V2 CATHETER (K112082) | Vascular Solutions, Inc. | 2011-12-01 |
| FLAATZ 760 (K111655) | Drtech Corp. | 2011-11-30 |
| NON-CONTACT TEAR FILM THERMOGRAGH (K111771) | United Integrated Services Co., Ltd. | 2011-11-30 |
| CENTRICITY CARDIO IMAGING (K112570) | Ge Healthcare Integrated IT Solutions | 2011-11-30 |
| DESARA MINI (K103418) | Caldera Medical, Inc. | 2011-11-30 |
| 5MP MONOCHROME LCD MONITOR, RADIFORCE GX530 (K112354) | Eizo Nanao Corporation | 2011-11-30 |
| ALAMO C (K112361) | Alliance Partners, LLC | 2011-11-30 |
| VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE (K110106) | bioMerieux, Inc. | 2011-11-30 |
| DIGNITY MINI PORT- ATTACHABLE; DIGNITY MINI PORT- PRE ATTACHED; DIGNITY LOW PROFILE PORT- ATTACHABLE; DIGNITY LOW PROFIL (K110424) | Medcomp ( Medical Components) | 2011-11-30 |
| CHARGER PTA BALLON DILATATION CATHETER (K112697) | Boston Scientific | 2011-11-30 |
| FOUNDATION (K111087) | Olympus Terumo Biomaterials Corporation | 2011-11-29 |
| SURECORE BIOPSY DEVICE (K102756) | Chest Innovations, Inc. | 2011-11-29 |
| RHAUSLER PLAGE ANTERIOR CERVICAL FUSION SYSTEM (K111272) | Rhausler, Inc. | 2011-11-29 |
| BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM (K111908) | Biomet Microfixation, Inc. | 2011-11-29 |
| BD EMERALD SINGLE USE, HYPODERMIC SYRINGE (K113241) | Becton Dickinson | 2011-11-28 |
| SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS (K111891) | Synthes (USA) Products, LLC | 2011-11-28 |
| NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML (K113198) | Navilyst Medical, Inc. | 2011-11-28 |
| RAPTOR FACET FIXATION SYSTEM (K110170) | Alphatec Spine, Inc. | 2011-11-28 |
| DP-20 AND DP-30 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM (K113153) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2011-11-28 |
| CYTOGUARD(TM) CLOSED LUER CONNECTOR (K112636) | B.Braun Medical, Inc. | 2011-11-26 |
| LIGHT GUIDE CABLE (K111342) | Schott North America | 2011-11-25 |
| HOTDOG PATIENT WARMING SYSTEM (K112488) | Augustine Biomedical & Design, LLC | 2011-11-23 |
| MAGNETOM AERA AND MAGNETOM SKYRA (K111242) | Siemens Medical Solutions USA, Inc. | 2011-11-23 |
| RECOVERY+ MODEL PS 511, DVTHERAPY MODEL PS 511A (K111748) | Joy Long | 2011-11-23 |
| TRABECULAR METAL (TM) FUSION DEVICE (K111119) | Zimmer Spine, Inc. | 2011-11-23 |
| HAMILTON-G5 (K103803) | Hamilton Medical AG | 2011-11-23 |
| SDX-4343CS (K112751) | Samsung Mobile Display Co., Ltd. | 2011-11-23 |
| VITALOGRAPH MODEL 7100 - VITALOJAK (K110525) | Vitalograph (Ireland) , Ltd. | 2011-11-23 |
| INGENUITY TF PET/MR (K103483) | Philips Healthcare (Cleveland) | 2011-11-23 |
| PROFEMUR GLADIATOR HA HIP STEM (K112150) | Wrightmedicaltechnologyinc | 2011-11-23 |
| CAROTID COIL GE 1.5T (K113280) | Tursiop Technologies, LLC | 2011-11-23 |
| PENUMBRA SYSTEM MAX (K113163) | Penumbra, Inc. | 2011-11-23 |
| ROM PLUS (K110605) | Clinical Innovations, LLC | 2011-11-23 |
| QUIXIE NEBULIZER (K112564) | Odyssey Medical Technologies | 2011-11-23 |
| ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS (K110619) | Biokit, S.A. | 2011-11-23 |
| ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I (K102644) | Siemens Healthcare Diagnostics | 2011-11-23 |
| VTRUST FINGER TYPE PULSE OXIMETER (K110893) | Taidoc Technology Corporation | 2011-11-22 |
| TD-4257 BLOOD GLUCOSE MONITORING SYSTEMS,TD 4257 MULTI BLOOD GLUCOSE MONITORING SYSTEMS (K112963) | Taidoc Technology Corporation | 2011-11-22 |
| MIGRA TAB, QUICKSPLINT MIGRAINE (K111066) | Migratherapy, LLC | 2011-11-22 |
| AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM (K112760) | STERIS Corporation | 2011-11-22 |
| FRAXION (K112210) | Medical Intelligence Medizintechnik GmbH | 2011-11-22 |
| ACCUMED WRIST AUTOMATIC BLOOD PRESSURE MONITOR (K112270) | Accumed Healthcare (Shanghai), Inc. | 2011-11-22 |
| ACCUMED UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR (K112273) | Accumed Healthcare (Shanghai), Inc. | 2011-11-22 |
| CLEARVISION (K112380) | Midmark Corp. | 2011-11-22 |
| ZAVATION SPINAL SYSTEM (K112484) | Zavation, LLC | 2011-11-22 |
| LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS (K113139) | Lin-Zhi International, Inc. | 2011-11-22 |
| RENASYS AB ABOMINAL DRESSING KIT (K112784) | Smith & Nephew, Inc. | 2011-11-22 |
| ANYRIDGE INTERNAL IMPLANT SYSTEM (K110955) | Megagen Co., Ltd. | 2011-11-22 |
| DEVINE SPINAL SYSTEM (K111690) | Changzhou Orthmed Medical Instrument Co., Ltd. | 2011-11-22 |
| TRUCLEAR OPERATIVE HYSTEROSCOPE (K112134) | Smith & Nephew, Inc. | 2011-11-22 |
| PREMIER HB9210 HBA1C ANALYZER (K112015) | Primus Corporation Dba Trinity Biotech | 2011-11-22 |
| DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVEL (K112220) | Devilbiss Healthcare, LLC | 2011-11-22 |
| NB3D BONE VOID FILLER (K111944) | Pioneer Surgical Technology, Inc. | 2011-11-22 |
| DIMENSION CLINICAL CHEMISTRY SYSTEM (K112999) | Siemens Healthcare Diagnostics | 2011-11-22 |
| BESTSHAPE BLOOD PRESSURE MONITORING SYSTEM (K112647) | Wistron Corporation | 2011-11-22 |
| SYNGO AORTIC VALVEGUIDE SOFTWARE (K113027) | Siemens Medical Solutions USA, Inc. | 2011-11-22 |
| UNIMED BLOOD PRESSURE CUFF (K112544) | Unimed Medical Supplies, Inc. | 2011-11-22 |
| INFINIX-CCI (K113052) | Toshiba America Medical Systems, In.C | 2011-11-22 |
| CONNEX(R) VITAL SIGNS MONITOR 6000 SERIES (K112687) | Welch Allyn, Inc. | 2011-11-22 |
| FEMTEC LASER SYSTEM FOR CAPSULOTOMY (K110427) | Technolas Perfect Vision GmbH | 2011-11-22 |
| SAFIRE (K103424) | Siemens Medical Solutions USA, Inc. | 2011-11-22 |
| CLYDESDALES SPINAL SYSTEM (K112405) | Medtronic Sofamor Danek USA, Inc. | 2011-11-21 |
| GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5 (K112097) | Exactech, Inc. | 2011-11-21 |
| DEPUY PULSE ANTERIOR CERICAL PLATE SYSTEM (K112724) | Medos International SARL | 2011-11-21 |
| SPIRODOC (K103530) | Medical International Research USA, Inc. | 2011-11-21 |
| COMPONEER (K112168) | Coltene/Whaledent AG | 2011-11-21 |
| S4 SPINAL SYSTEM (K112551) | Aesculap Implant System, Inc. | 2011-11-21 |
| CD HORIZON SPINAL SYSTEM (K113174) | Medtronic Sofamor Danek USA, Inc. | 2011-11-21 |
| APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE (DEN100026) | Aptus Endosystems, Inc. | 2011-11-21 |
| CHIBA SONO (K113209) | Pajunk GmbH | 2011-11-21 |
| INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE (K112425) | Alcon Manufacturing, Ltd. | 2011-11-21 |
| PASS LP SPINAL SYSTEM (K112493) | Medicrea International | 2011-11-21 |
| PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM (K110614) | Seju Engineering Co., Ltd. | 2011-11-21 |
| CALYPSO SYSTEMS WITH DYNAMIC EDGE GATING (K112768) | Calypso Medical Technologies, Inc. | 2011-11-18 |
| OSSEOTITE 2 DENTAL IMPLANTS (K111216) | Biomet 3i, Inc. | 2011-11-18 |
| TAPAS CATHETER (K112219) | Thermopeutix, Inc. | 2011-11-18 |
| MW100 (MAMMOGRAPHY) LCD MONITOR SYSTEM (K110596) | Wide Corporation | 2011-11-18 |
| CAROTID COIL (K112002) | Shanghai Chenguang Medical Technologies Co, Ltd. | 2011-11-18 |
| HIGH FLOW INSUFFLATION UNIT UHI-4 (K110294) | Olympus Medical Systems Corporation | 2011-11-18 |