| REVOLUTIONFULL FACE MASK (K082866) | Respironics Inc., Sleep & Home Respiratory Group | 2009-01-30 |
| MARVEL PEDIATRIC WHEELCHAIR (K083847) | Rogue Wheelchairs, Inc. | 2009-01-30 |
| MAXIM HYGIENE ORGANICALLY GROWN COTTON TAMPON (K090098) | Maxim Hygiene Products, Inc. | 2009-01-30 |
| QLASER SYSTEM (K080513) | 2035, Inc. | 2009-01-30 |
| ANTERIOR BUTTRESS PLATE (K081548) | Scient'X USA, Inc. | 2009-01-29 |
| ASAHI SUOH PTCA GUIDE WIRE (K083904) | Asahi Intecc Co., Ltd. | 2009-01-29 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7941 (K083319) | Andon Health Co, Ltd. | 2009-01-29 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5904 (K083318) | Andon Health Co, Ltd. | 2009-01-29 |
| FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5961 (K083246) | Andon Health Co, Ltd. | 2009-01-29 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5902 (K083317) | Andon Health Co, Ltd. | 2009-01-29 |
| RELIEVA STRATUS MICROFLOW SPACER (K083574) | Acclarent, Inc. | 2009-01-29 |
| FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7906 (K083247) | Andon Health Co, Ltd. | 2009-01-29 |
| STER-MATE STERILE LAVAGE KIT (K082973) | Dentsply Interntional | 2009-01-29 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN (GP) 4-128 UG/ML (K082852) | Becton, Dickinson & CO | 2009-01-29 |
| FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7902 (K083248) | Andon Health Co, Ltd. | 2009-01-29 |
| I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE (72 HOUR), MODELS 9090-7015, 9090-7016 (K073593) | Deltex Medical Limited | 2009-01-29 |
| ANGELITE FAMILY OF INTENSE PULSED LIGHT SYSTEMS, MODELS ANGELITE-DDC AND ANGELITE-SDC (K083915) | Advanced Technology Laser Co., Ltd. | 2009-01-29 |
| MAICO MB 11 WITH BERAPHONE PROBE (K082035) | Maico Diagnostics | 2009-01-29 |
| NUVO VERDE LED LIGHTING SYSTEM (K083323) | Nuvo, Inc. | 2009-01-28 |
| SMITH & NEPHEW BIPOLAR ADAPTER CABLE, MODEL 72200022 (K083528) | Smith & Nephew, Inc. | 2009-01-28 |
| PACS SCAN (K083618) | Pacsgear, Inc. | 2009-01-28 |
| PITT-EASY DENTAL IMPLANT SYSTEM (K083297) | Sybron Implant Solutions GmbH | 2009-01-28 |
| PILOT SPINAL SYSTEM (K083865) | Life Spine | 2009-01-28 |
| CALTRIX RESORBABLE BONE VOID FILLER (K083279) | Ag Digital Technology Corp. | 2009-01-28 |
| THD SLIDE ONE (K090009) | Thd Spa | 2009-01-28 |
| GREBSET MICRO-INTRODUCER KIT, MODELS 7950, 7951 (K081846) | Vascular Solutions, Inc. | 2009-01-28 |
| COLOR LCD MONITOR, RADIFORCE RX320 (K090045) | Eizo Nanao Corporation | 2009-01-28 |
| APIERON INSIGHT ENO SYSTEM (K083617) | Apieron, Inc. | 2009-01-27 |
| LEMAITRE TT TORTUOUS TRACKER INTRODUCER CATHETER DELIVERY SYSTEM (K081878) | LeMaitre Vascular, Inc. | 2009-01-27 |
| HDS HI 1.54 (K082799) | Paragon Vision Sciences | 2009-01-27 |
| NUGARD, SENSIFLEX PROCEDURE EXAMINATION GLOVES (K083337) | Terang Nusa Sdn Bhd | 2009-01-27 |
| AEQUALIS HUMERAL NAIL SYSTEM (K082754) | Tornier | 2009-01-27 |
| ACRYLIC HERBST SPLINT APPLIANCE (K083209) | Specialty Appliance Works, Inc. | 2009-01-27 |
| APOLLO ANTERIOR CERVICAL PLATE SYSTEM (K082504) | Apollo Spine, Inc. | 2009-01-27 |
| CAMLAB CRANIAL ORTHOSIS HELMET (K081787) | Biosculptor Corporation | 2009-01-27 |
| BEAU RX SCAR CARE GEL (K083718) | Beau RX Solutions, LLC | 2009-01-26 |
| GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING (K081838) | Gish Biomedical, Inc. | 2009-01-26 |
| CERCOM CEMENT (K083398) | Denali R&D Corporation | 2009-01-26 |
| BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND BERICHROM HEPARIN UF CONTROL 2 (K083175) | Siemens Healthcare Diagnostics | 2009-01-26 |
| GALAXY (K083874) | Respironics Inc., Sleep & Home Respiratory Group | 2009-01-26 |
| LANDLEX, MODEL: 402X (K083303) | Besteam Technology, Inc. | 2009-01-26 |
| PANTHERA MECHANICAL WHEELCHAIR, MODELS S2, U2, BAMBINO, MICRO, BT (K083231) | Panthera Production AB | 2009-01-26 |
| ZMATCH BLOCK (K083201) | Dentaim Co., Ltd. | 2009-01-26 |
| BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONTROL 1, AND BERICHROM HEPARIN LMW CONTROL 2 (K083159) | Siemens Healthcare Diagnostics | 2009-01-26 |
| BIO-SCREEN (K082668) | Addent, Inc. | 2009-01-23 |
| ARTHREX BIO-COMPOSITE SUTURE ANCHORS: ARTHREX BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK AND BIO-COMPOSITE CORKSCREW (K082810) | Arthrex, Inc. | 2009-01-23 |
| JETSTREAM PATHWAY PC ATHERECTOMY SYSTEM, MODEL OV10300 (K083489) | Pathway Medical Technologies, Inc. | 2009-01-23 |
| ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR (K083835) | St Jude Medical | 2009-01-23 |
| CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200 (K083470) | Edwards Lifesciences, LLC | 2009-01-23 |
| EASYPLUS MINI R2N SELF MONITORING GLUCOSE TEST SYSTEM (K081796) | Eps Bio Technology Corp. | 2009-01-23 |
| AIRSTRIP OB (K090061) | Airstrip Technologies, LP | 2009-01-23 |
| MEDISIZE BLUE, MEDISIZE GREEN, MEDISIZE RED (K081536) | Medisize BV | 2009-01-23 |
| GISH TUBING AND CONNECTORS WITH HA COATING (K081881) | Gish Biomedical, Inc. | 2009-01-23 |
| AIRGENT, MODEL AG7000010 (K082138) | Perfaction, Inc. | 2009-01-23 |
| VALO, MODEL 5919 (K083647) | Ultradent Products, Inc. | 2009-01-23 |
| PASTURE, MODELS: F550, A520 (K083176) | Pasture Pharma Pte, Ltd. | 2009-01-23 |
| PRO-TECH DELIVERY SYSTEM ELECTRODES, MODEL TT-2000 (K081279) | Transfer Technology | 2009-01-23 |
| COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM, MODEL WHF-314 (POWER-Q1000) (K080134) | Wonjin Mulsan Co., Ltd. | 2009-01-23 |
| SAFECHILD ENTERAL FEEDING TUBE AND ACCESSORIES AND FEEDING TUBE EXTENSION SET (K082710) | Neochild, LLC | 2009-01-23 |
| RADPRO ION (K083725) | Virtual Imaging, Inc. | 2009-01-22 |
| LAGUNA POLYAXIAL PEDICLE SCREW SYSTEM (K083826) | Allez Spine, LLC | 2009-01-22 |
| RAYAUTOPLAN 1.0 (K083264) | Raysearch Laboratories AB | 2009-01-22 |
| SYRINGE WITH HANDI-FIL (K082212) | Mallinckrodt Inc., Liebel-Flarsheim Business | 2009-01-22 |
| EXTREMITY MEDICAL SUTURE ANCHOR (K083151) | Extremity Medical, LLC | 2009-01-22 |
| ENDEARE BREAST PUMP (K081932) | Hygeia Medical, Inc. | 2009-01-22 |
| MERCURY SPINAL SYSTEM (K082353) | Spinal Elements, Inc. | 2009-01-22 |
| IMAGE STORAGE SYSTEM, MODEL KSS-400 (K081797) | Konan Medical, Inc. | 2009-01-22 |
| INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND CURVED INSTRUMENT SET, MODELS: FG0018, FG0026 (K083856) | Relievant Medsystems, Inc. | 2009-01-22 |
| CLEAR BRAVO (K083473) | Denali R&D Corporation | 2009-01-22 |
| CFS FLEXIBLE (K081537) | Comfort and Flexible Systems | 2009-01-22 |
| PATLOG, PATLOG PATIENT HANDLING SYSTEM, PATLOG TOPLOG TABLE TOP, MODEL(S) 1.0, 1.0, C (K090044) | Oncolog Medical QA AB | 2009-01-22 |
| CYNOSURE SMARTLIPO MPX LASER (K083795) | Cynosure, Inc. | 2009-01-21 |
| UNIVERSAL ELECTRODES (K083818) | Neurometrix, Inc. | 2009-01-21 |
| SPIRO-MASTER PC-10 SPIROMETRY SYSTEM (K080921) | Chest M.I., Inc. | 2009-01-21 |
| A.V. FISTULA BLUNT NEEDLE SET (K082882) | Jms North America Corp. | 2009-01-21 |
| SOLAR LASER ABLATION SYSTEM, MODELS: LU-1083-25, LF-1083, PC-1000, IC-1083, LW-2000, LG-2001, LK-001, PM-1083, TF-1083 (K082409) | Endophotonix, Inc. | 2009-01-21 |
| CARE3 PLUS (K081811) | Nakanishi, Inc. | 2009-01-21 |
| IBOND TOTAL ETCH (K083652) | Heraeus Kulzer,GmbH | 2009-01-21 |
| COSTORSOL (K083453) | Preservation Solutions, Inc. | 2009-01-21 |
| COULTER 6C CELL CONTROL, MODELS 628027 & A59925 (K081822) | Beckman Coulter, Inc. | 2009-01-21 |
| PM-1000F+PATIENT MONITOR (K082887) | Advanced Instrumentations, Inc. | 2009-01-16 |
| VIRTUOSAPH (TM) ENDOSCOPIC VEIN HARVESTING DISPOSABLE SYSTEM, MODEL MCVS550 (K083194) | Terumo Cardiovascular Systems Corp. | 2009-01-16 |
| EPIVISION SL SYSTEM (K072102) | Gebauer Medizintechnik GmbH | 2009-01-16 |
| PAM 3000 (K082626) | Wireless 2000 RF & Uwb Technologies , Ltd. | 2009-01-16 |
| DUAL NEEDLE SUTURE PASSER SYSTEM (K082518) | Cayenne Medical, Inc. | 2009-01-16 |
| EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008 (K083099) | Eps Bio Technology Corp. | 2009-01-16 |
| NORAS CPC MULTIFUNCTIONAL COIL (K083578) | Noras Mri Products GmbH | 2009-01-16 |
| BIOLAND BLOOD PRESSURE MONITOR (K083681) | Bioland Technology, Ltd. | 2009-01-16 |
| CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2 (K081908) | Cliniqa Corporation | 2009-01-16 |
| COBAS INTEGRA 400/800 BILIRUBIN TOTAL (K081193) | Roche Diagnostics | 2009-01-16 |
| MEDIGARD BLOOD COLLECTION DEVICE (K082511) | Medigard Limited | 2009-01-16 |
| EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM (K082521) | Card Guard Scientific Survival , Ltd. | 2009-01-16 |
| VERTEX RECONTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM (K082728) | Medtronic Sofamor Danek USA, Inc. | 2009-01-16 |
| MODIFICATION TO KOWA NONMYD ALPHA-DIII (K083387) | Kowa Co. , Ltd. | 2009-01-16 |
| NASO-LARYNGO-PHARYNGOSCOPE (K083553) | Schoelly Imaging, Inc. | 2009-01-16 |
| COULTER LIN-X LINEARITY CONTROL (K081641) | Beckman Coulter, Inc. | 2009-01-16 |
| OMNILUX CLEAR-U (K081307) | Photo Therapeutics, Inc. | 2009-01-16 |
| HEALTH MANAGER, VERSION 1.1 (K081499) | Biocomfort Diagnostics GmbH & Co. KG | 2009-01-16 |
| FORA TELEHEALTH SYSTEM (K083046) | Taidoc Technology Corporation | 2009-01-16 |
| INTELLIVUE PATIENT MONITOR, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, AND MP90 (K083517) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2009-01-16 |