| ACCUPULSE PULSE OXIMETER (K062724) | Eagle Medical Equipment Co. | 2007-05-11 |
| WN SYNOCTA GOLD ABUTMENT (K063789) | Straumann USA | 2007-05-10 |
| POWDERED NATURAL RUBBER LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE (K070821) | Medtexx Manufacturing Sdn. Bhd. | 2007-05-10 |
| SUPERSTAR 0.35T MRI SYSTEM (K071154) | Neusoft Medical Systems Co., Ltd. | 2007-05-10 |
| SPY INTRA-OPERATIVE IMAGING SYSTEM, MODEL SP2000 (K071037) | Novadaq Technologies, Inc. | 2007-05-10 |
| OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM (K071015) | Siemens Medical Solutions USA, Inc. | 2007-05-10 |
| SENSACARE MODEL SAA-102 ARM TYPE DIGITAL BLOOD PRESSURE MONITOR (K070086) | Sensacare , Ltd. | 2007-05-10 |
| FUSION RESIN CEMENT AND CORE KIT (K070702) | Denali Corporation | 2007-05-10 |
| POGS, MODEL 33C (K063454) | On Site Gas Systems, Inc. | 2007-05-09 |
| SHARPOINT PDO (POLYDIOXANONE) SUTURES (K063680) | Surgical Specialties Corp | 2007-05-09 |
| ACCU-CHEK SMART PIX (K062395) | Roche Diagnostics Corp. | 2007-05-09 |
| PRO-DENSE BONE VOID FILLER (K070437) | Wrightmedicaltechnologyinc | 2007-05-09 |
| TOPAS SYSTEM (K070993) | American Medical Systems, Inc. | 2007-05-09 |
| STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID3937 (K063584) | Regeneration Technologies, Inc. | 2007-05-09 |
| COLIN PRESS MATE, MODEL BP S510 (K063690) | Omron Healthcare, Inc. | 2007-05-09 |
| EAGLE + ANTERIOR CERVICAL PLATE SYSTEM (K070994) | Depuy Spine, Inc. | 2007-05-09 |
| LMA STONEBREAKER DEVICE; PROBE SIZE 1.0MM, 1.6MM, 2.0MM (K062475) | The Laryngeal Mask Co., Ltd. | 2007-05-09 |
| POLYSMITH SLEEP SYSTEM, MODEL NTI5498 (K062943) | Neurotronics, Inc. | 2007-05-09 |
| AURAVUE PIT & FISSURE SEALANT (K070693) | Denali Corporation | 2007-05-09 |
| REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM (K071008) | Radiant Medical | 2007-05-09 |
| SYNEPIX 4600 DETECTOR (K070829) | Analogic Corporation | 2007-05-09 |
| AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS (K071162) | Agfa Healthcare Corp. | 2007-05-08 |
| MALE NATURAL RUBBER LATEX CONDOM (WITH COLORING AND FLAVORING) (K070830) | Karex Industries Sdn. Bhd. | 2007-05-08 |
| METASURG SUBTALAR IMPLANT (K070441) | Metasurg | 2007-05-08 |
| 4 FR SINGLE LUMEN (SL) POWERPICC CATHETER (K070996) | C.R. Bard, Inc. | 2007-05-08 |
| AFF (MARK I) VOLUMETRIC INFUSION PUMP (K070529) | Definitive Medical Technologies, Ltd. | 2007-05-08 |
| RESONANCE METALLIC URETERAL STENT (K063742) | Cook Ireland, Ltd. | 2007-05-08 |
| SONOSITE MAXX SERIES DIAGNOSTIC ULTRASOUND SYSTEM (K071134) | Sonosite,Inc. | 2007-05-08 |
| BIPAP SYNCHRONY WITH AVAPS (K070328) | Respironics Inc., Sleep & Home Respiratory Group | 2007-05-08 |
| INTERWORKS (K070755) | Avreo, Inc. | 2007-05-08 |
| 3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE; 3M N95 HOME RESPIRATOR (DEN060009) | 3M Company | 2007-05-08 |
| ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399 (K071106) | Ultradent Products, Inc. | 2007-05-08 |
| GROWTH CONTROL PLATING SYSTEM (K070823) | Biomet Trauma | 2007-05-07 |
| MODIFICATON TO: GIVEN DIAGNOSTIC IMAGING SYSTEM (K070475) | Given Imaging , Ltd. | 2007-05-07 |
| LENSTEC LC INJECTION SYSTEM (K063802) | Lenstec, Inc. | 2007-05-07 |
| MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, METHAMPHETAMINE (K063545) | Alfa Scientific Designs, Inc. | 2007-05-07 |
| KOREAMEDICO CHEXTIC HCG URINE PREGNANCY TEST (K062096) | Koreamedico Co. , Ltd. | 2007-05-07 |
| TOP-RANK ADHESIVE ELECTRODE (K070612) | Top-Rank Health Care Equipment Co., Ltd. | 2007-05-07 |
| TRACKRECORD DATA MANAGEMENT SOFTWARE (K070593) | Home Diagnostics, Inc. | 2007-05-07 |
| SURFLO WINGED INFUSION SET (K070362) | Terumo Europe N.V. | 2007-05-07 |
| CHAD THERAPEUTICS BONSAI MODEL 800 (K070740) | Chad Therapeutics, Inc. | 2007-05-07 |
| AERONEB PROFESSIONAL NEBULIZER SYSTEM (K070642) | Aerogen (Ireland), Ltd. | 2007-05-07 |
| NASOPORE EAR (K070715) | Polyganics B.V., | 2007-05-07 |
| NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS (K070068) | Nova Biomedical Corp. | 2007-05-07 |
| FIRMGRIP PERIPHERALLY INSERTED CATHETER DEVICE (K063363) | Flexicath , Ltd. | 2007-05-07 |
| VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU (K070452) | Bio-Rad Laboratories, Inc. | 2007-05-07 |
| NOGA AUTOMATED SLEEP STUDY SCORING AND DATA MANAGEMENT SYSTEM (K070326) | Widemed, Ltd. | 2007-05-05 |
| CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1, 2, & 3 (K070741) | Cliniqa Corporation | 2007-05-04 |
| SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT (K070626) | Beckman Coulter, Inc. | 2007-05-04 |
| LIFESENSE, MODEL LS1-9R (K063752) | Nonin Medical, Inc. | 2007-05-04 |
| UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIES (K070331) | Laborie Medical Technologies | 2007-05-04 |
| LAGWIRE SYSTEM (K070393) | Fxdevices | 2007-05-04 |
| ARCUATE VERTEBRAL AUGMENTATION SYSTEM (K070527) | Medtronic Sofamor Danek | 2007-05-04 |
| DBEST HCG PANEL TEST KIT (K061257) | Ameritek USA, Inc. | 2007-05-04 |
| REUNION HA FRACTURE STEM (K070963) | Howmedica Osteonics Corp. | 2007-05-04 |
| ANGIODYNAMICS, INC., MORPHEUS CT PICC AND PROCEDURE KIT (K070615) | AngioDynamics, Inc. | 2007-05-04 |
| NEXT GENERATION ANTERIOR CERVICAL PLATING SYSTEM (K070681) | Alphatec Spine, Inc. | 2007-05-04 |
| CORSCREEN (K070614) | Viasys Healthcare GmbH | 2007-05-04 |
| CARTO XP EP NAVIGATION SYSTEM, VERSION 9 (K070240) | Biosense Webster, Inc. | 2007-05-04 |
| TRIO PLATE SYSTEM, TRIO SPINAL FIXATION SYSTEM, TRIO+ SPINAL SYSTEM (K070368) | Stryker Corp. | 2007-05-04 |
| APEX MEDICAL XT1 CPAP, MODEL 9S-005 (K070609) | Apex Medical Corp. | 2007-05-04 |
| SEJOY DIGITAL THERMOMETER, MT SERIES (MT-201, MT-301, MT-402, MT-403 AND MT-405) (K062784) | Sejoy Electronics & Instruments Co., Ltd. | 2007-05-04 |
| FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST (K070054) | Church & Dwight Co., Inc. | 2007-05-04 |
| ACQUASEAL BENZ (K070289) | Acquamed Technologies, Inc. | 2007-05-04 |
| 100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES (K070399) | Biomet Manufacturing, Inc. | 2007-05-04 |
| ORTHADAPT BIOIMPLANT (K071065) | Pegasus Biologics, Inc. | 2007-05-04 |
| IPC-BOOT (K070324) | C-Boot , Ltd. | 2007-05-03 |
| OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802 (K071055) | Ultradent Products, Inc. | 2007-05-03 |
| 100KGY E-POLY MAXROM ACETABULAR LINERS (K070364) | Biomet, Inc. | 2007-05-03 |
| AUTOVENT MODEL 4000 (K070120) | Allied Healthcare Products, Inc. | 2007-05-03 |
| MONOLISA ANTI-HAV EIA (K063318) | Bio-Rad Laboratories | 2007-05-03 |
| MONOLISA ANTI-HAV IGM EIA (K063319) | Bio-Rad Laboratories | 2007-05-03 |
| RANGE SPINAL SYSTEM (K070229) | K2m, Inc. | 2007-05-03 |
| 247 BP DEVICE (K070750) | Suntech Medical, Inc. | 2007-05-02 |
| DDRCOMPACT, DDRCOMPACT PLUS AND DDRCOMPACT CHEST (K070678) | Swissray International, Inc. | 2007-05-02 |
| SYNTHES ADOLESCENT LATERAL ENTRY FEMORAL NAIL SYSTEM (K070843) | Synthes (Usa) | 2007-05-02 |
| PRODERMA LIQUID BANDAGE (K063202) | Procurement Technology Systems, LLC | 2007-05-02 |
| ENVITEC OXIPEN PULSE OXIMETER AND ACCESSORIES (K070193) | Envitec-Wismar GmbH | 2007-05-02 |
| HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH (K052480) | Hansen Medical, Inc. | 2007-05-02 |
| MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR (K070925) | Depuy Mitek, A Johnson & Johnson Company | 2007-05-02 |
| IMPLANT LOCATION SOFTWARE-T (K070713) | Tactile Technologies, Ltd. | 2007-05-02 |
| KELSEY INTERSITITAL LASER THERAPY SYSTEM (K070353) | Kelsey, Inc. | 2007-05-02 |
| IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS) (K071017) | Siemens Medical Solutions Diagnostics | 2007-05-02 |
| PROFILE MULTI-PLATFORM SYSTEM (K070388) | Sciton, Inc | 2007-05-02 |
| COOL-TIP SWITCHING CONTROLLER, CTSW CONTROL (K070446) | Valleylab,A Division of Tyco Healthcare Group LP | 2007-05-02 |
| CTS-7700 DIGITAL ULTRASOUND IMAGING SYSTEM (K070982) | Shantou Institute of Ultrasonic Instuments | 2007-05-02 |
| NIO COLOR 3MP AND MDNC 3120 (K070726) | Barcoview, Medical Imaging Systems | 2007-05-02 |
| STERI -MATE HANDPIECE SLEEVE WITH LED LIGHT (K070307) | Dentsply International, Inc. | 2007-05-02 |
| EPI-C PLUS (K070494) | Espansione Marketing S.P.A | 2007-05-01 |
| PHARMASMART PUBLIC USE BLOOD PRESSURE MONITOR, MODELS PS-1000/PS-1500/PS-2000 (K063137) | Pharmasmart, Inc. | 2007-05-01 |
| VIEWMATE SYSTEM (K071028) | Ep Medsystems | 2007-05-01 |
| CONTACT LENS CASE (K071081) | Ningbo Kaida Rubber and Plastic Technology Co., LT | 2007-05-01 |
| MODIFICATON TO: ZIMMER PERIARTICULAR LOCKING PLATES AND SCREWS (K070906) | Zimmer, Inc. | 2007-05-01 |
| KSEA MINIATURE ENDOSCOPE, MODEL 11565 (K070752) | KARL STORZ Endoscopy-America, Inc. | 2007-05-01 |
| CRYOSPRAY ABLATION SYSTEM, MODEL CU 8407020500 (K070893) | CSA Medical, Inc. | 2007-05-01 |
| FLUOROPERM 92, 60, 30 AND 151 AND PARAGON HDS, HDS 100 AND THIN RIGID GAS PERMEABLE CONTACT LENSES (K070637) | Paragon Vision Sciences | 2007-05-01 |
| ULTRASONIC SCALER, VARIOS 560 (K062731) | Nakanishi, Inc. | 2007-05-01 |
| OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS. (K070628) | Contamac, Ltd. | 2007-05-01 |
| MODIFICATION TO: ENSITE SYSTEM, MODEL, EE3000 (K070902) | St Jude Medical | 2007-05-01 |
| CARBON DIOXIDE LIQUID STABLE REAGENT (K070251) | Pointe Scientific, Inc., | 2007-04-30 |