| DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604 (K100375) | Siemens Healthcare Diagnostics, Inc. | 2011-04-06 |
| MULTIPLE BIOPSY SYSTEM (K103326) | United States Endoscopy Group, Inc. | 2011-04-06 |
| ISA CO2, ISA AX+, ISA OR+ (K103604) | Phasein AB | 2011-04-06 |
| IMPRESSION COMPOUND (K110378) | Spofadental | 2011-04-05 |
| ESTELITE COLOR (K110178) | Tokuyama Dental Corporation | 2011-04-05 |
| SHARPS CONTAINER (K110262) | Noble Marketing | 2011-04-05 |
| INTEGRITY SPINAL CARE SYSTEM (K103248) | Integra Life Sciences | 2011-04-05 |
| HEMOSIL LA POSITIVE CONTROL (K102552) | Instrumentation Laboratory CO | 2011-04-05 |
| V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS (K102985) | Respironics, Inc. | 2011-04-05 |
| QUICKDRAW CONVERTIBLE FIXATION IMPLANT SYSTEM (K103262) | Tornier, Inc. | 2011-04-05 |
| RT200 (K103370) | Restorative Therapies, Inc. | 2011-04-05 |
| REVERSE MEDICAL REFLEX GUIDE CATHETER (K110055) | Reverse Medical Corporation | 2011-04-05 |
| CUTERA GENESISPLUS LASER SYSTEM (K103626) | Cutera, Inc. | 2011-04-05 |
| TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM (K100767) | Church & Dwight Co., Inc. | 2011-04-05 |
| AQUAMANTYS DOUBLE CONE BIPOLAR SEALER MODEL: 23-310-1 (K101057) | Salient Surgical Technologies | 2011-04-05 |
| CARDIOHELP SYSTEM (K102726) | Maquet Cardiopulmonary, AG | 2011-04-04 |
| NITRILE POWDER FREE PATIENT EXAMINATION GLOVES (K110185) | Tangshan Baojie Glove Co., Ltd. | 2011-04-04 |
| MODIFIED HD GUIDE CATHETER (K110483) | Concentric Medical, Inc. | 2011-04-04 |
| EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT (K101088) | Medica Corp. | 2011-04-04 |
| KNEEALIGN SYSTEM (K103829) | Orthalign, Inc. | 2011-04-04 |
| RT600 (K103366) | Restorative Therapies, Inc. | 2011-04-04 |
| BRAINLAB KNEE (K102990) | Brainlab AG | 2011-04-04 |
| VAULT ALIF SYSTEM (K103369) | Spinal USA | 2011-04-04 |
| THE ARTAS SYSTEM FROM RESTORATION ROBOTICS (K103428) | Restoration Robotics, Inc. | 2011-04-04 |
| SOUND SURGICAL TECHNOLOGIES LLC POWERX LIPO SYSTEM (K110255) | Sound Surgical Technologies, LLC | 2011-04-04 |
| DIGITAL FOREHEAD THERMOMETER (K103617) | K-Jump Health Co., Ltd. | 2011-04-04 |
| 1.5 GE 6-CHANNEL PHASED ARRAY FLEX COIL, 3.0 GE 6-CHANNEL PHASED ARRAY FLEX COIL (K110610) | Ge Medical Systems, LLC | 2011-04-01 |
| VENTRALIGHT (TM) ST MESH WITH ECHO PS (TM) POSITIONING SYSTEM (K110820) | C.R. Bard, Inc. | 2011-04-01 |
| ALYTE Y-MESH GRAFT (K101722) | C.R. Bard, Inc. | 2011-04-01 |
| COMPRESSYN BAND (K101484) | Dallen Medical | 2011-04-01 |
| CONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEAD (K110542) | Consensus Orthopedics, Inc. | 2011-04-01 |
| HYLATOPICPLUS CREAM (K110727) | Precision Dermatology Incorporated | 2011-04-01 |
| EQUINOXE REVERSE SHOULDER COMPRESSION SCREW / 38MM AND 42MM GLENOSPHERE / SUPERIOR AUGMENT GLENOID PLATE, 10 DEGREES... (K110708) | Exactech, Inc. | 2011-04-01 |
| ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS (K102699) | Abbott Laboratories | 2011-04-01 |
| ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM (K103595) | Acclarent, Inc. | 2011-04-01 |
| VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM (K110522) | Medtronic Sofamor Danek USA, Inc. | 2011-04-01 |
| CSMC CARDIAC SUITE-NUCLEAR MEDICINE SOFTWARE APPLICATON MODEL 2010-01 (K100714) | Cedars-Sinai Medical Center | 2011-04-01 |
| TORFLEX TRANSSEPTAL GUIDING SHEATH (K102948) | Baylis Medical Co., Inc. | 2011-04-01 |
| STERRAD SEALSURE CHEMICAL INDICATOR TAPE (K103219) | Advanced Sterilization Products | 2011-04-01 |
| EXPEDIUM SYSTEM, VIPER SYSTEM (K110216) | Depuy Spine, Inc. | 2011-04-01 |
| OSSEOTITE II MODEL XIFOSSXXX (K100724) | Biomet 3i, Inc. | 2011-04-01 |
| STERRAD CHEMICAL INDICATOR STRIP (K103218) | Advanced Sterilization Products | 2011-04-01 |
| SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE (K110796) | Biomers Products, LLC | 2011-03-31 |
| EM-9000 (K101482) | Elite Medical, Inc. | 2011-03-31 |
| BPA-FREE PIT AND FISSURE SEALANT (K110058) | Novocol Inc. Dba Septodont and Confi-Dental Produc | 2011-03-31 |
| MANDOMETER III (DEN070014) | Ab Mando | 2011-03-31 |
| TDS ABUTMENT FOR FRIADENT XIVE (K103339) | Pou YU Biotechnology Co., Ltd. | 2011-03-31 |
| ARTHREX BIOCOMPOSITE SUTURETAK (K110660) | Arthrex, Inc. | 2011-03-31 |
| INSPIRA AIR BALLOON DILATION SYSTEM (K110218) | Acclarent, Inc. | 2011-03-31 |
| INTELLIVUE PATIENT MONITOR (K110622) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2011-03-31 |
| ZMACHINE, MODEL DT-100 (K101830) | Consolidated Research of Richmond, Inc. | 2011-03-31 |
| A SCOPE (K103499) | Active Signal Technologies, Inc. | 2011-03-31 |
| NITRILE EXAMINATION GLOVES POLYMER COATED (WHITE, BLUE, AND BLACK COLOR) (K103670) | Innovative Gloves Co;, Ltd. | 2011-03-31 |
| WIDEXLINK IN CLEAR SERIES HEARING AIDS (DEN100025) | Office Research IN Clinical Amplifiction | 2011-03-31 |
| LAKONG ULTRASONIC SCALER (K103498) | Lakong Medical Device Company, Ltd. | 2011-03-31 |
| ODFS PACE (K102115) | Odstock Medical, Ltd. | 2011-03-30 |
| IOS FASTSCAN SPRAY (K103586) | Ios Technnologies, Inc. | 2011-03-30 |
| HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R (K102936) | Baxter Healthcare Corp | 2011-03-30 |
| CHLORASHIELD TM ANTIMICROBIAL DRESSING (K103106) | Care Fusion 213, LLC | 2011-03-30 |
| GAUNYING INFRARED LAMP (K110721) | Foshan Gaunying Electronics Co., Ltd. | 2011-03-30 |
| SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPINAL SPACER SYSTEM (K102402) | Alphatec Spine, Inc. | 2011-03-30 |
| TRUCLEAR MORCELLATOR SYSTEM (K110038) | Smith & Nephew, Inc. | 2011-03-30 |
| NEOPAP SYSTEM (K103410) | Childrens Medical Ventures, LLC | 2011-03-30 |
| MC 1504G-16R, 1.5T, 16-CHANNEL, MC 3004G-16R, 3.0T, 16-CHANNEL HEAD COIL (K110591) | Mr Instruments, Inc. | 2011-03-29 |
| FLEXIVA TRACTIP (K110685) | Boston Scientific Corp | 2011-03-29 |
| EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D (K101530) | Cook Ireland, Ltd. | 2011-03-29 |
| DIGITAL RADIOGRAPHY (K103591) | Canon Inc. -Medical Equipment Group | 2011-03-29 |
| DUET DRF (K103038) | Cmt Medical Technologies, Ltd. | 2011-03-29 |
| ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM (K103425) | Genoray America, Inc. | 2011-03-29 |
| WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR (K103596) | Fujifilm Medical Systems U.S.A, Inc. | 2011-03-29 |
| ELECTRO SENSOR -BODY COMPOSITION (K103026) | Ld Technology, LLC | 2011-03-29 |
| BILI-THERAPY SPOT TYPE (K103828) | Atom Medical Corporation | 2011-03-29 |
| PANTINO PRO POSITINER (K102521) | Somnomed, Inc. | 2011-03-28 |
| IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN6 (K093987) | Siemens Healthcare Diagnostics, Inc. | 2011-03-28 |
| FIT TEST C&B (K110050) | Voco GmbH | 2011-03-28 |
| ACCUTRAC (K110686) | Boston Scientific Corp | 2011-03-28 |
| CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-L (K101154) | Airsep Corp. | 2011-03-28 |
| FX 222-02 POWERED WHEELCHAIR (K110036) | Lanzhou Wanli Aviation Electromechanical, Inc. | 2011-03-28 |
| NEW STETIC ACRYLICS (K102874) | New Stetic | 2011-03-28 |
| ORTHODONTIC SCREW (K103105) | Osstem Implant Co., Ltd. | 2011-03-25 |
| THERMEDX 37-5 ELECTROCAUTERY PROBES, MODELS MPJ200, MPJ210, MPS220, MPN230, BPH240 (K102275) | Thermedx, LLC | 2011-03-25 |
| LIGAMAX 5 (K110699) | Ethicon Endo-Sugery, LLC | 2011-03-25 |
| INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EXTENSION SET KITS, (K103551) | Baxter Healthcare Corp | 2011-03-25 |
| TRUCLEAR INCISOR PLUS BLADE 2.9 (K103389) | Smith & Nephew, Inc. | 2011-03-25 |
| APEX PS KNEE SYSTEM (K102578) | Omni Life Science, Inc. | 2011-03-25 |
| LANX SPINAL SYSTEM (K103237) | Lanx, Inc. | 2011-03-25 |
| MEDLINE RETRACTABLE SAFETY SYRINGE (K101560) | Medline Industries, Inc. | 2011-03-25 |
| SYNTEC OS SPINAL FIXATION SYSTEM (K101971) | Syntec Scientific Corp. | 2011-03-25 |
| CAPTIVA SPINE FUSELOX CERVICAL CAGE (K110585) | Captiva Spine, Inc. | 2011-03-25 |
| VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS (K102640) | Vertex-Dental B.V. | 2011-03-25 |
| ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE (K110526) | ZOLL Medical Corporation | 2011-03-25 |
| ECHELON FLEX 45 / 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER (K110385) | Ethicon Endo-Surgery, Inc. | 2011-03-25 |
| COMPUTED TOMOGRAPHY X-RAY SYSTEM (K102196) | VATECH Co., Ltd. | 2011-03-25 |
| WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA (K101721) | Regulatory and Marketing Services, Inc. | 2011-03-24 |
| ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE... (K102647) | Elitechgroup Vital Scientific BV | 2011-03-24 |
| ZEST PETITE NASAL MASK (K103786) | Fisher & Paykel Healthcare, Ltd. | 2011-03-24 |
| NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE (K110054) | Zimmer Cas | 2011-03-24 |
| GMK REVISION KNEE SC LINERS (K103170) | Medacta International S.A. | 2011-03-24 |
| CLEARCANVAS RIS / PACS (K110332) | Clearcanvas, Inc. | 2011-03-24 |
| PERFORMAX TOTAL FACE MASK (K103395) | Respironics, Inc. | 2011-03-24 |