| IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT (K090257) | Siemens Healthcare Diagnostics | 2009-05-26 |
| CARESTREAM DRYVIEW 5850 LASER IMAGER (K090469) | Carestream Health, Inc. | 2009-05-22 |
| NEOSS IMPLANT SYSTEM 03.25 (K090452) | Neoss, Ltd. | 2009-05-22 |
| C-PORT - HP POWER INJECTABLE PORT (K091099) | Phs Medical GmbH | 2009-05-22 |
| CAAS MR FLOW 1.0 (K090155) | Pie Medical Imaging BV | 2009-05-22 |
| STRAUMANN MEMBRAGEL (K082111) | Institut Straumann AG | 2009-05-22 |
| BAROSENSE ENDOGASTRIC TUBE (EGT), MODEL F0034 (K082589) | Barosense, Inc. | 2009-05-22 |
| DIAGNOSTIC CATHETER SYSTEM (K091250) | Cardinal Health, Inc. | 2009-05-22 |
| IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0 (K090461) | Tomtec Imaging Systems GmbH | 2009-05-22 |
| ENABLER-P CATHETER, 1000 PART NUMBER:1160 (K083833) | Endocross, Ltd. | 2009-05-22 |
| MEDICALGORITHMICS REAL-TIME ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL POCKETECG (K090037) | Medicalgorithmics SP Z.O.O. | 2009-05-22 |
| SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527A (K091417) | Terumo Corp. | 2009-05-22 |
| FREEHAND (K090340) | Prosurgics Limited | 2009-05-22 |
| TERUMO SYRINGE WITH/WITHOUT NEEDLE (K083514) | Terumo Europe N.V. | 2009-05-22 |
| BIOPRO FEMORAL HEADS (K090208) | Biopro, Inc. | 2009-05-22 |
| ENSITE SYSTEM, MODEL EE3000, AND ENSITE NAVX SURFACE ELECTRODE, MODEL EN0010 (K083328) | St Jude Medical | 2009-05-22 |
| FREEDOM STIM 100 AND 200 ELECTRODE AND LEADWIRE EXTENSION (K083441) | Motion Medical Products, LLC | 2009-05-22 |
| RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER (K082455) | Gulf Coast Hyperbarics, Inc. | 2009-05-22 |
| MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES (K090676) | Anthogyr | 2009-05-22 |
| EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM-SMALL/LARGE, MODEL 22437-19/22438-19 (K090665) | Abbott Vascular-Vascular Solutions | 2009-05-22 |
| DEPUY SPINE BENGAL, CONCORDE, COUGAR, DEVEX AND LEOPARD SYSTEMS (K081917) | Depuy Spine, Inc. | 2009-05-22 |
| ANKYLOS C/X DENTAL IMPLANT SYSTEM (K083805) | Dentsply Intl., Inc. | 2009-05-22 |
| DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270 (K090330) | Siemens Healthcare Diagnostics, Inc. | 2009-05-22 |
| OSTEOCRETE BONE VOID FILLER (K071004) | Bone Solutions, Inc. | 2009-05-21 |
| THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY (K083391) | Diagnostic Hybrids, Inc. | 2009-05-21 |
| METAMORPHOSIS (K091023) | Kerr Corporation | 2009-05-21 |
| SYNTHES SYNAPSE TRANSCONNECTOR (K090549) | Synthes Spine | 2009-05-21 |
| ORALUBE (K090457) | Pulpdent Corporation | 2009-05-21 |
| INVACARE TPOC PORTABLE CONCENTRATOR, MODEL TPOC100 (K083751) | Invacare Corporation | 2009-05-21 |
| PRIMUS STEAM STERILIZER, MODELS PSS5-G-1 AND PSS5-M (K082817) | Primus Sterilizer Company, LLC | 2009-05-21 |
| PERCUTANEOUS DISCECTOMY SYSTEM (K090815) | Laurimed, LLC | 2009-05-21 |
| POWER INFUSER, MODEL M100B-3A (K090736) | ZOLL Medical Corporation | 2009-05-20 |
| FUSION MEDICAL STI (K081755) | John Riccio | 2009-05-20 |
| EMERGENCY PORTABLE VENTILATOR, MODEL EPV200 (K090356) | Allied Healthcare Products, Inc. | 2009-05-20 |
| ZELTIQ SYSTEM (K090094) | Zeltiq Aesthetics | 2009-05-20 |
| SYNERGEYES SIG (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS (K083921) | Synergeyes, Inc. | 2009-05-20 |
| SPIN-LOC SUTURE ANCHOR SYSTEM FG-0302-01,FG-0305-01 (K090530) | Ross Creek Medical, Inc. | 2009-05-20 |
| EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMS (K083850) | Euroimmun Us, Inc. | 2009-05-20 |
| BABI*PLUS BUBBLE PAP VALVE (K090317) | A Plus Medical | 2009-05-20 |
| HINGE PEDIATRIC PLATING SYSTEM (K090440) | Pega Medical, Inc. | 2009-05-20 |
| APLION TOPICAL CARE SYSTEM (K091133) | Aplion Medical,Llc | 2009-05-20 |
| SYNGO TRUED (K091373) | Siemens Medical Solutions USA, Inc. | 2009-05-20 |
| SUPRATHEL WOUND AND BURN DRESSING (K090160) | Polymedics Innovations, GmbH | 2009-05-20 |
| OCULUS MICROCYN WOUND GEL (K090725) | Oculus Innovative Sciences, Inc. | 2009-05-20 |
| GUIDED LATERAL INTERBODY FUSION (GLIF) SYSTEM (K090425) | Alphatec Spine, Inc. | 2009-05-19 |
| EG-3870UTK (K090197) | Pentax Medical Company | 2009-05-19 |
| MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM (K091070) | Sierra Scientific Instruments, Inc. | 2009-05-19 |
| EG-3670URK (K090196) | Pentax Medical Company | 2009-05-19 |
| BRANEMARK INTEGRATION BIOHELIX IMPLANTS (K090005) | Branemark Integration AB | 2009-05-19 |
| BONGROS HA (K090793) | Bioalpha, Inc. | 2009-05-19 |
| DEPUY SPINE LATERAL SYSTEM (K090899) | Depuy Spine, Inc. | 2009-05-19 |
| MASTERSCREEN PAED - BABY BODY (K081823) | Viasys Healthcare GmbH | 2009-05-18 |
| UTRECHT INTERSTITIAL FLETCHER CT/MR APPLICATOR SET, MODEL 110.270, INTERSTITIAL RING CT/MR APPLICATOR SET,MODEL 110.330, (K091154) | Nucletron Corporation | 2009-05-18 |
| WV1417A DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM (K090062) | Direct Digital Imaging Technology (Beijing), Inc. | 2009-05-18 |
| BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS (K083507) | Allied Healthcare Products, Inc. | 2009-05-18 |
| ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191 (K090749) | Villa Sistemi Medicali S.P.A. | 2009-05-18 |
| MY LABS25 GOLD/MYLAB30 GOLD CARDIOVASCULAR MODEL 7340, MY LAB70/MY LAB70XVISION/MYLAB60, MODEL 6150 (K091009) | Esaote, S.p.A. | 2009-05-18 |
| STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE) (K090520) | Shandong Huayue Glove Co., Ltd. | 2009-05-18 |
| VS-100 ILLUMINATION AND IMAGING SYSTEM (K090800) | Schoelly Imaging, Inc. | 2009-05-18 |
| INTELLIGENT POWER UNIT, INTELLIGENT CONSOLE, INTELLIGENT DELIVERY SYSTEM, INTELLIGENT SURGICAL INSTRUMENT (K091215) | Power Medical Interventions, Inc. | 2009-05-18 |
| AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS (K090672) | Agfa Healthcare N.V. | 2009-05-18 |
| SYNGOCIRCULATION DYNAMICPET, VERSION 1.0 (K083327) | Siemens Medical Solutions USA, Inc. | 2009-05-18 |
| LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE, MODEL ZLK-100 (K083455) | Medi-Khan USA, Inc. | 2009-05-18 |
| ALGISEAL PAD (K091194) | Evolution Medical Technologies, LLC | 2009-05-18 |
| SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODEL (K091206) | Transoma Medical | 2009-05-18 |
| RESPIRONICS SLEEPEASY CPAP SYSTEM (K091112) | Respironics, Inc. | 2009-05-15 |
| EPICARDIA 5000 (K090834) | Medicomp, Inc. | 2009-05-15 |
| MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LT (K082403) | Gish Biomedical, Inc. | 2009-05-15 |
| MODIFICATION TO THE CROSSER SYSTEM (K091119) | Flowcardia, Inc. | 2009-05-15 |
| POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 OF GLOVE (K090066) | Wear Safe (Malaysia) Sdn. Bhd. | 2009-05-15 |
| BACKSTOP CATHETER, MODEL 60-0000-3100 (K090270) | Pluromed, Inc. | 2009-05-15 |
| ZIEHM VISION RFD (K083545) | Ziehm Imaging, Inc. | 2009-05-15 |
| INVIROBLUNT CANNULA WITH AND WITHOUT EZ WINGS, MODELS 120522 AND 120022 (K083851) | Inviro Medical Devices, Inc. | 2009-05-15 |
| AMIGO CATEGORY III FULL-SIZED REGULAR DUTY 3 WHEEL (310000) AND AMIGO CATEGORY V HEAVY DUTY 3 WHEEL (650000) (K090966) | Svrc Industries, Inc. | 2009-05-15 |
| NEUCODIA (K081591) | Verisci Corporation | 2009-05-15 |
| APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM MODEL SSA-790A VERSION 4.0 (K091295) | Toshiba America Medical Systems, In.C | 2009-05-15 |
| SYNGO US WORKPLACE (K091286) | Siemens Medical Solutions USA, Inc. | 2009-05-15 |
| CD HORIZON SPINAL SYSTEM (K090390) | Medtronic Sofamor Danek | 2009-05-15 |
| BRAVO AUTOCLAVE, MODELS 17, 17V AND 21V (K090265) | Scican , Ltd. | 2009-05-15 |
| LOTUS II PULSED ER: YAG LASER SYSTEM (K083253) | Laseroptek Co., Ltd. | 2009-05-15 |
| SPECTRA SYSTEM DENTAL IMPLANTS 2008 (K090234) | Implant Direct, LLC | 2009-05-15 |
| BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER (K081130) | Bridgepoint Medical | 2009-05-14 |
| DVX SPINE SYSTEM (K090424) | Bk Meditech, Co., Ltd. | 2009-05-14 |
| WBR XPRESS.CARDIAC AND XPRESS3.CARDIAC INCLUDING ATTENUATION AND SCATTERING CORRECTIONS (K091073) | Ultraspect , Ltd. | 2009-05-14 |
| GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL (K083648) | Efratgo, Ltd. HI Tech Bio-Surgical | 2009-05-14 |
| AONGEN COLLAGEN MATRIX (K080868) | Aeon Astron Europe B.V. | 2009-05-14 |
| AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES (K090470) | Covidien | 2009-05-14 |
| TEARLAB OSMOLARITY SYSTEM (K083184) | Ocusense, Inc. | 2009-05-14 |
| MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B (K083385) | Allied Healthcare Products, Inc. | 2009-05-14 |
| BREAS VIVO 40 SYSTEM (K090113) | Breas Medical AB | 2009-05-14 |
| ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026 (K090489) | Kci USA, Inc. | 2009-05-14 |
| VITAL SIGNS MONITOR (K083821) | Edan Instruments, Inc. | 2009-05-14 |
| A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC (K090413) | Bayer Healthcare, LLC | 2009-05-14 |
| ELITE MPX LASER SYSTEM WITH CRYO C (K091169) | Cynosure, Inc. | 2009-05-13 |
| MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IRIDVI-1 (K091040) | Microlife Intellectual Property GmbH | 2009-05-13 |
| ST. JUDE MEDICAL EPICARDIAL CATHETER SYSTEM (K081803) | St Jude Medical | 2009-05-13 |
| CRONO S-PID 50 (K091042) | Cane S.R.L. | 2009-05-12 |
| AMPLATZER TORQVUE 45DEGREEX45DEGREE DELIVERY SHEATH, MODELS 9-TV45X45-09F-100, 9-TV45X45-10F-100 (K083214) | Aga Medical Corp. | 2009-05-12 |
| FORA G30 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241 (K090187) | Taidoc Technology Corporation | 2009-05-12 |
| SEGMENT (K090833) | Medviso | 2009-05-12 |