| DISPOSABLE REFLECTIVE MARKER SPHERES (K100038) | Brainlab AG | 2010-07-14 |
| NIHON KOHDEN QP-160AK EEG TREND PROGRAM (K092573) | Nihon Kohden America, Inc. | 2010-07-09 |
| EARPROBE (K100661) | Path Medical GmbH | 2010-07-01 |
| WAVESTATE NEUROMONITOR (K092625) | Wavestate, Inc. | 2010-06-29 |
| 4 CHANNELS MULTIPLE MODEL DIGITAL ELECTRICAL STIMULATOR, MODEL NUVOSTIM IV, WL-2504A (K100399) | Well-Life Healthcare Limited | 2010-06-25 |
| MYOSCIENCE CRYO-TOUCH (K100447) | Myoscience, Inc. | 2010-06-25 |
| CLEARPOINT SYSTEM (K100836) | Surgivision, Inc. | 2010-06-16 |
| OLYMPIC BRAINZ MONITOR MODEL OBM70001 (K093949) | Natus Medical, Inc. | 2010-06-16 |
| SUDOSCAN (K100233) | Impeto Medical | 2010-06-14 |
| MINTA RYAN RF THERMOCOUPLE ELECTRODE (RYAN-50, 100, 150 AND 200), MINTA INTERMEDIATE CABLE (RYAN-C, -R, -B) (K090608) | Minta Medical Limited | 2010-06-14 |
| BRAINLAB KNEE ARTHROSCOPY (K093118) | Brainlab AG | 2010-06-11 |
| SCENAR, MODEL 10 (K092117) | Ritm Okb Zao | 2010-05-28 |
| TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM (K093973) | Codman & Shurtleff, Inc. | 2010-05-26 |
| MODIFCATION TO: NUVASIVE NEUROVISION EMG ENDOTRACHEAL TUBE (K094054) | Nuvasive, Inc. | 2010-05-14 |
| VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED (K092467) | Brainlab AG | 2010-05-06 |
| BE MICRO, TREA (K093728) | Eb Neuro S.P.A. | 2010-04-29 |
| HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V (K100454) | MicroVention, Inc. | 2010-04-22 |
| LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES (K094018) | Biocompatibles UK Limited | 2010-04-16 |
| LASERTOUCHONE (OTC) (K100116) | Laser Health Technologies, LLC | 2010-04-15 |
| SYNTHES AIR PEN DRIVE (APD) SYSTEM (K093361) | Synthes (Usa) | 2010-04-14 |
| NEUROLINK IP MODEL: PK1117 (K100683) | Natus Medical Incorporated | 2010-04-09 |
| CAS FIXATION PIN 3.2 DIA X 180 MM STR, CAS FIXATON PIN 3.2 DIA X 80 MM STR, CAS FIXATON PIN 3.2 DIA X 150 MM (K100599) | Orthosoft, Inc. | 2010-04-05 |
| IMNS MEDACTA NAVIGATION SYSTEM,33.221000US (K100314) | Medacta International S.A. | 2010-03-31 |
| HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2 (K092448) | Hivox Biotek, Inc. | 2010-03-30 |
| LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM (K093494) | Pathfinder Therapeutics, Inc. | 2010-03-30 |
| MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION (K091940) | Tonica Elektronik A/S | 2010-03-26 |
| KNEEALIGN SYSTEM WITH REFERENCE SENSOR (K093998) | Orthalign, Inc. | 2010-03-22 |
| NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800 (K092699) | Neurotronics, Inc. | 2010-03-18 |
| FIXIT HEADREST CLAMP SYSTEM (K083803) | Medicon EG | 2010-03-10 |
| GRINDCARE (K092675) | Medotech A/S | 2010-03-03 |
| MAKO SURGICAL CORP ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA (K093425) | Mako Surgical Corp. | 2010-02-24 |
| SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V2.0 (K100107) | Smith & Nephew, Inc. | 2010-02-23 |
| NATUS NEUROWORKS, MODEL 104196 (K090019) | Natus Medical, Inc. | 2010-02-22 |
| JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS (K092227) | Integra Lifesciences Corp. | 2010-02-17 |
| WAYPOINT STEREOTACTIC SYSTEM (K092192) | FHC, Inc. | 2010-02-12 |
| OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407 (K091757) | Well-Life Healthcare Limited | 2010-02-05 |
| TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEM (K093142) | Boston Scientific Corp | 2010-02-04 |
| STATNET, MODEL 3100 (K092828) | Hydrodot, Inc. | 2010-01-29 |
| OWL UNIVERSAL RF SYSTEM URF-3AP (ML) (K093185) | Diros Technology, Inc. | 2010-01-22 |
| OSV II LOW FLOW LOW PRO VALVE (K093968) | Integra LifeSciences Corporation | 2010-01-22 |
| SIPHONX GRAVITATIONAL ANTISIPHON DEVICE (K091328) | Sophysa SA | 2010-01-22 |
| DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGRA SPINAL MEND DURAL REGENERATION MATRIX, MO (K092388) | Integra LifeSciences Corporation | 2010-01-21 |
| MICROPLEX COIL SYSTEM-COSMOS MODEL 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-V (K093919) | MicroVention, Inc. | 2010-01-21 |
| TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK (K090953) | Praxim Medivision, SA | 2010-01-21 |
| COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG (K093223) | Compumedics Limited | 2010-01-15 |
| MICROPLEX COIL SYSTEM-COSMOS, MODELS 81451CS-V, 181555CS-V, 16=81652CS-V (K093358) | MicroVention, Inc. | 2010-01-15 |
| INF 4160 PLUS, MODEL D-FJ31F (K092780) | Fuji Dynamics Limited | 2010-01-07 |
| MICHIGAN CRANIAL RESHAPING ORTHOSIS (K090341) | Danmar Products, Inc. | 2010-01-06 |
| SWIFT-LOCK ANCHOR, MODEL 1192 (K092371) | Advanced Neuromodulation Systems | 2009-12-23 |
| DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE (K091762) | Covidien | 2009-12-22 |
| SMART TENS, MODEL: D-BC05T (K091045) | Body Clock Health Care, Ltd. | 2009-12-18 |
| GMDASZ TENS ELECTRODES, MODELS CWN1005, DIA. 5CM, DWN2505, 5CMX5CM, CWN1007.DIA. 7CM, CWN2509,5CMX9CM (K092546) | Gmdasz Manufacturing Co., Ltd. | 2009-12-18 |
| NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP) (K083371) | Natus Medical, Inc. | 2009-12-08 |
| NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM (K091457) | Nexstim OY | 2009-12-08 |
| MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411 (K092793) | Bio-Medical Research, Ltd. | 2009-12-07 |
| EMSI GARMENT ELECTRODES (K090889) | Emsi | 2009-12-04 |
| OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM (K092395) | Integra Lifesciences Corp. | 2009-11-19 |
| ROSA SURGICAL DEVICE, MODEL ROSA 1.1 (K092239) | Medtech S.A | 2009-11-17 |
| KRYPTONITE BONE CEMENT (K091382) | Doctors Research Group, Inc. | 2009-11-16 |
| VIGILANT EEG MONITOR, VIGILANT 2.0 (K091963) | Infinite Biomedical Technologies, LLC | 2009-11-06 |
| BIS QUATRO SENSOR (K093183) | Aspect Medical Systems, Inc. | 2009-10-23 |
| AMD 6605 TENS/NMES (K092990) | Advantageous Medical Devices, LLC | 2009-10-23 |
| NEUROCALM MODEL 1 AND 2 (K090866) | Neuromed Devices, Inc. | 2009-10-21 |
| ORTHOREX INTRA-OPERATIVE LOAD SENSOR (K090474) | Orthosensor, Inc. | 2009-10-19 |
| IDENTEVENT, VERSION 1.0G (K092039) | Optima Neuroscience, Inc. | 2009-10-16 |
| PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS (K092337) | Baylis Medical Co., Inc. | 2009-10-16 |
| WIN-NEUS STEREOTACTIC SURGERY TREATMENT PLANNING SYSTEM (K090190) | Nuclemed S.A. | 2009-10-09 |
| IF TRUE SINE INTERFERENTIAL STIMULATOR, WL-2206D (K092763) | Well-Life Healthcare Limited | 2009-10-08 |
| INZONE DETACHMENT SYSTEM, MODEL M00345100940, IZDS CONNECTING CABLE, MODEL M00345100250 (K092666) | Boston Scientific Corp | 2009-09-30 |
| SYNERGY (K083378) | Innerspace, Inc. | 2009-09-29 |
| ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-HIP (K091998) | Mako Surgical Corp. | 2009-09-28 |
| SONOWAND INVITE (K083597) | Sonowand AS | 2009-09-25 |
| KNEEALIGN SYSTEM (K091411) | Orthalign, Inc. | 2009-09-25 |
| MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS (K092562) | FHC, Inc. | 2009-09-18 |
| SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM, VERSION 1.1 (K092497) | Smith & Nephew, Inc. | 2009-09-11 |
| CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIP (K091921) | Codman & Shurtleff, Inc. | 2009-09-08 |
| ICS CHARTR EP 200 (K092373) | Gn Otometrics | 2009-09-03 |
| PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM (K091312) | Medtronic Neurosurgery | 2009-09-02 |
| HEAD FIXATION ARC AND TABLE BASE (K091439) | Surgivision, Inc. | 2009-08-25 |
| NEUROMED ELECTROANALGESIC DELIVERY SYSTEMS (K083250) | Aa Neuromed Corp. | 2009-08-18 |
| SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORS (K083758) | The Electrode Store, Inc. | 2009-08-14 |
| POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-400 (K090342) | Sophysa SA | 2009-08-11 |
| ZOOM-100DC (K082886) | Brainscope Company, Inc. | 2009-08-10 |
| MONTERIS MEDICAL UFO (K090240) | Monteris Medical, | 2009-08-06 |
| I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), I-PORTAL NEURO OTOL (K083603) | Neuro Kinetics | 2009-08-06 |
| RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581 (K090750) | Restorative Therapies, Inc. | 2009-08-05 |
| LIFECARE ELECTRODES (K083302) | Everyway Medical Instruments Co.,Ltd | 2009-08-03 |
| RAPID PROGRAMMER, VERSION 3.3.0 (K091993) | Advanced Neuromodulation Systems, Inc. (Ans Inc.) | 2009-07-31 |
| MANTRA COMBO, MODEL MECS 320 (K091236) | Mantra Intl. (Hk) , Ltd. | 2009-07-30 |
| PMT HALO SYSTEM (K090733) | Pmt Corp. | 2009-07-28 |
| PG471W , PG471/50W, PG474W, PG477W, PG479/32W, PG479/50W, PG479/75W FIAB DISPOSABLE ELECTRODES WITH CABLE FOR ELECTRO-ST (K091163) | Fiab Spa | 2009-07-22 |
| STARLIGHT (K090587) | Orthomerica Products, Inc. | 2009-07-17 |
| SMITH & NEPHEW RF CANNULATE (K090955) | Smith & Nephew, Inc. | 2009-07-16 |
| SMARTSCREENER-PLUS2 (K090579) | Intelligent Hearing Systems | 2009-07-07 |
| BIS CLICK SENSOR/CABLE (K091854) | Aspect Medical Systems, Inc. | 2009-07-02 |
| S12X WITH ESAX OPTION (K082629) | Chatten Associates, Inc. | 2009-07-01 |
| HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT) (K091641) | MicroVention, Inc. | 2009-06-30 |
| GUARDIAN 150 ELECTRODE (K083756) | Selectivemed Components, Inc. | 2009-06-26 |
| LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK (K091317) | Bio-Medical Research, Ltd. | 2009-06-25 |
| ORTHOPILOT NEXT GENERATION-UKA SOFTWARE, MODEL FS210 (K090375) | Aesculap Implant System, Inc. | 2009-06-23 |