| VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34 (K100015) | Abbott Molecular, Inc. | 2011-08-09 |
| NAVIAID(TM) BGC DEVICE (K111760) | Smart Medical Systems , Ltd. | 2011-08-09 |
| CYBOW READER, MODELS 300 & 720 (K102188) | DFI Co., Ltd. | 2011-08-09 |
| ANTLIA III WOUND TREATMENT SYSTEM (K111333) | Innovative Therapies, Inc. | 2011-08-08 |
| INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM 3.4MM IMPLANT ANGLED ABUTMENTS (K111199) | Intra-Lock International, Inc. | 2011-08-08 |
| SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM (K111540) | Synthes (Usa) | 2011-08-08 |
| Y-KNOT ALL-SUTURE ANCHOR MODEL HF13 (K111779) | Conmed Linvatec | 2011-08-08 |
| CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (K111047) | Mauna Kea Technologies, Inc. | 2011-08-08 |
| T2 FEMORAL NAIL MODEL 1825-XXXXCP, 1828-XXXXCP (K112059) | Stryker | 2011-08-08 |
| ROG SUTURE ANCHOR, ROG KNOTLESS SUTURE ANCHOR (K111590) | Rog Sports Medicine, Inc. | 2011-08-08 |
| BRAINLAB TRAUMA (K110204) | Brainlab AG | 2011-08-05 |
| ECG-6 SERIES ELECTROCARDIOGRAPH (K112135) | Advanced Instrumentations, Inc. | 2011-08-05 |
| FREEWAY COMFORT BITE GUARD (K110468) | Randmark Dental Products, LLC | 2011-08-05 |
| PERIMETER C SPINAL SYSTEM (K100967) | Medtronic Sofamor Danek USA, Inc. | 2011-08-05 |
| SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY (K101517) | Sedecal., Sa. | 2011-08-05 |
| IBIS EXPLORER AND MARKUP SOFTWARE (K111319) | Medqia | 2011-08-05 |
| ST AIA-PACK DHEA-S CALIBRATOR SET (K111762) | Tosoh Bioscience, Inc. | 2011-08-05 |
| INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000V (K112054) | Toshiba Medical Systems Corporation, Japan | 2011-08-05 |
| ORTHOPEDIATRICS BLADE PLATE SYSTEM (K110959) | OrthoPediatrics Corp. | 2011-08-05 |
| GLIASITE RTS (K111931) | Isoray Medical, Inc. | 2011-08-05 |
| IMPAX NEXT GENERATION (K111945) | Agfa Healthcare N.V. | 2011-08-05 |
| HEADWAY 27 MICROCATHETER (K110813) | MicroVention, Inc. | 2011-08-05 |
| SURGICAL FACE MASK; SURGICAL FACE MASK (K110027) | Angeline Group , Ltd. | 2011-08-05 |
| ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, ICROSS CORONARY IMAGING CATHETER (K111043) | Boston Scientific Corp | 2011-08-04 |
| TAL PALLINDROME (TM) SYMMETRIC TIP DUAL LUMEN CATHETER, MAHURKAR (R) MAXID (TM) DUAL LUMEN CATHETER, PALINDROME (TM)... (K111372) | Covidien | 2011-08-04 |
| CORIN OPTIMOM MODULAR HEAD (K111911) | Corin USA | 2011-08-04 |
| LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER (K111387) | Iquum, Inc. | 2011-08-04 |
| AESCULAP SIBD XP SPINAL SYSTEM (K111122) | Aesculap Implant Systems, Inc. | 2011-08-04 |
| STRYKER SPINE POWER ADAPTOR (ACCESSORY INSTRUMENT) (K111478) | Stryker Corporation | 2011-08-04 |
| MICROSCAN(R) MICROSTREP PLUS(R) (K111677) | Siemens Healthcare Diagnostics, Inc. | 2011-08-04 |
| UNITED UTF STEM (K110245) | United Orthopedic Corporation | 2011-08-04 |
| MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT) (K110410) | Nihon Kohden Corp. | 2011-08-04 |
| SYNCRO - BLUE TUBE, THE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE- 8FR TUBE (K110005) | Syncro Medical Innovations, Inc. | 2011-08-04 |
| KNEEHAB XP (K110350) | Bio-Medical Research, Ltd. | 2011-08-03 |
| TELEMEDCARE HEALTH MONITOR (K103796) | Telemedcare Pty, Ltd. | 2011-08-03 |
| CONSTRUX EXTERNAL FIXATION DEVICE (K111376) | Ebi, LLC | 2011-08-03 |
| TANDA MAX OTC SYSTEM (K110735) | Pharos Life Corporation | 2011-08-03 |
| CARE BACK PAIN RELIEF STIMULATOR; CARE BACK PAIN RELIEF STIMULATOR (K110707) | Shenzhen Dongdixin Technology Co., Ltd. | 2011-08-03 |
| ATRICURE CRYO MODULE SYSTEM (K112072) | AtriCure, Inc. | 2011-08-03 |
| MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT (K111527) | Eragen Biosciences, Inc. | 2011-08-03 |
| BREEZE ELECTRIC TRANSPORT CHAIR MODEL 1025 (K111095) | Electro Kinetic Technologies, LLC | 2011-08-03 |
| VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS (K111195) | Ethicon Endo-Surgery, Inc. | 2011-08-03 |
| EKOSONIC ENDOVASCULAR SYSTEM (K111705) | Ekos Corporation | 2011-08-03 |
| ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001 (K102760) | Atlas Medical | 2011-08-03 |
| DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-01-1222, 1200-02-46XX, 2200-01-0000 (K101934) | Medshape Solutions | 2011-08-03 |
| VU C*POD INTERVERTEBRAL BODY FUSION DEVICE (K111675) | Theken Spine, LLC | 2011-08-02 |
| DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM (K110679) | Phygen, LLC | 2011-08-02 |
| VANTAGE TITAN 3T (K102489) | Toshiba Medical Systems Corporation, Japan | 2011-08-02 |
| ARTHREX DISTAL EXTREMITY PLATE SYSTEM (K111253) | Arthrex, Inc. | 2011-08-02 |
| MESA SPINAL SYSTEM (KEYSTONE RODS) (K110991) | K2m, Inc. | 2011-08-02 |
| ANCHORWIRE GUIDEWIRE (K111288) | Lake Region Medical | 2011-08-02 |
| SIGMA STERILIZATION POUCH & ROLL (K102158) | Sigma Medical Supplies Corp. | 2011-08-02 |
| JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILE (K111067) | Kunshan Jiehong Nonwoven Product Co., Ltd. | 2011-08-02 |
| LO-BAK TRAX (K110858) | Roland F Berthiaume, DC | 2011-08-02 |
| TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR (K103802) | GE Healthcare Finland Oy | 2011-08-02 |
| WV3000T DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM (K110801) | Direct Digital Imaging Technology (Beijing), Inc. | 2011-08-02 |
| UNITED U2 XPE TOTAL KNEE SYSTEM (K103733) | United Orthopedic Corporation | 2011-08-02 |
| INTRICON DATRIX CENTAURI MT AMBULATORY PATIENT ECG TELEMETRY SYSTEM (APETS) (K111160) | Intricon Datrix Corporation | 2011-08-01 |
| BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20 (K110383) | A Plus Medical | 2011-08-01 |
| SONOLITH I-MOVE (K111808) | Edap Tms France | 2011-08-01 |
| A & D MEDICAL UA-1000 FAMILY DAGITAL BLOOD PRESSURE MONITORS (K111686) | A&D Company, Ltd. | 2011-08-01 |
| CURE CATHETER (K110653) | Cure Medical, LLC | 2011-08-01 |
| VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH (K110958) | Smith & Nephew, Inc. | 2011-08-01 |
| KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER (K111745) | Card Guard Scientific Survival , Ltd. | 2011-08-01 |
| B1P ADHESIVE (K111431) | Pentron Clinical | 2011-08-01 |
| SYPHILIS HEALTH CHECK (K102400) | Diagnostics Direct, LLC | 2011-08-01 |
| PRIMEWIRE PRESTIGE PLUS (K111395) | Volcano Corporation | 2011-08-01 |
| IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT (K101572) | Siemens Healthcare Diagnostics | 2011-08-01 |
| BENELLI ACCESS DEVICE (K111334) | Vascular Solutions, Inc. | 2011-08-01 |
| JIANGSU SHENLI MEDICAL PRODUCTION CO. LTD. PISTON SYRINGE (5CC LUER LOCK) (K103830) | Jiangsu Shenli Medical Production Factory | 2011-07-29 |
| VACUETTE PREMIUM SAFETY NEEDLE SYSTEM TUBE-TOUCH (K111424) | Medpro Safety Products, Inc. | 2011-07-29 |
| ETG 255 COMBO STIMUALTOR, TEN 260 STIMUALTOR (K110390) | Handelshaus Dittman GmbH | 2011-07-29 |
| AMSCO WARMING CABINET (K111870) | STERIS Corporation | 2011-07-29 |
| GLIDECROSS SUPPORT CATHETER (K111556) | Terumo Medical Corp. | 2011-07-29 |
| SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE (K103740) | Spectra Medical Devices, Inc. | 2011-07-29 |
| HEARTNAVIGATOR RELEASE 1 (K111245) | Philips Medical Systems Nederland B.V. | 2011-07-29 |
| OSI O-BALL ABUTMENT HEAD IMPLANTS (K110548) | Juell Dental | 2011-07-29 |
| OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME (K111884) | LeMaitre Vascular, Inc. | 2011-07-29 |
| BIODENTA CUSTOMIZED ABUTMENT (K110778) | Biodenta Swiss AG | 2011-07-29 |
| PE-210AK SWITCH BOX (K110376) | Nihon Kohden Corp. | 2011-07-29 |
| ENDOMAXX FULLY COVERED ESOPHAGEAL STENT (K111611) | Merit Medical Systems, Inc. | 2011-07-29 |
| XCELA HYBRID PICC WITH PASV VALVE TECHNOLOGY (K111906) | Navilyst Medical, Inc. | 2011-07-29 |
| MAGNUM CORE TISSUE BIOPSY NEEDLE MODEL MN1820, RP CUTTING NEEDLE MODEL RP-1820, MCN CORE TISSUE BIOPSY NEEDLE MODEL MCN- (K111529) | Insert Molding Solutions, Inc. | 2011-07-29 |
| VOYAGER PERITONEAL DIALYSIS SYSTEM (K103220) | Deka Research & Development Corp. | 2011-07-29 |
| COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN (K110600) | Collagen Matrix, Inc. | 2011-07-29 |
| PAIN BUDDY (K102051) | Biomedical Life Systems, Inc. | 2011-07-29 |
| VENNER TRACHEAL SEAL MONITOR (K110631) | Venner Medical (Singapore) Pte, Ltd. | 2011-07-28 |
| SYNTHES STERNAL ZIPFIX SYSTEM (K110789) | Synthes (Usa) | 2011-07-28 |
| TELCARE BLOOD GLUCOSE MONITORING SYSTEM, TEST STRIPS, CONTROL SOLUTIONS, TELSERVE-HOME USE, TELSERVE-PROFESSIONAL USE (K110571) | Telcare, Inc. | 2011-07-28 |
| INTELLISPACE PACS 4.X (K111804) | Philips Healthcare Informatics, Inc. | 2011-07-28 |
| BIOPSY VALVE (K111821) | Endochoice, Inc. | 2011-07-28 |
| VITREAVIEW SOFTWARE 6.1 (K111892) | Vital Images, Inc. | 2011-07-28 |
| SNAP (R) WOUND CARE SYSTEM (K111393) | Spiracur, Inc. | 2011-07-28 |
| ENI-EYE SH TORIC (EFROFILCON A) SOFT HYDROPHILIC TORIC CONTACT LENS FOR DAILY WEAR, MULTIFOCAL CONTACT LENS, KERATOCONUS (K110261) | Soflex Limited | 2011-07-28 |
| AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS (K110419) | Stryker Spine | 2011-07-28 |
| MRI-Q SYSTEM (K111222) | Resonance Health Analysis Services Pty, Ltd. | 2011-07-28 |
| XELIS 3D (K103130) | Infinitt Co., Ltd. | 2011-07-28 |
| PREGNANCY ONE STEP RAPID TEST (K103574) | Lehnus & Associates Consulting | 2011-07-28 |
| M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS (K110723) | Masimo Corporation | 2011-07-28 |
| SMR SHOULDER SYSTEM- REVISION STEMS (K111212) | Lima Corporate S.P.A. | 2011-07-28 |