| 27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA (K110951) | Alcon Research, Ltd. | 2011-10-17 |
| CORONIS 5MP (K111990) | Barco N.V. | 2011-10-17 |
| ZYSTON STRAIGHT SPACER SYSTEM (K112014) | Biomet Spine | 2011-10-17 |
| SEGMENTATION ASSISTANT FOR PROSTATE-AUTO CONTOURING (K111311) | Omisa Inc. (Segasist Technologies) | 2011-10-17 |
| UNIMAX TROCAR SYSTEM (K112358) | Unimax Medical Systems, Inc. | 2011-10-17 |
| MICROGARD II (K111408) | Carefusion Germany 234 GmbH | 2011-10-17 |
| GLADIATOR HIP STEM (K111910) | Wrightmedicaltechnologyinc | 2011-10-14 |
| PORCINE SURGICAL MESH, PORCINE DERMAL MATRIX (K111436) | Brennen Medical, LLC | 2011-10-14 |
| TRILOGY SERIES VENTILATOR WITH OXIMETRY (K111610) | Respironics, Inc. | 2011-10-14 |
| CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK (K111975) | Kuraray Medical, Inc. | 2011-10-14 |
| WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM (K112370) | Welldoc, Inc. | 2011-10-14 |
| BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG (K112771) | Sorin Group Italia S.R.L. | 2011-10-14 |
| ADVIA CENTAUR VITAMIN D TOTAL ASSAY (K110586) | Siemens Healthcare Diagnostics, Inc. | 2011-10-14 |
| MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE (K112086) | Medrad, Inc. | 2011-10-14 |
| MPXX POWDER FREE NATURAL RUBBER EXAMINATION GLOVES (K110250) | Total Gloves Sdn Bhd | 2011-10-14 |
| ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORS (K103627) | Abbott Laboratories | 2011-10-14 |
| POLARCUP DUAL MOBILITY SYSTEM (K110135) | Smith & Nephew, Inc. | 2011-10-14 |
| EDWARDS LIFESCIENCES ENDOCLAMP AORTIC CATHETER (K112694) | Edwards Lifesciences, LLC | 2011-10-14 |
| CLEARFIL TRI-S BOND PLUS (K111980) | Kuraray America, Inc. | 2011-10-14 |
| CSM SUBMERGED-R IMPLANT SYSTEM (K111120) | Csm Implant | 2011-10-14 |
| TETRIC EVOCERAM BULK FILL (K111958) | Ivoclar Vivadent, Inc. | 2011-10-14 |
| VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE (K103752) | bioMerieux, Inc. | 2011-10-14 |
| RANDOX DIGOXIN ASSAY (K102346) | Randox Laboratories, Ltd. | 2011-10-14 |
| DISPOSABLE ELECTRODE (K111737) | Sanibel Supply | 2011-10-14 |
| NOVABNE PUTTY BIOACTIVE SYNTHETIC BONE GRAFT (K112773) | Novabone Products, LLC | 2011-10-14 |
| MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4) (K101774) | Alcon Manufacturing, Ltd. | 2011-10-13 |
| MTF NEW BONE VOID FILLER (K110003) | Musculoskeletal Transplant Foundation | 2011-10-13 |
| ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MODEL 2.5, ZIMMER PATIENT SPECIFIC INSTRUMENTS (K111492) | Materialise NV | 2011-10-13 |
| IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT (K103757) | Grifols | 2011-10-13 |
| DISPOSABLE STIMULATING ELECTRODE (K111597) | Nuvasive, Inc. | 2011-10-13 |
| SULCUS BLUE (K111978) | Produits Dentaires Pierre Rolland | 2011-10-13 |
| NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX (K100163) | Vygon Corp. | 2011-10-13 |
| INVISIPORT (K110407) | Stealth Therapeutics, Incorporated | 2011-10-13 |
| 3B FLEX-LITE (K103434) | 3B Products, LLC | 2011-10-13 |
| FEMCHEC PRESSURE MANAGEMET DEVICE (K110993) | Femasys, Inc. | 2011-10-12 |
| LUNGPOINT PLANNING AND VIRTUAL BRONCHOSCOPIC NAVIGATION (VBN) SOFTWARE (K112051) | Broncus Technologies, Inc. | 2011-10-12 |
| CORNERSTONE (R) PSR CERVICAL FUSION SYSTEM (K111264) | Medtronic Sofamor Danek USA | 2011-10-12 |
| SFC VERTEBRAL BODY REPLACEMENT (K110153) | Konigsee Implantate GmbH | 2011-10-12 |
| MAC-LAB SYSTEM, CARDIOLAB SYSTEM, COMBOLAB SYSTEM, SPECIALSLAB SYSTEM (K111200) | GE Healthcare | 2011-10-12 |
| PRODIGY DIABETES MANAGEMENT SOFTWARE (K103115) | Prodigy Diabetes Care, LLC | 2011-10-12 |
| SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM (K112646) | Samsung Medison Co., Ltd. | 2011-10-12 |
| VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5) (K111543) | Ventana Medical Systems, Inc. | 2011-10-12 |
| BEAMMED SUNLIGHT MINIOMNI BONE SONOMETER (K110646) | Beam-Med, Ltd. | 2011-10-12 |
| BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP (K112019) | Corentec Co., Ltd. | 2011-10-12 |
| BANTAM CATHETER (280MM BALLOON LENGTHS) (K112335) | ClearStream Technologies , Ltd. | 2011-10-12 |
| HEALTH-E-CONNECT SYSTEM (K102063) | Alr Technologies | 2011-10-11 |
| ONSET ACCESS CATHETER SYSTEM (K112629) | Onset Medical Corporation | 2011-10-11 |
| CONCORDE BULLET SPINAL SYSTEM (K110694) | Johnson & Johnson | 2011-10-11 |
| SURESIGNS VS2+ -SURESIGNS VSI (K112652) | Philips Medical Systems | 2011-10-11 |
| RELIEVA SPIN SINUS DILATION SYSTEM (K111875) | Acclarent, Inc. | 2011-10-11 |
| RAUMEDIC ICP MONITORING SYSTEM (K112017) | Raumedic AG | 2011-10-11 |
| AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM (K112615) | Tornier, Inc. | 2011-10-11 |
| SMITH & NEPHEW CANNULATED SCREWS AND WASHERS (K111994) | Smith & Nephew, Inc. | 2011-10-11 |
| APEX KIRSCHNER WIRES AND STEINMANN PINS (K112254) | Apex Tools & Orthopedics Co. | 2011-10-11 |
| VENUS SWAN SYSTEM (K111784) | Venus Concept , Ltd. | 2011-10-07 |
| MONTBLANC SURGICAL CONTRA-ANGLE AND STRAIGHT HANDPIECE (K111532) | Anthogyr Sas | 2011-10-07 |
| RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL) (K110687) | Acclarent, Inc. | 2011-10-07 |
| GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM (K102316) | Broadmaster Biotech Corporation | 2011-10-07 |
| TOMOTHERAPY TREATMENT SYSTEM (K112446) | Tomotherapy Incorporated | 2011-10-07 |
| HUIBAO BODY FAT SCALE (K111404) | Zhongshan Huibao Weighing Apparatus Co., Ltd. | 2011-10-07 |
| MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORY (K112263) | Intuitive Surgical, Inc. | 2011-10-07 |
| MECTACER BIOLOX(R) DELTA FEMORAL HEADS (K112115) | Medacta International | 2011-10-07 |
| OSTEOMED HAND FUSION SYSTEM (K111419) | Osteomed LP | 2011-10-07 |
| CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY (K110836) | Zimmer GmbH | 2011-10-07 |
| MULTIPLE (K112460) | Larson Medical Products, Inc. | 2011-10-07 |
| ORTHOLOC(TM) BONE SCREWS (K112772) | Wrightmedicaltechnologyinc | 2011-10-07 |
| ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II (K110780) | Elitechgroup | 2011-10-07 |
| BABI PLUS INFANT NASAL CANNULA SYSTEM (K110471) | A Plus Medical | 2011-10-07 |
| U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS (K112635) | Kimberly-Clark Corp. | 2011-10-07 |
| FORTIFY(TM) AND FORTIFY(TM)-R CORPECTOMY SPACERS (K112756) | Globus Medical, Inc. | 2011-10-07 |
| ICEEDGE 2.4 CRYOABLATION NEEDLE,ICEEDGE 2.4 CRYOABLATION NEEDLE MULTIPACK (K111859) | Galil Medical, Inc. | 2011-10-07 |
| DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL) (K102772) | Siemens Heatlhcare Diagnostics, Inc. | 2011-10-07 |
| GLOBALCARDIO (K111320) | Cardiocomm Solutions, Inc. | 2011-10-07 |
| PRECISION FLOW(R) - HELIOX (K111640) | Vapotherm, Inc. | 2011-10-07 |
| RANGE SPINAL SYSTEM (MESA AND DENALI) (K112037) | K2m, Inc. | 2011-10-06 |
| ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM (K111371) | ACON Laboratories, Inc. | 2011-10-06 |
| ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS (K110579) | Abbott Laboratories | 2011-10-06 |
| SENOGRAPH DS, SENOGRAPH ESSENSTIAL (K103485) | General Electric Company | 2011-10-06 |
| ERASE HAND- HELD CONTROLLER; ERASE SINGLE USE ELECTRIC CATRIDGE SYSTEM (K101592) | Cheng Medical, Corporation | 2011-10-06 |
| EASYLOCK OSTEOSYSTEM (K111266) | TriMed, Inc. | 2011-10-06 |
| OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE (K103625) | Draeger Medical Systems, Inc. | 2011-10-06 |
| CROSSTEX ISOFLUID PLUS SURGICAL EARLOOP MASK-BLUE, CROSSTEX ISOFLUID PLUS FOGFREE SURGICAL EARLOOP FACE MASK-BLUE, CROSS (K111343) | Crosstex International, Inc. | 2011-10-06 |
| DRYVIEW CHROMA IMAGING SYSTEM (K111566) | Carestream Health, Inc. | 2011-10-06 |
| C2 NERVEMONITOR SYSTEM WITH ACCESSORIES (K111647) | Inomed Medizintechnik GmbH | 2011-10-06 |
| ENDOFLIP ECD (K110531) | Crospon, Ltd. | 2011-10-06 |
| ASCOT HOME MEDICAL MONITORING SYSTEM (HMMS) (K103643) | Ascot Technologies, Inc. | 2011-10-06 |
| XL EXTRACTION CATHETER (K112571) | Vascular Solutions, Inc. | 2011-10-06 |
| WILDCAT 5F GUIDEWIRE SUPPORT CATHETER (K112579) | Avinger, Inc. | 2011-10-06 |
| CANDELA GENTLEMAX FAMILY OF LASERS (K112715) | Candela Corp. | 2011-10-05 |
| AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION (K111740) | Ameriwater | 2011-10-05 |
| EXETER X3 RIMFIT ACETABULAR CUP (K111848) | Stryker Corp. | 2011-10-05 |
| ZIMMER PERIARTICULAR SCREWS (K111447) | Zimmer, Inc. | 2011-10-05 |
| CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2 (K112007) | Biosense Webster, Inc. | 2011-10-05 |
| SINGHMED ROOLIP MANIPULATOR (K110819) | J.Singh Instruments | 2011-10-05 |
| SPEACELABS MULTIGAS MODULE (K112173) | Spacelabs Healthcare | 2011-10-05 |
| FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST (K103487) | Taidoc Technology Corporation | 2011-10-04 |
| INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216 (K111905) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2011-10-04 |
| OXIMETRY INTERFACE KIT (K111378) | Philips Respironics, Inc. | 2011-10-04 |
| TECO DIAGNOSTICS SALIVA ALCOHOL TEST (K111206) | Teco Diagnostics | 2011-10-04 |
| SOVEREIGN SPINAL SYSTEM (K110063) | Medtronic Sofamor Danek, Inc. | 2011-10-04 |