| SAFETYMATE TALKING FIRST AID (K110625) | Safetymate, Inc. | 2011-06-17 |
| PRISMAFLEX (K110823) | Gambro Renal Products, Inc. | 2011-06-17 |
| FIXTEMP C&B (K102917) | Exacta Dental Direct, Inc. | 2011-06-17 |
| TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES (K111131) | Carefusion 209, Inc. | 2011-06-17 |
| NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICE (K110291) | Smart Medical Systems , Ltd. | 2011-06-17 |
| EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRIC (K103783) | Fiab Spa | 2011-06-16 |
| APEX K1 HIP STEM (K110947) | Omni Life Science, Inc. | 2011-06-16 |
| SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS) (K111297) | Premier Medical Gloves Factory | 2011-06-16 |
| BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX (K103476) | Ge Medical Systems, LLC | 2011-06-16 |
| TULA IONTOPHORESIS SYSTEM (K110636) | Acclarent, Inc. | 2011-06-16 |
| AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301 (K101641) | Ag Digital Technology Corp. | 2011-06-16 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR (K111459) | Jiangsu Alfa Glove Co., Ltd. | 2011-06-16 |
| MAXFIRE MARXMEN MENISCAL REPAIR DEVICE (K111564) | Biomet Sports Medicine | 2011-06-16 |
| ENCOR ENSPIRE BREAST BIOPSY SYSTEM (K111100) | C.R. Bard, Inc. | 2011-06-16 |
| ELTA WOUND CLEANSER (K103713) | Swiss American Products, Inc. | 2011-06-16 |
| GUARDACARE (K103641) | Hem Con Medical Technologies, Inc. | 2011-06-16 |
| BIOSPINE VBR SYSTEM (K110864) | Aesculap Implant Systems, LLC | 2011-06-15 |
| NOBELPROCERA ZI ABUTMENT THOMMEN PLATFORMS (K110171) | Nobel Biocare USA, LLC | 2011-06-15 |
| COLONOSCOPY ASSISTANT (K102949) | Sti Medical Systems, LLC | 2011-06-15 |
| MD301C4 29.8 DIAGNOSTIC IMAGING LCD MONITOR, L309TY (K111237) | Nec Display Solutions , Ltd. | 2011-06-15 |
| PONTO PRO POWER (K103594) | Oticon Medical AB | 2011-06-15 |
| AZUR DETACHABLE 35 PLATINUM COIL SYSTEM (K111307) | MicroVention, Inc. | 2011-06-15 |
| ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT (K102274) | Arvik Enterprises/ Mini Lap Technologies | 2011-06-15 |
| VISENSIA, VISENSIA WITH ALERT (K110953) | Obs Medical | 2011-06-15 |
| POWDER FREE NITRILE (BLACK) EXAMINATION GLOVES (K110297) | Comfort Rubber Gloves Industries Sdn. Bhd. | 2011-06-15 |
| AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM (K110599) | Tornier, Inc. | 2011-06-14 |
| SPACELABS PATHFINDER SL HOLTER ANALYZER (K110001) | Spacelabs Healthcare, Ltd. | 2011-06-14 |
| ENTELLUS MEDICAL SINUS GUIDEWIRE (K110739) | Entellus Medical, Inc. | 2011-06-14 |
| ADDITIVE CAP (K111217) | Baxter Healthcare Corp | 2011-06-14 |
| TEMPFLEX (K110747) | Kerr Corporation | 2011-06-14 |
| EV1000 CLINICAL PLATFORM (K110597) | Edwards Lifesciences | 2011-06-14 |
| TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) (K111244) | Cook, Inc. | 2011-06-14 |
| HYDROFIX SURGICAL SHEET (K100313) | Mimedx Group, Inc. | 2011-06-14 |
| AEU-26L ELCTRONIC ENDODONTIC SYSTEM (K111078) | Aseptico, Inc. | 2011-06-14 |
| 4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM (K102458) | Solco Biomedical Co., Ltd. | 2011-06-13 |
| MAX PULSE SYSTEM (K110374) | Medicore Co., Ltd. | 2011-06-13 |
| SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE (K110933) | Spineology, Inc. | 2011-06-13 |
| MECTALIF (K110927) | Medacta International | 2011-06-13 |
| AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR (K102507) | Tz Medical, Inc. | 2011-06-13 |
| ETHICON ENDO-SURGERY GENERATOR G11, MODEL GEN11 (K101990) | Ethicon Endo-Sugery, LLC | 2011-06-13 |
| POWDER FREE NUTRILE PATIENT EXAMINATION GLOVES, BLUE COLOR (K110247) | Jiangsu Dongling Plastic & Rubber Co., Ltd. | 2011-06-10 |
| ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS (K103584) | Shenzhen Envisen Industry Co. Limited | 2011-06-10 |
| ATLANTIS ABUTMENT FOR CAMLOG IMPLANT, DUPLICATE ABUTMENT, LATER ABUTMENT (K110640) | Astra Tech, Inc. | 2011-06-10 |
| POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WHITE COLOR (K110248) | Jiangsu Dongling Plastic & Rubber Co., Ltd. | 2011-06-10 |
| I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560) (K111344) | Infimed, Inc. | 2011-06-10 |
| DMC MEDICAL SINGLE-USE POLYCARBONATE SYRINGE (K103736) | Dmc Medical, Ltd. | 2011-06-10 |
| PRESSURE MANOMETER (K110119) | Neoforce Group, Inc. | 2011-06-10 |
| TEMPOCEM (K110759) | Dmg USA, Inc. | 2011-06-10 |
| CUSA NXT EXTENDED LENGTH TIP (K102258) | Integra Radionics, Inc. | 2011-06-10 |
| ABBOTT ARCHITECT LH CALIBRATORS (K111023) | Abbott Laboratories | 2011-06-10 |
| ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENT (K110356) | Astra Tech, Inc. | 2011-06-10 |
| EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE) (K111471) | Medshape Solutions, Inc. | 2011-06-10 |
| EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER (K110133) | Creganna-Tactx Medical | 2011-06-10 |
| AUTODELFIA NEONATAL IRT KIT (K110274) | Wallac Oy, A Subsidiary of Perkinelmer, Inc. | 2011-06-10 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K110969) | Ppp Medical and Safety Products Company Limited | 2011-06-10 |
| AUDIT MICROCV IMMUNOASSAY LINEARITY SET (K103601) | Aalto Scientific, Ltd. | 2011-06-10 |
| NAVIGATOR APPLICATIONS SUITE (K102389) | GE Healthcare Finland Oy | 2011-06-10 |
| VEGA CPAP SYSTEM/HEATED HUMIDIFIER, MODEL CP-03 (K102625) | Vega Technologies, Inc. | 2011-06-10 |
| DEFENDO Y-OPSY IRRIGATOR (K110088) | Byrne Medical Incorporated | 2011-06-10 |
| DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT (K110936) | AngioDynamics, Inc. | 2011-06-10 |
| ENGAGE/ENGAGE TR INTRODUCERS (K111092) | St Jude Medical | 2011-06-09 |
| ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON) (K110394) | Vital Diagnostics (Manufacturing) Ptyltd | 2011-06-09 |
| SAFEPORT MANIFOLD (TM) (OR STOPCOCK) (K111016) | Elcam Medical Acal | 2011-06-09 |
| ATRICURE DISSECTOR (K111020) | AtriCure, Inc. | 2011-06-09 |
| K-PACK II NEEDLE- 27G & 30G THIN WALL (K110850) | Terumo Europe N.V. | 2011-06-09 |
| AEROVENT PLUS CHC (K110273) | Monaghan Medical Corporation | 2011-06-09 |
| ELECSYS SHBG CALCHECK 5 (K111349) | Roche Diagnostics | 2011-06-09 |
| KJ MASK (K103019) | Kj Meditech Co., Ltd. | 2011-06-09 |
| POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUS (K102496) | Cardiac Science Corporation | 2011-06-09 |
| IMESH TACKER (K110728) | Easylap , Ltd. | 2011-06-08 |
| STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUG (K110272) | Cardinal Health, Inc. | 2011-06-08 |
| MULTIPURPOSE DRAINAGE CATHETER (K111315) | Navilyst Medical, Inc. | 2011-06-08 |
| PACEART OPTIMA SYSTEM SOFTWARE (K110693) | Medtronic, Inc. | 2011-06-08 |
| EQUINOXE UHMWPE 12* POSTERIOR AUGMENT PEGGED GLENOID, SMALL / MEDIUM / LARGE / EXTRA-LARGE, LEFT / RIGHT (K111379) | Exactech, Inc. | 2011-06-08 |
| ERKA. PERFECT-ANEROID (K103637) | Erka Kallmeyer Medizintechnik GmbH | 2011-06-08 |
| HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) (K111339) | Medtronic, Inc. | 2011-06-08 |
| NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM (K110284) | Medyssey Co, Ltd. | 2011-06-08 |
| TSRH SPINAL SYSTEM (K110070) | Medtronic Sofamor Danck USA, Inc. | 2011-06-08 |
| BIOGRAPH MMR (K103429) | Siemens Medical Solutions USA, Inc. | 2011-06-08 |
| ENDOPATH ETS 35MM ENDOSCOPIC LINEAR CUTTER AND RELOADS, AND ETS-FLEX 35MM ENDOSCOPIC ARTICULATING LINEAR CUTTER AND RELO (K111111) | Ethicon Endo-Surgery, LLC | 2011-06-08 |
| J-STYLE BONE MARROW BIOPSY / ASPIRATION NEEDLE WITH SNARE-IT MARROW ACQUISITION CANNULA (K110883) | Busse Hospital Disposables | 2011-06-08 |
| 10 MP GRAYSCALE FLAT PANEL DISPLAY (GX 1030) (K103724) | Eizo GmbH | 2011-06-08 |
| MIDWEST REPROCESSING CENTER REPROCESSED LNCS SESSORS; MIDWEST REPROCESSING CENTER REPROCESSED OXIMAX SENSORS; MIDWEST RE (K111007) | Midwest Reprocessing Center, LLC | 2011-06-08 |
| ILLUMINATING SINUS SEEKER (K110158) | Entellus Medical, Inc. | 2011-06-07 |
| DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC (K103086) | Dynarex Corporation | 2011-06-07 |
| K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE (K110527) | Terumo Europe N.V. | 2011-06-06 |
| MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM (K110753) | Dentsply International, Inc. | 2011-06-06 |
| REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES (K101733) | Sac, LLC Dba Pinnacle Medical Surgical | 2011-06-06 |
| TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SEAL WITH STERRAD CHEMICAL INDICATORS (K103210) | Advanced Sterilization Products | 2011-06-06 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR (K110972) | Ppp Medical and Safety Products Company Limited | 2011-06-06 |
| BEHIND EAR GENTLE TOUCH THERMOMETER (K103839) | Kaz, Inc. | 2011-06-06 |
| MINI VARIABLE SYSTEM (K111041) | Orthohelix Surgical Designs, Inc. | 2011-06-06 |
| CLEARTEMP (K111017) | Ultradent Products, Inc. | 2011-06-06 |
| BLUE POWDERFREE NITRILE EXAMINATION GLOVE (K102623) | Pt. Medisafe Technologies | 2011-06-06 |
| TRUBLUE NASAL MASK (K110405) | Respironics, Inc. | 2011-06-06 |
| BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR (K110645) | Sonosite,Inc. | 2011-06-03 |
| ORTHO EASY PIN (K110275) | Forestadent Bernhard Forster GmbH | 2011-06-03 |
| ISTAND (K103266) | Optovue, Inc. | 2011-06-03 |
| DISCOVERY NM 630 (K111445) | GE Healthcare | 2011-06-03 |
| CARDIO XP (K102767) | Bionet Co., Ltd. | 2011-06-03 |