| VIEWFLEX PLUS ICE CATHETER (K101239) | St Jude Medical | 2010-06-02 |
| CLYDESDALE SPINAL SYSTEM (K100175) | Medtronic Sofamor Danek | 2010-06-02 |
| GEON RAPID DIGITAL THERMOMETER MODEL: MT-B117, MT-B127, MT-B130, MT-B132FA (K100563) | Geon Corporation | 2010-06-02 |
| XPERT MRSA/SA NASAL ASSAY (K100822) | Cepheid | 2010-06-01 |
| TAMPAX PEARL UNSCENTED TAMPONS, LIGHT, REGULAR, SUPER & SUPER PLUS, TAMPAX PEARL UNSCENTED TAMPONS, ULTRA (K091281) | Procter & Gamble Co. | 2010-06-01 |
| MASIMO RESPONSABLE OXIMETRY SENSORS MODEL S2-25/25D; S2-20/20D (K100617) | Masimo Corporation | 2010-05-28 |
| SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX (K092608) | Collagen Matrix, Inc. | 2010-05-28 |
| SCENAR, MODEL 10 (K092117) | Ritm Okb Zao | 2010-05-28 |
| RESPIRATORY HUMIDIFIER , HEATED DELIVERY SYSTEM, ADAPTOR, MODELS MR880, RT241, 900MR441 (K100554) | Fisher & Paykel Healthcare, Ltd. | 2010-05-28 |
| REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER (K100254) | Ascent Healthcare Solutions | 2010-05-28 |
| VINYL EXAMINATION GLOVE, POWDER FREE, NON-COLORED (K093264) | Qingdao Lang Hui Import & Export Co., Ltd. | 2010-05-28 |
| ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03 (K092704) | Abbott Molecular, Inc. | 2010-05-28 |
| FORA GW 9014 TELEHEALTH GATEWAY/TD-9014 TELEHEALTH GATEWAY (K100427) | Taidoc Technology Corporation | 2010-05-28 |
| VATEA ENDONTIC IRRIGATION SYSTEM (K100606) | Redent Nova, Ltd. | 2010-05-28 |
| APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM), H3-828XX (OD44 TO 60MM) (K100151) | Omnlife Science | 2010-05-28 |
| NON-INVASIVE INFRARED (NIR) (K090386) | Medisim, Ltd. | 2010-05-28 |
| MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WATCH BP OFFICE AFIB (TWIN200 AFS). (K101275) | Microlife Intellectual Property GmbH | 2010-05-28 |
| AMEDA PLATINUM BREAST PUMP (K100435) | Evenflo Company, Inc. | 2010-05-28 |
| ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501 (K092705) | Abbott Molecular, Inc. | 2010-05-28 |
| MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573 (K093902) | Fresenius Medical Care North America | 2010-05-27 |
| EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM 36MM GLENOSPHERE AND HUMERAL LINER (K093275) | Exactech, Inc. | 2010-05-27 |
| HANDYLAB GBS ASSAY, HANDYLAB JAGUAR INSTRUMENT, HANDYLAB DNA EXTRACTION STRIP, HANDYLAB E3 EXTRACTION REAGENT, HANDYLAB (K090191) | Handylab, Inc. | 2010-05-27 |
| GLUCOPHONE BLOOD GLUCOSE TEST SYSTEM, MODEL IGM-0025 (K091168) | Infopia Co, Ltd. | 2010-05-27 |
| FUSION MEDICAL RING LOCK SYSTEM (K100857) | John J Riccio | 2010-05-27 |
| NOVATION CROWN CUP GXL LINERS (K100269) | Exactech, Inc. | 2010-05-27 |
| MAIA, MODEL 1 (K092187) | Centervue S.P.A. | 2010-05-27 |
| SYNGO.CT CORONARY ANALYSIS (K100637) | Siemens AG Medical Solutions | 2010-05-26 |
| HEARTWAY POWER MOBILITY SCOOTER, S11 (K101143) | Heartway Medical Products Co., Ltd. | 2010-05-26 |
| IQVITALS AND IQVITALS SYSTEM (K100913) | Brentwood Medical Technology Corp. | 2010-05-26 |
| SELF CATH CATHETER (K100878) | Coloplast Manufacturing Us, LLC | 2010-05-26 |
| COMPRESSIBLE LIMB THERAPY SYSTEM MODEL WHF-324 (POWER-Q1000 PLUS) (K100656) | Wonjin Mulsan Co., Ltd. | 2010-05-26 |
| TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM (K093973) | Codman & Shurtleff, Inc. | 2010-05-26 |
| AVITA NASAL ASPIRATOR, MODEL, NS1 SERIES (K090379) | Avita Corporation | 2010-05-26 |
| U-RIGHT EAR THEMOMETER, MODELS TD-1115 AND TD-1118 (K100942) | Taidoc Technology Corporation | 2010-05-26 |
| HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S34 (K101142) | Heartway Medical Products Co., Ltd. | 2010-05-26 |
| CERAMICS2IN1 (K100150) | Biodenta Swiss AG | 2010-05-25 |
| PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES (K093405) | Wrightmedicaltechnologyinc | 2010-05-25 |
| BLOOD PRESSURE METER MODEL CH-101 (K100553) | Citizen Systems Japan Co., Ltd. | 2010-05-25 |
| CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT) (K092021) | Cryolife, Inc. | 2010-05-25 |
| HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025 (K093390) | Depuy Spine, Inc. | 2010-05-25 |
| MECHANICAL WHEELCHAIR, MODEL DS 202-S (K100824) | Suzhou KD Medical | 2010-05-25 |
| SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500 (K100148) | Focus Diagnostics, Inc. | 2010-05-24 |
| HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL (K101011) | Abbott Vascular, Inc. | 2010-05-24 |
| POLYTEL(R) APT MODEL: PWA-08-01 (K100524) | Polymap Wireless, LLC | 2010-05-24 |
| EVERON 1.0 (K092062) | Earlysense, Ltd. | 2010-05-24 |
| SYNC-RX SYSTEM, MODEL AS00010 (K100849) | Sync-Rx, Ltd. | 2010-05-21 |
| VITEK 2 YEAST VORICONAZOLE (K092454) | bioMerieux, Inc. | 2010-05-21 |
| HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS (K091556) | Instrumentation Laboratory CO | 2010-05-21 |
| PROSTIVA RF THERAPY MODEL 8929 HAND PIECE (K101139) | Medtronic, Inc. | 2010-05-21 |
| SYNTHETIC SEEDING SPACER MODEL SS9 X 50-50, SS9 X 55-50, SS9 X 55-150, SS9 X 1CM-30 (K100847) | Biocompatibles, Inc. | 2010-05-21 |
| CONMED MACROLYTE DISPERSIVE ELECTRODE (K100686) | Conmed Corporation | 2010-05-21 |
| MEDIFLASH AND ESTEFLASH (K093168) | Dermeo | 2010-05-21 |
| FIXCET SPINAL FACET SCREW SYSTEM (K100154) | X-Spine Systems, Inc. | 2010-05-21 |
| PENUMBRA SYSTEM SEPARATOR FLEX (026,032,041,054), MODELS PSF026, PSF032, PSF041, PSF054 (K100769) | Penumbra, Inc. | 2010-05-21 |
| GUARDIAN II NC HEMOSTASIS VALVE (K101113) | Zerusa Limited | 2010-05-21 |
| LUMINESSE ZR BLANKS (K100232) | Talladium, Inc. | 2010-05-21 |
| MAMBO, MODEL CS 18XX-XX (K090861) | Ulrich GmbH & Co. KG | 2010-05-21 |
| BIOMET FORERUNNER LOCKING PLATE SYSTEM (K092528) | Biomet Trauma (Aka Ebi, Lp) | 2010-05-21 |
| SONIC SHOT GX (K091734) | Nemoto Kyorindo Co., Ltd. | 2010-05-21 |
| TRANSCORP TRANS-PLATE ANTERIOR CERVICAL PLATE SYSTEM (K092695) | Transcorp, Inc. | 2010-05-21 |
| DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200 (K100626) | Shenzhen Biocare Electronics Co., Ltd. | 2010-05-21 |
| AUDIT MICROCV ASO LINEARITY SET, MODEL K721M-5 (K100750) | Aalto Scientific, Ltd. | 2010-05-21 |
| ULTRA DCI MODEL 5000 (K100363) | Ultrasound Medical Devices, Inc. | 2010-05-21 |
| VISTAKON (NARAFILCON B) CONTACT LENS VISIBILITY TINTED WITH UV BLOCKER (K100349) | Johnson & Johnson Vision Care, Inc. | 2010-05-21 |
| OPTICAL INTEGRITY LASERGUARD FIBERS (K100194) | Optical Integrity, Inc. | 2010-05-20 |
| LYMPHA PRESS 201MAX, MODEL 201MAX (K100677) | Mego Afek AC , Ltd. | 2010-05-20 |
| DESARA MESH MODEL: CAL-DS01 (K101169) | Caldera Medical, Inc. | 2010-05-20 |
| MANUKAPLI WOUND DRESSING (K092689) | Manuka Medical Limited | 2010-05-20 |
| POWDER-FREE NITRILE GLOVES, BLACK (K100369) | Hl Rubber Industries Sdn Bhd | 2010-05-20 |
| KFX APPIANFX PEEK FEMORAL IMPLANT WITH INSERTER (K101175) | Kfx Medical | 2010-05-20 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K100699) | Shijiazhuang Star Plastic Co., Ltd. | 2010-05-20 |
| FARRELL VALVE WITH CORFLO ANTI-IV CONNECTORS MODEL 20-4300AIV (K100365) | Corpak Medsystems | 2010-05-20 |
| ENTERAL FEEDING TUBE AND ACCESSORIES, FEEDING TUBE EXTENSION SET (K092628) | Alan Reid | 2010-05-20 |
| ALLY PLATFORM SYSTEM (K093895) | Continuity Health Solutions | 2010-05-20 |
| KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618 (K100616) | Life Technologies Corporation | 2010-05-20 |
| ROYAL GUARD (K092617) | Shun Thai Rubber Gloves Industry Public Co., Ltd. | 2010-05-20 |
| SUBFIX ARTHROEREISIS IMPLANT, MODELS SUT0065, SUT0080, SUT0090, SUT0100, SUT0115 (K093820) | Memometal Technologies | 2010-05-19 |
| POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K100856) | Suzhou Shengyuda Plastic Products Co., Ltd. | 2010-05-19 |
| JETSTREAM G3 L SYSTEM, PV CONSOLE, MODELS PV31400, PV31300, PVCN100 (K100462) | Pathway Medical Technologies, Inc. | 2010-05-19 |
| DISPOSABLE SUCTION AND IRRIGATION SYSTEM (K093479) | Modern Medical Equipment Mfg., Ltd. | 2010-05-19 |
| IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBF (K083798) | Medicrea Technologies | 2010-05-19 |
| REGENT ANTERIOR CERVICAL PLATE (K101151) | Custom Spine | 2010-05-19 |
| ADVIA CHEMISTRY SALICYLATE REAGENT (K093939) | Siemens Healthcare Diagnostics | 2010-05-19 |
| TERUMO LAUER LOCK ADAPTER (K093992) | Terumo Cardiovascular Systems Corporation | 2010-05-19 |
| INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2026,2026-CH, 2310, 2320, 2330 (K092129) | Intersurgical, Inc. | 2010-05-18 |
| TITAN TI SUTURE ANCHOR SYSTEM, MODELS 22-9055, 22-9055N, 22-9065, 22-9065N, 22-9022, 22-9005,, 22-9006 (K101184) | Arthrocare Corp. | 2010-05-18 |
| THYRETAIN TM TSI REPORTER BIOASSAY (K092229) | Diagnostic Hybrids, Inc. | 2010-05-18 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K100735) | Rayu Plastic Products Limited | 2010-05-18 |
| OTOMAG BONE CONDUCTION HEARING SYSTEM (K100193) | Sophono, Inc. | 2010-05-18 |
| KENSEY NASH ECM SURGICAL PATCH (K094061) | Kensey Nash Corporation | 2010-05-18 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K100734) | Huanfu Plastic Products Limited | 2010-05-18 |
| CARDO MEDICAL CERAMIC HIP SYSTEM (K100008) | Cardo Medical, Inc. | 2010-05-18 |
| FEMEYE TWO (K093218) | Fem Suite, LLC | 2010-05-18 |
| HANDHELD PULSE OXIMETER MODEL MD300A/ MD300K2/ MD300M (K100203) | Beijing Choice Electronic Technololgy Co., Ltd. | 2010-05-17 |
| CLEARJET (K101094) | Easyglide , Ltd. | 2010-05-17 |
| POLARIS SPINAL SYSTEM (K100220) | Ebi, L.P. | 2010-05-17 |
| MICROLIFE NON-CONTACT INFRARED FOREHEAD THERMOMETER, MODEL FR1DZ1 (K100953) | Microlife Intellectual Property GmbH | 2010-05-17 |
| ORTHOPEDIATRICS PEDILOC TIBIA PLATE SYSTEM (K100240) | OrthoPediatrics Corp. | 2010-05-17 |
| ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE (K100704) | Disetronic Medical Systems AG | 2010-05-14 |
| FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring System (K092602) | Abbott Diabetes Care, Inc. | 2010-05-14 |