| STELLAR 150 (K103167) | Resmed Germany, Inc. | 2011-03-01 |
| MSA HIP SYSTEM (K102172) | Global Manufacturing Technology | 2011-03-01 |
| V-TRUST MODEL TD-2202 PORTABLE ECG RECORDER (K101569) | Taidoc Technology Corporation | 2011-03-01 |
| RANDOX ECSTASY (MDMA) ASSAY (K092275) | Randox Laboratories, Ltd. | 2011-03-01 |
| DIGITAL ELECTROCARDIOGRAPH, MODELS ECG-1210, ECG-1230, ECG-3010, ECG-6010 (K101876) | Shenzhen Biocare Electronics Co., Ltd. | 2011-03-01 |
| THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES (K103647) | Thd Spa | 2011-03-01 |
| TROKAMED MORCELLATOR (K091010) | Trokamed GmbH | 2011-03-01 |
| GENERAL DENISTRY MOTOR (K103399) | Aseptico, Inc. | 2011-02-28 |
| VANGUARD ASYMMETRICAL PATELLAR COMPONENT (K110362) | Biomet Manufacturing Corp | 2011-02-28 |
| KYPHON XPEDE BONE CEMENT (K102397) | Medtronic | 2011-02-28 |
| LANX CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM (K103660) | Lanx, Inc. | 2011-02-28 |
| VERTICOR K-WIRE SYSTEM (K110047) | Verticor, Ltd. | 2011-02-28 |
| CURVED / STRAIGHT / MINI / HOOK SCISSOR TIP, DISSECTOR TIP, SURGICAL HANDLE (K103840) | Flexbar Machine Corp. | 2011-02-28 |
| CORIN BIOLOX DELTA FEMORAL HEADS (K103120) | Corin USA | 2011-02-28 |
| FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815 (K100799) | Contract Medical Intl. GmbH | 2011-02-25 |
| SNORE GUARD (K103004) | Ranir, LLC | 2011-02-25 |
| MULTIPLE NAME (K103337) | Ideal Quality Sdn., Bhd. | 2011-02-25 |
| APPROACH PRO ST WIRE GUIDE (K110163) | Cook Incorporated | 2011-02-25 |
| TOSHIBA 1.5T EXTRA LARGE KNEE COIL (K103185) | Quality Electrodynamics | 2011-02-25 |
| STERRAAD 100NX EXPRESS CYCLE TEST PACK (K092755) | Advanced Sterilization Products | 2011-02-25 |
| BRACHYTHERAPY NEEDLES, RP SLEEVE, RP BRACHY-SPACER, GOLD MAKERS (K103449) | Riverpoint Medical | 2011-02-25 |
| CHALLENGE-EVER (K102223) | Hallim Dentech Co., Ltd. | 2011-02-25 |
| VINYL EXAMINATION GLOVE POWDER FREE (CLEAR, NON-COLRED) /YELLOW/WHITE) (K103772) | Advanced Medical Devices Factory | 2011-02-25 |
| ENDOLOGIX GUIDEWIRE (K110241) | Techdevice Corporation | 2011-02-25 |
| STERRAD CYCLESURE BIOLOGICAL INDICATOR (K103222) | Advanced Sterilization Products | 2011-02-25 |
| HLS CANNULA NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING (K102532) | Maquet Cardiopulmonary, AG | 2011-02-25 |
| ESCOM 100 (K110428) | Spident Co., Ltd. | 2011-02-25 |
| ACCUVIX XG DIAGNOSTIC ULTRASOUND SYSTEM (K103397) | Medison Co., Ltd. | 2011-02-25 |
| ROCHE FLUDI METHAMPHETAMINE (K093884) | Roche Diagnostics | 2011-02-25 |
| ADAPT, MODEL AX-03SN (K100954) | Apeliotus Vision Science, Inc. | 2011-02-25 |
| NON-CONTACT INFRARED THERMOMETER (K102947) | K-Jump Health Co., Ltd. | 2011-02-25 |
| IPS EMPRESS DIRECT FLOW (K103528) | Ivoclar Vivadent, Inc. | 2011-02-25 |
| ECHELON RAPID CARDIAC COIL (K110120) | Hitachi Medical Systems America, Inc. | 2011-02-25 |
| FLASH PTA BALLOON DILATATION CATHETER 5MM X 19MM X 135CM; FLASH PTA BALLOON DILATATION CATHETER 6MM X 19MM X 135CM (K102482) | Ostial Corporation | 2011-02-25 |
| LUCIA (K102375) | Meridian Co., Ltd. | 2011-02-25 |
| SPECTRASHIELD 9500 SURGICAL MASK (K090414) | Nexera Medical, Inc. | 2011-02-24 |
| SINGLE USE BILIARY DRAINAGE STENT V (K103478) | Olympus Medical Systems Corporation | 2011-02-24 |
| TROPHON (K103059) | Nanosonics Limited | 2011-02-24 |
| RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM (K110080) | Biolitec, Inc. | 2011-02-24 |
| ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10 (K110012) | Meridian Bioscience, Inc. | 2011-02-24 |
| PATIENT SAFE LUER CAP (K101708) | Retractable Technologies, Inc. | 2011-02-24 |
| PICCOLO COMPOSITE PLATE SYSTEM (K102597) | N.M.B. Medical Applications, Ltd. | 2011-02-24 |
| BILLY BOY MALE LATEX CONDOM (K103119) | Sheila Pickering PHD | 2011-02-24 |
| SONICISION CORDLESS ULTRASONIC DISSECTION DEVICE MODEL SCD391, SCD396, SCT12, SCG, SCB, SCSK, SONICISION STERILIZATION T (K101797) | Covidien, Formerly Valleylab, A Division of Tyco | 2011-02-24 |
| BHDENTAL IMPLANT SYSTEM (K103280) | Bhdental, Ltd. | 2011-02-24 |
| SILS PORT (K103253) | Coviden (Formerly Registered AS US Surgical, A Div | 2011-02-24 |
| VACPLUS SUCTION UNIT (K103535) | Apex Medical Corp. | 2011-02-24 |
| ICUFF REPAIR PLATE, RIGHT; CUFF REPAIR PLATE. LEFT; ANCHOR BOLT, 10MM THROUGH 50MM (K102539) | Shoulder Options, Inc. | 2011-02-24 |
| FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH; FEMOSTOP II PLUS SET; FEMOSTOP II PLUS ARCH, BILATERAL ADAPTER; F (K110193) | St. Jude Medical Systems AB | 2011-02-24 |
| INDISCAL DIGITAL MANOMETER (K102192) | Baylis Medical Co., Inc. | 2011-02-23 |
| CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE, (K103128) | Cadwell Lab, Inc. | 2011-02-23 |
| FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK (K102971) | Microtek Medical, Inc. | 2011-02-23 |
| ASTRA TECH IMPLANT SYSTEM (K101732) | Astra Tech AB | 2011-02-23 |
| NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE (K102769) | Jjgc Industria E Comercio DE Materiais Dentarios S | 2011-02-23 |
| PATIENT-SPECIFIC VANGUARD FEMORAL COMPONETS (K102125) | Biomet, Inc. | 2011-02-23 |
| NIDEK MULTICOLOR LASER PHOTOCOAGULATOR (K110228) | Nidek Incorporated | 2011-02-23 |
| V-GO INSULIN DELIVERY SYSTEM (K103825) | Valeritas, Inc. | 2011-02-23 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-931 (K102939) | Andon Health Co, Ltd. | 2011-02-23 |
| RIDASCREEN NOROVIRUS 3RD GENERATION EIA (DEN110001) | R-Biopharm AG | 2011-02-23 |
| ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO (K103264) | Olympus Medical Systems Corporation | 2011-02-23 |
| ASCOM CLINICALCONNEX CARDIOMAX (K103634) | Ascom (Us), Inc. | 2011-02-23 |
| DYNAFLEX (K103076) | Dyna Flex | 2011-02-23 |
| UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION (K100464) | Wako Chemicals USA, Inc. | 2011-02-23 |
| EBONY PTA .035 PERIPHERAL DILATATION CATHETER (K103354) | Natec Medical , Ltd. | 2011-02-23 |
| ML24000 UVA-1 PHOTOTHERAPY UNIT (K103708) | The Daavlin Distributing Company | 2011-02-22 |
| MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY (K101793) | Derma Sciences, Inc. | 2011-02-22 |
| ALACER SURGICAL SCAFFOLD (K103445) | Alacer Biomedical, Inc. | 2011-02-22 |
| ENVITEC REUSABLE SPO2 SENSORS TYPE NIHON-KOHDEN (K102270) | Envitec-Wismar GmbH | 2011-02-22 |
| ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS (K103701) | Siemens Healthcare Diagnostics, Inc. | 2011-02-18 |
| FASTPACK TESTO IMMUNOASSAY (K101388) | Qualigen, Inc. | 2011-02-18 |
| DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM (K102259) | VATECH Co., Ltd. | 2011-02-18 |
| ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10 (K102206) | Mortara Instrument, Inc. | 2011-02-18 |
| STEMPRO MSC SFM (K103302) | Life Technologies Corporation | 2011-02-18 |
| EXTRA-ORAL, ADDITIVE COMPUTER AIDED MANUFACTURE AND CURING SYSTEM (K102776) | Deltamed GmbH | 2011-02-18 |
| VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE (K103260) | Vasonova, Inc. | 2011-02-18 |
| MIM 5.2 (BRACHY) (K103576) | Mim Software, Inc. | 2011-02-18 |
| VTS1000 (K101838) | Vuetek Scientific, LLC | 2011-02-18 |
| INFINITY CNAP SMARTPOD (K102968) | Draeger Medical Systems, Inc. | 2011-02-18 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K110330) | Andon Health Co, Ltd. | 2011-02-18 |
| VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET (K103255) | Vasonova, Inc. | 2011-02-18 |
| PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN) (K110167) | Edwards Lifesciences, LLC | 2011-02-18 |
| LIQUIBAND DUAL, MODEL LBD 001 (K102076) | Medlogic Global Limited | 2011-02-18 |
| SAFE'N'SOUND PASSIVE DELIVERY SYSTEM (K101233) | Rexam Pharma | 2011-02-18 |
| X2ABS DUAL CHANNEL FITNESS BELT (K102295) | Leto Enterprises Incorporation | 2011-02-18 |
| SYNTHES SCOUT VESSEL GUARD (K103558) | Synthes Spine | 2011-02-18 |
| PATIENT EXAMINATION GLOES (K102840) | Thai Hua Holding Co., Ltd. | 2011-02-18 |
| REPROCESSED PULSE OXIMETER SENSORS (K102560) | Sterilmed, Inc. | 2011-02-18 |
| HOLTER IN-LINE SHUNT FILTER, HOLTER CEREBRAL CATHETER RESERVOIR, ACCU-FLO CONNECTORS; ACCU-FLO THREE WAY CONNECTOR; CODM (K102961) | Codman & Shurtleff, Inc. | 2011-02-18 |
| STERILIZATION MATS (K103226) | STERIS Corporation | 2011-02-18 |
| TECO DIAGNOSTICS UTI DETECTION STRIPS (K100024) | Teco Diagnostics | 2011-02-17 |
| EXPEDIUM SPINE SYSTEM, MOSS MIAMI SPINE SYSTEM (K103490) | Johnson & Johnson | 2011-02-17 |
| ZOLL AED PLUS WITH 2010 AHA GUIDLINES SOFTWARE UPDATE (K110154) | Zoll Medical Corporation, World Wide Headquarters | 2011-02-17 |
| G-SCAN (K110238) | Esaote, S.p.A. | 2011-02-17 |
| IVOBASE HYBRID, IVOBASE HIGH IMPACT (K103391) | Ivoclar Vivadent, Inc. | 2011-02-17 |
| MODIFIED RETRIEVER (MODIFIED, LINE EXTENSION), MODELS 90152, 90153 (K093610) | Concentric Medical, Inc. | 2011-02-17 |
| SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM (K103383) | Spartek Medical, Inc. | 2011-02-17 |
| GOLIFE NASAL MASK (K110008) | Respironics, Inc. | 2011-02-17 |
| ZOLL E SERIES WITH 2010 AHA GUIDLINES SOFTWARE UPDATE (K110168) | Zoll Medical Corporation, World Wide Headquarters | 2011-02-17 |
| BEL-CYPHER N (K110160) | Takara Belmont Corporation | 2011-02-17 |
| ROCKWOOD CLAVICLE PINS (K103001) | DePuy Orthopaedics, Inc. | 2011-02-17 |