| ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2 (K121724) | Richard Wolf Medical Instruments Corp. | 2012-09-20 |
| AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIV (K121022) | Ameriwater | 2012-09-17 |
| PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2 (K122593) | Optim, LLC | 2012-09-13 |
| STRYKER VIDEO URETEROSCOPE (K121112) | Stryker Endoscopy | 2012-09-12 |
| INTEGRA JARIT VIDEO ASSISTED THORACIC SURGERY INSTRUMENTS (K120012) | Integra LifeSciences Corporation | 2012-09-11 |
| ROTH NET RETRIEVER (K122462) | United States Endoscopy Group, Inc. | 2012-09-11 |
| ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION) (K120766) | Prosurg, Inc. | 2012-09-11 |
| BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE (K120126) | Barosense, Inc. | 2012-09-10 |
| PADLOCK CLIP-12 (K120814) | Aponos Medical Corp. | 2012-09-06 |
| ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE (K121309) | Advanced Surgical Concepts | 2012-09-06 |
| PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS) (K121383) | Medical Components, Inc. | 2012-09-05 |
| LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON (K122030) | Degania Silicone , Ltd. | 2012-09-05 |
| STRYKER SDC3 HD INFORMATION MANAGEMENT SYSTEM (K121893) | Stryker Endoscopy | 2012-09-05 |
| CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES (K122042) | Mauna Kea Technologies | 2012-09-04 |
| ARC ENDOCUFF (K122565) | Boddingtons Plastics, Ltd. | 2012-09-04 |
| DISPOSABLE HEMOSTASIS CHIP (K121505) | Wilson-Cook Medical Inc./Cook Endoscopy | 2012-08-31 |
| BAROSTAT SOFTWARE OPTION (K120997) | Crospon, Ltd. | 2012-08-27 |
| INWAVE (K121820) | Zynex Medical, Inc. | 2012-08-24 |
| SWANNSHIDI BONE MARROW ASPIRATION NEEDLE (K121181) | Alliance Partners, LLC | 2012-08-22 |
| SUPERA VERITAS(R) INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K111627) | Idev Technologies, Inc. | 2012-08-21 |
| ENDOSERVICE ENDOSCOPIC INSTRUMENTS & ACCESSORIES AND MINIMALLY INVASIVE GI AND GU DEVICES (K113062) | Endoservice Optical Instruments GmbH | 2012-08-21 |
| VENOFER PUMP (K121497) | Renal Solutions, Inc. | 2012-08-17 |
| TRUETOME (K122203) | Boston Scientific Corp | 2012-08-17 |
| FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2 (K120446) | Fujinon, Inc. | 2012-08-13 |
| WIRELESS IMAGE TRANSMITTER UNIT (K120278) | Olympus Medical Systems Corp. | 2012-08-10 |
| XENX (K113692) | Xenolith Medical | 2012-08-09 |
| UROPLASTY RIGID ENDOSCPIC NEEDLES (K121337) | Uroplasty, Inc. | 2012-08-03 |
| KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA (K120898) | Richard Wolf Medical Instruments Corp. | 2012-08-03 |
| SOLAR GI (K121014) | Medical Measurement Systems B.V. | 2012-08-01 |
| ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT (K121604) | Obp Corporation | 2012-07-27 |
| FUJINON COLONOSCOPES (K112391) | Fujinon, Inc. | 2012-07-26 |
| RESOLVE BILIARY LOCKING DRAINAGE CATHETER (K121832) | Merit Medical Systems, Inc. | 2012-07-17 |
| OSTOMY IRRIGATION SET (K121833) | Coloplast A/S | 2012-07-16 |
| NCIRCLE(R) NITINOL TIPLESS STONE EXTRACTOR NGAGE(R) NITINOL STONE EXTRACTOR (K120468) | Cook Incorporated | 2012-07-06 |
| FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM (K121125) | Flexible Stenting Solutions, Inc. | 2012-07-06 |
| BIOPURE PORTABLE RO SYSTEMS (K112331) | Arion Water, Inc. | 2012-07-05 |
| ARCHSTENT BILIARY SYSTEM (K113582) | Ostial Corporation | 2012-06-29 |
| SYSTEMS INTEGRATION (K121701) | Olympus Medical Systems Corp. | 2012-06-29 |
| CLEARPATH 24 (K112318) | Promedic, Inc. | 2012-06-29 |
| SONY PVM-2551MD OLED MONITOR (K120611) | Sony Electronics, Inc. | 2012-06-28 |
| I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE (K120002) | Busse Hospital Disposables, Inc. | 2012-06-26 |
| PENTAX EPK-I5020 VIDEO PROCESSOR (K113873) | Pentax of America, Inc. | 2012-06-22 |
| OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM (K113566) | Life Technologies, Inc. | 2012-06-21 |
| SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM (K120524) | Mui Scientific | 2012-06-21 |
| GYRUS AMCI PK BUTTON ELECTRODE (K120567) | Gyrus Acmi, Inc. | 2012-06-20 |
| ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES (K120418) | Olympus Winter & Ibe GmbH | 2012-06-20 |
| ENDOGATER AVANTAGE CO2 INSUFFLATOR (K113310) | Byrne Medical, Inc. | 2012-06-20 |
| BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS (K120823) | Fresenius Medical Care North America, Design Cente | 2012-06-15 |
| TUBECLEAR (K121571) | Actuated Medical, Inc. | 2012-06-13 |
| MODULTH SLK (K120769) | KARL STORZ Endoscopy-America, Inc. | 2012-06-12 |
| REPROCESSED ENDOSCOPIC TROCARS (K121240) | Sterilmed, Inc. | 2012-06-11 |
| PERISTEEN ANAL IRRIGATION SYSTEM, PERISTEEN ANAL IRRIGATION ACCESSORY UNIT, PERISTEEN ANAL IRRIGATION RECTAL CATHETER (K112860) | Coloplast A/S | 2012-06-08 |
| CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM (K120303) | Cybersonics, Inc. | 2012-06-05 |
| THD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE, RECTOSCOPE AND LIGHT-SCOPE (K121135) | Thd Spa | 2012-06-01 |
| ENDOSCOPIC RETRIEVAL DEVICE (K120084) | United States Endoscopy Group, Inc. | 2012-05-30 |
| WIS1000 (K112621) | Foreseeson Custom Displays, Inc. | 2012-05-30 |
| PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY (K120333) | Gambro Renal Products | 2012-05-25 |
| AMT T-FASTENER ANCHOR KIT (K120587) | Applied Medical Technology, Inc. | 2012-05-25 |
| WECK VISTA OPTICAL BLADELESS LAPAROSCOPIC ACCESS PORT (K121380) | Teleflexmedical, Inc. | 2012-05-25 |
| FALLER TROCAR (K120130) | Medigroup, Inc. | 2012-05-21 |
| MIROCAM CAPSULE ENDOSCOPE SYSTEM (K111450) | Intromedic Co., Ltd. | 2012-05-18 |
| CONCENTRIC BALLOON GOOGLE (K112698) | United States Endoscopy Group, Inc. | 2012-05-18 |
| SRS ENDOSCOPIC STAPLING SYSTEM (K120299) | Medigus , Ltd. | 2012-05-18 |
| PRESTO BREAST BIOPSY DEVICE (K120440) | Sontina Medical, LLC | 2012-05-17 |
| CLEARPATH LOWER GI (K113050) | Easyglide , Ltd. | 2012-05-16 |
| CLEARPATH UPPER GI (K113166) | Easyglide , Ltd. | 2012-05-16 |
| ROCAMED ROCAUS PLATINUM (K120160) | Promepla Sam | 2012-05-14 |
| DOBBHOFF DUAL PORT FEEDING TUBE (K112511) | Covidien Lp, Formerly Registered AS Kendall | 2012-05-11 |
| LLICS(TM) LAPARASCOPIC LENS INTERNAL CLEANING SYSTEM (K120821) | Misder, LLC | 2012-05-11 |
| SINGLE-SITE MEDIUM-LARGE CLIP APPLIER, SINGLE-SITE CADIERE GRASPER, SINGLE-SITE FUNDUS GRASPER, SINGLE-SITE CROCODILE (K120215) | Intuitive Surgical, Inc. | 2012-04-30 |
| NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER (K112314) | Nephros, Inc. | 2012-04-27 |
| ENDOGATOR ADVANTAGE IRRIGATION PUMP (K113119) | Byrne Medical, Inc. | 2012-04-27 |
| PROSTATE MECHANICAL IMAGER (DEN100016) | Artann Laboratories, Inc. | 2012-04-27 |
| FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM (K112342) | Convatec, Inc. | 2012-04-26 |
| APLAN A.V. FISTULA NEEDLE SET (K112734) | Aplan Well Enterprise Co., Ltd. | 2012-04-24 |
| FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM (K120452) | Flexible Stenting Solutions, Inc. | 2012-04-24 |
| SAFETY SCREW CONNECTOR (K113719) | Abbott Laboratories | 2012-04-20 |
| CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES (K120208) | Mauna Kea Technologies | 2012-04-20 |
| NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES (K120182) | Neomed, Inc. | 2012-04-19 |
| LOFRIC SINGLE USE URINARY CATHETER (K113424) | Astra Tech AB | 2012-04-17 |
| SPIDER FLEXIBLE BLUNT DISSECTOR AND BAND PASSER (K120403) | Transenterix, Inc. | 2012-04-16 |
| IMAGE1 GI CCU MODEL 22203020-114 (K111997) | KARL STORZ Endoscopy-America, Inc. | 2012-04-06 |
| MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER (K120674) | Covidien | 2012-04-04 |
| MAXIFLEX - SEMI FLEX SCOPE, 25 TO 65 CM (K111480) | Technology Delivery Systems, Inc. | 2012-04-04 |
| JETPREP FLUSHING DEVICE OL-103037 / OL-133037 / OL-168037 / PE-105038 / PE-150038 / PE-170038 / FU-169038 (K111274) | Jetprep, Ltd. | 2012-04-04 |
| URETRON MODEL URT (K111058) | Med-Sonics Corp. | 2012-03-30 |
| MCOMPASS ANORECTAL MANOMETRY SYSTEM (K120088) | Medspira, LLC | 2012-03-29 |
| ENTERAL ADMINISTRATION SET WITH SOLUTION CONTAINER, ENTERAL ADMINISTRATION SET, ENTERAL EXTENSION SET WITH MINITUBE CONN (K112863) | Acta Medical, LLC | 2012-03-29 |
| ACDS (K120005) | Isopure, Corp. | 2012-03-29 |
| AQUASHIELD CO2 SYSTEM (K120123) | United States Endoscopy Group, Inc. | 2012-03-28 |
| WOUND PROTECTOR (K120061) | Covidien, Formerly US Surgical A Divison of Tyco H | 2012-03-27 |
| MAMMOTOME ELITE BIOPSY SYSTEM (K112411) | Devicor Medical Products, Inc. | 2012-03-20 |
| V1 SYSTEM (K111756) | Olympus Medical Systems Corp. | 2012-03-20 |
| PLEURX PERITONEAL CATHETER SYSTEM (K113854) | Care Fusion | 2012-03-19 |
| CODAN SAFEFEED ENTERAL FEEDING RESERVOIR (K112268) | Codan US Corp. | 2012-03-19 |
| ENDOSCOPIC APPLICATOR (K120608) | Micromedics, Inc. | 2012-03-15 |
| VETA PERITONEAL DIALYSIS CATHETER (K113354) | Pfm Medical, Inc. | 2012-03-13 |
| HEMO-CATH 10F, HEMO-CATH 12.5F (K113487) | Medical Components, Inc. | 2012-03-09 |
| SURGICAL RETRACTORS (K112659) | Surgical Innovations Plc | 2012-03-09 |
| THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE (K113872) | Vidacare Corporation | 2012-03-08 |