| BUILD-IT TOTAL CORE (K102703) | Pentron Clinical | 2011-01-05 |
| S9 VPAP ST WITH H5I (K102513) | Resmed, Ltd. | 2011-01-05 |
| ARTHREX TIBIAL GRAFTBOLT (K103060) | Arthrex, Inc. | 2011-01-05 |
| CERETENE SOLUBLE IMPLANT MATERIAL (K103047) | Ceremed , Inc. | 2011-01-05 |
| LTF-Y0009; MAJ-YOO41; XOEV-3D1 (K102379) | Olympus Medical Systems Corporation | 2011-01-05 |
| GLIDERXTREME PTA BALLOON CATHETER (CB) (OVER THE WIRE) 0.014 / 0.018 GUIDE WIRE (K103534) | Trireme Medical, Inc. | 2011-01-05 |
| TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM (K103618) | Ev3, Inc. | 2011-01-05 |
| MULTIFIT TOTAL HIP SYSTEM (K101472) | Otis Biotech Co., Ltd. | 2011-01-05 |
| RADSCAN EQUIPMENT SLICKER (K101350) | Radscan Medical Equipment, Inc. | 2011-01-04 |
| CONGRUENT BONE PLATE SYSTEM (K102998) | Acumed, LLC | 2011-01-04 |
| CERAROOT IMPLANT SYSTEM (K093595) | Oral Iceberg S.L. | 2011-01-04 |
| INTELLISPHERE EVENT MANAGMENT SYSTEM REL. 10.00 (K102974) | Philips Medical Systems | 2011-01-04 |
| YOBOSHI DENTAL UNIT (K103550) | Fosham Yoboshi Medical Equipment Co., Ltd. | 2011-01-04 |
| DUAL INCU I (K102226) | Atom Medical Corporation | 2011-01-04 |
| I-SEED (K103319) | Theragenics Corp. | 2011-01-03 |
| TANDA MAX (K103415) | Pharos Life Corporation | 2011-01-03 |
| F20 (K103433) | Teknimed, S.A. | 2011-01-03 |
| ROUGHRIDER (K103212) | Whirlwind Wheelchair International | 2011-01-03 |
| PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115 (K101853) | Diadexus, Inc. | 2011-01-03 |
| KRYSTALRAD (ATAL8) (K102285) | Medicatech USA | 2011-01-03 |
| SUPER CHAIR FOR KIDS BY ORION (K103073) | Future Mobility Healthcare, Inc. | 2011-01-03 |
| KRYSTALRAD 560 (FLAATZ 560) (K102284) | Medicatech USA | 2011-01-03 |
| 1.5T 16-CHANNEL HAND-WRIST COIL (K103149) | Invivo Corporation | 2011-01-03 |
| DX-D 100 (K103597) | Agfa Healthcare N.V. | 2011-01-03 |