| LAVA FRAME, LAVA FRAME SHADE, LAVA CERAM (K011394) | Espe Dental AG | 2001-06-29 |
| AESCULAP, INC., MONOSYN SYNTHETIC ABSORBABLE SURGICAL SUTURE (K011375) | Aesculap, Inc. | 2001-06-29 |
| HOME HEALTH MONITORING SYSTEM (K010029) | Avid Care Corp. | 2001-06-29 |
| LIPOMATIC; LIPOMATIC LIPOSUCTION DEVICE (K010311) | Euromi S.A | 2001-06-29 |
| PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT (K011619) | Planmeca Oy | 2001-06-29 |
| TRAM 2001 MODULE (K011000) | General Electric Medical Systems Information Techn | 2001-06-29 |
| READYSWIM (K011346) | Nidacon International AB | 2001-06-28 |
| MULTIRATE INFUSOR SV; MULTIRATE INFUSER LV; BAXTER PAIN MATE PAIN MANAGEMENT SYSTEM (K011317) | Baxter Healthcare Corp | 2001-06-28 |
| SPACELABS MEDICAL ANESTHESIA DELIVERY SYSTEM (ADS) WITH PRESSURE CONTROL MODE (K003663) | Spacelabs Medical, Inc. | 2001-06-28 |
| GOVAN+ WHEELCHAIR AND DOCKING ACCESSORY (K011752) | Accufast, Inc. | 2001-06-28 |
| HOMMED OBSERVER, MODEL I (K003180) | Hommed, LLC | 2001-06-28 |
| BIPAP PRO BI-LEVEL SYSTEM (K011714) | Respironics, Inc. | 2001-06-28 |
| SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL STRAIGHT HANDPIECES TYPES, S-9, S-10, S-11 (K011061) | W&H Dentalwerk Buermoos GmbH | 2001-06-28 |
| MODIFICATION TO KSEA ENDOTIP SYSTEM (K011359) | KARL STORZ Endoscopy-America, Inc. | 2001-06-28 |
| GLOBAL ADVANTAGE HUMERAL STEM WITH POROCOAT (K011047) | DePuy Orthopaedics, Inc. | 2001-06-28 |
| AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR (K003759) | Aesculap, Inc. | 2001-06-28 |
| ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER (K010422) | Innerspace, Inc. | 2001-06-28 |
| MAXONE, BLOOD, BLOOD PRODUCTS AND IV FLUID WARMER (K002409) | Automatic Medical Technologies, Inc. | 2001-06-28 |
| SCORPIO CR SUPERFLEX TIBIAL INSERT (K011643) | Howmedica Osteonics Corp. | 2001-06-28 |
| VACUETTE EVACUATED BLOOD COLLECTION TUBES (K011699) | Greiner Bio-One Vacuette North America | 2001-06-28 |
| AVIVA SYSTEM, MODEL SL 2020; AVIVA SLX SYSTEM SYSTEM, MODEL SLX 1010 (K003999) | American Telecare, Inc. | 2001-06-28 |
| ARTHROCARE SYSTEM 2000 CONTROLLER, CABLE, FOOTSWITCH, POWER CORD & ARTHROCARE ARTHROWAND (K011083) | Arthrocare Corp. | 2001-06-28 |
| MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS (K011831) | Denver Biomedical, Inc. | 2001-06-28 |
| NEUROPACK MICRO, MODEL MED-9100A SERIES (K010590) | Nihon Kohden America, Inc. | 2001-06-28 |
| SIDEPORT PINCH CLAMP DEVICE (K010888) | Medivice Systems, Ltd. | 2001-06-27 |
| RESTORE-PF VIC; RESTORE-PF VLC CAPSULE (K011295) | First Scientific Limited | 2001-06-27 |
| A-LINE AEP MONITOR (K010965) | Alaris Medical Systems, Inc. | 2001-06-27 |
| CT/MASTER, VERSION 1.0 (K011180) | Columbia Scientific, Inc. | 2001-06-27 |
| NPAC EAR THERMOMETER MODEL TD 402 (K011704) | Norm Pacific Automation Corp. | 2001-06-27 |
| LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201 (K010998) | Langham Ophthalmic Technologies | 2001-06-27 |
| SYNTHES STERNAL FIXATION SYSTEM (K010943) | Synthes (Usa) | 2001-06-27 |
| CYPRESS SYSTEM (K010950) | Acuson Corp. | 2001-06-27 |
| KEYST0NE MEDICAL PICC CATHETER (K011860) | Keystone Medical | 2001-06-27 |
| EMS 3000 (K010745) | Dan Med, Inc. | 2001-06-27 |
| SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM (K011034) | Synthes (Usa) | 2001-06-27 |
| MODIFICATION TO EXCITE (K011490) | Ivoclar North America, Inc. | 2001-06-27 |
| ORTHOGENESIS LPS SYSTEM (K003182) | Depuy, Inc. | 2001-06-27 |
| EBI XFIX ACCESS PELVIC FIXATOR (K011697) | Ebi, L.P. | 2001-06-27 |
| SMITH AND NEPHEW 5.00MM ABSORBABLE POLYMER ANCHOR (K011299) | Smith & Nephew, Inc. | 2001-06-27 |
| EASYBELL (K011075) | Biopsybell S.A.S. | 2001-06-27 |
| Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02 (K003927) | Cheen Houng Ent. Co. , Ltd. | 2001-06-26 |
| SYNGO MULTIMODALITY WORKSTATION (K010938) | Siemens Medical Solutions USA, Inc. | 2001-06-26 |
| PARA 5X (K011410) | Streck Laboratories, Inc. | 2001-06-26 |
| MODIFICATION TO XPS 3000 SYSTEM (K011321) | Medtronic Xomed, Inc. | 2001-06-26 |
| LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT (K011554) | Biomet, Inc. | 2001-06-26 |
| SPECIALTY D-UV (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALTY D-UV MULTIFOCAL (OCUFLICON D) (K011542) | Specialty Ultravision, Inc. | 2001-06-26 |
| MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES (K011191) | Medtronic Xomed, Inc. | 2001-06-26 |
| LYPHOCHEK TUMOR MARKER CONTROL, LEVELS 1 AND 2, 2ML, MODEL 580 (K011579) | Bio-Rad | 2001-06-26 |
| HARD RELINER (K011277) | S & C Polymer GmbH | 2001-06-26 |
| MANAN SPRITACRE SPINAL NEEDLES (K011209) | Manan Medical Products, Inc. | 2001-06-26 |
| DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSORIES (WITH TRUTRAK+MOTION CORRECTION PERFORMANCE (K011670) | Datex-Ohmeda | 2001-06-26 |
| WAKO LIPID CALIBRATOR (K010334) | Wako Chemicals USA, Inc. | 2001-06-25 |
| ADVENT IMPLANT SYSTEM, SWISS PLUS IMPLANT SYSTEM (K011245) | Sulzer Dental, Inc. | 2001-06-25 |
| OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER (K011720) | Olympus America, Inc. | 2001-06-25 |
| MICRODOSE CATH, MODELS 90121-201, -202, -203 (K011383) | Durect Corp. | 2001-06-25 |
| QUELL DESENSITIZER (K010957) | Jeneric/Pentron, Inc. | 2001-06-25 |
| ORACLE ORAL MASK (K003894) | Fisher & Paykel Healthcare, Ltd. | 2001-06-25 |
| PHASE II GBM IGG ANTIBODY EIA TEST (K011348) | Scimedx Corp. | 2001-06-25 |
| PORTABELL, MODEL 4200 (K011222) | Bell Dental Products, LLC | 2001-06-25 |
| CALIBRATOR FOR AUTOMATED SYSTEMS (K011226) | Roche Diagnostics Corp. | 2001-06-25 |
| SAVINA (K003068) | Drager Medizintechnik GmbH | 2001-06-25 |
| ADVANTAGE MARIJUANA (THC) HOME DRUG TEST (K010921) | Advantage Diagnostics Corp. | 2001-06-25 |
| SEP-10S PLUS, AND SP-12S PRO. (K010937) | Viltechmeda | 2001-06-25 |
| IL TEST PROS (K011424) | Instrumentation Laboratory CO | 2001-06-25 |
| MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658 (K011145) | Roche Diagnostics Corp. | 2001-06-25 |
| WAKO AUTOKIT C3 (K010326) | Wako Chemicals USA, Inc. | 2001-06-25 |
| INTER-VIAL (K010703) | Duoject Medical Systems, Inc. | 2001-06-25 |
| ICS MEDICAL CHARTR OAE WITH TYMP (K011181) | Ics Medical Corp. | 2001-06-25 |
| BRACHYSEED PD-103 MODELS #PD1 (K011119) | Draximage, Inc. | 2001-06-25 |
| WAKO AUTOKIT C4 (K010325) | Wako Chemicals USA, Inc. | 2001-06-25 |
| COCAINE DIPSTICK TEST, MODEL D747-A (K010239) | Teco Diagnostics | 2001-06-25 |
| DORNIER LITHOTRIPTER 140(DOLI 140) (K011773) | Dornier | 2001-06-22 |
| BIOTECH MANUAL WHEELCHAIR C650 SERIES TOUR LIGHT WHEELCHAIR (K011701) | Taiwan Armada Enterprise Co., Ltd. | 2001-06-22 |
| JP CAST 50 (K011330) | Jeneric/Pentron, Inc. | 2001-06-22 |
| AMS SLING FIXATION SYSTEM (K010990) | American Medical Systems, Inc. | 2001-06-22 |
| TAUT BALLOON CATHETER, MODEL 50640 (K011018) | Taut, Inc. | 2001-06-22 |
| JP CAST 40 (K011331) | Jeneric/Pentron, Inc. | 2001-06-22 |
| ML BLADE, MODEL ML7030 (K010872) | Med-Logics, Inc. | 2001-06-22 |
| TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING (K010920) | Medical Cables, Inc. | 2001-06-22 |
| STRYKER T4 HYTREL (R) TOGAS (K011755) | Stryker Corp. | 2001-06-22 |
| MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM (K011612) | Hydrocision, Inc. | 2001-06-22 |
| LUTE VLC; CORE VLC (K011309) | First Scientific Limited | 2001-06-22 |
| CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 (K011015) | C.R. Bard, Inc. | 2001-06-22 |
| MEDLITE Q-SWITCHED ND:YAG LASER REPLACED BY THE MEDLITE C3 Q-SWTICHED ND:YAG LASER (K011677) | Continuum Electro-Optics, Inc. | 2001-06-22 |
| PROCEDURE MASKS: PM4-301 AND PM4-304 (K011789) | Primeline Medical Products, Inc. | 2001-06-22 |
| NEUROGEN NERVE GUIDE (K011168) | Integra Lifesciences Corp. | 2001-06-22 |
| POWDER FREE NITRILE EXAMINATION GLOVES (K010233) | P.T. Healthcare Glovindo | 2001-06-22 |
| CHESS HAND SURGERY SYSTEM (K010184) | Canica Design, Inc. | 2001-06-22 |
| MEDTRONIC SPINAL CORD STIMULATION AND PERIPHERAL NERVE STIMULATION SYSTEMS FOR PAIN RELIEF (K011584) | Medtronic Vascular | 2001-06-22 |
| THE NIMBLE ROCKET POWERED WHEELCHAIR (K010941) | Nimble, Inc. | 2001-06-22 |
| SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026 (K002427) | Sandhill Scientific, Inc. | 2001-06-22 |
| HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM (K011435) | Hmt, Inc. | 2001-06-22 |
| MAR COR SERVICES SEMPER PURE RO MACHINE (K003877) | Mar Cor Services, Inc. | 2001-06-22 |
| THE AUTOTAC SYSTEM (K011675) | BioHorizons Implant Systems, Inc. | 2001-06-22 |
| AUTOMATED CORE BIOPSY DEVICE (K011270) | Promex, Inc. | 2001-06-22 |
| DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINE TEST CARTRIDE, DADE PFA COLLEAGEN /ADP (K002885) | Dade Behring, Inc. | 2001-06-21 |
| INDUO BLOOD GLUCOSE METER (K011616) | Inverness Medical Innovations, Inc. | 2001-06-21 |
| FOX PTA CATHETER, 3.0, 4.0, 5.0, 6.0, 7.0, AND 8.0 X 40 MM, MODELS A14003, A14004, A14005, A14006, A14007, A14008 (K010838) | Jomed AG | 2001-06-21 |
| HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL) (K011389) | Canterbury Health Laboratories | 2001-06-21 |
| 6F MACH 1, MODEL 34356-XXX (K010874) | Boston Scientific Corp | 2001-06-21 |