| RANDOX IGE (K010855) | Randox Laboratories, Ltd. | 2001-05-15 |
| DYNATRON STS (K010565) | Dynatronics Corp. | 2001-05-15 |
| OLYMPUS GF UC140P-AL5 ULTRASONIC ENDOSCOPE WITH ALOKA SSD-5500 ULTRASOUND SYSTEM (K011314) | Aloka Co., Ltd. | 2001-05-15 |
| GUIDANT RETRIEVER DEVICE (K001694) | Guidant Cardiac and Vascular Surgery | 2001-05-15 |
| DYNATRON STS RX (K010948) | Dynatronics Corp. | 2001-05-15 |
| EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z (K011151) | The Olympus Optical Co. | 2001-05-15 |
| COLLEAGUE VOLUMETRIC INFUSION PUMP (K010566) | Baxter Healthcare Corp | 2001-05-15 |
| EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229 (K011289) | Syva Co., Dade Behring, Inc. | 2001-05-15 |
| BREEZY WHEELCHAIR, MODEL 300 (K011268) | Sunrise Medical, Inc. | 2001-05-15 |
| SSD 5500 WITH OLYMPUS GF TYPE UC140P-AL5 (K011315) | Aloka Co., Ltd. | 2001-05-15 |
| DISPOSABLE BENDING CANNULA PR-233Q (K011149) | The Olympus Optical Co. | 2001-05-15 |
| RUBICON PROTHROMBIN TIME MONITORING SYSTEM (K001699) | Lifescan, Inc. | 2001-05-15 |
| TAPER-LOCK DENTAL IMPLANT SYSTEM (K011038) | Sulzer Dental, Inc. | 2001-05-15 |
| POWER TILT AND RECLINE SYSTEM (K010917) | Sunrise Medical, Inc. | 2001-05-15 |
| LIFELINES TRACKIT (K010460) | Lifelines , Ltd. | 2001-05-14 |
| MODIFICATION TO IMPLANTABLE CLIP (K011236) | Applied Medical Resources Corp. | 2001-05-14 |
| DENSTAT (K010465) | Elmed, Inc. | 2001-05-14 |
| ARTHREX FIBERWIRE, MODEL SPU-02NB-3800 (K010673) | Arthrex, Inc. | 2001-05-14 |
| TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001; TEMPUS MONITORING STATION, MODEL 01-0011 (K010436) | Remote Diagnostic Technologies , Ltd. | 2001-05-14 |
| MAGNUM FLOW IRRIGATION SYSTEM (K010519) | Scion Valley, Inc. | 2001-05-14 |
| MODIFICATION TO SOLO (K011107) | Ranger All Season Corp. | 2001-05-14 |
| IMPRA CARBOFLO EPTFE VASCULAR GRAFTS (K004012) | Impra, Inc. | 2001-05-14 |
| SMARTFLOW, MODEL SFIP 2000 (K003122) | Florence Medical , Ltd. | 2001-05-14 |
| EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET (K010197) | Exelint International, Co. | 2001-05-14 |
| MODIFICATION TO THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM (K011380) | Bioplate, Inc. | 2001-05-14 |
| ARTHREX TWISTLOC SUTURE ANCHOR, MODEL AR-1924 (K010457) | Arthrex, Inc. | 2001-05-14 |
| SKINGARD POLYCOAT GLOVE (K004018) | Top Quality Mfg., Inc. | 2001-05-11 |
| CG-900P FETAL/MATERNAL MONITOR (K010552) | Card Guard Scientific Survival , Ltd. | 2001-05-11 |
| REGAL MOTOTRIZED 3 WHEELED VEHICLE (K011227) | Bruno Independent Living Aids, Inc. | 2001-05-11 |
| BIOKNOTLESS ANCHOR (K002639) | Mitek Products | 2001-05-11 |
| RT-PLUS MODULAR CEMENTED KNEE COMPONENTS (K003504) | Plus Orthopedics | 2001-05-11 |
| BIOFIND (K003480) | Bio-Scan, Inc. | 2001-05-11 |
| POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR (K010803) | Hwa Teh Industrial Sdn. Bhd. | 2001-05-11 |
| CARDIAC FUNCTION LABORATORY; PRESSURE INTERFACE; PRESSURE / VOLUME CATHETER (K003020) | Cd Leycom BV | 2001-05-11 |
| R & D 4K RETIC (K010470) | R&D Systems, Inc. | 2001-05-11 |
| AMYSEAT TILT/RECLINE SEATING (K011006) | Amysystems | 2001-05-11 |
| E-POWER (K010395) | Dalton Medical Corp. | 2001-05-11 |
| MANDREL GUIDEWIRE ASSEMBLY (K011084) | Lake Region Mfg., Inc. | 2001-05-10 |
| DENTO-PREP PARTICLE MICROBLASTER (K010816) | Ronvig A/S | 2001-05-10 |
| IMMUNETICS C6 LYME ELISA KIT (K003754) | Immunetics, Inc. | 2001-05-10 |
| MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229 (K011166) | Syva Co., Dade Behring, Inc. | 2001-05-10 |
| MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229 (K011163) | Syva Co., Dade Behring, Inc. | 2001-05-10 |
| THE MAESTRO SYSTEM (K010458) | BioHorizons Implant Systems, Inc. | 2001-05-10 |
| ITI DENTAL IMPLANT SYSTEM (K010291) | Straumann USA | 2001-05-10 |
| UNIGLOVE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K010879) | N.S. Uni-Gloves Sdn. Bhd. | 2001-05-10 |
| BECKMAN COULTER DNASE B CALIBRATOR (K010696) | Beckman Coulter, Inc. | 2001-05-10 |
| CRP HS TEST SYSTEM (K003400) | Roche Diagnostics Corp. | 2001-05-10 |
| RD-3008 (K011036) | Heraeus Kulzer, Inc. | 2001-05-10 |
| BRIDGE III RECEIVER (K010794) | Meridian Medical Technologies , Ltd. | 2001-05-10 |
| MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229 (K011164) | Syva Co., Dade Behring, Inc. | 2001-05-10 |
| RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM (K010633) | Mitek Products | 2001-05-09 |
| INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND TRANSDUCER, MODEL 2271.501, ULTRASOUND PROBES (SONO) (K011065) | Richard Wolf Medical Instruments Corp. | 2001-05-09 |
| RUSCH MMG/O'NEIL CATHETER (K010420) | Rusch, Inc. | 2001-05-09 |
| ANDERSEN INTESTINAL TUBE, MILLER-ABBOTT TYPE (AN 22) (K011077) | Andersen Products, Inc. | 2001-05-09 |
| MP3HD BIG BOY, POWER WHEELCHAIR (K010380) | Merits Health Products., Inc. | 2001-05-09 |
| SURGICAL TITANIUM MESH SYSTEM (K003043) | Depuyacromed | 2001-05-08 |
| CLARIS PLATE SYSTEM (K010369) | Ortho Tec, LLC | 2001-05-08 |
| MACS MODULAR ANTERIOR CONSTRUCT SYSTEM (K002824) | Aesculap, Inc. | 2001-05-08 |
| EXHALE RF PROBE (K011267) | Broncus Technologies, Inc. | 2001-05-08 |
| RANDOX MYOGLOBIN (K010700) | Randox Laboratories, Ltd. | 2001-05-08 |
| PATIENT DOSE VERIFICATION SYSTEM, MODEL TN-RD-50 (K010472) | Thomson & Nielsen Electronics, Ltd. | 2001-05-08 |
| POWDER-FREE LATEX EXAMINATION GLOVE, BLUE COLORED (K011271) | Perusahaan Getah Asas Sdn. Bhd. | 2001-05-08 |
| MEDLINE STERISET STERILIZATION CONTAINER (K010825) | Medline | 2001-05-08 |
| SNN SYSTEM INCLUDING THE TOMOGUIDE OPTION (K010542) | Surgical Navigation Specialists, Inc. | 2001-05-08 |
| AQUARIUS WORKSTATION (K011142) | Terarecon,Inc. | 2001-05-08 |
| ENVOY PATIENT MONITOR (K001120) | Mennen Medical , Ltd. | 2001-05-08 |
| BLOOD OXYGENATION LEVEL DEPENDENT (BOLD) OPTION (K010691) | Philips Medical Systems (Cleveland), Inc. | 2001-05-08 |
| QUICKVUE DIPSTICK STREP A (K011097) | Quidel Corp. | 2001-05-08 |
| BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR (K003735) | Blackstone Medical, Inc. | 2001-05-08 |
| MULTITAK CONICAL TIP BONE SOFT TISSUE SUTURE ANCHOR (K010479) | Bonutti Research, Inc. | 2001-05-08 |
| OMNILINK .018 BILIARY STENT SYSTEM (K011039) | Guidant Corp. | 2001-05-08 |
| DJ ORTHOPEDICS INTERFERENCE SCREW (K010595) | Dj Orthopedics, LLC | 2001-05-08 |
| GLUCOPRO INFUSION SET, MODEL GPISXXXXXXXX SERIES (K011120) | Nipro Diabetes Systems, Inc. | 2001-05-08 |
| NEUROFAX, MODELS EEG-1100A, EEG-9100A (K011204) | Nihon Kohden America, Inc. | 2001-05-08 |
| GEM PREMIER 3000- ADDITION OF GLUCOSE AND LACTATE AS NEW PARAMETERS (K010520) | Instrumentation Laboratory CO | 2001-05-07 |
| SIMPLICT (K010813) | Neorad AS | 2001-05-07 |
| ACON STREP A RAPID TEST STRIP (K010582) | Acon Laboratories Co. | 2001-05-07 |
| MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900 (K010361) | Medtronic PS Medical | 2001-05-07 |
| XPS 3000 SYSTEM (K010677) | Medtronic Xomed, Inc. | 2001-05-07 |
| ATLAST DATA MANAGEMENT SOFTWARE (DMS) (K010605) | Amira Medical, Inc. | 2001-05-07 |
| ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999 (K003403) | Highland / Marietta, Inc. | 2001-05-07 |
| XPS 3000 SYSTEM WITH RECIPROCATING ADAPTER AND SUCTION CANNULAE (K010666) | Medtronic Xomed, Inc. | 2001-05-07 |
| ENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, EMF-2000 TO 2999,ENDOSCOPICS MONOPOLARFOEPS-GRASPERS, EMF-3000 TO 3999, ENDOSCOPO (K003405) | Highland / Marietta, Inc. | 2001-05-07 |
| D/C CORE MATERIAL (K010475) | Parkell, Inc. | 2001-05-07 |
| DEVILBISS HUMIDIFIER (K003626) | Sunrise Medical Hhg, Inc. | 2001-05-04 |
| MODIFICATION TO TSRH SPINAL SYSTEM (K011067) | Medtronic Sofamor Danek, Inc. | 2001-05-04 |
| MICROGAS 7650 TRANSCUTANEOUS MONITOR (K003943) | Linde Medical Sensors AG | 2001-05-04 |
| REMREST (K002763) | Medical Industries America, Inc. | 2001-05-04 |
| MICROSTREAM ORAL NASAL CANNULA FILTERLINE (K011050) | Oridion Medical 1987 , Ltd. | 2001-05-04 |
| MPS M ELECTRODE (K002801) | Medical Physics and Services, Inc. | 2001-05-04 |
| MODIFICATION TO EDI VERIS SYSTEM (K003442) | Electro-Diagnostic Imaging, Inc. | 2001-05-04 |
| RENAX A.V. FISTULA NEEDLE SETS (K003123) | Sunder Biomedical Tech. Co., Ltd. | 2001-05-04 |
| IVD (IN VIVO DOSIMETER), MODEL 1131 (K010449) | Sun Nuclear Corp. | 2001-05-04 |
| WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR (K011178) | Wilson-Cook Medical, Inc. | 2001-05-04 |
| APEX FIXATION PINS (K011136) | Howmedica Osteonics Corp. | 2001-05-04 |
| HDI 5000 ULTRASOUND SYSTEM WITH ASSISTED BORDER DETECTION (ABD), XRES IMAGING, AND PANORAMIC MEASUREMENT CAPABILITY (K011224) | Advanced Technology Laboratories, Inc. | 2001-05-04 |
| TETRAD TC-C3-ACP (K002193) | Tetrad Corp. | 2001-05-04 |
| REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATOR (K011098) | Medtronic Vascular | 2001-05-04 |
| ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP (K002256) | Arrow Intl., Inc. | 2001-05-03 |
| TANTALUM BEADS - RADIOGRAPHIC MARKER (K010348) | Biomet, Inc. | 2001-05-03 |