| SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYSTEM-T PLATE (K010766) | Synthes (Usa) | 2001-06-12 |
| GERATHERM BABYWATCH TEMPERATURE MONITOR (K001281) | Geratherm AG | 2001-06-12 |
| CD HORIZON SPINAL SYSTEM, 4.5 ROD FOR POSTERIOR APPLICATION (K010181) | Medtronic Sofamor Danek, Inc. | 2001-06-12 |
| ELECTRO-NERVE STIMULATOR TENS, MODEL HE-DIGITAL (K010209) | Biomedical Life Systems, Inc. | 2001-06-12 |
| MM-87 MOTOR-DRIVE MANIPULATOR (K011420) | Narishige Co., Ltd. | 2001-06-12 |
| AMBULATORY ENTERAL NUTRITION PUMP (K003047) | Ross Product Div. Abbott Laboratories | 2001-06-12 |
| CD HORIZON SPINAL SYSTEM (K011508) | Medtronic Sofamor Danek, Inc. | 2001-06-12 |
| MEDCOMP ULTRA-FLOW CATHETER (K003207) | Medical Components, Inc. | 2001-06-12 |
| EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229 (K011605) | Syva Co., Dade Behring, Inc. | 2001-06-12 |
| PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK (K011336) | Churchill Medical Systems, Inc. | 2001-06-12 |
| ISOLA BAND CLAMP (K010972) | Depuyacromed | 2001-06-12 |
| BCI ADVISOR VITAL SIGNS MONITOR (9200) (K010770) | Bci, Inc. | 2001-06-12 |
| TROCHANTERIC NAIL (K010780) | DePuy Orthopaedics, Inc. | 2001-06-12 |
| T2 HUMERAL NAIL SYSTEM (K011529) | Howmedica Osteonics Corp. | 2001-06-12 |
| TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55 (K011007) | Arthrex, Inc. | 2001-06-12 |
| BALLERT CRANIAL MOLDING HELMET (K011433) | Gema, Inc. | 2001-06-12 |
| MULTI-STIM, MODEL MS-100 (K001897) | Metron Medical Australia, Pty, Ltd. | 2001-06-12 |
| NAC PLUS NEEDLELESS ACCESS CONNECTOR (K011193) | Porex Medical Products | 2001-06-12 |
| HEARTCARD, MODEL 5258 (K010945) | Instromedix | 2001-06-12 |
| H-SCRIBE (K004017) | Mortara Instrument, Inc. | 2001-06-11 |
| ART BICARBONATE FOR HEMODIALYSIS, ART BICARBONATE LIQUID FOR HEMODIALYSIS (K010760) | Advanced Renal Technologies, Inc. | 2001-06-11 |
| EN BLOC BIOPSY SYSTEM (K003190) | Neothermia Corp. | 2001-06-11 |
| BPFONE, MODEL UA 767IT (K010751) | Medical Monitors Pty Limited | 2001-06-11 |
| RESIN CEM (K011431) | S & C Polymer GmbH | 2001-06-11 |
| ISLAND WOUND DRESSING WITH MICROBAN (K010951) | Island Dressing, LLC | 2001-06-11 |
| HEARTSTREAM XL DEFIBIBRILLATOR/MONITOR, MODEL M4735A, HEARTSTREAM XLT DEFIBRILLATOR/MONITOR.MODEL M2500B (K010634) | Agilent Technologies, Inc. | 2001-06-11 |
| AESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGY (K010752) | Aesculap, Inc. | 2001-06-11 |
| IMMUNOWELL EA (D) IGG TEST (K010301) | Genbio | 2001-06-11 |
| INFANT FLOW SYSTEM, MODEL M672P (K011516) | Eme (Electro Medical Equipment) , Ltd. | 2001-06-08 |
| INSULIN PEN NEEDLE ADAPTER (K010887) | Ohana Needle Co. | 2001-06-08 |
| CARDIOCAM MODEL 9CSY0799 (K011611) | Danish Diagnostic Development A/S | 2001-06-08 |
| REMOTE PRESENCE AND CARE SYSTEM (RPCS 5000) (K010791) | Adsis , Ltd. | 2001-06-08 |
| CARDIAC VIEW, MODEL 2001 (K010802) | Magna Lab, Inc. | 2001-06-08 |
| MEDLEY SP02 MODULE, MODEL 8220 (K010966) | Alaris Medical Systems, Inc. | 2001-06-08 |
| ULTRASOUND SCANNER, TYPE 2102 (K011417) | B-K Medical A/S | 2001-06-08 |
| AIRLIFE HEPA FILTER (K011132) | Allegiance Healthcare Corp. | 2001-06-08 |
| M2376A DEVICELINK SYSTEM, MODEL M2376A (K011578) | Agilent Technologies, Inc. | 2001-06-08 |
| ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX (K011601) | Ardo Medical AG | 2001-06-08 |
| SIGMA DELTA (K002343) | Penlon , Ltd. | 2001-06-08 |
| ORIGEN DUAL LUMEN CATHETER (K003288) | Origen Biomedical, Inc. | 2001-06-08 |
| LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1,2,3,1, ML, LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 3 ML, LIQUICHEK IMMUNOLOGY CONTROL (K011494) | Bio-Rad | 2001-06-08 |
| WELCH ALLYN IMPACT BLOOD PRESSURE SYSTEM (K010186) | Welch Allyn, Inc. | 2001-06-08 |
| LIVESURE AMPHETAMINE SCREEN TEST (K011609) | Pan Probe Biotech, Inc. | 2001-06-08 |
| LIFEJET PRINTER 400 (K011617) | Ferrania S.P.A. Stabilimento DI Ferrania | 2001-06-08 |
| BREAST-BOARD (MULTIPLE) (K003778) | Arplay Medical S.A. | 2001-06-08 |
| VERDICT -II TCA, VERDICT-II MTD (K011545) | Medtox Diagnostics, Inc. | 2001-06-08 |
| SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO (K011465) | Beckman Coulter, Inc. | 2001-06-08 |
| EXPEDIO 500D R&F X-RAY SYSTEM (K011624) | GE Medical Systems | 2001-06-08 |
| LIVESURE METHAMPHETAMINE SCREEN TESTS (K011610) | Pan Probe Biotech, Inc. | 2001-06-08 |
| ONE-STEP PLUS (K011159) | Bisco, Inc. | 2001-06-08 |
| MAR COR SERVICES BICARB SYSTEM (K003560) | Mar Cor Services, Inc. | 2001-06-08 |
| ULTRAFREE MAX STERILE LATEX POWEDER-FREE SURGICAL GLOVES WITH PROTEIN LABELING CLAIM, 50 PER GRAM OR LESS OF TOTAL WATER (K010862) | Allegiance Healthcare Corp. | 2001-06-07 |
| COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE) (K010799) | Standard Textile Co., Inc. | 2001-06-07 |
| NON-STERILE POWDER-FREE BLUE LATEX EXAMINATION GLOVES, WITH AND WITHOUT BUBBLEGUM SCENTING & A PROTEIN LABELING CLAIM (5 (K011377) | Sgmp Co., Ltd. | 2001-06-07 |
| PARADIGM QUICK-SET INFUSION SET (K011071) | Maersk Medical A/S | 2001-06-07 |
| HYCARE LATEX EXAMINATION GLOVE, POWDERED (K010875) | Hycare Intl. Co., Ltd. | 2001-06-07 |
| TEAM-UP TM DENTAL ELECTRONIC ANESTHESIA SYSTEM (K011001) | Satelec | 2001-06-07 |
| UNI-LASER 470 (K010885) | Medart Corp. | 2001-06-07 |
| DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132 (K011033) | Dade Behring, Inc. | 2001-06-07 |
| CUSTOM TCI (TINNITUS CONTROL INSTRUMENT) (K011364) | Siemens Hearing Instruments, Inc. | 2001-06-07 |
| NON-STERILE POWDER FREE PURPLE LATEX EXAMINATION GLOVE WITH AND WITHOUT GRAPE SCENT AND WITH PROTEIN LABELING (50 MICROG (K011370) | Sgmp Co., Ltd. | 2001-06-07 |
| ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN (K010455) | Diagnostica-Stago | 2001-06-07 |
| SOLA 700,SOLA 500, SOLA 300 (K010724) | Drager Medizintechnik GmbH | 2001-06-07 |
| XSCAN32 TELERADIOLOGY SOFTWARE (K002911) | Radiographic Digital Imaging, Inc. | 2001-06-07 |
| NON-STERILE POWDER FREE PINK LATEX EXAMINATION GLOVE AND NON-STERILE POWDER FREE PINK LATEX EXAMINATION GLOVE WITH STRAW (K011371) | Sgmp Co., Ltd. | 2001-06-07 |
| CPR EZY MASK AND PAD (K003937) | Medteq Innovations Pty, Ltd. | 2001-06-06 |
| AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569 (K010471) | Irvine Biomedical, Inc. | 2001-06-06 |
| BACTEC MGIT 960 SIR KITS (K003062) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 2001-06-06 |
| CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY (K010953) | Abbott Laboratories | 2001-06-06 |
| STA-LIATEST FREE PROTEIN S TEST KIT (K010963) | Diagnostica Stago, Inc. | 2001-06-06 |
| OTRES TOOTHBRUSH SANITIZER MODEL TB100W (K003517) | Otres, LLC | 2001-06-06 |
| USS-LINE EXTENSION (K010108) | Synthes | 2001-06-06 |
| TPO IGG ANTIBODY EIA TEST (K011082) | Scimedx Corp. | 2001-06-06 |
| TRI-FIX SPINAL FIXATION SYSTEM (K010903) | Endius, Inc. | 2001-06-06 |
| SMITH & NEPHEW RESTIM (K003596) | Smith & Nephew, Inc. | 2001-06-06 |
| BACCHUS THROMBECTOMY CATHETER (BTC), MODEL BTC-0755 (K003570) | Bacchus Vascular, Inc. | 2001-06-06 |
| THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS (K011055) | Go Medical Industries Pty. , Ltd. | 2001-06-06 |
| TRI-FIX SPINAL FIXATION SYSTEM (K010922) | Endius, Inc. | 2001-06-06 |
| UNIQUE AMBULATORY EEG (K010697) | Axon Systems, Inc. | 2001-06-06 |
| STIMUPLEX HNS-11 (K003983) | Stockert GmbH | 2001-06-06 |
| STERILE BRIGHTWAY BRAND POWER-FREE, LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) TESTED (K010856) | Brightway Holdings Sdn. Bhd. | 2001-06-06 |
| INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX (K011057) | OraSure Technologies, Inc. | 2001-06-06 |
| CLARREN HELMET (K003035) | Children'S Hospital & Medical Center | 2001-06-06 |
| PARODI CATHETER FOR ANGIOGRAPHY (PARCA) (K001917) | Arteria Medical Science, Inc. | 2001-06-06 |
| QED DIODE DETECTORS, MODELS 1112-1116 (K011466) | Sun Nuclear Corp. | 2001-06-06 |
| HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR (K002846) | Headstar Medical Products Co., Ltd. | 2001-06-06 |
| FREED BIOELECTRIC: DYSPHAGIA TREATMENT DEVICE (K002410) | Dysphagia, LLC | 2001-06-06 |
| SYNERGY 4.0 MM, 4.5 MM VLS SCREWS (K011437) | Interpore Cross Intl. | 2001-06-06 |
| TEMP-A-SURE (K010866) | Homecare Technologies , Ltd. | 2001-06-06 |
| TBW (K010545) | Tri-Med, Inc. | 2001-06-06 |
| TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT, MODEL 466-P306A (K010083) | Cordis Corp. | 2001-06-06 |
| BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM (K011390) | Disc-O-Tech Medical Technologies, Ltd. | 2001-06-06 |
| SPARROWHAWK DISPOSABLE (K010473) | Atc Technologies, Inc. | 2001-06-06 |
| EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 (K011528) | Syva Co. | 2001-06-06 |
| PINNACLE MAGNETIC RESONANCE IMAGING SCANNER (K011485) | Fonar Corp. | 2001-06-06 |
| HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS (K010193) | International Technidyne Corp. | 2001-06-06 |
| DELDENT ULTRASONIC INSERTS (K011179) | Deldent , Ltd. | 2001-06-05 |
| ABBOTT PLUM A+INFUSION PUMP, MODEL 11971 (K011442) | Abbott Laboratories | 2001-06-05 |
| CARMEN (K011425) | Dentaurum, Inc. | 2001-06-05 |
| TRICERAM (K011428) | Dentaurum, Inc. | 2001-06-05 |