| INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA AND SAF-T-INTIMA INTRAVASCULAR CATHETERS (K013073) | Becton Dickinson Infusion Therapy Systems, Inc. | 2001-11-08 |
| 3CC NMT SAFETY SYRINGE (K010819) | New Medical Technology , Ltd. | 2001-11-08 |
| SPECTRUM VENTRICULAR CATHETER (K011812) | Cook, Inc. | 2001-11-08 |
| IQUANTIFY, VERSION 1.0 (K011196) | Insightful Corporation | 2001-11-08 |
| EBI XFIX DFS SYSTEM (K013378) | Ebi, L.P. | 2001-11-08 |
| REPROCESSED ARTHROSCOPIC BLADES, ARTHROSCOPIC SHAVERS, SHAVER BLADE, BLADE, LIMITED REUSE BLADE, ARTHROSCOPIC BURS (K012624) | Medical Instruments Technology, Inc. | 2001-11-08 |
| SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273 (K012724) | Smith & Nephew, Inc. | 2001-11-08 |
| ACRYDERM SILVER ANTTIMICROBIAL WOUND GEL MODEL# A-002101 (K011994) | Acrymed, Inc. | 2001-11-08 |
| MAROSIS PACS (K012844) | Marotech, Inc. | 2001-11-08 |
| UNI-GOLD STREP A TEST KIT (K011709) | Trinity Biotech, Plc | 2001-11-08 |
| PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS (K013339) | Oscor, Inc. | 2001-11-08 |
| REPROCESSED PHACO TIPS (K012579) | Sterilmed, Inc. | 2001-11-08 |
| REPROCESSED RF ARTHROSCOPY PROBES (K012679) | Sterilmed, Inc. | 2001-11-08 |
| TULSA CONTRA ANGLES (K012720) | Dentsply Intl. | 2001-11-08 |
| NEUROMOVE NM900 (K012885) | Dan Med, Inc. | 2001-11-08 |
| TISSUE GRASPING FORCEPS, SCISSORS, CLAMPS AND DISSECTORS FOR LAPAROSCOPIC SURGERIES (K012725) | Endo-Therapeutics, Inc. | 2001-11-08 |
| LIGHTSPEED 4.0 CT SCANNER SYSTEM (K013561) | GE Medical Systems | 2001-11-08 |
| REPROCESSED DYONICS ARTHROSCOPIC BURS (K012652) | Alliance Medical Corp. | 2001-11-08 |
| WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001 (K012326) | Wiener Laboratories Saic | 2001-11-08 |
| LIFTLOC SAFETY INFUSION SET (K013394) | Specialized Health Products, Inc. | 2001-11-08 |
| BODY FAT ANALYZER, MODEL HBF-306 (K011652) | Omron Healthcare, Inc. | 2001-11-07 |
| REPROCSSED LINVATEC SHAVERS (K012613) | Alliance Medical, Inc. | 2001-11-07 |
| REPROCESSED ATHROSCOPICS BURS (K012605) | Alliance Medical Corp. | 2001-11-07 |
| REPROCESSED ENDOSCOPIC TROCAR (K012578) | Sterilmed, Inc. | 2001-11-07 |
| SUMMIT OCCIPITO-CERVICO- THORACIC (OCT) SPINAL SYSTEM (K013222) | Depuyacromed | 2001-11-07 |
| REPROCESSED LAPAROSCOPIC ELECTRIC INSTUMENTS (K012598) | Sterilmed, Inc. | 2001-11-07 |
| QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00 (K013531) | Impac Medical Systems, Inc. | 2001-11-07 |
| MODIFICATION TO SCOOPER DRUG/ADULTERATION TEST CUP (K013124) | Branan Medical Corp. | 2001-11-07 |
| REPROCESSED HARMONIC (K012571) | Sterilmed, Inc. | 2001-11-07 |
| PARADIGM-FONTONA PEROVSKITE ND: YAP LASER SYSTEM AND ACCESSORIES (K011174) | Fotona D.D. | 2001-11-07 |
| HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP)MIC SUSCEPTIBILITY PLATES (K013195) | Trek Diagnostic Systems, Inc. | 2001-11-07 |
| GEMINI IMAGING SYSTEM (K013521) | Adac Laboratories | 2001-11-07 |
| CONGRUENT BONE PLATE SYSTEM (K012655) | Acu Med, Inc. | 2001-11-07 |
| SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF (K013255) | Ellman Intl., Inc. | 2001-11-07 |
| MODIFICATION TO DEPUY C-STEM SYSTEM (K013350) | DePuy Orthopaedics, Inc. | 2001-11-07 |
| SOMATOM P30 CT SYSTEMS (K013522) | Siemens Medical Systems, Inc. | 2001-11-07 |
| REPROCESSED DYONICS ARTHROSCOPIC SHAVERS (K012611) | Alliance Medical, Inc. | 2001-11-07 |
| REPROCESSED STRYKER ARTHROSCOPIC SHAVERS (K012635) | Alliance Medical Corp. | 2001-11-07 |
| DUR-8, MODELS DUR-8 (K012925) | Circon Video | 2001-11-07 |
| MODIFICATION TO: STACKABLE CAGE SYSTEM (K013382) | Depuyacromed | 2001-11-07 |
| VANGUARD REPROCESSED ENDOSCOPIC INSTRUMENTS (K012700) | Vanguard Medical Concepts, Inc. | 2001-11-07 |
| DRT4 LASER DOPPLER PERFUSION AND TEMPERATURE MONITOR (K011070) | Moor Instruments, Ltd. | 2001-11-07 |
| TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL, MODEL 8119, 8120, 8130, 8131 (K010989) | Interpore Cross Intl. | 2001-11-07 |
| PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER (K012987) | Phoenix Diagnostics, Inc. | 2001-11-07 |
| REPROCESSED AUTOSUTURE UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS (K012603) | Alliance Medical Corp. | 2001-11-07 |
| JOSTRA ARTERIAL PERFUSION CANNULAE, MODEL A... (K012617) | Jostra AG | 2001-11-06 |
| PSYCHEMEDICS RIA COCAINE ASSAY (K010868) | Psychemedics Corp. | 2001-11-06 |
| SURESET INFUSION SET, MODEL 8023 (K012429) | Applied Diabetes Research, Incorporated | 2001-11-06 |
| MODIFICATION TO SKYLIGHT IMAGING SYSTEM (K013496) | Adac Laboratories | 2001-11-06 |
| PF 5050 PRESSURE UNIT, MODEL PF 5050 (K011899) | Perimed AB | 2001-11-06 |
| SICKLE-CHEX (K013316) | Streck Laboratories, Inc. | 2001-11-06 |
| WATCH-PAT 100 (K010739) | Itamar Medical (C.M.) 1997 , Ltd. | 2001-11-06 |
| PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB (K011195) | Surgin Surgical Instrumentation, Inc. | 2001-11-06 |
| BERNOULLI VENTILATOR MANAGEMENT SYSTEM (K011861) | Cardiopulmonary Corp. | 2001-11-06 |
| EVERSTICKNET (K011799) | Stick Tech , Ltd. | 2001-11-05 |
| THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500 (K012942) | Circulatory Technology, Inc. | 2001-11-05 |
| ARAMIS DERMATLOGIC LASER (K012545) | Lumedics, Ltd. | 2001-11-05 |
| EVERSTICK (K011788) | Stick Tech , Ltd. | 2001-11-05 |
| SCITON IMAGE HAIR REMOVAL LASER (K012552) | Sciton, Inc | 2001-11-05 |
| ONTRAK TESTCARD 9 (K012396) | Roche Diagnostics Corp. | 2001-11-05 |
| PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT (K012794) | Prime Dental Manufacturing, Inc. | 2001-11-05 |
| TST CONTROL INTEGRATOR FOR STEAM STERILIZERS (K002937) | Albert Browne , Ltd. | 2001-11-05 |
| DEEP GRAY (K012563) | Cortechs Labs, Inc. | 2001-11-02 |
| DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX (K012531) | Datex-Ohmeda | 2001-11-02 |
| PORTADUR P 2, MODEL #2031 (K012843) | Wieland Edelmetalle GmbH & Co. | 2001-11-02 |
| DEVICE MODIFICATION OF ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE (K012147) | Zevex, Inc. | 2001-11-02 |
| VARICES INJECTION NEEDLE (K012977) | Endo-Therapeutics, Inc. | 2001-11-02 |
| GLYCOSAL II HBA 1C TEST (K011933) | Provalis Diagnostics , Ltd. | 2001-11-02 |
| ICONNECTION 3D (K012779) | Hinnovation, Inc. | 2001-11-02 |
| SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT ANCHOR KIT (K011985) | Smith & Nephew, Inc. | 2001-11-02 |
| MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR (K011439) | Cardiodynamics International Corp. | 2001-11-02 |
| OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER & DIGITAL DOLPHIN DISPOSABLE OPTICAL SENDOR (K012626) | Osi Medical, Inc. | 2001-11-02 |
| OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM (K012546) | Sedecal USA, Inc. | 2001-11-02 |
| SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE (K012921) | Trek Diagnostic Systems, Inc. | 2001-11-02 |
| ADVANCE UNICONDYLAR KNEE SYSTEM (K012591) | Wrightmedicaltechnologyinc | 2001-11-02 |
| OMNI C ANALYZER (K013373) | Roche Diagnostics Corp. | 2001-11-02 |
| DUAL ENERGY AND TISSUE EQUALIZATION SOFTWARE OPTION (K013481) | GE Medical Systems | 2001-11-02 |
| REPROCESSED POWERED ARTHROSCOPIC ACCESSORIES (K012536) | Sterilmed, Inc. | 2001-11-02 |
| STRIPMAX 1210 URINE CHEMISTRY ANALYZER, URIMATE REAGENT STRIP FOR URINALYSIS (K012829) | Biocare Corp. | 2001-11-02 |
| MODIFICATION TO: DATASCOPE 8FR. POLYIMIDE ALT B IAB, 25CC, 34CC, 40CC, DATASCOPE INSERTION KIT FOR 8 FR, POLYIMIDE ALT B (K013326) | Datascope Corp. | 2001-11-02 |
| MINIME NASAL MASK, MODEL P/N 50220 (K013306) | Sleepnet Corporation | 2001-11-02 |
| KADANCE 2000 (K012492) | Kada Research, Inc. | 2001-11-02 |
| PORTA AURIUM, MODEL 2067 (K012827) | Wieland Edelmetalle GmbH & Co. | 2001-11-01 |
| RENU MULTIPLUS NO RUB MULTI-PURPOSE SOLUTION (K011796) | Bausch & Lomb, Inc. | 2001-11-01 |
| S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL (K012767) | S & C Polymer GmbH | 2001-11-01 |
| PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT (K012761) | Prime Dental Manufacturing, Inc. | 2001-11-01 |
| ADC 656 ELECTRONIC STETHOSCOPE (K012304) | American Diagnostic Corp. | 2001-11-01 |
| PORTA GEO TI MODEL #2004 (K012834) | Wieland Edelmetalle GmbH & Co. | 2001-11-01 |
| BIO PORTADUR, ORDER-NO.:2017 (K012831) | Wieland Edelmetalle GmbH & Co. | 2001-11-01 |
| DIACLEAR ULTRAFILTER (K003957) | Gambro Renal Products | 2001-11-01 |
| PORTA MAXIMUM, MODEL# 2066 (K012835) | Wieland Edelmetalle GmbH & Co. | 2001-11-01 |
| W.O.M. LASER U100 (K011175) | W.O.M. World of Medicine GmbH | 2001-11-01 |
| KSEA SIALOENDOSCOPES AND ACCESSORIES (K012527) | KARL STORZ Endoscopy-America, Inc. | 2001-11-01 |
| BIOPORTA G, MODEL 2052 (K012826) | Wieland Edelmetalle GmbH & Co. | 2001-11-01 |
| DYNAPULSE 500G (DP500G) BLLOD PRESSURE MONITORING SYSTEM (K012498) | Pulse Metric, Inc. | 2001-11-01 |
| CEREC3 VITABLOCKS (K012517) | Sirona Dental Systems GmbH | 2001-11-01 |
| PORTA SMK 82, MODEL 2032 (K012828) | Wieland Edelmetalle GmbH & Co. | 2001-11-01 |
| ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR (K012714) | Koon Seng Sdn Bhd | 2001-10-31 |
| OWL RADIOFREQUENCY SYSTEM, MODEL URF-2A, AND ASSOCIATE RADIOFREQUENCY LESION PROBES (K010202) | Leslie W. Organ | 2001-10-31 |
| SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES (K011916) | Horizon Medical Products, Inc. | 2001-10-31 |