| RPM RESPIRATORY GATING SYSTEM (K983629) | Varian Medical Systems, Inc. | 1999-06-08 |
| SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 15CM, SOFT-LINE LUMEN CATH (K983511) | Medical Components, Inc. | 1999-06-08 |
| DISTENDER SERIES II BAROSTAT (K991288) | G & J Electronics, Inc. | 1999-06-08 |
| SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS W/FLUORO OPTION (K991553) | Shimadzu Corp. | 1999-06-08 |
| DOSE CALC, MODEL VS. 1.02 (K990833) | Integrity Medical Software, Inc. | 1999-06-08 |
| IDS4 V3.2 IMAGE DISPLAY SYSTEM (K991643) | O Tech, Inc. | 1999-06-08 |
| MINIMED 508 INSULIN PUMP (K990801) | Medtronic Minimed | 1999-06-08 |
| MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER; CARDIAC PATHWAYS EGM ADAPTER CABLES (K990795) | Cardiac Pathways Corp. | 1999-06-08 |
| VIVOSONIC (K984562) | Sonotech, Inc. | 1999-06-08 |
| HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALVE - SOFT PLUG, HOC SET WITHOUT VALVE - SOFT PLUG, OPS WITHOU (K990913) | Laboratoires Prodimed | 1999-06-08 |
| PRODIMED MICROINJECTION PIPETTES (K983713) | Prodimed | 1999-06-08 |
| AMIGO MODEL 590000 (K983987) | Amigo Mobility Intl., Inc. | 1999-06-08 |
| VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY TINT, WITH UV BLOCKER, FOR DAILY WEAR (K991163) | Vistakon, Johnson & Johnson Vision Products, Inc. | 1999-06-08 |
| LINEAR SHOULDER COIL, MODEL 414GE-09 (K991115) | Medical Advances, Inc. | 1999-06-08 |
| COOLTOUCH V ND:YAG (K983984) | Laser Aesthetics, Inc. | 1999-06-07 |
| LEICA AT550 (K990869) | Leica Microsystems, Inc. | 1999-06-07 |
| HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE P (K991773) | Hewlett-Packard GmbH | 1999-06-07 |
| MEDIPOINT (K982961) | Medipoint , Ltd. | 1999-06-07 |
| MASIMO SET 2000 PULSE OXIMETER, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNOP -PDT-PEDIATRIC/SMALL DIS (K990966) | Masimo Corp. | 1999-06-07 |
| CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15 (K990814) | Precision Biologic | 1999-06-07 |
| SOLO ORTHO (K990743) | Sybron Dental Specialties, Inc. | 1999-06-04 |
| AUTO SUTURE ABBI SYSTEM (K983296) | United States Surgical, A Division of Tyco Healthc | 1999-06-04 |
| COPALIS MULTIPLEX EBV ANTIBODY ASSAY (K991660) | DiaSorin, Inc. | 1999-06-04 |
| MODIFICATION TO WOUN'DRES (K991202) | Coloplast Corp. | 1999-06-04 |
| STRYKER INFRAVISION ESOPHAGEAL KIT (K983220) | Stryker Endoscopy | 1999-06-04 |
| RC CORNET, MODEL #44F50 (K983308) | Pari Holding Co. | 1999-06-04 |
| GASTRIC AND RECTAL CATHETERS (K973844) | G & J Electronics, Inc. | 1999-06-04 |
| SUGITA TITANIUM ANEURYSM CLIP (K990202) | Mizuho America, Inc. | 1999-06-04 |
| SURGISORB (K984374) | Samyang Corp. | 1999-06-04 |
| STERIS SMOKE EVACUATION SYSTEM (K991167) | STERIS Corporation | 1999-06-03 |
| LC MICROFILL (K991442) | S & C Polymer GmbH | 1999-06-03 |
| OPERA CUPFLANGED ACETABULAR COMPONENTS (K991538) | Smith & Nephew, Inc., Orthopaedic Div. | 1999-06-03 |
| MTP HAMOU ENDOMAT DISPOSABLE TUBING SETS (K990910) | Mtp Medical Technical Promotion GmbH | 1999-06-03 |
| INSIGHT MILLENNIUM (K990778) | Fasstech | 1999-06-03 |
| SSA-370A/POWERVISION 6000 (K991710) | Toshiba America Medical Systems, In.C | 1999-06-03 |
| SOFTINJECT (K991680) | Androsystems Srl | 1999-06-03 |
| AUTODOSE INFUSION SYSTEM (K990889) | Tandem Medical, Inc. | 1999-06-03 |
| SPACELABS MEDICAL ULTRAVIEW DIGITAL TELEMTRY SYSTEM (K983996) | Spacelabs Medical, Inc. | 1999-06-03 |
| POWDER FREE BLUE NITRILE GLOVE (K990668) | Tg Medical Sdn. Bhd. | 1999-06-03 |
| KSEA NEURO-FIBERSCOPE (K991069) | KARL STORZ Endoscopy-America, Inc. | 1999-06-03 |
| AIA-PACK CA 125 (K990431) | Tosoh Medics, Inc. | 1999-06-03 |
| SMARTSPOT 2000 (K991578) | Cmt Medical Technologies, Ltd. | 1999-06-03 |
| COLORSOFT, COLOR ENHANCED TINTED SOFT CONTACT LENS (K990815) | Colorsoft Laboratories Corp. | 1999-06-03 |
| XK-95 HIGH SPEED MOTOR DRILL SYSTEM (K984035) | Komet Medical | 1999-06-03 |
| UNI-CLIP STAPLE (K991482) | New Deal, S.A. | 1999-06-03 |
| MTP ARTHROPUMP DISPOSABLE TUBING SET (K990911) | Mtp Medical Technical Promotion GmbH | 1999-06-03 |
| POWDERED NITRILE EXAMINATION GLOVE, WHITE (NON-COLORED) (K991511) | Perusahaan Getah Asas Sdn. Bhd. | 1999-06-03 |
| METRA PS PROCEDURE KIT (K984600) | Inlet Medical, Inc. | 1999-06-03 |
| A P HARNESS (K981860) | Paraworks Enterprise, Ltd. | 1999-06-03 |
| ORTHOGONAL EP CATHETERS (K990958) | Irvine Biomedical, Inc. | 1999-06-03 |
| LAMITRODE LEADS (K990469) | Advanced Neuromodulation Systems | 1999-06-03 |
| THERMAL CAUTERY DEVICE, FORCEPS (K990728) | Starion Instruments | 1999-06-03 |
| RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777 (K990483) | Biotronik, Inc. | 1999-06-03 |
| OSTEONICS SPINAL SYSTEM VERSATILE CROSS CONNECTOR (K990922) | Howmedica Osteonics Corp. | 1999-06-02 |
| BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007 (K991432) | Biocheck, Inc. | 1999-06-02 |
| INTRACOIL PERIPHERAL STENT (K990221) | Intratherapeutics, Inc. | 1999-06-02 |
| SYNTHES PEDIATRIC ROD SYSTEM (K991552) | Synthes (Usa) | 1999-06-02 |
| GENERAL PURPOSE NEOFLEX TRANSDUCER COVER, EDOCAVITY NEOFLEX TRANSDUCER COVER, SURGI-TIP INTRAOPERATIVE TRANSDUCER COVER, (K991236) | CIVCO Medical Instruments Co., Inc. | 1999-06-02 |
| TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005 (K991311) | Biocheck, Inc. | 1999-06-02 |
| FIXION INTRAMEDULLARY NAILING SYSTEM (K990717) | Disco-O-Tech Medical Technologies, Ltd. | 1999-06-02 |
| AILEE SUTURES AND AILEE NEEDLES (K982646) | Myco Medical Supplies, Inc. | 1999-06-02 |
| THYROCHEK ONE-STEP WHOLE BLOOD RAPID TSH ASSAY (K990658) | Little Nell Labs, Inc. | 1999-06-02 |
| BONE SCREWS (K990351) | Bregma International Trading Company , Ltd. | 1999-06-01 |
| WRIST TYPE DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-303S (K991688) | Jawon Medical Co., Ltd. | 1999-06-01 |
| KSEA EPIDUROSCOPE (K991051) | KARL STORZ Endoscopy-America, Inc. | 1999-06-01 |
| COOPERSURGICAL COAGULATOR FOR TATTOO REMOVAL (K990850) | CooperSurgical, Inc. | 1999-06-01 |
| 8MM FORGED CEMENTED STEM (K991227) | Encore Orthopedics, Inc. | 1999-06-01 |
| FOUNDATION POROUS HIP STEM (K991226) | Encore Orthopedics, Inc. | 1999-06-01 |
| IMPLEX RADIAL HEAD REPLACEMENT SYSTEM (K984290) | Implex Corp. | 1999-06-01 |
| UNI-GRAFT K DV VASCULAR GRAFT (K991813) | Atrium Medical Corp. | 1999-06-01 |
| KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM (K990154) | Karl Storz Imaging, Inc. | 1999-06-01 |
| AT HOME COCAINE & THC SCREENING TEST, MODEL 9170 (K991641) | Phamatech | 1999-06-01 |
| MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206 (K991707) | Beckman | 1999-06-01 |
| MODIFICATION OF N PROTEIN STANDARD SL (K991181) | Dade Behring, Inc. | 1999-06-01 |
| VITAL PEP (K984468) | Vital Signs, Inc. | 1999-06-01 |
| SMARTLIGHT DIGITAL FILM VIEWER, MODELS SL 4000PLUS, SL 2000PLUS (K991302) | Smartlight, Inc. | 1999-06-01 |
| COAG-A-MATE MAX (K991101) | Organon Teknika Corp. | 1999-06-01 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK (K990943) | Ortho-Clinical Diagnostics, Inc. | 1999-06-01 |
| ALPHAMED GEMINI SENSOR, SNORING SENSOR (K990321) | Alphamed, Inc. | 1999-06-01 |
| STAINLESS STEEL FIXATION PINS (K990353) | Bregma International Trading Company , Ltd. | 1999-06-01 |
| PERFECTA RS LATERALIZED HIP STEM, BRIDGE HIP SYSTEM (K991123) | Wrightmedicaltechnologyinc | 1999-06-01 |
| AVOGEL (K981353) | Avocet Polymer Technologies, Inc. | 1999-06-01 |
| CRP (K991372) | Abbott Laboratories | 1999-06-01 |
| MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000 (K982889) | Electromed, Inc. | 1999-06-01 |
| QTEXX POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED (K991462) | Latexx Partners Bhd. | 1999-05-28 |
| SMARTPREP CENTRIFUGE SYSTEM (K991430) | Harvest Technologies, LLC | 1999-05-28 |
| VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLE (K991088) | Becton Dickinson Vacutainer Systems | 1999-05-28 |
| LATEX EXAMINATION GLOVES- POWDER FREE, SIZES EXTRA SMALL, SMALL,MEDIUM,LARGE,EXTRA LARGE (K991158) | P. T. Tata Rubberindo Industries | 1999-05-28 |
| SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER (K991661) | Siemens Medical Solutions USA, Inc. | 1999-05-28 |
| INSURE PREGNANCY TEST (K991515) | Inbios Intl., Inc. | 1999-05-28 |
| STERISHARP 2.5-GALLON RSDC, MODEL #RSDC2.5G (K991612) | Sterilogic Waste Systems, Inc. | 1999-05-28 |
| STARDENTAL AXCS STERILE WATER SYSTEM (K990844) | Dentalez Group | 1999-05-28 |
| MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR (K991528) | Danek Medical, Inc. | 1999-05-28 |
| MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI (K991299) | Princeton BioMeditech Corp. | 1999-05-28 |
| ROCHE COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE (K974342) | Roche Molecular Systems, Inc. | 1999-05-28 |
| MODIFICATION TO ALCYON DIRECT BILIRUBIN (K991175) | Abbott Laboratories | 1999-05-28 |
| HEALTH AID PREMIUM PRE-POWDERED NITRILE EXAMINATION GLOVES (K991640) | M.R.G. Industries Berhad | 1999-05-28 |
| SENSIFLEX POWDERFREE LATEX EXAMINATION GLOVE (K990488) | Terang Nusa Sdn Bhd | 1999-05-28 |
| MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470 (K990247) | Polymer Technology Systems, Inc. | 1999-05-28 |
| DPD-12PCC (K990734) | Scanditronix Medical AB | 1999-05-28 |