| MERCURY MEDICAL REUSABLE CPR BAG (K970756) | Mercury Medical | 1997-10-31 |
| CURVTEK TSR SYSTEM (K972860) | Biolectron, Inc. | 1997-10-31 |
| RETRIEVER II (K964210) | Target Therapeutics | 1997-10-31 |
| IMMULITE THIRD GENERATION PSA (LKUPI,LKUP5) (K972021) | Diagnostic Products Corp. | 1997-10-31 |
| GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE (K971375) | Wilson Greatbatch Technologies, Inc. | 1997-10-31 |
| ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (K973743) | Beckman Instruments, Inc. | 1997-10-31 |
| AMPLAID 171S (K972862) | Amplifon S.P.A. | 1997-10-31 |
| ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (K973966) | Beckman Instruments, Inc. | 1997-10-31 |
| ACTIVE INTACT PTH (K973514) | Diagnostic Systems Laboratories, Inc. | 1997-10-31 |
| CPA 125 II ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (K964098) | Bayer Corp. | 1997-10-31 |
| GLYCARTISSUE REPAIR PATCH FAMILY OF PRODUCTS; GLYCAR VASCULAR REPAIR PATCH ALTERNATIVE PROPRIETARY NAME POSSIBLE (K963368) | Glycar, Inc. | 1997-10-31 |
| QUICK CARD HCG ONE STEP PREGNANCY TEST (K973570) | Phamatech | 1997-10-31 |
| DUET GLUCOSE CONTROL MONITORING SYSTEM (K973140) | Lxn Corp. | 1997-10-31 |
| GLYCAR PERICARDIAL PATCH (K963967) | Glycar, Inc. | 1997-10-31 |
| SERVO-CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW960, MANUAL CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW970 (K972885) | Fisher & Paykel Electronics , Ltd. | 1997-10-30 |
| SONIQUE HAIR REMOVER (K973174) | Global TV Concepts, Ltd. | 1997-10-30 |
| ROCKWELL MEDICAL SUPPLY, LLC. CONCENTRATE SOLUTIONS FOR ACETATE DIALYSATE (K973253) | International Medical Products, Inc. | 1997-10-30 |
| INTERPORE INDUCER BONE GRAFT DELIVERY SYRINGE (K972842) | Interpore Intl. | 1997-10-30 |
| SONICSYS INLAY (K972648) | Ivoclar North America, Inc. | 1997-10-30 |
| HX-20/21-1 ENDOSCOPIC LIGATOR (K964661) | Olympus America, Inc. | 1997-10-30 |
| ROEKO CALCIUM HYDROXIDE POINTS (K973539) | Roeko USA, Inc. | 1997-10-30 |
| DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS (K973051) | Draeger Medical, Inc. | 1997-10-30 |
| ULTRASAFE INJECTION SYSTEM NEEDLE GUARD, MODELS B50,B100L,B150,B225, AND B300 (K972878) | Safety Syringes, Inc. | 1997-10-30 |
| CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNT (K970638) | Cardiothoracic Systems, Inc. | 1997-10-30 |
| FEMINIQUE SONIC HAIR REMOVER (K973179) | Global TV Concepts, Ltd. | 1997-10-30 |
| NARKOMED MRI ANESTHESIA SYSTEM (K972848) | Draeger Medical, Inc. | 1997-10-30 |
| SURGIC II IMPLANT CONTROL UNIT (K972924) | Nsk Nakanishi, Inc. | 1997-10-30 |
| REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVE (K971514) | London International Group, Inc. | 1997-10-29 |
| IMMUNOSCAN PR3-ANCA (K971690) | Euro-Diagnostica AB | 1997-10-29 |
| SPOROX (K970230) | Reckitt Benckiser, Inc. | 1997-10-29 |
| AIR CONDUCTION HEARING AID (K973846) | Baron Trading, Inc. | 1997-10-29 |
| KSEA ARTHROPUMP PLUS (K971649) | KARL STORZ Endoscopy-America, Inc. | 1997-10-29 |
| 2 GALLON ALTERNATE CARE SHARPS CONTAINER (K973911) | Sage Products, Inc. | 1997-10-29 |
| IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT (K971464) | Euro-Diagnostica AB | 1997-10-29 |
| C4 (K970143) | Clinicon Corp. | 1997-10-29 |
| ZEUS SCIENTIFIC, INC., ANTI-CARDIOLIPIN IGA ELISA REAGENTS (K973196) | Zeus Scientific, Inc. | 1997-10-29 |
| DURATION STABILIZED UHMWPE KNEE COMP., WEAR CLAIMS (K972864) | Howmedica Corp. | 1997-10-29 |
| IMMUNOSCAN ANTI-MYELOPEROXIDASE ANTIBODIES (MPO-ANCA) QUANTITATIVE KIT (K971689) | Euro-Diagnostica AB | 1997-10-29 |
| COSMAN COAGULATOR (CC-1) SYSTEM (K973297) | Radionics, Inc. | 1997-10-29 |
| SOLIDEX (K972292) | Shofu Dental Corp. | 1997-10-29 |
| DURATION STABILIZED UHMWPE KNEE COMPONENTS (K972863) | Howmedica Corp. | 1997-10-29 |
| POWERSTAR BIPOLAR SCISSORS (K973173) | ETHICON, Inc. | 1997-10-29 |
| MSI PRESSURE INFUSOR (K973843) | Smith Assoc. | 1997-10-29 |
| IMMUSURE (K973894) | Quantimetrix Corp. | 1997-10-29 |
| THE MERETEK UBT BREATH TEST FOR H.PYLORI (K972352) | Meretek Diagnostics, Inc. | 1997-10-29 |
| LERNER MEDICAL, INC. AUTOCLAVABLE 10 MM LAPAROSCOPE (K972984) | Lerner Medical, Inc. | 1997-10-29 |
| TUTTNAUER TABLE-TOP AUTOCLAVE (K973550) | Tuttnauer U.S.A Co, Ltd. | 1997-10-29 |
| COULTER AC.T DIFF ANALYZER (K973634) | Coulter Corp. | 1997-10-29 |
| NEUROLOGICAL ENDOSCOPE (K970162) | Richard Wolf Medical Instruments Corp. | 1997-10-29 |
| ARTISAN PULSE LAVAGE SYSTEM (K972551) | Howmedica Corp. | 1997-10-29 |
| ROYAL SHIELD NON-STERILE POWDERFREE, COLORED NITRILE EXAMINATION GLOVE (K972757) | Shield Gloves Manufacturer (M) Sdn Bhd | 1997-10-29 |
| MATRIX PLUS MULTI-CALIBRATOR KIT (K973345) | Verichem Laboratories, Inc. | 1997-10-29 |
| CSCO FOREHEAD FIXATION SYSTEM (K963502) | Howmedica Corp. | 1997-10-28 |
| CHASE TEMPERATURE PROBE (K971013) | Chase Medical, Inc. | 1997-10-28 |
| MEDSTATION (K973090) | Program S.R.L. | 1997-10-28 |
| CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEM (K970264) | Cordis Webster, Inc. | 1997-10-28 |
| UBI MAGIWEL OPIATE METABOLITES (K973155) | United Biotech, Inc. | 1997-10-28 |
| NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE- MODEL MED 3631-A (K972271) | Ml Strategies, Inc. | 1997-10-28 |
| DERMA K LASER SYSTEM (K972872) | Esc Medical Systems , Ltd. | 1997-10-28 |
| UBI MAGIWEL COCAINE METABOLITES (K973156) | United Biotech, Inc. | 1997-10-28 |
| ERCO-RIBBON (K972353) | Ercons, Inc. | 1997-10-28 |
| DUALINE 100 BTE (K973948) | Bernafon-Maico, Inc. | 1997-10-28 |
| UBI MAGIWEL AMPHETAMINE METABOLITES (K973153) | United Biotech, Inc. | 1997-10-28 |
| LASETTE (K973431) | Cell Robotics, Inc. | 1997-10-28 |
| AM SERIES HEARING AID (K973579) | A & M Hearing, Ltd. | 1997-10-28 |
| XPLAN-1 (K972905) | Radionics Software Applications, Inc. | 1997-10-28 |
| HELIOS LASER IMAGER 1417 (K973028) | Sterling Diagnostic Imaging, Inc. | 1997-10-28 |
| CRICKET 2000 RECORDING PULSE OXIMETER (K972829) | Respironics, Inc. | 1997-10-28 |
| LASERSHARE PRINT SPOOLER(2100[SOLARIS X86]/(1500[WINDOWS NT]) (K973422) | Dejarnette Research Systems | 1997-10-28 |
| HYDRAGEL 7,15,30, CHOL-HDL KIT (K972015) | Morax | 1997-10-27 |
| OPUS HLH CONTROLS (K973832) | Behring Diagnostics, Inc. | 1997-10-27 |
| SPIFE (K972274) | Helena Laboratories | 1997-10-27 |
| COMBIPORT FLUID LAVAGE DEVICE (K971259) | B.Braun Medical, Inc. | 1997-10-27 |
| BRAND NAME *1-STEP PREGNANCY (K973352) | Armkel, LLC | 1997-10-27 |
| COMPRESSION CERCLAGE GUNDOLF CCG-GF (K973098) | Plus Orthopedics | 1997-10-27 |
| URO MED NERVE STIMULATOR (K970971) | Uromed Corp. | 1997-10-27 |
| RAPID FIRE HAIR IMPLANTER CAROUSEL (K972918) | Apex Medical Products, LLC | 1997-10-27 |
| SUPER SILIPLUGS EAR PLUGS (K972923) | Interview Medical Technology Corp. | 1997-10-27 |
| VOX/BASE FOR WINDOWS (K972933) | J-Mac System, Inc. | 1997-10-27 |
| MODEL C-1 HEARING AID (K973043) | Better Hearing, Inc. | 1997-10-27 |
| TBD* ONE-STEP OVULATION PREDICTOR TEST (K973310) | Armkel, LLC | 1997-10-27 |
| NMC HEMODIALYSIS ARTERIAL BLOOD TUBING SET (K971313) | National Medical Care, Inc. | 1997-10-27 |
| BRAINSCAN CONFORMAL RT MODULE (K971367) | Brainlab AG | 1997-10-27 |
| MIDAS TOUCH ELECTROSURGICAL ELECTRODE (K973234) | Iti Medical Technologies, Inc. | 1997-10-27 |
| SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED (K964398) | Polymedica Industries, Inc. | 1997-10-24 |
| CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP (K970595) | Circon Video | 1997-10-24 |
| CRAFT DUO-VAC SUCTION UNIT, CRAFT SUCTION UNIT (K972867) | Rocket Medical Plc | 1997-10-24 |
| DURALASTIC ANATOMICAL MALAR IMPLANT (K973574) | Hanson Medical, Inc. | 1997-10-24 |
| PROFEEL POWDER FREE SURGICAL GLOVES (PROTEIN CONTENT LABELING) (K972621) | Wembley Rubber Products (M) Sdn Bhd | 1997-10-24 |
| EVI SUTURED-CLIP APPLIER (K971588) | Elective Vascular Intervention Inc. (Evi) | 1997-10-24 |
| HANSATOME MICROKERATOME (K972808) | Chiron Vision Corp. | 1997-10-24 |
| HANAULUX BLUE 75 AND HANAULUX BLUE 120 (K973466) | Heraeus Med GmbH | 1997-10-24 |
| DIGITAL 3-CHIP COLOR VIDEO CAMERA, ILLUMINATORS, VIDEO COMPONENTS AND ACCESSORIES (K972471) | Smith & Nephew, Inc. | 1997-10-24 |
| TOTAL PERFORMANCE SYSTEM SHAVER (K973195) | Stryker Endoscopy | 1997-10-24 |
| VIAL-MATE RECONSTITUTION DEVICE (2B8071) (K973654) | Baxter Healthcare Corp | 1997-10-24 |
| AUTO SUTURE BONE WAX (K971680) | United States Surgical, A Division of Tyco Healthc | 1997-10-24 |
| TRI TALON RETRIEVAL FORCEPS (K973071) | Medical Engineering Laboratory, Inc. | 1997-10-24 |
| SMC ACETABULAR COMPONENT (K971018) | Signal Medical Corp. | 1997-10-24 |
| DERMASCAN SURGICAL LASER SCANNER (K972028) | Esc Medical Systems , Ltd. | 1997-10-24 |
| EDEMA SYSTEM (K962783) | Bioanalogics, Inc. | 1997-10-23 |