| NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI (K970300) | Intermedics Orthopedics | 1997-07-03 |
| RATATIONAL ANGIOGRAPHY OPTION FOR PHILIPS MULTIDIAGNOST 4 (K971489) | Philips Medical Systems North America, Inc. | 1997-07-03 |
| BONE & MARROW CLLECTION SYSTEM (K971268) | Biomedical International Corp. | 1997-07-03 |
| CORDIS OPTA LP PTA BALLOON CATHETER (K971448) | Cordis Corp. | 1997-07-03 |
| NOVIGUARD QUICK DRY (K961044) | Dr. Novis Smith & Co., Inc. | 1997-07-03 |
| PIPERACILLIN/TAZOBACTAM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K971633) | Oxoid , Ltd. | 1997-07-03 |
| N-ASSAY TIA MULTI CRP CALIBRATOR SET (K965110) | Crestat Diagnostics, Inc. | 1997-07-03 |
| NASAL SEPTAL BUTTON (K972060) | Boston Medical Products, Inc. | 1997-07-03 |
| MEDISURF (K971347) | International Regulatory Consultants | 1997-07-03 |
| ARGOSY DYNAMEQ (K971699) | Argosy Electronics | 1997-07-03 |
| SILKAIR LOW AIRLOSS THERAPY (K964873) | Hill-Rom, Inc. | 1997-07-03 |
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500 (K971826) | Alexander Mfg. Co. | 1997-07-03 |
| ISOLATE (K971809) | Irvine Scientific Sales Co., Inc. | 1997-07-03 |
| TBD (K965245) | Utah Medical Products, Inc. | 1997-07-03 |
| RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION (K971605) | Resound Corp. | 1997-07-03 |
| ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA (K971834) | Monobind | 1997-07-03 |
| ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA (K971835) | Monobind | 1997-07-03 |
| CEFOTETAN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K971631) | Oxoid , Ltd. | 1997-07-03 |
| ULTRASONIC HAND INSTRUMENTS (K971861) | United States Surgical, A Division of Tyco Healthc | 1997-07-01 |
| TRANSEND EX PLATINUM GUIDEWIRE (K971254) | Boston Scientific Corp | 1997-07-01 |
| SUNGLASSES (K971462) | D.G. Prove Co. | 1997-07-01 |
| HSV-1 ANTIGEN CONTROL SLIDES (K964874) | Viral Antigens, Inc. | 1997-07-01 |
| ACCU-PREP (K970484) | Bisco, Inc. | 1997-07-01 |
| QA-40M DEFIBRILLATOR TESTER (K963190) | Metron U.S., Inc. | 1997-07-01 |
| SYSTEM 96 INTRA-AORTIC BALLOON PUMP (IABP) (K965236) | Datascope Corp. | 1997-07-01 |
| V2 (K970481) | Survivalink Corp. | 1997-07-01 |
| (BRAND NAME) (K971384) | Long IN Time Ent. Co., Ltd. | 1997-07-01 |
| RESTRAINTS (VESTS AND JACKETS) (K971536) | E.M. Adams Co., Inc. | 1997-07-01 |
| HSV-2 ANTIGEN CONTROL SLIDES (K971101) | Viral Antigens, Inc. | 1997-07-01 |
| SIL-TEC NONREINFORCED SHEETING, REINFORCED SHEETING, RADIOPAQUE SHEETING, REINFORCED RADIOPAQUE SHEETING, EXTRA FIRM GRA (K971472) | Technical Products, Inc. | 1997-07-01 |
| TWEEZER-TYPE EPILATOR (K970338) | Igia Direct, Inc. | 1997-07-01 |
| OLYMPUS CD-6C-1 COAGULATION ELECTRODE (K971328) | Olympus America, Inc. | 1997-07-01 |
| LMI THROMBECTOMY CATHETER (K970657) | Lucas Medical, Inc. | 1997-07-01 |
| COULTER ACT TRON CELL CONTROL (K971469) | Coulter Corp. | 1997-06-30 |
| DIASCOPE TRAVELLER PLUS (4053) (K964593) | S & W Medico Teknik A/S | 1997-06-30 |
| ETEST FOR CEFTAZIDIME (K971694) | Ab Biodisk | 1997-06-30 |
| RCT GEL ROOT CANAL THERAPY GEL (K972234) | Dentsply Intl. | 1997-06-30 |
| LASERSCOPE MICROBEAM IV MICROMANIPULATOR (K971250) | Laserscope | 1997-06-30 |
| PC BASED ELECTROCARDIOGRAPH SYSTEM (PC-ECG) (K963578) | Intl. Products, Inc. | 1997-06-30 |
| MASTERCAP AM 5.0/MASTERCAP RM 5.0 (K970420) | Pharmacia, Inc. | 1997-06-30 |
| MEDPOR OCULAR SCREW AND ACCEOSSORIES (K971583) | Porex Technologies Corp. | 1997-06-30 |
| ENDOSSEOUS DENTAL IMPLANT (K971578) | Straumann USA | 1997-06-30 |
| INNOSENSE PELVIC FLOOR STIMULATION AND ELECTROMYOGRAPHY SYSTEM (K971527) | Empi | 1997-06-30 |
| HI DENSE TC (K971927) | Shofu Dental Corp. | 1997-06-30 |
| WELCH ALLYN PHACO ILLUMINATOR (K971750) | Welch Allyn, Inc. | 1997-06-30 |
| BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS (K965147) | Boston Scientific Corp | 1997-06-30 |
| ENCORE BOND (K971121) | Centrix, Inc. | 1997-06-27 |
| PYLORISET EIA-G (68926) (K971537) | Orion Diagnostica, Div. Orion Corp. | 1997-06-27 |
| RAND SURGICAL SPONGE (K971178) | Trans Aire | 1997-06-27 |
| LIMITED REUSE ENDOSCOPIC BLADES (K971676) | Smith & Nephew, Inc. | 1997-06-27 |
| J-FX CERCLAGE SYSTEM (K971682) | Johnson & Johnson Professionals, Inc. | 1997-06-27 |
| OSTEOPOWER SYSTEM AND ACCESSORIES (K971692) | Osteomed Corp. | 1997-06-27 |
| AMSCO SURGICAL TABLE (K971307) | STERIS Corporation | 1997-06-27 |
| ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT (K971602) | Beckman Instruments, Inc. | 1997-06-27 |
| PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (K971716) | Bayer Corp. | 1997-06-27 |
| ENDOSCOPE (K964131) | Akos Biomedical, Inc. | 1997-06-27 |
| LATEX EXAMINATION GLOVES, POWDER FREE (K970977) | Arista Medi Prima | 1997-06-27 |
| SMITH & NEPHEW IMAGES ENDOSCOPES AND ACCESSORIS/SEMI-RIGID AND FLEXIBLE MANUAL INSTRUMENTS (K971188) | Smith & Nephew, Inc. | 1997-06-27 |
| ANCHORLOK AND ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM (K971282) | Wrightmedicaltechnologyinc | 1997-06-27 |
| SMART - FIT, POWDERFREE NITRILE EXAMINATION GLOVES (K971665) | Sj Medical Products (M) Sdn Bhd | 1997-06-27 |
| AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM (K971103) | Tosoh Medics, Inc. | 1997-06-27 |
| DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500 (K971753) | Denver Biomaterials, Inc. | 1997-06-27 |
| LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE (K971293) | Abbott Mfg., Inc. | 1997-06-27 |
| HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE (K963160) | Olympus America, Inc. | 1997-06-27 |
| DEFEND FLUID RESISTANT PLEATED MASK (K971130) | Carl Parker Associates, Inc. | 1997-06-27 |
| STONE EXTRACTOR (K971123) | Phx Technologies Corp. | 1997-06-27 |
| OSTEO SMALL AND MINI BONE SCREWS (K971778) | Osteonics Corp. | 1997-06-27 |
| ZIRCONIA CERAMIC FEMORAL HEADS WITH FOUNDATION FORGED, TEXTURED AND POROUS STEMS, THE ENCORE VITALITY STEMS AND SL AND (K965002) | Encore Orthopedics, Inc. | 1997-06-27 |
| ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER AND THE ENDOPATH EZ45 NO KNIFE ENDOSCOPIC LINEAR STAPLER (K970720) | Ethicon Endo-Surgery, Inc. | 1997-06-27 |
| IDS4 IMAGE DISPLAY SYSTEM SERIES (K971368) | O Tech, Inc. | 1997-06-26 |
| ESCORT LINK CENTRAL STATION MONITOR (K970012) | Medical Data Electronics | 1997-06-26 |
| SPECTACLE FRAMES (NON-PRESCRIPTION) (K972246) | Alimar Trading, Inc. | 1997-06-26 |
| MEDIVISION SINOSCOPE (K971995) | Medivision Scope Service Center, Inc. | 1997-06-26 |
| QUIKSTRIP ONE STEP METHAMPHETAMINE (K970395) | Drial Consultants, Inc. | 1997-06-26 |
| SIGNA SP CROWN COILS (NUMBERS 1 THROUGH 3) (K964969) | GE Medical Systems | 1997-06-26 |
| EPI-MAX EPISTAXIS CATHETER (K972076) | Boston Medical Products, Inc. | 1997-06-26 |
| SYNERMED IR 200 CHEMISTRY ANALYZER (K971491) | Synermed, Inc. | 1997-06-26 |
| NICHOLS ADVANTAGE CHEMILUMINESCENCE TRI-LEVEL SPECIALTY CONTROLS (K972070) | Nichols Institute Diagnostics | 1997-06-26 |
| STA LIATEST CONTROL [N]+[P] KIT (K964716) | American Bioproducts Co. | 1997-06-26 |
| TV MONITOR (P12/17) (K972136) | Perkins Mfg. Co. | 1997-06-26 |
| EPI-STOP EPISTAXIS CATHETER (K972077) | Boston Medical Products, Inc. | 1997-06-26 |
| BAIR HUGGER MODEL 630 CARDIAC BLANKET (K964673) | Augustine Medical, Inc. | 1997-06-26 |
| THERATRON 780E (K964606) | Theratronics, Inc. | 1997-06-26 |
| PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER CANNULA (K963732) | Mallinckrodt Medical | 1997-06-26 |
| ENDO-SEAL (K971899) | Ultradent Products, Inc. | 1997-06-26 |
| WISE IMAGE MANAGEMENT SYSTEM (K971451) | O Tech, Inc. | 1997-06-26 |
| BOBCAT DX (K970543) | Quest Enabling Designs , Ltd. | 1997-06-26 |
| CLINICATH IR PERIPHERALLY INSERTED CATHETER (K970269) | Sims Deltec, Inc. | 1997-06-26 |
| NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES (K971167) | Neoprobe Corp. | 1997-06-26 |
| STA-LIATEST D-DI TEST KIT (K964728) | American Bioproducts Co. | 1997-06-26 |
| MODEL ME 300 MUSCLE TESTER (K943535) | Regulatory Strategies, Inc. | 1997-06-25 |
| I-SCOPE OPHTHALMIC ENDOSCOPE (K971679) | Ophthalmic Technologies, Inc. | 1997-06-25 |
| EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH) (K971600) | Behring Diagnostics, Inc. | 1997-06-25 |
| VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE - TAMPON (K971541) | Hollister, Inc. | 1997-06-25 |
| BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST (K971841) | Bionike Laboratories, Inc. | 1997-06-25 |
| CONTIDRAIN CATHETER (K964757) | Contimed, Inc. | 1997-06-25 |
| CODMAN LUMBAR DRAINAGE CATHETER KIT (K964923) | Johnson & Johnson Professionals, Inc. | 1997-06-25 |
| AESUCLAP SOCON SPINAL SYSTEM (K970285) | Aesculap, Inc. | 1997-06-25 |
| CARDIOVIT CS-200 (K970879) | Schiller America, Inc. | 1997-06-25 |
| HARMAC QUADPOLAR MAPPING PACING CATHETER (K963074) | Harmac Medical Products, Inc. | 1997-06-25 |