| PATIENT EXAMINATION GLOVES; CHLORINATED POWDERFREE NITRILE EXAMINATION GLOVES (K964148) | Hartalega Sdn Bhd | 1997-02-07 |
| RUSCH SUPRAPUBIC TRAY (K970021) | Rusch, Inc. | 1997-02-07 |
| AMBIDERM (COLOR POW LATEX EXAM GLOVES W/ PROTEIN) (K962737) | Supertex Industrial, S.A. DE C.V. | 1997-02-07 |
| KENDALL CURITY URETERAL CATHETER (K964899) | Kendall Healthcare Products Co. Div.Of Tyco Health | 1997-02-07 |
| RACAL N95 RESIRATOR (K964723) | Racal Filter Technologies, Inc. | 1997-02-07 |
| ULTRASOUND GASTROSCOPE GF TYPE UM30P (K963023) | Olympus America, Inc. | 1997-02-07 |
| STABILIZER SOFT TISSUE ANCHOR, 8MM MODEL TA1008, ANCHOR INSERTER/SUTURE ORGANIZER, 8MM MODEL AI1008, STABILIZER DRILL, 8 (K964927) | R. Thomas Grotz, M.D., Inc. | 1997-02-07 |
| CEFACLOR ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K964489) | Unipath , Ltd. | 1997-02-07 |
| RIGID FIBER OPTIC LAPAROSCOPE (K962246) | Health Care International Assoc. | 1997-02-07 |
| KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4) (K964401) | Ludlow Technical Products | 1997-02-06 |
| CEFIXIME ANTIMICROBIAL SUSCEPTIBILTY TEST DISC (K964496) | Unipath , Ltd. | 1997-02-06 |
| OFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K964493) | Unipath , Ltd. | 1997-02-06 |
| MLC FIT (K962335) | Impac Medical Systems, Inc. | 1997-02-06 |
| STABLELIN ENZYME LINEARITY TEST SET C (ITEM NO. 003) (K965169) | Specialized Assays, Inc. | 1997-02-06 |
| ORATEC INTERVENTIOUNS ELECTROSURGICAL PROBES (K965007) | Oratec Interventions, Inc. | 1997-02-06 |
| TITANIUM CD HORIZON SPINAL SYSTEM (K962708) | Sofamor Danek USA,Inc. | 1997-02-06 |
| LEIBINGER LUHR SMALL CRANIOMAXILLOFACIAL BONE SCREWS (K963741) | Howmedica Leibinger, Inc. | 1997-02-06 |
| DEPUY DUPONT PHANTOM SUTURE ANCHOR (K964521) | Depuy, Inc. | 1997-02-06 |
| TITANIUM CD HORIZON ANTERIOR SPINAL SYSTEM (K964623) | Sofamor Danek USA,Inc. | 1997-02-06 |
| TAYMAN MEDICAL, INC. STEPPING & STABILIZING SYSTEM (K963302) | Tayman Medical, Inc. | 1997-02-06 |
| OLYMPUS TRANSFERRIN IMMUNOTURBIDIMETRIC REAGENT (K963139) | Olympus America, Inc. | 1997-02-06 |
| TARGET MYOGLOBIN TEST (K963680) | Texas Immunology, Inc. | 1997-02-06 |
| AS/3 ESTPR MODULE (K953175) | Datex Division Instrumentarium Corp. | 1997-02-06 |
| ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM (K964786) | Wrightmedicaltechnologyinc | 1997-02-06 |
| UHMWPE HIP AND KNEE COMPONENTS - PACKAGING CHANGE (K964655) | Howmedica Corp. | 1997-02-06 |
| METALLIC SPHERICAL CMC IMPLANT (K960534) | Wrightmedicaltechnologyinc | 1997-02-06 |
| LYFO(TM) DIFFERENTIAL DISK-BACITRACIN (K970009) | Microbiologics, Inc. | 1997-02-06 |
| GORE-TEX SOFT TISSUE PATCH PLUS/DUALMESH PLUS BIOMATERIAL/MYCROMESH PLUS BIOMATERIAL/DUALMESH PLUS BIOMATERIAL WITH HOLE (K965038) | W. L. Gore & Associates, Inc. | 1997-02-06 |
| SULBACTAM/AMPICILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K964501) | Unipath , Ltd. | 1997-02-06 |
| CEFTIZOXIME ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K964512) | Unipath , Ltd. | 1997-02-06 |
| RESCH ARTHROSCOPIC AND PERCUTANEOUS SCREW FIXATION SYSTEM (A.S.F.) (K961498) | Howmedica, Inc. | 1997-02-06 |
| CERALAS DIODE LASER SYSTEM (CERALAS D15) (K964497) | Ceram Optec, Inc. | 1997-02-06 |
| CERAMIC SPHERICAL CMC IMPLANT (SUBJECT TO MARKETING APPROVAL) (K960659) | Wrightmedicaltechnologyinc | 1997-02-06 |
| MASIMO SET MS-1 PULSE OXIMETER & THE LNOP SERIES OF SENSORS & CABLES (K962603) | Masimo Corp. | 1997-02-06 |
| M AND R REUSABLE ELECTRODES (MULTIPLE) (K963125) | M & R Mfg., Inc. | 1997-02-06 |
| ULTRAFERA WOUND DRESSING (K964614) | American White Cross, Inc. | 1997-02-06 |
| COBE HEMODYNAMIC RECIRCULATION MONITOR (K954003) | Cobe Renal Care, Inc. | 1997-02-06 |
| SYSMEX CA-6000 (K964139) | Dade Intl., Inc. | 1997-02-06 |
| HCG CONTROLS (K970176) | International Newtech Development, Inc. | 1997-02-06 |
| PLANNED SOPHIED CLASSIC (K962105) | Planmed OY | 1997-02-05 |
| SUGITA AVM MICROCLIP (K960037) | Mizuho America, Inc. | 1997-02-05 |
| DENTINSENSE (K964735) | Centrix, Inc. | 1997-02-05 |
| AT 62 EEG (A.K.A THE A;PHA-THETA TRAINER) (K965006) | Stoelting Co. | 1997-02-05 |
| TCB TEMPORARY CROWN AND BRIDGE MATERIAL (K964691) | Scican | 1997-02-04 |
| STABLELIN ENZYME LINERARITY TEST SET A (ITEM NO. 001) (K965166) | Specialized Assays, Inc. | 1997-02-04 |
| DE-TOX CONTROL 1 AND DE-TOX CONTROL 19 (K964771) | Dyna-Tek Industries | 1997-02-04 |
| MRT-35A V9.0 (K964608) | Toshiba America Mri, Inc. | 1997-02-04 |
| CETIBUTEN, 30MCG, SENSI-DISC (K965159) | Becton Dickinson Microbiology Systems | 1997-02-04 |
| MIRACLE - EAR (ITE/ITC/CIC) (K964419) | Miracle-Ear, Inc. | 1997-02-04 |
| ALKALINE PHOSPHATASE (K964914) | Derma Media Lab., Inc. | 1997-02-04 |
| SLEEPWIZARD (K964494) | Nellcor Puritan Bennett, Inc. | 1997-02-04 |
| HERPES GROUP IGG ELISA TEST SYSTEM (K963645) | Armkel, LLC | 1997-02-04 |
| OSOM CLASSIC HCG-URINE TEST (115) (K965227) | Wyntek Diagnostics, Inc. | 1997-02-04 |
| RAPID GRAM-POSITIVE ID SYSTEM (K961730) | Becton Dickinson Microbiology Systems | 1997-02-04 |
| BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB (K961024) | Princeton BioMeditech Corp. | 1997-02-04 |
| SAFE MICRO (K953976) | Polystan A/S | 1997-02-04 |
| ACCESS CHLAMYDIA ASSAY (K960850) | Bio-Rad Laboratories, Inc. | 1997-02-04 |
| SYMPACATH HYDROGEL COATED FOLEY (K964575) | Rusch Intl. | 1997-02-04 |
| PORTPRO ELECTRONIC PORTAL IMAGING SYSTEM (K964485) | Eliav , Ltd. | 1997-02-04 |
| MICROGYN RESECTION LOOP, COAGULATING ELECTRODE, CISS SHEATH ELECTRODE, LOOP ELECTRODE KIT AND COAGULATING ELECTRODE KIT (K962653) | Microgyn Corp. | 1997-02-04 |
| STABLELIN ENZYME LINEARITY TEST SET B (ITEM NO. 002) (K965168) | Specialized Assays, Inc. | 1997-02-04 |
| VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005) (K964720) | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-02-04 |
| IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR,PHE,PHY, & THE) REAGENTS (K963673) | Beckman Instruments, Inc. | 1997-02-04 |
| PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY (K964864) | Alexon Biomedical, Inc. | 1997-02-04 |
| BBLCRYSTAL GRAM-POSITIVE ID SYSTEM (K961968) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1997-02-04 |
| PERFECTA PREGNANCY TEST (K965184) | Wyntek Diagnostics, Inc. | 1997-02-04 |
| 9.5 FR.- FLEXI-CATH INTRA-AORTIC AND CONTROL SYSTEM (K963104) | Arrow Intl., Inc. | 1997-02-04 |
| ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN (K964670) | Roche Diagnostic Systems, Inc. | 1997-02-04 |
| PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS (K964245) | Starkey Laboratories, Inc. | 1997-02-04 |
| FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY) (K964892) | Gynecare Innovation Center | 1997-02-04 |
| MINK LUNG CELL CULTURE (K965047) | Neogenex | 1997-02-04 |
| HEDROCEL ACETABULAR RESTRICTOR (K962468) | Implex Corp. | 1997-02-03 |
| MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG) (K964933) | Mekanika, Inc. | 1997-02-03 |
| IAMIN WET DRESSING (COPPER-SALINE) (K964468) | Procyte Corp. | 1997-02-03 |
| RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT (K964472) | Biologically Oriented Prostheses | 1997-02-03 |
| STORZ E8010 ERGOTEC/PREMIERE ADAPTOR (K964743) | Storz Instrument Co. | 1997-02-03 |
| OSTEONICS FLANGED POLYETHYLENE ACETABULAR CUP (K963671) | Osteonics Corp. | 1997-02-03 |
| MULTITAK SS SUTURE SYSTEM (K964532) | Bonutti Research | 1997-02-03 |
| TOTALCARE (K962942) | Hill-Rom, Inc. | 1997-02-03 |
| FAVC: FEMORAL ARTERY VASCULAR CLAMP - MODEL NUMBER RMDS 1000-15, RMDS 1000-20, RMDS 2000-15, RMDS 2000-20, RMDS 3000-15 (K964662) | Rmds, Inc. | 1997-02-03 |
| RTA RETINAL THICKNESS ANALYZER (K964137) | Talia Technology , Ltd. | 1997-02-03 |
| ENTRACARE THERMOMTER MODEL 1000 (K964851) | Entracare Corp. | 1997-02-03 |
| FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P) (K963248) | J-Lloyd Medical, Inc. | 1997-02-03 |
| SMARTOAE (K964426) | Intelligent Hearing Systems | 1997-02-03 |
| SYS STIM 226 (K964028) | Mettler Electronics Corp. | 1997-02-03 |
| CONCEPTUS FALLOPIAN TUBE CATHETEIZATION WITH MICROENDOSCOPY SYSTEM (K962587) | Conceptus, Inc. | 1997-01-31 |
| STRYKER STRYKEFLOW ELECTROCAUTERY PROBES (K963765) | Stryker Endoscopy | 1997-01-31 |
| ULTRA-ETCH STAT (K965060) | Ultradent Products, Inc. | 1997-01-31 |
| SHUNT TAP WITH ICP MONITORING ACCESS PORT (K964371) | Integra Neurocare, LLC | 1997-01-31 |
| RADIONICS CONTOUR FLEX PLUS VALVE (K964386) | Radionics, Inc. | 1997-01-31 |
| IMAGYN FALLOPOSCOPY SYSTEM (K963580) | Imagyn Medical, Inc. | 1997-01-31 |
| CHASE VESSEL OCCLUDER (K964390) | Chase Medical, Inc. | 1997-01-31 |
| COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVER (K962288) | Pinnacle Products, Inc. | 1997-01-30 |
| STERILEMAX (K953938) | Barnstead/Thermolyne Corp. | 1997-01-30 |
| PATIENT EXAMINATION GLOVE (K961521) | Shanghai PT Plastics Enterprise Company, Ltd. | 1997-01-30 |
| ELECSYS CALCHECK TESTOSTERONE (K970146) | Boehringer Mannheim Corp. | 1997-01-30 |
| CUTANEOUS COMPRESSION DEVICE FOR USE IN HEMODIALYSIS (K964041) | Robert R. Stevens | 1997-01-30 |
| VITROS IMMUNODIAGNOSITCS PRODUCTS-FREE T3 REAGENT PACK (GEM.1020)/FREE T3 CALIBRATORS (GEM.C020) (K970016) | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-01-30 |
| POLYFIN WITH WINGS INFUSION SETS, MODELS 306, 307, 333 (K964455) | Medtronic Minimed | 1997-01-30 |
| OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006) (K964445) | Dlp, Inc. | 1997-01-30 |