| NEXGEN COMPLETE KNEE SOLUTION (K963148) | Zimmer, Inc. | 1997-02-13 |
| SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM (K963045) | Synthes (Usa) | 1997-02-13 |
| IN-TAC BONE ANCHOR SYSTEM (K964953) | Influence, Inc. | 1997-02-13 |
| TRUSTEX GRAPE FLAVORED CONDOM IN PURPLE COLOR (K964591) | Line One Laboratories | 1997-02-13 |
| EMS SWISS LITHOCLAST LITHOTRIPTER (K963285) | Electro Medical Systems SA | 1997-02-13 |
| B-P HEMISPHERICAL ACETABULAR COMPONENT (K963101) | Endotec, Inc. | 1997-02-12 |
| METAGEN HIGH TIBIAL OSTEOTOMY SYSTEM (K963700) | Metagen, LLC | 1997-02-12 |
| 6 FRENCH, 7 FRENCH, AND 8 FRENCH GUIDING CATHETERS WITH PHOSPHORYLCHOLINE (PC) POLYMER COATING (K962717) | Biocompatibles Cardiovascular, Inc. | 1997-02-12 |
| TRU-PULSE LASER (MODIFIED) (K963683) | Tissue Technologies, Inc. | 1997-02-12 |
| IMPLATECH RP MEDICAL GRADE SILICONE GEL SHEETING (K964846) | Implantech Associates, Inc. | 1997-02-12 |
| BREATHE FIT (K963326) | Cambridge Assoc. | 1997-02-12 |
| ANSPACH SUTURE ANCHOR (K965069) | The Anspach Effort, Inc. | 1997-02-12 |
| CHOICE POWERED WHEELCHAIR (K963808) | American Medical Technology, Inc. | 1997-02-12 |
| TROCAR CANNULA (K963115) | United States Surgical, A Division of Tyco Healthc | 1997-02-12 |
| PASSY-MUIR O2 ADAPTER; PMA2000 (K970365) | Passy-Muir, Inc. | 1997-02-12 |
| EPIDURAL MINI KIT, ELDOR COMBINED SPINAL/EPIDURAL KIT (K964783) | Alexander Medical, Inc. | 1997-02-12 |
| BIONECT CREAM (K963004) | Fidia Pharmaceutical Corp. | 1997-02-12 |
| TRONZO ACETABULAR FIXATION COMPONENT (1 99-02-00XX (ACE. FIXATION CUP) XX=OD OF ACE. CUP (K963100) | Endotec, Inc. | 1997-02-12 |
| LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P. (K965162) | Lukens Medical Corp. | 1997-02-12 |
| ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TA (K964561) | Bioenterics Corp. | 1997-02-11 |
| BEAM BLOCK TRAYS (K964840) | Aktina Medical Physics Corp. | 1997-02-11 |
| ONE-STEP DIPSTICK PREGNANCY TEST (K964536) | Teco Diagnostics | 1997-02-11 |
| HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2) (K960817) | Transonic Systems, Inc. | 1997-02-11 |
| PHASED ARRAY NECK COIL (K964678) | Philips Medical Systems (Cleveland), Inc. | 1997-02-11 |
| SUPER K-AMP, EZ-COMPRESSION, TRIM-PRO, HF-PRO, ENVIRO-PRO, COMPRESSION-PRO, COMPRESSION 3000, HF 3000, OCTIVA, REFLEX HF (K964657) | Micro-Ear Technology, Inc. | 1997-02-11 |
| MATRIX 3000 FLEXIBLE SPINE COIL (K964753) | Us Asia Instruments, Inc. | 1997-02-11 |
| HOFFMAN H/A COATED LONG-TERM VENTILATION TUBE WITH LINER (K963727) | Medtronic Xomed | 1997-02-11 |
| BEMIS TWO GALLON CHEMOTHERAPY CONTAINER (K964858) | Bemis Mfg. Co. | 1997-02-11 |
| STERI-OSS GOLD ATTACHMENT SYSTEM (K963945) | Steri-Oss, Inc. | 1997-02-11 |
| UNIVISION ECHOCARDIOLOGY SYSTEM (K964803) | Network Concepts, Inc. | 1997-02-11 |
| OSTEONICS SPINAL SYSTEM - VARIABLE OFFSET CONNECTOR ASSEMBLY (K964544) | Osteonics Corp. | 1997-02-11 |
| CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM (K970248) | Canyon Diagnostics, Inc. | 1997-02-11 |
| IMMAGE IMMUNOCHEMISTRY SYSTEM GENTAMICIN(GEN)/TOBRAMYCIN(TOB) REAGENT / BECKMAN DRUG CLAIBRATOR 3 PLUS (K964009) | Beckman Instruments, Inc. | 1997-02-11 |
| MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURGACE COIL (K964854) | Medrad, Inc. | 1997-02-11 |
| EPI 2 (K935706) | Universal H.R. System, Inc. | 1997-02-11 |
| AMD HOME HEALTH MONITOR SYSTEM AND AMD MONITORING STATION (K964697) | Advance Medical Device, Inc. | 1997-02-11 |
| 8500A PULSE OXIMETER (K945290) | Nonin Medical, Inc. | 1997-02-11 |
| ONE-STEP URINE/SERUM COMNO PREGNANCY DIPSTICK TEST (K964462) | Teco Diagnostics | 1997-02-11 |
| ONE -STEP URINE/SERUM COMBO PREGNANCY CARD TEST (K964461) | Teco Diagnostics | 1997-02-11 |
| THE NOMOS MINICRANE (K964740) | Nomos Corp. | 1997-02-11 |
| TRACH CARE SET WITH MICROBAN (K964369) | Ballard Medical Products | 1997-02-11 |
| ULTRASOUND SYSTEM MODEL UF-3500 (K955543) | Fukuda Denshi USA, Inc. | 1997-02-11 |
| SAFE KNIGHTS (K955183) | L & N Corp. | 1997-02-11 |
| CARDIAC T TROPONIN T RAPID ASSAY (K964372) | Boehringer Mannheim Corp. | 1997-02-10 |
| SOMATOM PLUS 4 CT SCANNER (K964747) | Siemens Medical Solutions USA, Inc. | 1997-02-10 |
| GLUCOMETER ENCORE BLOOD GLUCOSE TEST STRIPS (K964004) | Bayer Corp. | 1997-02-10 |
| ELECSYS CALCHECK PROLACTIN (K970147) | Boehringer Mannheim Corp. | 1997-02-10 |
| SCIMED 5 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS (K964859) | Scimed Life Systems, Inc. | 1997-02-10 |
| PFINGST PRESSURE PASTE (K965026) | Pfingst & Co., Inc. | 1997-02-10 |
| SEIRIN JR ACUPUNCTURE NEEDLES (K970260) | Seirin-America, Inc. | 1997-02-10 |
| TROPONIN-I TEST SYSTEM (K964862) | Dade Intl., Inc. | 1997-02-10 |
| DERMADAM (K964810) | Ultradent Products, Inc. | 1997-02-10 |
| NITRILE POWDER-FREE EXAMINATION GLOVES (K964628) | Shen Wei (Usa), Inc. | 1997-02-10 |
| IMMAGE IMMUNOCHEMISTRY SYSTEM KAPPA LIGHT CHAIN (KAP) REAGENT IMMAGE IMMUNOCHEMISTRY SYSTEM LAMDA LIGHT CHAIN (LAM) REAG (K964260) | Beckman Instruments, Inc. | 1997-02-10 |
| EDGE/VISTA SYSTEM ENHANCEMENT PACKAGE (K964626) | Philips Medical Systems (Cleveland), Inc. | 1997-02-10 |
| NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER AND I.V. SET (K964812) | Critical Device Corp. | 1997-02-10 |
| STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY (K965213) | Dade Intl., Inc. | 1997-02-10 |
| TANDEMRX (K970054) | Boston Scientific Corp | 1997-02-10 |
| PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) (K946279) | Cobe Renal Care, Inc. | 1997-02-10 |
| SHARPS CONTAINER MODEL# SC001 (K963830) | Image Medical, Inc. | 1997-02-10 |
| MINERAL TRIOXIDE AGGREGATE (MTA) (K964174) | Tulsa Dental Products, Ltd. | 1997-02-10 |
| IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENT (K964010) | Beckman Instruments, Inc. | 1997-02-10 |
| TEMPFIL C&B (K964981) | Sybron Dental Specialties, Inc. | 1997-02-10 |
| EVERT-IT (K962828) | Genesis Industries, Inc. | 1997-02-10 |
| FG-36UX, ULTRASOUND UPPER GI FIBERSCOPE (K961974) | Pentax Precision Instrument Corp. | 1997-02-10 |
| HEARTPORT ENDOVENOUS DRAINAGE CANNULA (K962835) | Heartport, Inc. | 1997-02-10 |
| VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET (K965202) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1997-02-10 |
| SEIRIN PYONEX ACUPUNCTURE NEEDLES (K970254) | Seirin-America, Inc. | 1997-02-10 |
| VENTANNA ANTI-DESMIN PRIMARY ANTIBODY (K941516) | Ventana Medical Systems, Inc. | 1997-02-10 |
| LIBERTY RECTAL PELVIC FLOOR EXERCISER (K964526) | Utah Medical Products, Inc. | 1997-02-10 |
| TEFGEN GUIDED TISSUE MEMBRANE (K964656) | American Custom Medical, Inc. | 1997-02-10 |
| NORTH AMERICAN SCIENTIFIC (NASI) 1-125 RADIONUCLIDE BRACHYTHERAPY SOURCE (K964647) | North American Scientific, Inc. | 1997-02-10 |
| OMNICAN SYRINGE (K962084) | B. Braun Medical AG | 1997-02-10 |
| GAMMA GUIDANCE SYSTEM (K961321) | Radiation Monitoring Devices, Inc. | 1997-02-10 |
| GLUCOMETER ELITE BLOOD GLUCOSE METER (K964630) | Bayer Corp. | 1997-02-10 |
| VINYL PATIENT EXAMINATION GLOVES (K964629) | Arista Medi Prima | 1997-02-10 |
| WHITE CORE (K964931) | Bisco, Inc. | 1997-02-10 |
| CVP POLYURETHANE CATHETER (K961552) | Abbott Laboratories | 1997-02-10 |
| SPLINE X ENDOSSEOUS DENTAL IMPLANT SYSTEM (K962576) | Calcitek, Inc. | 1997-02-10 |
| SHEATHES (NON-LATEX) (K963831) | Medical Resources | 1997-02-10 |
| ROUND DENTAL BUR (K964944) | Steri-Oss, Inc. | 1997-02-10 |
| ELECSYS CALCHECK ESTRADIOL (K970148) | Boehringer Mannheim Corp. | 1997-02-10 |
| AMBIDERM (WHITE POW LATEX EXAM GLOVES W/ PROTEIN) (K963866) | Supertex Industrial, S.A. DE C.V. | 1997-02-10 |
| PARASCAN SCANNING DEVICE (K964520) | Laserscope | 1997-02-10 |
| PROTEC (1024) (K963730) | Proportional Technologies, Inc. | 1997-02-10 |
| PATIENT EXAMINATION GLOVES : NITRILE EXAMINATION GLOVES (K963804) | Hartalega Sdn Bhd | 1997-02-10 |
| IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM) (K963868) | Beckman Instruments, Inc. | 1997-02-10 |
| RECOVER INFANT HEEL WARMER (5100) (K964523) | Florida Medical Industries, Inc. | 1997-02-10 |
| ANTI-VIMENTIN PRIMARY ANTIBODY (K941397) | Ventana Medical Systems, Inc. | 1997-02-10 |
| CIPROFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K964492) | Unipath , Ltd. | 1997-02-07 |
| CEFEPINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K964495) | Unipath , Ltd. | 1997-02-07 |
| DELTA N95 RESPIRATOR (K964722) | Racal Filter Technologies, Inc. | 1997-02-07 |
| REMEL STAPH LATEX KIT (K964315) | Remel, L.P. | 1997-02-07 |
| NORFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K964491) | Unipath , Ltd. | 1997-02-07 |
| AZTREONAM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K964490) | Unipath , Ltd. | 1997-02-07 |
| MITRAFLEX PIGMENTED WOUND DRESSING (K964701) | Polymedica Industries, Inc. | 1997-02-07 |
| FEMEXAM TESTCARD (K962718) | Litmus Concepts, Inc. | 1997-02-07 |
| SUTURE APPLICATOR (K964672) | Laurus Medical Group | 1997-02-07 |
| IMIPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K964487) | Unipath , Ltd. | 1997-02-07 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K964964) | Sunmax Enterprise Shanghai Co. , Ltd. | 1997-02-07 |