| SOLO-SLED (K970090) | Solo-Sled, LLC | 1997-04-21 |
| JANUS I (K963863) | 3D Ultrasound, Inc. | 1997-04-21 |
| AESCULAP ANGLED NEUROENDOSCOPES (K964281) | Aesculap, Inc. | 1997-04-21 |
| BTI DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM (K970897) | Biodynamic Technologies, Inc. | 1997-04-21 |
| RIGHT ANGLE LASER FIBERS;OPTILASE ND:YAG LASER;OPTILASE PL100 ND LASER SYSTEMS (K970422) | Trimedyne, Inc. | 1997-04-21 |
| HUMAN PROTEIN S RID TEST KIT (K951640) | The Binding Site, Ltd. | 1997-04-21 |
| SMARTSITE ACCESS PIN (K970485) | Ivac Medical Systems | 1997-04-21 |
| SIREGRAGH T.O.P. 33 AND SIREGRAPH T.O.P. 40 UNIVERSAL FLUOROSCOPIC X-RAY SYSTEMS (K970734) | Siemens Medical Solutions USA, Inc. | 1997-04-21 |
| AST OR SGOT (K971344) | Carolina Liquid Chemistries Corp. | 1997-04-21 |
| CAPNOCHECK PLUS (K970209) | Bci Intl., Inc. | 1997-04-18 |
| MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR (K961972) | Aequitron Medical, Inc. | 1997-04-18 |
| GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS (K955487) | Cobe Renal Care, Inc. | 1997-04-18 |
| QUARTET CLINICAL SYSTEM (K963761) | Respironics, Inc. | 1997-04-18 |
| QFC UMBILICAL CLAMP (K963889) | Qfc Industries | 1997-04-18 |
| POWERED TOOTHBRUSH (K970381) | Emjoi Action USA, Ltd. | 1997-04-18 |
| ALEXANDER BOX, BATTERY, RECHARGEABLE (K963305) | Alexander Mfg. Co. | 1997-04-17 |
| RAICHEM RHEUMATOID FACTOR SPIA (K970373) | Henage Diagnostics, Inc. | 1997-04-17 |
| LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4 (K970778) | More Diagnostics | 1997-04-17 |
| VS-100 VIDEO SIGMOIDOSCOPE (K970382) | Welch Allyn, Inc. | 1997-04-17 |
| SASI-DC1TS (K970580) | Substance Abuse Specialties, Inc. | 1997-04-17 |
| SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS (K971210) | Beckman Instruments, Inc. | 1997-04-17 |
| CHASE SUCKER (K971022) | Chase Medical, Inc. | 1997-04-17 |
| IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT (K965035) | Beckman Instruments, Inc. | 1997-04-17 |
| RESPOSABLE OMNI TIP(TM) SWITCHABLE TIPS (MULTIPLE) (K964585) | Trimedyne, Inc. | 1997-04-17 |
| GRAM SWAB (K970834) | Remel, Inc. | 1997-04-17 |
| OPTIVENT (K963793) | Health Care Products, Inc. | 1997-04-16 |
| PROXIDERM (D-460,D 90 460,D 180,460, PS 460) (K970439) | Progressive Surgical Products, Inc. | 1997-04-16 |
| CBC-4K HEMATOLOGY CONTROL (K970331) | R&D Systems, Inc. | 1997-04-16 |
| 700-MP DISPOSABLE RADIOLUCENT MULTI-PAD ELECTRODES (K970719) | Cardiotronics Systems, Inc. | 1997-04-16 |
| CHASE MULTIPLE PERFUSION SET (K964200) | Chase Medical, Inc. | 1997-04-16 |
| MODEL 1700 TRANQUILITY BILEVEL SYSTEM (K970173) | Healthdyne Technologies, Inc. | 1997-04-16 |
| SLIPPERY GLASS (K970941) | Jeneric/Pentron, Inc. | 1997-04-16 |
| PRECISE (K970827) | Allan Schulman,D.D.S., M.S. | 1997-04-16 |
| CABLE HOLDER, SUCTION TUBE HOLDER (K971040) | Contour Fabricators, Inc. | 1997-04-16 |
| SINUSCAN 102/SINUSPRINT (K960421) | Ferguson Medical | 1997-04-16 |
| PIXI BONE DENSITOMETER (K970224) | Lunar Corp. | 1997-04-16 |
| STATNET (K970525) | Gorca Systems, Inc. | 1997-04-16 |
| HANAULUX BLUE 80 HOSPITAL (K970886) | Heraeus Med GmbH | 1997-04-16 |
| INNOVASIVE 8MM LIGAMENT FASTENER (K970316) | Innovasive Devices, Inc. | 1997-04-16 |
| HEIDELBERG EXTERNAL FIXATOR (K970751) | Smith & Nephew, Inc., Orthopaedic Div. | 1997-04-16 |
| EDTA CAVIT (K970246) | Karolinski | 1997-04-16 |
| CHASE CURVED LEFT HEART VENT CATHETER (K964194) | Chase Medical, Inc. | 1997-04-16 |
| MINIMATIC VARIOUS IMPLANT SYSTEMS (K952905) | Minimatic, Inc. | 1997-04-16 |
| STRYKER STRYKEFLOW SUCTION IRRIGATOR GRAVITY FLOW (K963646) | Stryker Endoscopy | 1997-04-16 |
| HR POLYURETHANE PICC AND MIDLINE CATHETERS (K964556) | Johnson & Johnson Medical, Inc. | 1997-04-16 |
| SIMON NITINOL FILTER/STRAIGHT LINE SYSTEM (K970099) | Nitinol Medical Technologies, Inc. | 1997-04-16 |
| EXPANDED REFERENCE VALUES FOR DPX BON DENSITOMETERS (K964307) | Lunar Corp. | 1997-04-16 |
| BARD AND BTA TEST (K964151) | Bard Diagnostic Sciences,Inc. | 1997-04-16 |
| N-ASSAY TIA FIBRINOGEN TEST KIT (K965113) | Crestat Diagnostics, Inc. | 1997-04-16 |
| FOUNDATION INDIRECT COMPOSITE RESIN (K970495) | Sybron Dental Specialties, Inc. | 1997-04-16 |
| PICC CATHETER/MIDLINE CATHETER (K964447) | Menlo Care, Inc. | 1997-04-16 |
| CHASE AORTIC ARCH CANNULA (K964193) | Chase Medical, Inc. | 1997-04-16 |
| E-TYPE SPEED REDUCER CONTRA ANGLE (K970953) | Nsk Nakanishi, Inc. | 1997-04-15 |
| ROLL AID (K970164) | Stand Aid of Iowa, Inc. | 1997-04-15 |
| VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE-SMALL (K970602) | Hollister, Inc. | 1997-04-15 |
| CONTINUOUS FLUSH DEVICE (K962129) | Merit Medical Systems, Inc. | 1997-04-15 |
| IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT (K971192) | Impra, Inc. | 1997-04-15 |
| MODEL 1100 COLD THERAPY DEVICE (K970533) | Smith & Nephew, Inc. | 1997-04-15 |
| HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402) (K964382) | Gibeck, Inc. | 1997-04-15 |
| COMPRESSOR/NEBULIZER #3650 (K970289) | Devilbiss Health Care, Inc. | 1997-04-15 |
| EXL-12SP,12DP,15DP,20DP LINAC (K970137) | Mitsubishi Electronics America, Inc. | 1997-04-15 |
| EGS4000 (K955666) | S&P Electrical Industries, Inc. | 1997-04-15 |
| STEALTHSHIELD (K970755) | Vital Connections, Inc. | 1997-04-15 |
| EPIX VT (K970203) | Empi | 1997-04-14 |
| DISPENS-O-DISC SPARFLOXACIN (K971211) | Difco Laboratories, Inc. | 1997-04-14 |
| URIC, UA, OR URIC ACID (K971133) | Carolina Liquid Chemistries Corp. | 1997-04-14 |
| HERRICK ULTIMATE PUNCTUM PLUG (K963708) | Lacrimedics, Inc. | 1997-04-14 |
| DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE (K970330) | Dade Intl., Inc. | 1997-04-14 |
| PROFORM CEMENTED TITANIUM REVISION FEMORAL COMPONENT (K970194) | Stelkast Company | 1997-04-14 |
| RAPID DRUG SCREEN (K964900) | American Bio Medica Corp. | 1997-04-14 |
| DISPENS-O-DISC (TM) LEVOFLOXACIN (K971120) | Difco Laboratories, Inc. | 1997-04-14 |
| ARTHROCARE DERMATOLOGIC ELECTROSURGERY SYSTEM (K964849) | Arthrocare Corp. | 1997-04-14 |
| NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS (K964918) | Critical Device Corp. | 1997-04-14 |
| AQUALITE INTACT PTH (K970483) | Sealite Sciences, Inc. | 1997-04-14 |
| SNORE TEC (K963063) | Marketing Technologies, Inc. | 1997-04-14 |
| AMERIGEL OINTMENT (K970133) | Amerx Health Care Corp. | 1997-04-14 |
| HERRICK ULTIMATE PUNCTUM PLUG (K963501) | Lacrimedics, Inc. | 1997-04-14 |
| KIPP MED I.V. MANIFOLD (K970255) | The Kipp Group | 1997-04-14 |
| 3 DIMENSIONAL VIDEO ENDOSCOPE (K970214) | Oktas | 1997-04-14 |
| VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK (GEM.1075), TOTAL B-HCG CALIBRATORS (GEM.C075) (K970894) | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-04-14 |
| VISTA MINI CAMERA SYSTEM (K970369) | Oktas | 1997-04-14 |
| DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER (K962814) | Denver Biomaterials, Inc. | 1997-04-14 |
| PATIENT RESTRAINTS (K970274) | Fla Orthopedics, Inc. | 1997-04-11 |
| ISOCAM I (SINGLE HEAD GAMMA CAMERA)/ISOCAM II (DUAL HEAD GAMMA CAMERA) (K970128) | Park Medical Systems, Inc. | 1997-04-11 |
| VENISECT LASER LANCET (K955653) | Venisect, Inc. | 1997-04-11 |
| LEIBINGER IMF SCREW (K963030) | Howmedica Leibinger, Inc. | 1997-04-11 |
| PATIENT RESTRAINTS (K970273) | Fla Orthopedics, Inc. | 1997-04-11 |
| OLYMPUS NA-10J-1 ASPIRATION NEEDLE (K970563) | Olympus America, Inc. | 1997-04-11 |
| LEE PLATE (K970911) | Howmedica Leibinger, Inc. | 1997-04-11 |
| B. BRAUN MEDICAL INC. TRANSORBENT AND THINSITE BORDER DRESSING (K970453) | B.Braun Medical, Inc. | 1997-04-11 |
| DENTSPLY CAVITRON SPS SCALER SYSTEM (K970123) | Dentsply Intl. | 1997-04-11 |
| MICROVASIVE GOLD PROBE (K970278) | Boston Scientific Corp | 1997-04-11 |
| HYBRID RESIN COMPOSITE (K964867) | Parkell, Inc. | 1997-04-11 |
| IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM (K961924) | Irvine Biomedical, Inc. | 1997-04-11 |
| DERMA 20 LASER SYSTEM (K964253) | Esc Medical Systems , Ltd. | 1997-04-11 |
| SMF STAINLESS STEEL BONE SCREWS (K964261) | Synthes (Usa) | 1997-04-11 |
| PATIENT RESTRAINTS (K970275) | Fla Orthopedics, Inc. | 1997-04-11 |
| OLYMPUS UES-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES (K970184) | Olympus America, Inc. | 1997-04-11 |
| PATIENT RESTRAINT (K970272) | Fla Orthopedics, Inc. | 1997-04-11 |
| MYELOPEROXIDASE ELISA TEST SYSTEM (K964446) | Zeus Scientific, Inc. | 1997-04-10 |