| KSEA C.C.L. VAGINAL EXTRACTOR AND ACCESSORIES (K962985) | KARL STORZ Endoscopy-America, Inc. | 1997-12-19 |
| SKYVAL (K973610) | Pyramid Air Systems | 1997-12-19 |
| TOMCAT GUIDE WIRE, EXTENDER WIRE, GUIDE WIRE EXTENSION TOOL (K973708) | Merit Medical Systems, Inc. | 1997-12-19 |
| COBAS INTEGRA HDL-CHOLESTEROL DIRECT (K973284) | Roche Diagnostic Systems, Inc. | 1997-12-18 |
| SNOREX (K971818) | Snorex (Nz) , Ltd. | 1997-12-18 |
| DIGITAL ADD ON MULTI SYSTEM (K973710) | Swissray International, Inc. | 1997-12-18 |
| POLYMER NITRILE EXAMINATION GLOVES (K974185) | Sri Johani Sdn. Bhd. | 1997-12-18 |
| DERMACLEAN STERILE (PROTEIN LABELING CLAIM) EXAM GLOVES (K974218) | Ansell Perry | 1997-12-18 |
| IDA-4 AND IPT-MC (K973609) | Bio-Tek Instruments, Inc. | 1997-12-18 |
| MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE (K973913) | Pwa Industries Sdn. Bhd. | 1997-12-18 |
| AQUA PATCH (K973693) | Pci Technology | 1997-12-18 |
| POLYMER NITRILE EXAMINATION GLOVES (BLUE COLOUR) (K974183) | Sri Johani Sdn. Bhd. | 1997-12-18 |
| DASH, VITAL GARD (K974114) | Dash Medical Gloves Sdn Bhd | 1997-12-18 |
| IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULE (K974396) | Diametrics Medical, Inc. | 1997-12-18 |
| BIPOLAR ARTHROSCOPIC PROBE, STRAIGHT, BIOPOLAR ARTHROSCOPIC PROBE, ANGLED, BIPOLAR ARTHROSCOPIC PROBE, STRAIGHT, (K973682) | Electroscope, Inc. | 1997-12-18 |
| BOUSER'S URINAL (K970465) | General Polymers | 1997-12-18 |
| SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE (K974164) | Medical Device Consultants, Inc. | 1997-12-18 |
| CLEARFIELD ANTI-FOG STERILE WIPE, PRODUCT NUMBER 300-004 (K974454) | Tucson Medical Corp. | 1997-12-18 |
| FOUNDATION UNIPOLAR FEMORAL HEAD WITH MODULAR NECK LENGTH SLEEVES (K973614) | Encore Orthopedics, Inc. | 1997-12-18 |
| VINYL PATIENT EXAMINATION GLOVES (POWDERED) (K974151) | Shanghai Super Gloves Co., Ltd. | 1997-12-18 |
| FOUNDATION PLASMA SPRAYED METAL-BACKED PATELLA (K973672) | Encore Orthopedics, Inc. | 1997-12-18 |
| NITRILE, POWDER FREE, POLY COATED PATIENT EXAMINATION GLOVES (K974223) | Derlin Company , Ltd. | 1997-12-18 |
| SHANG HO (K970795) | Shang HO Industrial Corp. , Ltd. | 1997-12-18 |
| LATERAL FLARE INTERNAL COLLAR (LFIC) (K971900) | Pro-Lfic, LLC | 1997-12-18 |
| HIGH RISK POLYMER LATEX EXAMINATION GLOVES (BLUE COLOUR) (K974184) | Sri Johani Sdn. Bhd. | 1997-12-18 |
| STERITITE SEALED CONTAINERS MODEL SCO4Q (K974638) | Case Medical, Inc. | 1997-12-18 |
| COMBIDERM ACD (K973717) | Convatec, A Bristol-Myers Squibb Co. | 1997-12-17 |
| ALLOY PRIMER (K974089) | Kuraray America, Inc. | 1997-12-17 |
| PERCEPTION INC. GPS-XYZ DIAGNOSTIC ULTRASOUND SYSTEM (K972192) | Perception, Inc. | 1997-12-17 |
| EXTENSION SET WITH MICROBORE TUBING, EXTENSION SET WITH MICROBORE TUBING AND 0.2 U FILTER, EXTENSION SET WITH MICROBORE (K974013) | Sims Deltec, Inc. | 1997-12-17 |
| KNOLL/MIDUS (MALE IMPOTENCE DIAGNOSTIC ULTRASONIC SYSTEM) (K971790) | Urometrics, Inc. | 1997-12-17 |
| POWDERED NITRILE EXAMINATION GLOVES (BLUE COLOUR) (K974182) | Sri Johani Sdn. Bhd. | 1997-12-17 |
| ELECSYS CK-MB STAT (K974421) | Boehringer Mannheim Corp. | 1997-12-17 |
| PILOT TUBE REPAIR KIT (K973755) | Instrumentation Industries, Inc. | 1997-12-17 |
| DENT-TEMP ACRYLIC (K972198) | Health-Dent Intl., Inc. | 1997-12-17 |
| BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28) (K971242) | Ipax, Inc. | 1997-12-17 |
| ELEKTA ONCOLOGY SYSTEMS ICOM/QUICKMODE SOFTWARE OPTIONS (K973540) | Elekta Oncology Systems, Inc. | 1997-12-17 |
| POWDERFREE NITRILE EXAMINATION GLOVES (BLUE COLOUR) (K973903) | Sri Johani Sdn. Bhd. | 1997-12-17 |
| DUODERM EXTRA THIN CGF DRESSING (K973716) | Convatec, A Bristol-Myers Squibb Co. | 1997-12-17 |
| LACTEST I (K971944) | Jwt, Inc. | 1997-12-17 |
| IL TEST UREA NITROGEN (K974337) | Instrumentation Laboratory CO | 1997-12-17 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K974120) | Shanghai Super Gloves Co., Ltd. | 1997-12-17 |
| PULPDENT DENTASTIC UNO (K974014) | Pulpdent Corp. | 1997-12-17 |
| PROTOS 100ML BURETTE INFUSION SET/ PROTOS 150ML BURETTE INFUSION SET (K972839) | Globe Ent., Inc. | 1997-12-17 |
| MPORT FOLDABLE LENS PLACEMENT SYSTEM (K970727) | Chiron Vision Corp. | 1997-12-17 |
| VACUETTE MULTI-SAMPLE NEEDLE (K973620) | Greiner Meditech, Inc. | 1997-12-17 |
| CENTURY ALLOY (K974035) | Dentsply Intl. | 1997-12-17 |
| ULTRACELL SUCTION SPONGE (K972634) | Ultracell Medical Technologies, Inc. | 1997-12-17 |
| ULTRACELL SUCTION SPONGE (K972633) | Ultracell Medical Technologies, Inc. | 1997-12-17 |
| VASOCOR PVR 100 (K973659) | Vasocor, Inc. | 1997-12-17 |
| DBEST ONE-STEP HCG SERUM/URINE TEST (K973957) | Ameritek, Inc. | 1997-12-17 |
| MINI FORCEPS WITH HF, 3.5MM; MICRO FORCEPS WITH HF, 2MM (K973648) | Richard Wolf Medical Instruments Corp. | 1997-12-17 |
| IL TEST AMYLASE (K974125) | Instrumentation Laboratory CO | 1997-12-17 |
| PATHWAY ELECTROMYOGRAPH (K973537) | The Prometheus Group | 1997-12-17 |
| PRE-VIEW CHOLANGIOGRAPHY CLAMP (K973621) | Nashville Surgical Instruments | 1997-12-17 |
| POLYMER LATEX EXAMINATION GLOVES (K973904) | Sri Johani Sdn. Bhd. | 1997-12-17 |
| ELITE LIGHTWEIGHT WHEELCHAIR (K974197) | Jaken Co., Inc. | 1997-12-17 |
| ALERT (K974131) | Jeneric/Pentron, Inc. | 1997-12-17 |
| DAPELLE HAIR REMOVER (K973773) | Wellquest Intl., Inc. | 1997-12-17 |
| GORE RESOLUT XT REGENERATIVE MATERIAL (K973594) | W. L. Gore & Associates, Inc. | 1997-12-17 |
| SUPERSKIN (K972081) | Medlogic Global Corp. | 1997-12-17 |
| OLICON IMAGING SYSTEMS, INC. GATEWAY AND/OR SOFTWARE (K973793) | Olicon Imaging Systems, Inc. | 1997-12-17 |
| PROTOS I.V. ADMINISTRATION SET (15 DROPS/ML) I4070S/(60 DROPS/ML)I4670S PRELIMINARY (K972854) | Globe Ent., Inc. | 1997-12-17 |
| THERMO-STAT SYSTEM (K970367) | Aquarius Medical Corp. | 1997-12-17 |
| 3M DENT SYSTEM II PLUS (K973961) | 3M Company | 1997-12-17 |
| VIGIL LIPID CONTROL (K974452) | Beckman Instruments, Inc. | 1997-12-17 |
| KENDALL CURITY PETROLATUM GAUZE (K973511) | Kendall Healthcare Products Co. Div.Of Tyco Health | 1997-12-16 |
| MAURICE WORLDWIDE SHUNT SYSTEM (K973525) | Integra Neurocare, LLC | 1997-12-16 |
| TOF-WATCH (K972698) | Organon Teknika Corp. | 1997-12-16 |
| PRESTIGE AQUEOUS GLUCOSE CONTROL LOW, PRESTIGE AQUEOUS GLUCOSE CONTROL HIGH (K973676) | Sorrento Biochemical, Inc. | 1997-12-16 |
| PROTOS BLOOD TRANSFUSION SET (K972843) | Globe Ent., Inc. | 1997-12-16 |
| EXEL I.V. ADMINISTRATION SET (K963659) | Exel Intl. | 1997-12-16 |
| STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII) (K970714) | Stryker Instruments | 1997-12-16 |
| T-REX BIOPSY FORCEPS (K973818) | Boston Scientific Corp | 1997-12-16 |
| FLEXVIEW CO2 BLOWER WITH MIST (K973803) | Ethicon Endo-Surgery, Inc. | 1997-12-16 |
| ULTRALON POWDER FREE LATEX SURGICAL GLOVE (K973699) | Johnson & Johnson Medical, Inc. | 1997-12-16 |
| HEARTPORT ENDOAORTIC CLAMP CATHETER (K974175) | Heartport, Inc. | 1997-12-16 |
| OCU-GUARD ORBITAL IMPLANT WRAP, SUPPLE OCU-GUARD ORBITAL IMPLANT WRAP (K973552) | Bio-Vascular, Inc. | 1997-12-16 |
| N-TERFACE (K973538) | Winfield Laboratories, Inc. | 1997-12-16 |
| ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM DATA DOCK (K972473) | Lifescan, Inc. | 1997-12-16 |
| CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL) (K973919) | Medental Intl. | 1997-12-16 |
| BENEFIT B3--- SERIES (K974254) | M.C. Healthcare Products, Inc. | 1997-12-16 |
| BIRTHNET II PERINATAL PATIENT DATA MANAGEMENT SYSTEM (K965008) | Spacelabs Medical, Inc. | 1997-12-16 |
| ABCA-NT GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEM (K974322) | Europa Scientific, Ltd. | 1997-12-16 |
| ARAGO (K971118) | Premier Laser Systems, Inc. | 1997-12-16 |
| ULTRA + AQUEOUS GLUCLOSE CONTROL LOW ULTRA + AQUEOUS GLUCOSE CONTROL HIGH (K973678) | Sorrento Biochemical, Inc. | 1997-12-15 |
| BECKMAN CALIBRATOR 2 (CAL2) (K973932) | Beckman Instruments, Inc. | 1997-12-15 |
| COURIER ST BALLOON DILATATION CATHETER (K973008) | Boston Scientific Corp | 1997-12-15 |
| OPUS 2 - CANAL SERIES (ITC) (K974069) | Bernafon-Maico, Inc. | 1997-12-15 |
| KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317) (K973507) | Kendall Healthcare Products Co. Div.Of Tyco Health | 1997-12-15 |
| ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS (K973662) | Boehringer Mannheim Corp. | 1997-12-15 |
| OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC) (K974152) | Bernafon-Maico, Inc. | 1997-12-15 |
| OPUS 2 - FULL CONCHA SERIES - ITE (K974211) | Bernafon-Maico, Inc. | 1997-12-15 |
| DIASCAN AQUEOUS GLUCOSE CONTROL LOW, DIASCAN AQUEOUS GLUCOSE CONTROL HIGH (K973677) | Sorrento Biochemical, Inc. | 1997-12-15 |
| MINI TROCAR SLEEVE AND TROCARS 3.5 MM, MICRO TROCAR SLEEVE AND TROCARS 2 MM, DILATATION SLEEVE AND GUIDE ROD 2 MM TO 3.M (K973737) | Richard Wolf Medical Instruments Corp. | 1997-12-12 |
| ADVANCE MODULAR TIBIAL COMPONENT (K973524) | Wrightmedicaltechnologyinc | 1997-12-12 |
| DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLONAL ANTIBODY FOR IMMUNOENZYMATIC STAINING (K971905) | Dako Corp. | 1997-12-12 |
| SEEMOR - DISPLAY & PROCESSING PROGRAM EXECUTING ON PERSONAL COMPUTER SYSTEM (K973653) | Areeda Assoc., Ltd. | 1997-12-12 |
| RETINAL CUBE (K973950) | Applied Spectral Imaging , Ltd. | 1997-12-12 |
| SWIFT DELIVERY PRODUCT #300 (K973942) | Swift Delivery Products | 1997-12-12 |