| SHAH PERMAVENT (K974007) | Exmoor Plastics , Ltd. | 1997-12-12 |
| HOSPITAL'S CLAMP (K974227) | Gps | 1997-12-12 |
| NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES COLORED (K974518) | Yty Industry (Manjung) Sdn Bhd | 1997-12-12 |
| HI-TORQUE BALANCE GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDG (K973494) | Guidant Corp. | 1997-12-12 |
| SPECULITE (K963391) | Trylon Corp. | 1997-12-12 |
| ENDOSCOPICALLY DELIVERALBE ULTRASOUND POINT PORBE SYSTEM (ENDOSCOPY) (K971528) | Fujinon, Inc. | 1997-12-12 |
| CIRCUMCISION TRAY, CAT. NO. 70340 (K974286) | Trinity Laboratories, Inc. | 1997-12-12 |
| RESOUND STEALTH CIC (K974081) | Resound Corp. | 1997-12-12 |
| UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE (K974340) | Unitron Industries, Inc. | 1997-12-12 |
| SMART MOTORIZED VIEWER (K973965) | Smartlight, Ltd. | 1997-12-12 |
| MINXRAY HF100H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT (K973712) | Minxray, Inc. | 1997-12-12 |
| UNITRON MODEL SOUND F/XD PROGRAMMABLE (K974339) | Unitron Industries, Inc. | 1997-12-12 |
| UNITRON MODEL F/X PROGRAMMABLE (MINI BTE) (K974338) | Unitron Industries, Inc. | 1997-12-12 |
| HI-69E, HI-69N, HI-69P (K974129) | Rockwin Corp. | 1997-12-12 |
| HOSPITAL'S SPEC (K974228) | Gps | 1997-12-12 |
| COMPACT OR COMP-X (K972365) | Eurotec, S.R.L. | 1997-12-12 |
| RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER) (K974257) | Resound Corp. | 1997-12-12 |
| GREATBATCH SCIENTIFIC MR COMPATIBLE LAPAROSCOPES AND OPERATING LAPAROSCOPES (K972280) | Wilson Greatbatch Technologies, Inc. | 1997-12-11 |
| IVT 0.014 PTFE-COATED TRACKWIRE (K971688) | Boston Scientific /International Technologies | 1997-12-11 |
| MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG (K972887) | Medline Industries, Inc. | 1997-12-11 |
| FAVP: FEMORAL ARTERY VASCULAR PAD - MODEL NUMBER PAD2EK-01, PAD2EK-2X, PAD5EK-R, PAD5EK-RX, PAD6EK-F AND PAD6EK-FX (K964663) | Rmds, Inc. | 1997-12-11 |
| POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES (K973778) | Hartalega Sdn Bhd | 1997-12-11 |
| SOWELL COBALT-CHROME METAL ALLOY (K973567) | C.K. International Trading | 1997-12-11 |
| AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL (K973781) | Dentsply Intl. | 1997-12-11 |
| COURIER ST BALLOON DILATATION CATHETER (K972744) | Boston Scientific Corp | 1997-12-11 |
| EXPRESSE AND PREMIER POWERED BREAST PUMPS (K973501) | Ameda Medizintechnik AG | 1997-12-11 |
| LOW POWDER POLYMER LATEX EXAMINATION GLOVES (WITH PROTEIN LABELING CLAIM) (K973871) | Hartalega Sdn Bhd | 1997-12-11 |
| GERM TRAPPER SUCTION TUBE HOLDER (K972372) | Rzv Medical Specialties, Inc. | 1997-12-11 |
| SOWELL NICKEL-CHROME-MOLYBDENUM ALLOY (K973569) | C.K. International Trading | 1997-12-11 |
| HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL (K973927) | Hyunjae Corp. | 1997-12-11 |
| CRIT-LINE MONITOR (CLMIII) (K972470) | In-Line Diagnostics Corp. | 1997-12-11 |
| SOWELL NICKEL-CHROME NON-PRECIOUS METAL ALLOY (K973568) | C.K. International Trading | 1997-12-11 |
| ACCUSIGN DOA 2, ACCUSIGN DOA, ACCUSIGN BAR/BZO, BIOSIGN DOA 2, BIOSIGN BAR/BZO, FIRST CHECK PANEL 2 BAR/BZO, STATUS DS B (K974181) | Princeton BioMeditech Corp. | 1997-12-11 |
| ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL (K974261) | Boston Biomedica, Inc. | 1997-12-11 |
| URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K) (K970277) | Astoria-Pacific, Inc. | 1997-12-11 |
| HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEM (K970078) | Davol Inc., Sub. C. R. Bard, Inc. | 1997-12-11 |
| SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUM (K972979) | Smith & Nephew, Inc. | 1997-12-11 |
| KENDALL CURITY NON-ADHERING DRESSING (K973619) | Kendall Healthcare Products Co. Div.Of Tyco Health | 1997-12-10 |
| OSMOCYTE ISLAND WOUND DRESSING (K972150) | Procyte Corp. | 1997-12-10 |
| ALPHA MX (20)/ULTRA PC (30) (K970163) | Technical Medical Products, Inc. | 1997-12-10 |
| INVOTEC CLEAN PAD (K973580) | Invotec International, Inc. | 1997-12-10 |
| B.U.S. ENDOTRON (K972148) | Medicamat S.A. | 1997-12-10 |
| OSMOCYTE RA WOUND DRESSING (K972329) | Procyte Corp. | 1997-12-10 |
| TRIAGE CARDIAC CONTROLS, TRIAGE TROPONIN-I CONTROL, TRIAGE CK-MB CONTROL, TRIAGE MYOGLOBIN CONTROL (K974461) | Biosite Incorporated | 1997-12-10 |
| UAS ULTRASONIC ASPIRATOR SYSTEM (K971580) | Wells Johnson Co. | 1997-12-09 |
| ULTRACELL NEURO SPONGES (K973083) | Ultracell Medical Technologies, Inc. | 1997-12-09 |
| PENCIL-GRIP FNA SYRINGE HOLDER AND EFFORTLESS NEEDLE REMOVER (K972496) | Tao & Tao Technologyt, Inc. | 1997-12-09 |
| OSTEO BOS SYSTEM PRODUCT LINE EXTENSION (K973438) | Osteonics Corp. | 1997-12-09 |
| HEART PROTECTOR (VER 1996) (K965158) | N.P.N.T., Inc. | 1997-12-09 |
| VISTA HEAD MOUNTED DISPLAY (K973436) | Vista Medical Technologies, Inc. | 1997-12-09 |
| ELITE POWDER FREE POLYURETHANE SYNTHETIC SURGICAL GLOVE (K973461) | Ansell Perry | 1997-12-09 |
| ENFRESH TONGUE BRUSH (K973424) | Enfresh Products, LLC | 1997-12-09 |
| CLINITEX CAST PADDING (K973420) | Clinitex Medical Corp. | 1997-12-09 |
| TORNIER CEMENT RESTRICTOR (K973453) | Tornier | 1997-12-09 |
| CLINITEX STOCKINETTE (K973417) | Clinitex Medical Corp. | 1997-12-09 |
| COHERENT POPEYE OPHTHALMIC LASER SYSTEM, COHERENT POPEYE OPHTHALMIC LASER SYSTEM IN COMBINATION WITH THE COHERENT ARGONS (K973470) | Lumenis, Inc. | 1997-12-09 |
| EPULSE MODEL 2940 ER:ASER ER:YAG LASER SYSTEM (K973576) | Epulse Technologies, Inc. | 1997-12-09 |
| ORION MEDICAL INC. DISPOSABLE BRAIN BIOPSY NEEDLE FOR STEROTACTIC GUIDED BIOPSY (K974158) | Ortho Development Corp. | 1997-12-09 |
| SURGIFLATOR-30 (K973432) | W.O.M. World of Medicine GmbH | 1997-12-09 |
| LYOPLANT DURA SUBSTITUTE(VARIOUS) (K970851) | Aesculap, Inc. | 1997-12-09 |
| RANDOX BILIRUBIN (K973995) | Randox Laboratories, Ltd. | 1997-12-08 |
| FREEDOM (K973089) | Southern Dental Industries, Inc. | 1997-12-08 |
| ENDO ANALYZER, MODEL 8005 (K973439) | Sybron Dental Specialties, Inc. | 1997-12-08 |
| DUPLOJECT (0.5/1.0 ML, 2.0 ML, 5.0 ML) (K973510) | Immuno-U.S., Inc. | 1997-12-08 |
| MULTI (K974414) | Morning Calm Corp. | 1997-12-08 |
| ELECSYS CALCHECK VITAMIN B12 (K974383) | Boehringer Mannheim Corp. | 1997-12-08 |
| NATURAL-KNEE II CONSTRAINED KNEE SYSTEM (K973412) | Sulzer Orthopedics, Inc. | 1997-12-08 |
| SUNGLASSES (K973528) | Jeou Jeou Long Industrial Co., Ltd. | 1997-12-08 |
| MODEL IRC 1199 SCOUT NEBULIZER (K973468) | Invacare Corp. | 1997-12-08 |
| WAVE (K973091) | Southern Dental Industries, Inc. | 1997-12-08 |
| SOWELL PATENTED NON-PRECIOUS METAL ALLOY (K973566) | C.K. International Trading | 1997-12-08 |
| CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN (K974325) | Chiron Diagnostics Corp. | 1997-12-08 |
| OSTEONICS SERIES 7000 TOTAL KNEE AUGMENTED FEMORAL COMPONENT (K973406) | Osteonics Corp. | 1997-12-08 |
| FRAG COMMANDER (K973749) | Scieran Technologies, Inc. | 1997-12-08 |
| 3M CDI H/S CUVETTES WITH HEPARON TREATMENT (K973472) | 3M Healthcare | 1997-12-08 |
| CLEARVIEW BLOWER/MISTER (K973485) | Dlp, Inc. | 1997-12-08 |
| AL-47 TORIC (ISOFILCON) SOFT (TORIC) DAILY WEAR CONTACT LENS (K973847) | Martin Dalsing | 1997-12-08 |
| STAE (K973092) | Southern Dental Industries, Inc. | 1997-12-08 |
| COBE OPTIMA XP HOLLOW FIBER MEMBRANE OXYGENATOR (K963518) | Cobe Cardiovascular, Inc. | 1997-12-08 |
| AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10 (K974053) | Diagnostic Chemicals , Ltd. | 1997-12-08 |
| AL-47 (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & TINTED, LATHE-CUT FROM LENS BLANK) (K973967) | Alden Optical Labs., Inc. | 1997-12-08 |
| ELECSYS CALCHECK FOLATE (K974384) | Boehringer Mannheim Corp. | 1997-12-08 |
| MERIDIAN TITANIUM FEMORAL STEMS (K972228) | Howmedica, Inc. | 1997-12-05 |
| ETHICON NON-STICK BIPOLAR FORCEPS (K973384) | ETHICON, Inc. | 1997-12-05 |
| CP BREAST ARRAY COIL/MAGNETOM HARMONY/SYMPHONY SYSTEM (K973630) | Siemens Medical Solutions USA, Inc. | 1997-12-05 |
| ACCESS RADIOLOGY (FRAMEWAVE) TELERADIOLOGY IMAGE ACQUISITION AND DISTRIBUTION SYSTEM WITH PICTURE AND ARCHIVING COMMUNIC (K972925) | Access Radiology Corp. | 1997-12-05 |
| STERI-OSS 3.25 MM REPLACE(TITANIUM PLASMA SPRAYED) DENTAL IMPLANT (K973433) | Steri-Oss, Inc. | 1997-12-05 |
| TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (K973616) | Bayer Corp. | 1997-12-05 |
| OVAL SHAPES (K973385) | Technical Products, Inc. | 1997-12-05 |
| THE THERATEST EL-B2GP1 (IGM, IGG, IGA) AND EL-B2GP1SCR (K972790) | Theratest Laboratories, Inc. | 1997-12-05 |
| ADVANTAGE 3000 (K973355) | Advantage Medical Division of Cme Telemetrix | 1997-12-05 |
| ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30 (K974003) | Diagnostic Chemicals , Ltd. | 1997-12-05 |
| EL-B2GP1SCR (K973882) | Theratest Laboratories, Inc. | 1997-12-05 |
| ACCUWELL PHENYLALANINE ASSAY (K974047) | Neometrics, Inc. | 1997-12-05 |
| STERI-OSS 3.25 MM REPLACE(HYDROXYAPATITE-COATED)DENTAL IMPLANT (K973423) | Steri-Oss, Inc. | 1997-12-05 |
| IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE(2100{SIKARUS X86}/(1500{WINDOWS NT} (K973421) | Dejarnette Research Systems | 1997-12-05 |
| CARBON FIBER CONFORMAL COUCH TOP (K973842) | Medtec, Inc. | 1997-12-05 |
| SPHINCTEROTOME (K973826) | Boston Scientific Corp | 1997-12-05 |
| ACIST ANGIOGRAPHIC INJECTOR (K963982) | Invasatec | 1997-12-05 |
| PERSONAL INFUSOR (K971362) | Science Incorporated | 1997-12-04 |