| 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 |
| NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES COLORED (K974518) | Yty Industry (Manjung) Sdn Bhd | 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 |
| 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 |
| RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER) (K974257) | Resound Corp. | 1997-12-12 |
| POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES (K973778) | Hartalega Sdn Bhd | 1997-12-11 |
| LOW POWDER POLYMER LATEX EXAMINATION GLOVES (WITH PROTEIN LABELING CLAIM) (K973871) | Hartalega Sdn Bhd | 1997-12-11 |
| HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL (K973927) | Hyunjae Corp. | 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 |
| 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 |
| 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 |
| CLINITEX STOCKINETTE (K973417) | Clinitex Medical Corp. | 1997-12-09 |
| MULTI (K974414) | Morning Calm Corp. | 1997-12-08 |
| ELECSYS CALCHECK VITAMIN B12 (K974383) | Boehringer Mannheim Corp. | 1997-12-08 |
| SUNGLASSES (K973528) | Jeou Jeou Long Industrial Co., Ltd. | 1997-12-08 |
| ELECSYS CALCHECK FOLATE (K974384) | Boehringer Mannheim Corp. | 1997-12-08 |
| ACCESS RADIOLOGY (FRAMEWAVE) TELERADIOLOGY IMAGE ACQUISITION AND DISTRIBUTION SYSTEM WITH PICTURE AND ARCHIVING COMMUNIC (K972925) | Access Radiology Corp. | 1997-12-05 |
| ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30 (K974003) | Diagnostic Chemicals , Ltd. | 1997-12-05 |
| IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE(2100{SIKARUS X86}/(1500{WINDOWS NT} (K973421) | Dejarnette Research Systems | 1997-12-05 |
| MECHANICAL FOLDING WHEEL CHAIR (K973491) | Heartway Medical Products Co., Ltd. | 1997-12-04 |
| KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING (K973509) | Kendall Healthcare Products Co. Div.Of Tyco Health | 1997-12-04 |
| POWDER-FREE EXAM GLOVES (K970773) | Pt. Sarana Indoprotex | 1997-12-04 |
| JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN (K973703) | Allegiance Healthcare Corp. | 1997-12-04 |
| TWEEZER-TYPE EPILATOR (K973340) | Mobit, Inc. | 1997-12-03 |
| SPECTRASCIENCE REUSABLE BIOPSY FORCEPS (K973611) | Spectrascience, Inc. | 1997-12-02 |
| BACT/ALERT FAN CULTURE BOTTLES (K973325) | Organon Teknika Corp. | 1997-12-02 |
| OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVE (K973463) | O Tech, Inc. | 1997-12-02 |
| INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450 (K972112) | Taut, Inc. | 1997-12-01 |
| BIODERM FOAM WOUND DRESSING (K973429) | Bioderm, Inc. | 1997-12-01 |
| GLENROE GLOW IN DARK ELASTOMERIC LIGATURES (K973495) | Glenroe | 1997-12-01 |
| NON-PRESCRIPTION SUNGLASSES (K974179) | Taipan Optical Company , Ltd. | 1997-12-01 |
| MEDI-DX 7000 (K964622) | Neuro-Diagnostic Assoc. | 1997-12-01 |
| SERUM HCG CONTROL SET (NEGATIVE, LOW POSITIVE AND HIGH POSITIVE) (K974108) | Quidel Corp. | 1997-11-26 |
| DICOM 3.0 SOFTWARE VERSION 2.0 (K973239) | Adac Laboratories | 1997-11-26 |
| IMATION MODEL 9410 NETWORK INTERFACE (K973303) | Imation Corp. | 1997-11-25 |
| STING SKIN PREP WIPE(59420600)/STING SKIN PREP SWAB (59420700) (K973228) | Smith & Nephew, Inc. | 1997-11-25 |
| ID. STORE (RELEASE 2.0) (K973413) | I.S.G. Technologies, Inc. | 1997-11-25 |
| 17 B-ESTRADIOL (ELISA) (K973901) | Kmi Diagnostics, Inc. | 1997-11-24 |
| ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM) (K973369) | Roche Diagnostic Systems, Inc. | 1997-11-21 |
| PROSTATE SEEDING NEEDLE (K973184) | Promex, Inc. | 1997-11-21 |
| HIGH RISK POWDERFREE LATEX EXAMINATION GLOVES (BLUE COLOUR) (K973801) | Sri Johani Sdn. Bhd. | 1997-11-21 |
| HIGH RISK POWDERED LATEX EXAMINATION GLOVES (BLUE COLOUR) (K973815) | Sri Johani Sdn. Bhd. | 1997-11-21 |
| QUICKIE ZIPPIE SERIES, QUICKIE BREEZY SERIES, QUICK FOLDING SERIES, QUICKIE RIGID SERIES (K973673) | Sunrise Medical, Inc. | 1997-11-20 |
| VENNETO (K974045) | Amsure Sports, Inc. | 1997-11-20 |
| DUAL RADIATION TARGETING SYSTEM DRTS DRAPE (K973162) | Hogan & Hartson | 1997-11-20 |
| MARKMAN TEMPLATE SYSTEM (K970306) | Barry Markman, M.D. | 1997-11-20 |
| IMTEC BONE COLLECTOR SYSTEM (K973248) | Imtec Corp. | 1997-11-19 |
| SKAR-KARE (K973271) | Target Health, Inc. | 1997-11-19 |
| GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE (K970619) | Wilson Greatbatch Technologies, Inc. | 1997-11-19 |
| CP&S INSTANT COLD PACK LIMB KIT TRANSPORTER (K974190) | Consolidated Products & Services, Inc. | 1997-11-19 |
| FUTURA 67M, 68M, MEGAPOWERMP97, INTEGRA 70,71,72,73, SUPRA 51,52, SUPRA 56,57,58,59, SUPREMA 45, 46, 47,48 (K973861) | Magnatone Hearing Aid Corp. | 1997-11-19 |
| VINYL PATIENT EXAMINATION GLOVES POWDERED (K973902) | Everrise Glove Products Co., Ltd. | 1997-11-18 |
| DISPOSABLE SILICONE EPISTAXIS CATHETER (K973656) | Specialty Surgical Products, Inc. | 1997-11-18 |
| SUNGLASSES (K973934) | Elegance Optical Manufactory, Ltd. | 1997-11-18 |
| OLYMPUS NA-10J-1 ASPIRATION NEEDLE (K973128) | Olympus America, Inc. | 1997-11-18 |
| VINYL PATIENT EXAMINATION GLOVES POWDER-FREE (K973998) | Everrise Glove Products Co., Ltd. | 1997-11-18 |
| Hi Coat Powder Free Latex Patient Examination Gloves (K972539) | P.T. Latexindo Tobaperkasa | 1997-11-18 |
| ULTRACELL PACKING WITH SLEEVE (K973085) | Ultracell Medical Technologies, Inc. | 1997-11-18 |
| BACT/ALERT CULTURE BOTTLES (K973305) | Organon Teknika Corp. | 1997-11-17 |
| SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER (K972109) | General Surgical Innovations | 1997-11-14 |
| RESTORE (A.K.A. CAPSURE) (K971359) | Nebl, Inc. | 1997-11-14 |
| PROGESTERONE ELISA (K973898) | Kmi Diagnostics, Inc. | 1997-11-13 |
| DHEA-S (K973897) | Kmi Diagnostics, Inc. | 1997-11-13 |
| EYE SYS VISTA (K973756) | Eyesys Technologies, Inc. | 1997-11-13 |
| PEDO CUSH PEDO CUDDLE (K972446) | Cavity Free Kids, Inc. | 1997-11-13 |
| ALLEGIANCE KWIK HEAT WARM PERINEAL PACK (K973770) | Allegiance Healthcare Corp. | 1997-11-13 |
| BONE GRAFT HARVESTER (K973560) | Ds Mfg., Inc. | 1997-11-12 |
| SIENET MAGICWEB (WEB SERVER), SIENET MAGICLINK I (ISI-GATEWAY) (K973131) | Siemens Medical Solutions USA, Inc. | 1997-11-12 |
| PATIENT NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED) (K973059) | Sri Johani Sdn. Bhd. | 1997-11-07 |
| PATIENT NITRILE EXAMINATION GLOVE (POWDERFREE) (K973058) | Sri Johani Sdn. Bhd. | 1997-11-07 |
| DADE TRU-LIQUID CARDIAC CONTROL (K973974) | Dade Intl., Inc. | 1997-11-06 |
| POLY (VINYL) EXAM GLOVE, POWDER-FREE (K972624) | Copioumed Intl., Inc. | 1997-11-06 |
| OMNI F.T. LATEX EXAMINATION GLOVE, POWDERED (K973134) | Omnigrace , Ltd. | 1997-11-06 |
| MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE (K973551) | Pwa Industries Sdn. Bhd. | 1997-11-06 |
| INVOTEC EAR TAMPON (WICK) W/STRING (K973578) | Invotec International, Inc. | 1997-11-06 |
| POWDER-FREE HYPOALLERGENIC NITRILE EXAMINATION GLOVES (K972090) | Shen Wei (Usa), Inc. | 1997-11-05 |
| PERFECT EAR/ MINI-CANAL/ PE-M, PE-ML, PE-MD), PERFECT EAR/ C.I.C./ (PEC, PE-CD) (WITH OR WITHOUT RID-WAX BARRIER) (K973972) | Perfect Ear | 1997-11-04 |
| Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30 (K974000) | Diagnostic Chemicals , Ltd. | 1997-11-04 |
| SERUM IRON-SL ASSAY, CATALOGUE NUMBERS 157-10, 157-30 (K973933) | Diagnostic Chemicals , Ltd. | 1997-11-04 |
| MUMPS IGG ELISA TESTY (K971857) | Gull Laboratories, Inc. | 1997-11-04 |
| MAGNATONE / STERLING/ ST; MAGNATONE/DB; MAGNATONE/ LIBERTY/ LB; MAGNATONE/ PEARL/PH C.I.C., S.P.I., ONE TOUCH, DESIGNER (K973665) | Magnatone Hearing Aid Corp. | 1997-11-04 |
| ELECSYS CALLCHECK DIGOXIN (K973973) | Boehringer Mannheim Corp. | 1997-11-04 |
| OTICON DIGISOUND COMPACT (K973886) | Oticon, Inc. | 1997-11-04 |
| OTICON DIGISOUND ITE (K973885) | Oticon, Inc. | 1997-11-04 |
| STABILIZER SOFT TISSUE ANCHOR 5MM MODEL TA1005, ANCHOR INSERTER/SUTURE ORGANIZER 5MM AI1005, STABILIZER DRILL 5MM NONSTE (K973031) | R. Thomas Grotz, M.D., Inc. | 1997-11-03 |
| CURVTEK TSR SYSTEM (K972860) | Biolectron, Inc. | 1997-10-31 |
| ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (K973743) | Beckman Instruments, Inc. | 1997-10-31 |
| SONIQUE HAIR REMOVER (K973174) | Global TV Concepts, Ltd. | 1997-10-30 |
| FEMINIQUE SONIC HAIR REMOVER (K973179) | Global TV Concepts, Ltd. | 1997-10-30 |
| SURGIC II IMPLANT CONTROL UNIT (K972924) | Nsk Nakanishi, Inc. | 1997-10-30 |