| LYPHOCHEK WHOLE BLOOD METALS CONTROL LEVELS 1,2,3, MODELS 527, 528, 529 (K984477) | Bio-Rad | 1999-01-29 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE VERIFIERS, VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS (K990026) | Ortho-Clinical Diagnostics, Inc. | 1999-01-29 |
| NUPRO PROPHYLAXIS PASTE WITH FLOURIDE AND TRICLOSAN (K983966) | Dentsply Intl. | 1999-01-29 |
| ARCHITECT B12 MASTERCHEK, MODEL # 6C09-O5 (K984626) | Bio-Rad | 1999-01-29 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLS (K983674) | Ortho-Clinical Diagnostics, Inc. | 1999-01-29 |
| SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT (K984402) | Beckman Coulter, Inc. | 1999-01-29 |
| MECHANICAL WHEELCHAIR (K984354) | Colours 'N Motion | 1999-01-28 |
| VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT (K984303) | Ortho-Clinical Diagnostics, Inc. | 1999-01-28 |
| ABBOTT LIQUID AMMONIA CONTROL, MODEL #'S 1E93-01,1E94-01,1E95-01 (K990162) | Bio-Rad | 1999-01-28 |
| ASKINA HYDROCOLLOID/THIN (K973227) | B.Braun Medical, Inc. | 1999-01-28 |
| ABBOTT LIQUID CSF CONTROL, MODEL #'S 1E98-01, 1E99-01 (K990161) | Bio-Rad | 1999-01-28 |
| ACTIVX (K984367) | Adorno Rogers Technology | 1999-01-28 |
| BIRCOLL BALLOON DISSECTOR (K984448) | Wells Johnson Co. | 1999-01-28 |
| UALB (K983774) | Abbott Laboratories | 1999-01-28 |
| RDI DIRECT LDL CHOLESTEROL TEST (K984107) | Reference Diagnostics, Inc. | 1999-01-28 |
| ONCOLOGY PLUS POWDER FREE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING) (K972616) | Wembley Rubber Products (M) Sdn Bhd | 1999-01-27 |
| PLANMECA INTRACAM STATION (K984013) | Planmeca Oy | 1999-01-26 |
| ABBOTT LIQUID LIPIDS CHEMISTRY, MODEL #'S 3E18-01, 3E19-01 (K990150) | Bio-Rad | 1999-01-26 |
| CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING) (K972615) | Wembley Rubber Products (M) Sdn Bhd | 1999-01-26 |
| VAGABOND SOFT RESTRAINT SYSTEM (K982178) | Emergent Innovations, Ltd. | 1999-01-26 |
| ABBOTT LIQUID PEDIATRIC CHEMISTRY CONTROL, MODEL # 4E37-01, 4E38-01 (K990149) | Bio-Rad | 1999-01-26 |
| TEXTURED POWDER-FREE LATEX EXAM GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K983145) | Shen Wei (Usa), Inc. | 1999-01-26 |
| ENTAXIS NASAL PACKING (K984069) | Les Laboratorires Brothier, S.A. | 1999-01-25 |
| ABBOTT IMMUNOASSAY-MCC (LIQUID) CONTROL, MODEL NUMBER 6E20-10 (K990017) | Bio-Rad | 1999-01-25 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS AFP RANGE VERIFIERS (K990061) | Ortho-Clinical Diagnostics, Inc. | 1999-01-25 |
| POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE (K984127) | Kilang Barangan Getah Dioh | 1999-01-25 |
| POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON COLORED) (K984605) | Perusahaan Getah Asas Sdn. Bhd. | 1999-01-25 |
| ALLEGIANCE PORTA-WARM MATTRESS (K982652) | Allegiance Healthcare Corp. | 1999-01-21 |
| POWDER FREE LATEX EXAMINATION GLOVES (K983998) | Sri Anusham Rubber Industries Pvt., Ltd. | 1999-01-21 |
| LOPRO SILICONISED LOW PROTEIN POWDERFREE LATEX EXAMINATION GLOVES (K982114) | M/S Midland Latex Products , Ltd. | 1999-01-21 |
| NITRIKLEEN- NITRILE EXAMINATION GLOVE POWDER FREE (K983828) | Sinetimed Latex Sdn Bhd | 1999-01-21 |
| ECHO-COAT ULTRASOUND NEEDLES (K983647) | Sts Biopolymers | 1999-01-20 |
| LOVYTEX SND BHD POWDER-FREE POLYMER COATED LATEX EXAMINATION GLOVES (K984147) | Lovytex Sdn Bhd | 1999-01-20 |
| WAKO L-TYPE UIBC, WAKO UIBC CALIBRATOR (K984122) | Wako Chemicals USA, Inc. | 1999-01-20 |
| OPTUM, INTRAORAL CAMERA SYSTEM (K983739) | Camsight, Inc. | 1999-01-19 |
| WORLD CLASS WHEELED CHAIR, MODEL SS (K984457) | Suiter Medical LLC | 1999-01-19 |
| WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR (K984119) | Wako Chemicals USA, Inc. | 1999-01-15 |
| UNIK TONGUE CLEANER (K983683) | Unik Products, Inc. | 1999-01-14 |
| VINYL EXAMINATION GLOVES, PREPOWDERED USP (K984094) | Trans Ancient Products Co., Ltd. | 1999-01-14 |
| GLOVE SEAL D'PRO LATEX EXAMINATION GLOVE (K983570) | Glove Seal Sdn Bhd | 1999-01-14 |
| MAXIKLEEN-LATEX EXAMINATION GLOVE POWDER FREE (K983827) | Sinetimed Latex Sdn Bhd | 1999-01-14 |
| SENSIFLEX POWDERFREE SURGEON'S GLOVE (K982957) | Terang Nusa Sdn Bhd | 1999-01-13 |
| HEART-LIFT BALLOON POSITIONER (K982419) | Cardiothoracic Systems, Inc. | 1999-01-13 |
| MICROSTAT 2 (K984485) | Chemlink Laboratories, LLC | 1999-01-13 |
| MB/BACT BLOOD CULTURE BOTTLE (K983772) | Organon Teknika Corp. | 1999-01-13 |
| BLOSSOM POWDERED LATEX EXAMINATION GLOVES (K984040) | Mexpo Intl., Inc. | 1999-01-13 |
| OMNIGRIP, LATEX SURGICAL GLOVE, POWDER-FREE WITH PROTEIN LABELING CLAIM (K984066) | Omni Intl., Inc. | 1999-01-13 |
| BELMONT UNIT, MODEL 6000 SERIES AND 7500 SERIES (K983661) | Belmont Equipment Corp. | 1999-01-12 |
| STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEM (K984000) | Surgical Navigation Technologies, Inc. | 1999-01-12 |
| S555 INTRAORAL DENTAL CAMERA (K983625) | Sopro | 1999-01-11 |
| THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH (K984133) | Zeus Scientific, Inc. | 1999-01-11 |
| THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR (K984126) | Zeus Scientific, Inc. | 1999-01-11 |
| THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM. (K984153) | Zeus Scientific, Inc. | 1999-01-11 |
| DIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (ADHL) FLEX REAGENT CARTRIDGE (K983849) | Dade Behring, Inc. | 1999-01-11 |
| ULTRAFREE TEXTURED STERILE LATEX POWDER-FREE SURGICAL GLOVES (K983962) | Cardinal Health,Medical Products and Services | 1999-01-08 |
| MAXXIM; MAXXIM HD (K984493) | Major Mobility Products, Inc. | 1999-01-08 |
| MODEL ACTION AT II MANUAL WHEELCHAIR (K984447) | Invacare Corp. | 1999-01-08 |
| EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC) (K982754) | A.Stein - Regulatory Affairs Consulting | 1999-01-08 |
| STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS (K983574) | Dentalez Group | 1999-01-08 |
| NITRILE PATIENT EXAMINATION GLOVE, BLUE OR GREEN COLORED (PREPOWDERED USP) (K984356) | Perusahaan Getah Asas Sdn. Bhd. | 1999-01-08 |
| OMNIGRIP, LATEX SURGICAL GLOVE, POWDER FREE (K984064) | Omni Intl., Inc. | 1999-01-08 |
| PALL DENTAL FILTRATION SYSTEM WITH AIR WATER SYRINGE HOUSING AND FILTER MEMBRANE (K983735) | Pall Medical | 1999-01-07 |
| ACETAL DENTAL/PREFORMED CLASP (K983558) | Dentamax, Inc. | 1999-01-07 |
| COMFEEL SEASORB DRESSING (K983519) | Coloplast Corp. | 1998-12-30 |
| MOUNTABLE ENDOSCOPIC KNIFE (K982142) | A.M. Surgical, Inc. | 1998-12-30 |
| AGATHA-A-H2010 (K983374) | Midian Intl. | 1998-12-23 |
| POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K982897) | Pt. Maja Agung Latexindo | 1998-12-23 |
| POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LABELLING CLAIM (50 MICROGRAMS OR LESS) (K984019) | Kossan Latex Industries(M)Sdn Bhd | 1998-12-23 |
| POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (150 MICROGRAMS OR LESS) (K984020) | Kossan Latex Industries(M)Sdn Bhd | 1998-12-23 |
| PROGUARD, RR-1, RR-2 (K982832) | Emerson & Co. Srl | 1998-12-23 |
| MICRATOME MS7000 -ADVANCED CORNEAL/REFRACTIVE INSTRUMENTATION (ACRI) (K981554) | Micra Instruments , Ltd. | 1998-12-22 |
| SUMMIT KRUMEICH-BARRAQUER MICROKERATOME (K980675) | Summit Technology, Inc. | 1998-12-22 |
| ARCHITECT FREE T3 MASTERCHECK, MODEL NUMBER 6C48-05 (K984319) | Bio-Rad | 1998-12-22 |
| CROSSLAPS ELISA (K972788) | Devices and Diagnostics Consulting Group | 1998-12-22 |
| ARCHITECT TOTAL T3 MASTERCHECK, MODEL NUMBER 6C51-05 (K984327) | Bio-Rad | 1998-12-22 |
| MODEL MS-1 HANDPIECE (K983413) | Parkell, Inc. | 1998-12-21 |
| LATEX PATIENT EXAMINATION GLOVE, CAT. NO. 1000M POWDERED (K982901) | Vitalcare Group, Inc. | 1998-12-21 |
| OSTAR D'PRO LATEX POWDERED EXAMINATION GLOVES, PROTEIN CLAIM OF 100 MCGM OR/LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER (K983568) | Contract Latex Dippers Sdn Bhd | 1998-12-21 |
| PALL DENTAL FILTRATION SYSTEM WITH INLINE HANDPIECE HOUSING AND FILTER MEMBRANE (K983731) | Pall Medical | 1998-12-21 |
| NUVO BARRIER FILM (K980117) | Biomedical Development Co. | 1998-12-18 |
| MODIFICATION TO SKVEKPATCH (K984177) | Marine Polymer Technologies, Inc. | 1998-12-18 |
| SUPREME II CONTROL SOLUTIONS (K983432) | Chronimed, Inc. | 1998-12-17 |
| FASTTAKE ADAPTER, MODEL # P/N 020-072-01 (K983468) | Selfcare, Inc. | 1998-12-17 |
| MODIFICATION TO: PREMIER PLATINUM HPSA (K983255) | Meridian Diagnostics, Inc. | 1998-12-17 |
| ARCHITECT FERRITIN MASTERCHECK, MODEL NUMBER 6C11-05 (K984325) | Bio-Rad | 1998-12-17 |
| LYPHOCHEK TUMOR MARKER CONTROL, MODEL #580 (K983807) | Bio-Rad | 1998-12-16 |
| ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS (K973718) | Roche Molecular Systems, Inc. | 1998-12-15 |
| ARCHITECT FSH MASTERCHECK, MODEL NUMBER 6C24-05 (K984318) | Bio-Rad | 1998-12-15 |
| ARCHITECT PROLACTIN MASTERCHECK, MODEL NUMBER 6C27-05 (K984324) | Bio-Rad | 1998-12-15 |
| ARCHITECT LH MASTERCHECK, MODEL NUMBER 6C25-05 (K984323) | Bio-Rad | 1998-12-15 |
| LATEX POWDER FREE EXAMINATION GLOVES (K981942) | Maika Rubber Products Sdn Bhd | 1998-12-14 |
| LIQUICHEK SERUM VOLATILES CONTROL, MODELS 383 AND 384 (K984225) | Bio-Rad | 1998-12-14 |
| ESP7 VENOUS IMAGE (K982612) | Ironmaster, Inc. | 1998-12-14 |
| ENCORE MARK IV POWDER FREE POLYMER COATED LATEX SURGICAL GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE) (K983489) | Ansell Perry | 1998-12-14 |
| ELECSYS CALCHECK TROPONIN T (K984372) | Boehringer Mannheim Corp. | 1998-12-14 |
| SIRONA C8 DENTAL OPERATIVE UNIT WITH ACCESSORIES (K983242) | Sirona Dental Systems GmbH | 1998-12-11 |
| POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE (K983729) | Perusahaan Getah Asas Sdn. Bhd. | 1998-12-11 |
| INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX (K983200) | Ximed/Prosure/Injectx | 1998-12-11 |
| OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, BLUE (K983730) | Omnigrace , Ltd. | 1998-12-11 |
| POWER BLOCK (K983227) | Kreativ, Inc. | 1998-12-11 |