| AARON 1200 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A1200 AARON 1200 HIGH FREQUENCY ELECTROSURGICAL GENERATOR MOD (K981570) | Aaron Medical Industries | 1998-09-14 |
| MONOPOLAR SUCTION COAGULATOR, MODEL # SB 110-1 (K982746) | New Deantronics Taiwan , Ltd. | 1998-09-14 |
| CONCISE COMPRESSION HIP SCREW SYSTEM (STERILE) (K982390) | Wrightmedicaltechnologyinc | 1998-09-14 |
| AEROTEE, MODEL # 1001 (K982408) | Piper Medical Products | 1998-09-14 |
| DEPUY MOTECH MOSS MIAMI SPINAL SYSTEMS (K982511) | Depuy, Inc. | 1998-09-14 |
| CHEMICAL CURE COMPOSITE WITH ENAMEL BOND (K982191) | Medental Intl. | 1998-09-14 |
| OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL (K982601) | Osteonics Corp. | 1998-09-14 |
| ULMER (VNG) VIDEO NYSTAGMOGRAPH (K982103) | Synapsys, Inc. | 1998-09-11 |
| ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING (K982083) | Guidant Corp. | 1998-09-11 |
| KELLER PULSE OXIMETER, MODEL 850+ (K982331) | Keller Medical Specialties Products, Inc. | 1998-09-11 |
| MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT (K982894) | Ballard Medical Products | 1998-09-11 |
| DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON, 2 PIECE WITH AND WITHOUT HOLSTER, MODELS SB 312PB, SB 312 PBH (K982744) | New Deantronics Taiwan , Ltd. | 1998-09-11 |
| LACTATE PRO SYSTEM (K980908) | Kdk Corp. | 1998-09-11 |
| ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522 (K982216) | Braebon Medical Corp. | 1998-09-11 |
| RANDOX DIRECT LDL CHOLESTEROL (K982529) | Randox Laboratories, Ltd. | 1998-09-11 |
| INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (HEPARIN COATED) (K980578) | Innerdyne, Inc. | 1998-09-11 |
| FOAM TIP INJECTOR (K980696) | Staar Surgical Co. | 1998-09-11 |
| VENTRIX SUBDURAL TUNNELING PRESSURE MONITORING KIT MODEL NL950-SD (K982702) | Camino Neurocare, Inc. | 1998-09-10 |
| VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEM (K982397) | Angiolaz, Inc. | 1998-09-10 |
| CETYLCIDE-G (K974188) | Kellerandheckman | 1998-09-10 |
| SURGEON'S GLOVE (K982589) | Shiva Medicare , Ltd. | 1998-09-10 |
| LAPARO CO2-PNEU (AND WITH VIDEO MONITORING) (K981334) | Richard Wolf Medical Instruments Corp. | 1998-09-10 |
| COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD (K982254) | Cobe Cardiovascular, Inc. | 1998-09-10 |
| DIGITAL IMAGING SYSTEM, MODELS DIGITREX-1000 AND DIGITREX-2000 (DIGITREX-X000 FAMILY) (K982120) | Trex Medical Corp. | 1998-09-10 |
| BARD PROFORMA AND APOLLO PRE-CURVED PAPILLOTOMES (K982557) | Bard Interventional Products Div. | 1998-09-10 |
| URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING (K981344) | Uresil Corp. | 1998-09-10 |
| CAPIOX SX HARDSHELL RESEVOIR (K982223) | Terumo Medical Corp. | 1998-09-10 |
| CYNOSURE CO3 ER:YAG LASER (K983034) | Cynosure, Inc. | 1998-09-10 |
| SMITH & NEPHEW DYONICS MICROLAPAROSCOPE (K982149) | Smith & Nephew, Inc. | 1998-09-10 |
| SYNOX SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , MODELS 120 444, 119 684, 120 438 AND 120 143 (K980869) | Biotronik, Inc. | 1998-09-10 |
| SPARFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K982526) | Oxoid , Ltd. | 1998-09-09 |
| AMOXICILLIN/CLAVULANIC ACID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K982524) | Oxoid , Ltd. | 1998-09-09 |
| NAFCILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K982528) | Oxoid , Ltd. | 1998-09-09 |
| HP M2600A VIRIDIA TELEMETRY SYSTEM (FORMERLY KNOWN AS THE HP 2600A OMNI-CARE TELEMETRY SYSTEM) (K980429) | Hewlett-Packard Co. | 1998-09-09 |
| CEFPROZIL ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K982517) | Oxoid , Ltd. | 1998-09-09 |
| SULFISOXAZOLE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K982523) | Oxoid , Ltd. | 1998-09-09 |
| MAXAIR NASAL DILATOR SYSTEM (K982929) | Hnl Technologies | 1998-09-09 |
| OXOID STREPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K982669) | Oxoid , Ltd. | 1998-09-09 |
| LIGHT SABER BONE BIOPSY NEEDLE (K982735) | Minrad, Inc. | 1998-09-09 |
| CEFONICID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K982520) | Oxoid , Ltd. | 1998-09-09 |
| LEVOFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K982519) | Oxoid , Ltd. | 1998-09-09 |
| JUMBO SILVER-REINFORCED GLASS IONOMER (K982665) | Centrix, Inc. | 1998-09-08 |
| OCULIGHT GL WITH THE DERMATOLOGY HANDPIECE (K982031) | Iridex Corp | 1998-09-08 |
| ATRISORB BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER KIT (K982865) | Atrix Laboratories, Inc. | 1998-09-08 |
| BWM SPINE SYSTEM (K982494) | Howmedica Corp. | 1998-09-08 |
| ISLAND BIOSURGICAL BLADDER NECK BOLSTR MODEL IBIBOL.002 (K982042) | Island Biosurgical, Inc. | 1998-09-08 |
| PROXIDERM, MODELS TN 460, TN 90 460, BK 460 (K982439) | Progressive Surgical Products, Inc. | 1998-09-08 |
| MAMMARY SIZER (K982258) | Specialty Surgical Products, Inc. | 1998-09-08 |
| ACCUPROBE 800 SERIES MODEL NUMBERS : 810, 820, 830, 840, 850, 860, 870 AND 880 (K982055) | Cryomedical Sciences, Inc. | 1998-09-08 |
| AL-GEN CALCIUM ALGINATE DRESSING (K982234) | Innovative Technologies , Ltd. | 1998-09-08 |
| MIDAS TOUCH BIPOLAR FORCEPS (K982705) | Iti Medical Technologies, Inc. | 1998-09-08 |
| ENDO ABSORBABLE INTERFERENCE SCREW (K980457) | Endo Surgical Concepts, Inc. | 1998-09-08 |
| RADIAL HEAD IMPLANT (K982288) | Avanta Orthopaedics, Inc. | 1998-09-08 |
| ALIGN SYSTEM (K981095) | Align Technology | 1998-09-08 |
| MODULAP (K982445) | Atc Medical Technology, Inc. | 1998-09-08 |
| MEDPOR SURGICAL GRANULE IMPLANTS (K982040) | Porex Surgical, Inc. | 1998-09-08 |
| QUICK TAP SELF DRILLING SCREW (K982927) | Kinamed, Inc. | 1998-09-08 |
| AQUACEL HYDROFIBER WOUND DRESSING (K982116) | Convatec, A Bristol-Myers Squibb Co. | 1998-09-08 |
| PROSTATE BIOPSY NEEDLE (K982401) | Remington Medical, Inc. | 1998-09-08 |
| CARDIOVIEW 3000 SOFTWARE (K974352) | Micromedical, Inc. | 1998-09-08 |
| IPS EMPRESS 2 (K982616) | Ivoclar North America, Inc. | 1998-09-08 |
| ALBATECH PERSONAL MONITOR (K981999) | Albatech, Inc. | 1998-09-04 |
| EVITA 4 (8411900) (K980642) | Drager, Inc. | 1998-09-04 |
| MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER (K982883) | Medtronics Interventional Vascular | 1998-09-04 |
| COLLEAGUE PUMP SYRINGE ADAPTER SET (K982672) | Baxter Healthcare Corp | 1998-09-04 |
| PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT (K982023) | Inova Diagnostics, Inc. | 1998-09-04 |
| VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE (K981314) | Sun Biomedical Laboratories, Inc. | 1998-09-04 |
| STOCKERT COMPACT SYSTEM (K982014) | Stoeckert Instrumente | 1998-09-04 |
| FLOW 7000 PERIPHERAL VASCULAR COIL (K982339) | Usa Instruments, Inc. | 1998-09-04 |
| FRIALIT-2 CORABASE (K980630) | Friatec AG | 1998-09-04 |
| FLUID CONTROL (K982117) | T.A. Coleman Ent. | 1998-09-04 |
| SINGLEDAY INFUSOR 2 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL, INFUSOR SV 5 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL CY (K982102) | Baxter Healthcare Corp | 1998-09-04 |
| HEARTPORT ENDOPULMONARY VENT CATHETER (K981009) | Heartport, Inc. | 1998-09-04 |
| AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM (K982088) | Ortho Kinetics Corp. | 1998-09-04 |
| BIOSENSORS EMBOLECTOMY CATHETER (K973477) | Sunscope Intl., Inc. | 1998-09-04 |
| HEWLETT-PACKARD M2475B WITH 12-LEAD OPTION (#C90) CODEMASTER 100 CONITOR/DEFIBRILLATOR (K982025) | Hewlett-Packard Co. | 1998-09-04 |
| NIM4 (K982595) | Xomed, Inc. | 1998-09-04 |
| MODIFICATION TO ALLIGER ULTRASONIC SURGICAL SYSTEM, MODEL AUSS-4 (K982841) | Misonix, Inc. | 1998-09-04 |
| BINDAZYME ANTIGLIADIN IGG/IGA COMBI KIT (K981929) | The Binding Site, Ltd. | 1998-09-03 |
| N-ASSAY GLU-UL (K980883) | Crestat Diagnostics, Inc. | 1998-09-03 |
| BINDAZYME ANTIGLIADIN IGG (K981644) | The Binding Site, Ltd. | 1998-09-03 |
| SANGUI BIOTECH, INC. CALCITONIN ELISA KIT (K982491) | Sangui Biotech, Inc. | 1998-09-03 |
| SYSTEM U3 FOR CIPROFLOXACIN (K981639) | Ab Biodisk | 1998-09-03 |
| ELECTROSURGICAL UNIT (ESU) (115 VOLT) MODEL 4810, ELECTROSURGICAL UNIT (ESU) (230 VOLT) MODEL 4811, INSTRUMENT CABLE, 19 (K981981) | Boston Scientific Corp | 1998-09-03 |
| SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM (K981973) | Ram Scientific | 1998-09-03 |
| ACCU-CHEK ADVANTAGE TEST STRIPS AND ACCU-CHEK ADVANTAGE H TEST STRIPS (K982089) | Boehringer Mannheim Corp. | 1998-09-03 |
| VASCATH OPTI-FLOW LONG TERM DUAL LUMEN HEMODIALYSIS CATHETER (K981994) | C.R. Bard, Inc. | 1998-09-03 |
| MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY (K982709) | Alexon - Trend, Inc. | 1998-09-03 |
| PYRAMID (K982645) | Bisco, Inc. | 1998-09-02 |
| ACCU-CHEK COMFORT CURVE TEST STRIP (K982002) | Boehringer Mannheim Corp. | 1998-09-02 |
| WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS (K982005) | Boston Scientific Scimed, Inc. | 1998-09-02 |
| MEDSCI 3% GLUTARALDEHYDE (K974062) | Medsci, Inc. | 1998-09-02 |
| ALGETRAL, CAVEX CHROMATIC, CA 37 SUPERIOR PINK, CA 37 FAST SET, CAVEX RAINBOW, CAVEX IMPRESSIONAL NORMAL SETTING, CAVEXI (K981970) | Cavex Holland BV | 1998-09-02 |
| VOLUMAX CT IMAGING SYSTEM (K982060) | Elscint, Inc. | 1998-09-02 |
| NUCAMMA RX (K982045) | Is2 Research, Inc. | 1998-09-02 |
| OMNI PRO LATEX SURGICAL GLOVE, POWDERED (K982613) | Omnigrace (Thailand) , Ltd. | 1998-09-02 |
| TREX MRI MAGNETIC RESONANCE DIAGNOSTIC DEVICE (K982157) | Field Effects | 1998-09-02 |
| AESCULAP HILAN MOTOR SYSTEM (K980686) | Aesculap, Inc. | 1998-09-02 |
| PHILIPS BV300 SERIES RELEASE 2.1 (K982706) | Philips Medical Systems, Inc. | 1998-09-02 |
| SOFT (HYDROPHILIC) CONTACT LENSES (K982774) | Cl-Tinters | 1998-09-02 |