| STERI-OSS' IMPROV TEMPORARY DENTAL CEMENT (K982400) | Steri-Oss, Inc. | 1998-09-23 |
| NBIL (K983134) | Abbott Laboratories | 1998-09-23 |
| ULTRA-COVER PU-TRANSDUCER COVER (K981069) | International Medical Products B.V. | 1998-09-23 |
| BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX (K982403) | Brennen Medical, Inc. | 1998-09-22 |
| DUAL PURPOSE CLOSED CATHETER (K982945) | Spirit Medical Systems, Inc. | 1998-09-22 |
| POLYTUBE (K982306) | Ferris Mfg. Corp. | 1998-09-22 |
| VTEC-RPLA SEIKEN (K981734) | Denka Seiken'S | 1998-09-22 |
| MAGNATEK80 (K983114) | Magna Advanced Technologies, Inc. | 1998-09-22 |
| OSTEO COMPRESSION HIP SCREW SYSTEM (K982553) | Osteonics Corp. | 1998-09-22 |
| WAKO DIRECT LDL-C (K982271) | Wako Chemicals USA, Inc. | 1998-09-22 |
| ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM (K982073) | Anchor Products Co. | 1998-09-22 |
| BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST (K980798) | Princeton BioMeditech Corp. | 1998-09-22 |
| VACUTAINER BRAND BLOOD COLLECTION SYRINGE (K982922) | Becton Dickinson Vacutainer Systems | 1998-09-22 |
| CHROMA ZONE COLOR STAIN (K982259) | Kuraray America, Inc. | 1998-09-22 |
| ELECSYS CALCHECK MYOGLOBIN (K983166) | Boehringer Mannheim Corp. | 1998-09-22 |
| ECTON LYNX ULTRASOUND SYSTEM (K982800) | Ecton, Inc. | 1998-09-22 |
| BIONECT HYDROGEL SPRAY (K973724) | Fidia Pharmaceutical Corp. | 1998-09-22 |
| SOFT TISSUE AUGMENTATION YUBE WITH INSERTION TOOL (K982475) | Tissue Technologies, Inc. | 1998-09-22 |
| ALM PRISMALIX (PRX) SURGICAL LIGHT (K982063) | Alm Surgical Equipment, Inc. | 1998-09-22 |
| JM-102 JAUNDICE METER (K972309) | Air-Shields, Inc. | 1998-09-22 |
| BIONECT HYDROGEL FOAM (K973722) | Fidia Pharmaceutical Corp. | 1998-09-22 |
| EASY TRANS TIP (K982565) | Carl Schuh | 1998-09-22 |
| KAPLAN PENDULASER 115 SURGICAL LASER WITH OPTOSCAN II (K980398) | Optomedic Medical Technologies , Ltd. | 1998-09-22 |
| OSTEONICS POLYETHYLENE ACETABULAR COMPONENTS (K974685) | Osteonics Corp. | 1998-09-22 |
| PREMIER AP (K982221) | American Imex | 1998-09-22 |
| SPLINE DENTAL IMPLANT SYSTEM-TEMPORARY ABUTMENT (K982305) | Sulzer Calcitek, Inc. | 1998-09-22 |
| FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTA (K980930) | Fibra Sonics, Inc. | 1998-09-22 |
| IMMUNODOT MONO-G TEST (K974226) | Genbio | 1998-09-22 |
| INSTACINE D-2000 (K983088) | Fidelity Medical, Inc. | 1998-09-22 |
| PHASER-2000 (K982546) | Diomedics, Inc. | 1998-09-22 |
| ASCENT SYSTEM (K982869) | Biomet, Inc. | 1998-09-22 |
| BIONECT CLEAR HYDROGEL (K973725) | Fidia Pharmaceutical Corp. | 1998-09-22 |
| BIONECT HYDROGEL GAUZE PADS (K973721) | Fidia Pharmaceutical Corp. | 1998-09-22 |
| KSEA FLIPPTACK (K982571) | KARL STORZ Endoscopy-America, Inc. | 1998-09-22 |
| IMMUNODOT MONO-M TEST (K974244) | Genbio | 1998-09-22 |
| KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M (K981260) | Clinical Innovations, Inc. | 1998-09-22 |
| MODIFICATION TO SYSTEM 83 PLUS (K983017) | Custom Ultrasonics | 1998-09-22 |
| BAYER ADVIA 60 HEMATOLOGY SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (K982802) | Bayer Corp. | 1998-09-22 |
| STRYKER URETERAL ILLUMINATOR SYSTEM III (K982542) | Stryker Endoscopy | 1998-09-22 |
| CAREGRAPH (K982319) | Siemens Medical Solutions USA, Inc. | 1998-09-22 |
| DIAMEDIX IS-CMV IGG TEST SYSTEM (K981163) | Diamedix Corp. | 1998-09-21 |
| UPRO (K981682) | Abbott Laboratories | 1998-09-21 |
| RAICHEM HDL-CHOLESTEROL DIRECT REAGENT, HDL-CHOLESTEROL CALIBRATOR (K982767) | Raichem | 1998-09-21 |
| PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM (K982394) | Dentsply Intl. | 1998-09-21 |
| QUICK SCREEN BARBITURATE SCREENING TEST MODELS 9020 AND 9021, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODL 9152 (K982152) | Phamatech | 1998-09-21 |
| QUADRATURE LOWER EXTREMITY COIL, MODEL # 473SI-42D (K982496) | Medical Advances, Inc. | 1998-09-18 |
| XOMED SILICONE PRE-FORM BLOCKS (K982294) | Xomed, Inc. | 1998-09-18 |
| MTEK-1400 (K982846) | Magna Advanced Technologies, Inc. | 1998-09-18 |
| KIRWAN SURGICAL PRODUCTS, INC. MODEL 28 1500 ELECTROSURGERY GENERATOR (K982176) | Kirwan Surgical Products, Inc. | 1998-09-18 |
| MANUAL RESUSCITATOR WITH ACE (K982215) | Medical Marketing Concepts | 1998-09-18 |
| FEMOSTOP II PLUS DISPOSABLE SET MODEL 11166, FEMOSTOP II PLUS COMPRESSION ARCH MODEL 11168, FEMOSTOP II BILATERAL ADAPT0 (K982182) | Radi Medical Systems AB | 1998-09-18 |
| RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES (K980816) | Fci Ophthalmics, Inc. | 1998-09-18 |
| IMMULITE OM-MA, MODELS LKOPZ, LKOP1, LKOP5 (K981297) | Diagnostic Products Corp. | 1998-09-18 |
| PERCUSSIVETECH HF, MODEL 2001 (K981726) | Vortran Medical Technology 1, Inc. | 1998-09-17 |
| HAMAMATSU PET SCANNER, MODEL SHR-22000 (K982171) | Hamamatsu Photonics K.K. | 1998-09-17 |
| 1 MASS TRANSIT INFUSION CATHETER, 1 VARIOUS (K983003) | Cordis Neurovascular, Inc. | 1998-09-17 |
| ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469 (K973448) | Beckman Instruments, Inc. | 1998-09-17 |
| ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT (K982121) | Trace Scientific , Ltd. | 1998-09-17 |
| TRUMIST AIR ENTRAINED DISPOSABLE NEBULIZER (K982179) | Trudell Medical | 1998-09-17 |
| MTEK-1000 (K982405) | Magna Advanced Technologies, Inc. | 1998-09-17 |
| TBIL (K983133) | Abbott Laboratories | 1998-09-16 |
| BIO-OSS COLLAGEN (K974399) | Geistlich-Pharma | 1998-09-16 |
| ORAL POTENTIAL METER (OPM) (K982105) | Pertec of Wisconsin, Inc. | 1998-09-16 |
| FAST-CATH INTRA-CARDIAC INTRODUCER (K982187) | Daig Corp. | 1998-09-16 |
| EUROMEDICAL HAEMATURIA FOLEY CATHETER (K973076) | Unomedical Sdn Bhd | 1998-09-16 |
| MINI POLYURETHANE CATHETER (K982507) | Med Institute, Inc. | 1998-09-16 |
| CLEAN SOURCE I, MODEL CS1000 (K981144) | Aquarius Technologies, Inc. | 1998-09-15 |
| VARIOUS DENTAL IMPLANTS (K982111) | Biotech Medical Instruments Corp. | 1998-09-15 |
| BIOSORBFX 1.5/2.0 BIOABSORBABLE FIXATION SYSTEM (K982139) | Bionx Implants, Inc. | 1998-09-15 |
| BIO-OSS ANORGANIC BOVINE BONE (K970321) | Geistlich-Pharma | 1998-09-15 |
| UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE (K981573) | United Biotech, Inc. | 1998-09-15 |
| ALLERGEN IMMUNOCAP MODELS D73, D74, E71, E72, E73, E74 E75, E76,E82,E88, F48, F90, F92, F96, F201, F215, M70, T17, T72,3 (K982343) | Pharmacia & Upjohn Co. | 1998-09-15 |
| BIOPAK MEASUREMENT SYSTEM (K981563) | Bio-Research Associates, Inc. | 1998-09-15 |
| PERIOVIEW MODEL DV-1 FIBERSCOPE AND WINDOW SHEATH. (K982480) | Dentalview, Inc. | 1998-09-15 |
| RENEW (K982729) | Bisco, Inc. | 1998-09-15 |
| HEMAPROMPT (K981661) | Aerscher Diagnostics | 1998-09-15 |
| SPECTRUM 800 CURING UNIT (K982318) | Dentsply Intl. | 1998-09-15 |
| HDLC PRECIPITATING REAGENT (K982539) | Ac Biochemicals, Inc. | 1998-09-15 |
| OSCILLOMATE EMS NIBP MONITOR MODEL 9001 (K982135) | Cas Medical Systems, Inc. | 1998-09-15 |
| FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX (K970700) | Fresenius USA, Inc. | 1998-09-15 |
| MONOPOLAR FOOT CONTROL PENCIL, MODEL # SB 112-2 (K982749) | New Deantronics Taiwan , Ltd. | 1998-09-14 |
| SHERLOCK THREADED SUTURE ANCHOR (TIN COATED) (K982169) | Doctor'S Research Group, Inc. | 1998-09-14 |
| DORNIER MEDILAS D (K982629) | Dornier Surgical Products, Inc. | 1998-09-14 |
| DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHOUT HOLSTER, MODEL #'S SB 313 PB, SB 313 PBH (K982743) | New Deantronics Taiwan , Ltd. | 1998-09-14 |
| FIBER OPTIC ENDOILLUMINATION PROBE (K982462) | Microvision, Inc. | 1998-09-14 |
| VISIVOX, MODEL V-2 (K982396) | Rsq, LLC | 1998-09-14 |
| SURGI STIM (K982388) | Vision Quest Industries, Inc. | 1998-09-14 |
| DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH, ONE PIECE AND ONE PIECE HOLSTER MODELS SB 313 RS, SB 313 RSH (K982742) | New Deantronics Taiwan , Ltd. | 1998-09-14 |
| PICTOOLS MEDICAL TOOL KIT MODEL 1.0 (K982146) | Pegasus Imaging Corp. | 1998-09-14 |
| DEPUY MOTECH PEAK FIXATION SYSTEM (K982483) | DePuy Orthopaedics, Inc. | 1998-09-14 |
| RETROGRADE ROD SYSTEM (K982602) | Howmedica Corp. | 1998-09-14 |
| DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM (K982320) | Depuy, Inc. | 1998-09-14 |
| DILKES LASER/SUCTION CANNULAE (K981143) | Exmoor Plastics , Ltd. | 1998-09-14 |
| LICHEN, BACTERIAL IN LINE BREATHING FILTER (K980662) | Dhd Healthcare Corp. | 1998-09-14 |
| CARBON DIOXIDE-SL ASSAY, CAT # 253-01 (K983019) | Diagnostic Chemicals , Ltd. | 1998-09-14 |
| DERMA K ER:YAG/CO2 LASER (K982827) | Esc Medical Systems, Inc. | 1998-09-14 |
| UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL (K972382) | Arrows Co., Ltd. | 1998-09-14 |
| VAXESS PERIPHERALLY INSERTED CENTRAL CATHETER (K980566) | Boston Scientific Corp | 1998-09-14 |
| DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH TWO PIECE, SB 312RS, TWO DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH (K982884) | New Deantronics, Ltd. | 1998-09-14 |
| OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS G2 AND G3 (K983127) | Medical Analysis Systems, Inc. | 1998-09-14 |