| CHASE LEFT VENT SAFETY VALVE (K964391) | Chase Medical, Inc. | 1997-05-13 |
| MBI CO-AXIAL ILLUMINATED RETINAL PICK (K964553) | M.B. Industries, Inc. | 1997-05-13 |
| CHASE CORONARY OSTIAL PERFUSION CANNULA (K971041) | Chase Medical, Inc. | 1997-05-13 |
| AURORA SUNGLASSES,SKI GOGGLES AND PROTECTIVE/SAFTEY GOGGLES (K970699) | Yeong Jiuh Corp. | 1997-05-13 |
| MEDLINE INDUSTRIES, INC. ORTHOPEDIC TRAYS/KITS/PACKS (K971208) | Medline Industries, Inc. | 1997-05-13 |
| MODIFICATION TO OTOACOUSTIC EMISSIONS (OAE0 TEST INSTRUMENT (K964132) | Bio-Logic Systems Corp. | 1997-05-13 |
| QUICKPAC II ONE STEP METHAMPHETAMINE TEST (K970724) | Drial Consultants, Inc. | 1997-05-13 |
| NUVO-LASE 660 LASER SYSTEM (K970667) | American Laser Medical | 1997-05-13 |
| MBI ILLUMINATED RETINAL PICK (K964405) | M.B. Industries, Inc. | 1997-05-13 |
| CHASE AORTIC PERFUSION CANNULA (K970914) | Chase Medical, Inc. | 1997-05-13 |
| SURESTEP PRO BLOOD GLUCOSE MONITORING SYSTEM (K970556) | Lifescan, Inc. | 1997-05-12 |
| BRAINLAB MICRO MULTI-LEAF COLLIMATOR (K970586) | Brainlab Med. Computersysteme GmbH | 1997-05-12 |
| DYNAMIC WEDGE (K970564) | Mitsubishi Electronics America, Inc. | 1997-05-12 |
| ODONT HEX SYSTEM (K961631) | Odontit S.A. | 1997-05-12 |
| GREINER VACUETTE BLOOD COLLECTION TUBE (K971239) | Greiner America, Inc. | 1997-05-12 |
| MEDLITE ND:YAG LASER SYSTEM: NEW DYE ACCESSORY HANDPIECE (K963340) | Continuum Biomedical, Inc. | 1997-05-12 |
| INNOFLOUR CALIBRATOR REAGENT SET (K970509) | Oxis Intl., Inc. | 1997-05-12 |
| INNOFLOUR TOPIRAMATE REAGENT SET (K970510) | Oxis Intl., Inc. | 1997-05-12 |
| DSL ACTIVE NON-EXTRACTION IGF-I ELISA (K971353) | Diagnostic Systems Laboratories, Inc. | 1997-05-12 |
| SPECTRUM DESIGNS SPECTRAGEL (K970702) | Spectrum Designs, Inc. | 1997-05-12 |
| GREINER VACUETTE BLOOD COLLECTION TUBE (K971236) | Greiner America, Inc. | 1997-05-12 |
| INNOFLUOR TOPIRAMATE CONTROL SET (K970517) | Oxis Intl., Inc. | 1997-05-12 |
| MEDISYSTEMS TRANDUCER PROTECTOR (K970536) | Medisystems Corp. | 1997-05-12 |
| MODEL DX MICRO COMPUTER CONTROL (K970094) | Invacare Respiratory Corp. | 1997-05-12 |
| GE ADVANTAGE DIGITIZER WORKSTATION (K970628) | Ge Medical Systems, Inc. | 1997-05-12 |
| OPTI-PLAST XL 5.5 F PTA CATHETER (K970725) | Vas-Cath, Inc. | 1997-05-09 |
| SYNTHES (U.S.A.) POLYPIN (K961608) | Synthes (Usa) | 1997-05-09 |
| FOTONA SKINSCAN (K970757) | Medical Laser Solutions | 1997-05-09 |
| TAYLOR SPATIAL FRAME EXTERNAL FIXATION SYSTEM (K970748) | Smith & Nephew, Inc., Orthopaedic Div. | 1997-05-09 |
| OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS (K970779) | Osteonics Corp. | 1997-05-09 |
| WS FREQUENCY SPECTRUM EFFECT PHYSIATRICS APPARATUS (K954577) | C.A.I. Industries Corp. | 1997-05-09 |
| HANNIBAL GUIDEWIRE (K970494) | Schneider (Europe) GmbH | 1997-05-09 |
| STAT PROFILE ULTRA M ANALYZER (K970710) | Nova Biomedical Corp. | 1997-05-09 |
| IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT (K964781) | Beckman Instruments, Inc. | 1997-05-09 |
| WINMAX SOFTWARE SYSTEMS (K965103) | Diagnostic Products Corp. | 1997-05-09 |
| NEUROMATE STEREOTACTIC SYSTEM (K963256) | Integrated Surgical Systems, S.A. | 1997-05-09 |
| HEARTPORT MAZE SYSTEM: CRYOPROBE SET (K970496) | Heartport, Inc. | 1997-05-09 |
| BLEDSOE COLD CONTROL (K964710) | Med Technology, Inc. | 1997-05-09 |
| UNIKA (K971327) | Eyewear Partners Co. | 1997-05-09 |
| ECLIPSE 400 MANUALLY OPERATED WHEELCAIR (K971389) | Pdg Product Design Group, Inc. | 1997-05-09 |
| COMBINATION OXIMETER/CARBON DIOXIDE GAS ANALYZER (K964239) | Spegas Industries, Ltd. | 1997-05-09 |
| SEE3 (LOTRAFILCON A) SOFT CONTACT LENS (K970746) | Ciba Vision Corporation | 1997-05-09 |
| VALUETRODE (K970426) | Axelgaard Mfg. Co., Ltd. | 1997-05-09 |
| T-RX RETRIEVAL FORCEPS (K970982) | Tri-Med Specialties, Inc. | 1997-05-09 |
| K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH (K970441) | Medi-Flex Hospital Products, Inc. | 1997-05-09 |
| TOMEY DTL ELECTRODE (K961805) | Tomey Corporation USA | 1997-05-09 |
| SULLIVAN AUTOSET HOME NASAL CPAP SYSTEM (K970516) | Resmed, Ltd. | 1997-05-09 |
| AD-TECH'S DEPTH ELECTRODE (K964644) | Ad-Tech Medical Instrument Corp | 1997-05-09 |
| PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT (K971048) | Bio-Vascular, Inc. | 1997-05-09 |
| AD-TECH SUBDURAL ELECTRODE (K970587) | Ad-Tech Medical Instrument Corp | 1997-05-09 |
| HEARTPORT THORACIC TROCAR (K964302) | Heartport, Inc. | 1997-05-09 |
| DASH 1000 PATIENT MONITOR (K970545) | Marquette Medical Systems, Inc. | 1997-05-08 |
| DIMS (DIGITAL IMAGING AND MEDICAL SYSTEM) CL1-5110/5111 (K970813) | Denvu, Inc. | 1997-05-08 |
| SYNCHRON SYSTEMS DRUG CALIBRATION 3 PLUS (K971287) | Beckman Instruments, Inc. | 1997-05-08 |
| UNITRON MODEL SOUND F/X CIC (K970692) | Unitron Industries, Inc. | 1997-05-08 |
| DSBAS OPTION THE MAMMOMAT 3000 MAMMOGRAPHY X-RAY SYSTEM (K964069) | Siemens Medical Solutions USA, Inc. | 1997-05-08 |
| EMPOWER ANTERIOR DIRECT SCREWS (K965224) | Smith & Nephew Richards, Inc. | 1997-05-08 |
| NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS (K971317) | National Healthcare Mfg. Corp. | 1997-05-08 |
| STERITEC INTEGRAPH MODEL CI-101 (K960441) | Steritec Products Mfg Co, Inc. | 1997-05-08 |
| RESOLUT REGENERATIVE MATERIAL (K970884) | W. L. Gore & Associates, Inc. | 1997-05-08 |
| DERMAMEND FOAM ISLAND DRESSING (K970600) | Dermarx Corp. | 1997-05-08 |
| VAPOR-TECH SLED ELECTRODE (K970717) | Northgate Technologies, Inc. | 1997-05-08 |
| CENTRE-DRIVE DRILL-FREE SCREW (K971297) | KLS-Martin L.P. | 1997-05-08 |
| ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM (K971196) | Innova Corp. | 1997-05-08 |
| EZ SURE (EXCEL) URINE MIDSTREAM PREGNANCY HOME TEST (K971286) | Excel Scientific, Inc. | 1997-05-08 |
| DUKAL ABD COMBINE PAD (K970457) | Dukal Corp. | 1997-05-08 |
| EVT ANGIOSCALE ANGIOGRAPHIC CATHETER (K970469) | Guidant Cardiac and Vascular Surgery | 1997-05-08 |
| ACROMED PEDICLE SCREW (K965102) | Acromed Corp. | 1997-05-08 |
| DUKAL NON ADHERENT DRESSING (K970455) | Dukal Corp. | 1997-05-08 |
| KODAK DIGITAL SCIENCE CARDIAC DIGITAL ACQUISITION UNIT (K970738) | Jamieson Film Co. | 1997-05-07 |
| LACTATE DEHYDROGENASE (LD) (K970684) | Randox Laboratories, Ltd. | 1997-05-07 |
| INFANT RADIANT WARMER - MODELS IW910 AND IW920 (K970432) | Fisher & Paykel Electronics , Ltd. | 1997-05-07 |
| BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER (K964814) | Bipore, Inc. | 1997-05-07 |
| WRIGHT PLASTER OF PARIS PELLETS (K963562) | Wrightmedicaltechnologyinc | 1997-05-07 |
| MAGNES 2500 WH BIOMAGNETOMETER (K962317) | Biomagnetic Technologies, Inc. | 1997-05-07 |
| SIMPLEX AIRBRATOR (K970249) | Simplex Medical Systems, Inc. | 1997-05-07 |
| EUB-8000 (K954220) | Hitachi Medical Corp. of America | 1997-05-07 |
| WAKO DIRECT BILIRUBIN V (K970986) | Wako Chemicals USA, Inc. | 1997-05-07 |
| ANGLED TIP POLYPECTOMY SNARE (K970945) | United States Endoscopy Group, Inc. | 1997-05-07 |
| VAIL 2000 ENCLOSED BED (K963622) | Vail Products, Inc. | 1997-05-07 |
| VISTA BRITE TIP CATHETERS (K963962) | Cordis Corp. | 1997-05-07 |
| DEPUY OPTI-CON AND E-Z SHIELD SYSTEMS (K964114) | Depuy, Inc. | 1997-05-06 |
| SYNTEC, INC. DISPOSABLE BARE END FIBER (K971338) | Syntec, Inc. | 1997-05-06 |
| GOLDEN STATE IMPORTS INTERNATIONAL, INC./ COLEMAN (K971249) | Andrew G. Halpern | 1997-05-06 |
| ARROW COMPANY (K971326) | Excel Eyewear Corp. | 1997-05-06 |
| HEALTHCARE SERVICE AND SUPPLY PVA (PNEUMATIC VENOUS AUGMENTATION) FOOT GARMENT (K964188) | Healthcare Service and Supply | 1997-05-06 |
| VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITOR (K955816) | Baxter Healthcare Corp | 1997-05-06 |
| SAFE-CONNECT I.V. SET (K970909) | Faulding Medical Device Co. | 1997-05-06 |
| LATEX PATIENT EXAMINATION (POWDERFREE GLOVE) (K970794) | Siam Sempermed Corp., Ltd. | 1997-05-06 |
| STERITITE SEALED CONTAINER(SC08F,SC06F,SC04F,SC08Q,SC06Q,SC04Q,SC08H,SC06H,SC04H) (K960738) | Engineered Custom Mfg., Inc. | 1997-05-06 |
| SOLAR SPECS (K970759) | Morris Rosenbloom & Co., Inc. | 1997-05-06 |
| CLASSIC MATCH (K971104) | Delagar Division Belcam, Inc. | 1997-05-06 |
| 3F ANGIOPTIC ANGIOGRAPHIC CATHETER (K964033) | AngioDynamics, Inc. | 1997-05-06 |
| REUSABLE VITRECTOMY PROBE (K970670) | Altex Vision | 1997-05-06 |
| SC9000/SC9015 MEDICAL INFORMATION BUS (MIS) PROTOCOL CONVERTER (K970368) | Siemens Medical Solutions USA, Inc. | 1997-05-06 |
| ENDOLIGHT FIBEROPTIC REGULAR MONOFILAMENT AND FINE MONOFILAMENT (K970878) | American Medical Devices, Inc. | 1997-05-06 |
| CAPIOX E HOLLOW FIBER OXYGENATOR WITH INTEGRATED HEAT EXCHANGER/ARTERIAL RESERVOIR (K970463) | Terumo Medical Corp. | 1997-05-06 |
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS721-P (K971108) | Alexander Mfg. Co. | 1997-05-06 |
| INSTRUMENT TRAY LINER (K971217) | General Hospital Supply Corp. | 1997-05-06 |
| LAXIMA INTERNATIONAL LIMITED SUNGLASSES (K970454) | Laxima Intl., Ltd. | 1997-05-06 |