| TWO-CHANNEL PREAMPLIFIER (K962457) | Cadwell Laboratories, Inc. | 1997-01-13 |
| SKYWAY (K964682) | Kid'S Wheel-Chairs | 1997-01-13 |
| AIA-PACK B12 ASSAY (K964348) | Tosoh Medics, Inc. | 1997-01-13 |
| VERSA-CATH ARTERIAL CATHETER (K961883) | Ideas For Medicine, Inc. | 1997-01-13 |
| MISTY OX TURBOHEATER (K962438) | Vital Signs, Inc. | 1997-01-13 |
| EL DORADO 40 (K964941) | Gateway Alloys, Inc. | 1997-01-13 |
| LIQUICHEK URIANLYSIS CONTROL (CAT. NO. 420,421,422,425,426) (K965171) | Bio-Rad | 1997-01-13 |
| AURORA 52 (PM-01) (K964948) | Gateway Alloys, Inc. | 1997-01-13 |
| GIBECK WARMBAG REUSABLE CONVECTIVE WARMING BLANKET (K960511) | Gibeck, Inc. | 1997-01-13 |
| ROCHE COBAS IBTEGRA REAGENT CASSETTES (K964457) | Roche Diagnostic Systems, Inc. | 1997-01-13 |
| FOUR-CHANNEL PREAMPLIFIER (K962455) | Cadwell Laboratories, Inc. | 1997-01-13 |
| REP 3 QUTO-FLUR CHOLESTEROL-30 (K962914) | Helena Laboratories | 1997-01-13 |
| SIMPLICITY TM ELECTRIC/BATTERY BREAST PUMP KIT (1068) (K964403) | The First Years, Inc. | 1997-01-13 |
| STAT IM 5000 CASSETTE AUTOCLAVE (K962179) | Scican | 1997-01-13 |
| MAXI-TORQUE PLUS SOFTIP ANGIOGRAPHIC CATHETER (K963092) | Adam Spencer Corp. | 1997-01-13 |
| LA PLATA 28 (PM-28) (K964950) | Gateway Alloys, Inc. | 1997-01-13 |
| TAOS 28 (K964940) | Gateway Alloys, Inc. | 1997-01-13 |
| CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER (K962458) | Cadwell Laboratories, Inc. | 1997-01-13 |
| MULTITAK SS SUTURE SYSTEM (K964324) | Bonutti Research | 1997-01-10 |
| WRITESTAR, AND VIEWSTAR (K964274) | Comview Corp. | 1997-01-10 |
| STERILE SOFT-TEMP (K962983) | Adroit Medical Systems, Inc. | 1997-01-10 |
| VARIAN XIMATRON C-SERIES RADIATION THERAPY SIMULATOR WITH VERSION 4.2 SOFTWARE (K964138) | Varian Medical Systems, Inc. | 1997-01-10 |
| DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM W/SINGLE NEEDLE SINGLE LUMEN OPTION (K955384) | Althin Medical AB an Affiliate of Baxter Intl | 1997-01-10 |
| MAGNETIC RESONANCE DIAGNOSTIC SYSTEM (K964370) | GE Medical Systems | 1997-01-10 |
| VOLMETRIC COINCIDENCE DETECTION SYSTEM (K962100) | Elscint, Inc. | 1997-01-10 |
| SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR (K962683) | Deknatel, Inc. | 1997-01-10 |
| LUMEX AIR (K963674) | Lumex, Inc. | 1997-01-10 |
| PIXELL MRI SYSTEM (K962249) | General Medical Equipment Corp. | 1997-01-10 |
| AEROGEAR ASTHMA ACTION KIT (K964130) | Monaghan Medical Corp. | 1997-01-10 |
| BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE (K963950) | Bioderm, Inc. | 1997-01-10 |
| GIANNI VERSACE SUNGLASSES, VERSUS SUNGLASSES, DIABLO SUNGLASSES (K964505) | I C Optics, Ltd. | 1997-01-10 |
| PHILIPS TOMOSCAN AV EXPANDER UPGRADE (K964318) | Philips Medical Systems North America, Inc. | 1997-01-10 |
| PROFILE MAMMOGRAPHY SYSTEM (M-PRO) (K964576) | Bennett X-Ray Corp. | 1997-01-10 |
| ANSPACH MICROMAX SYSTEM (K965080) | The Anspach Effort, Inc. | 1997-01-10 |
| SMART ADJUSTER (SA201) (K962239) | Sigma | 1997-01-10 |
| HYSTERO CO2-PNEU 2221 (K964136) | Richard Wolf Medical Instruments Corp. | 1997-01-10 |
| PORTAREM-3000, PFS-6000 (K964340) | Starkey Laboratories, Inc. | 1997-01-10 |
| FOTONA SKINLIGHT LASER SYSTEM (K962902) | Medical Laser Solutions | 1997-01-10 |
| MANAN PEDIATRIC BONE MARROW ACCESS NEEDLE (K962001) | Manan Medical Products, Inc. | 1997-01-10 |
| SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT (K964450) | Pilling Weck Group | 1997-01-10 |
| ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC (K962995) | Otodynamics, Ltd. | 1997-01-10 |
| CAP-AID (IMPROVED) (K964580) | Nebel, Inc. | 1997-01-10 |
| 3050 SPORT-NEB (K964078) | Medical Industries America, Inc. | 1997-01-10 |
| S3 CARDIOPLEGIA CONTROL (K962320) | Stoeckert Instrumente | 1997-01-10 |
| HEPA-TYPE AIR CLEANER MODEL 2586 AND TRUE HEPA AIR CLEANER MODELS 2587 AND 2588 (K960966) | Sunbeam-Oster Household Products | 1997-01-10 |
| OPTICAL DIGITIZER OPTION FOR VIEW POINT (K963221) | Philips Medical Systems (Cleveland), Inc. | 1997-01-10 |
| GAMMA-GLUTAMYL TRANSPEPTIDASE (K964916) | Derma Media Lab., Inc. | 1997-01-10 |
| AMERICAN DENTAL PRODUCTS HG 35 DESENSITIZER WITH FLUORIDE (K964133) | American Dental Products, Inc. | 1997-01-09 |
| AMOILS EPITHELIAL SCRUBBER (K962989) | S. Percy Amoils | 1997-01-09 |
| NUMO NM-1000 AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE (K955393) | Surgical Innovations Plc | 1997-01-09 |
| PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER) (K954331) | Pall Biomedical Products Co. | 1997-01-09 |
| SURETEMP (K964643) | Diatek Instruments, Inc. | 1997-01-09 |
| TENET RADIOLUCENT HAND TABLE (K963506) | Tenet Medical Engineering | 1997-01-09 |
| EYECHEK (K964290) | Reichert Ophthalmic Instruments, Div. Leica, Inc. | 1997-01-09 |
| HERITAGE HIP SYSTEM (K963109) | Zimmer, Inc. | 1997-01-09 |
| LACTATE DEHYDROGENASE (K964912) | Derma Media Lab., Inc. | 1997-01-09 |
| DAVIS BAYONET ELECTRODES (K964602) | Valleylab, Inc. | 1997-01-09 |
| VIDAS PROESTERONE (PRG) (30 409) (K965084) | bioMerieux, Inc. | 1997-01-09 |
| VOLLMAN PRONE POSITIONER (K963091) | Hill-Rom, Inc. | 1997-01-09 |
| LIGHTSTIC MODEL 360 (K962965) | Rare Earth Medical, Inc. | 1997-01-09 |
| RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT (K964338) | Rudolf Riester GmbH & Co. KG | 1997-01-09 |
| MINI-SYMM BIPOLAR COAGULATOR (K964143) | Valley Forge Scientific Corp. | 1997-01-09 |
| SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION (K964259) | Synthes (Usa) | 1997-01-09 |
| SUPER-DENT ETCHING GEL, SUPER-DENT MICRO-ETCH GEL AND SUPER-DENT ETCHING GEL SYRINGE TIPS (K964179) | S.S. White Mfg., Ltd. | 1997-01-09 |
| MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK, ROD, AND AND SACRAL SCREW FIXATION SYSTEM IN 316L STAINLESS STE (K963357) | Synthes (Usa) | 1997-01-09 |
| PANOGAUZE NON-WOVEN HYDROGEL DRESSING (K964620) | Sage Pharmaceuticals, Inc. | 1997-01-09 |
| AUTOLINK BODY PLETHYSMOGRAPH (K960121) | P.K. Morgan , Ltd. | 1997-01-09 |
| GLOVE, PATIENT EXAMINATION, VINYL (POWDERED) (K964321) | Shijiazhuang Hongray Plastic Products Co., Ltd. | 1997-01-09 |
| PERFECTA PLASMA SPRAY HIP STEM (K964218) | Wrightmedicaltechnologyinc | 1997-01-08 |
| NON-SHIELDED SURGICAL TROCAR AND SLEEVE (K963760) | Ethicon Endo-Surgery, Inc. | 1997-01-08 |
| DURA-BOARD ARMBOARD (K964273) | Allen Medical Systems, Inc. | 1997-01-08 |
| SIRIUS 180, 180L, 230, 230L (K961235) | Micro-Mega Societe Anonyme | 1997-01-08 |
| LASERSCOPE ERBIUM; YAG LASER SYSTEM AND ACCESSORIES (K964076) | Laserscope | 1997-01-08 |
| HP STAR ST AND ARRHHYTHMIA SOFTWARE (K964122) | Hewlett-Packard Co. | 1997-01-08 |
| DEGANIA SILICONE INDENTI LOOPS (K964547) | Degania Silicone , Ltd. | 1997-01-08 |
| LSI VIDEOSCOPIC DISPLAY SYSTEM (K963919) | Lsi Solutions | 1997-01-08 |
| LORI HEARING AID SIMULATOR (K964080) | Lori Medical Laboratories, Inc. | 1997-01-08 |
| CELL RECOVERY SYSTEM (K965037) | Medical Device Technologies, Inc. | 1997-01-08 |
| CCENTERMARK CATHETER INTRODUCER SHEALTH WITH PROTECTIV 2000 NEEDLE SAFETY SYSTEM (K962978) | Johnson & Johnson Medical, Inc. | 1997-01-07 |
| CPR BIO-BARRIER FACESHEILD (K960995) | O-Two Systems Intl., Inc. | 1997-01-07 |
| UNIT-MATT 5000 PRESSURE RELIEF SYSTEM (K962585) | United Medical Equipment, Inc. | 1997-01-07 |
| VERSATEC 310 ELECTRODE (K963975) | Versatec, Inc. | 1997-01-07 |
| 9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS (K963620) | 9th Wave, Inc. | 1997-01-07 |
| GENIE PROCESSING AND REVIEW WORKSTATION (K964012) | GE Medical Systems | 1997-01-07 |
| OXYLOG 2 (K954731) | P.K. Morgan , Ltd. | 1997-01-06 |
| MODEL 90022 ROLLING STAND (K963672) | Augustine Medical, Inc. | 1997-01-06 |
| CYTO-STAT TRICHROME CD45-FITC/CD8-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT IWTH ISOTYPIC CONTROL (K962305) | Coulter Corp. | 1997-01-06 |
| FIRST MIDCATH CATHETER (K964050) | Becton Dickinson Vascular Access, Inc. | 1997-01-06 |
| STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F INTRODUCER SYSTEM (K964284) | Boston Scientific Corp | 1997-01-06 |
| ARDENT NON GAMMA-2 70 (K964192) | Ardent Production Development | 1997-01-06 |
| OLYMPIQUE MEDICAL SUPPORT HOSE AND STOCKINGS (K964103) | Tournier-Bottu S.A. | 1997-01-06 |
| FIRST MIDCATH CATHETER KIT (K964048) | Becton Dickinson Vascular Access, Inc. | 1997-01-06 |
| FIRST MIDCATH CATHETER WITH DUAL LUMENS (K964049) | Becton Dickinson Vascular Access, Inc. | 1997-01-06 |
| CYTO-STAT TRICHROME CD45-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANITBODY REAGENT W/ISOTYPIC CONTROL (K962768) | Coulter Corp. | 1997-01-06 |
| SERAGARD VASCULAR ACCESS DEVICE (K963595) | Cutting Edge Technologies, Inc. | 1997-01-06 |
| PORTSMART NEEDLE DE-ACCESS ENCLOSURE (K964559) | Jireh, Inc. | 1997-01-03 |
| N95 FILTERING FACEPIECE (K962443) | Survivair, Inc. | 1997-01-03 |
| VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOSCOPE WITH ENDOSHEATH SYSTEM (K964326) | Vision-Sciences, Inc. | 1997-01-03 |
| TZ (K964777) | Gallini Intl., Inc. | 1997-01-03 |
| MICRO21 WITH NDNA (K964165) | Triangle Biomedical Sciences, Inc. | 1997-01-03 |