| ARRAY OPEN BREAST COIL (MODEL OBC-63 PA) (K961525) | Mri Devices Corp. | 1996-09-05 |
| TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND (K962361) | Laerdal Medical Corp. | 1996-09-05 |
| RIONET HB-55S (K963153) | Authorized Hearing Systems, Inc. | 1996-09-05 |
| MAICO MA25 SERIES II WITH SPEECH (K962275) | Bernafon-Maico, Inc. | 1996-09-05 |
| NEWMED ABP-LITE (K955887) | Newmed Corp. | 1996-09-05 |
| THUMPER CARDIOPULMONARY RESUSCITATOR (K962237) | Michigan Instruments, Inc. | 1996-09-05 |
| GELFLEX DELTA 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS (K962710) | Gelflex Laboratories | 1996-09-05 |
| GELFLEX ALPHA (POLYMACON) HYDROPHILIC CONTACT LENS (K962711) | Gelflex Laboratories | 1996-09-05 |
| ELVIS HSV GOLD (K960578) | Diagnostic Hybrids, Inc. | 1996-09-05 |
| BETTER-VENTER (K961594) | Circulatory Technology, Inc. | 1996-09-05 |
| MINI FLEX COIL (K961628) | W. L. Gore & Associates, Inc. | 1996-09-05 |
| RIONET HB-54AS (K963154) | Authorized Hearing Systems, Inc. | 1996-09-05 |
| ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER (K962499) | Bartels, Inc. | 1996-09-05 |
| SYNTHES TITANIUM EXTERNAL FIXATOR CLAMPS (TI EFC) (K962484) | Synthes (Usa) | 1996-09-05 |
| SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECTRODE - MODIFY (K962910) | Uni-Patch, Inc. | 1996-09-05 |
| HITACHI STRATIS, MRH-1500 MAGNETIC RESONANCE DIAGNOSTIC DEVICES VERSION 6 OPERATING SYSTEM SOFTWARE (K961969) | Hitachi Medical Systems America, Inc. | 1996-09-05 |
| RIONET HB-55AS (K963152) | Authorized Hearing Systems, Inc. | 1996-09-05 |
| BARD TAPERSEAL INTRA-AORTIC BALLOON CATHETER & INTRODUCER KIT (K962177) | C.R. Bard, Inc. | 1996-09-04 |
| KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS (K962595) | KARL STORZ Endoscopy-America, Inc. | 1996-09-04 |
| OMNI COLD GEL PACKS (K961176) | Omni Therm, Inc. | 1996-09-04 |
| SERAQUEST RUBELLA IGG (K961053) | Quest Intl., Inc. | 1996-09-04 |
| ACL 6000 SYSTEM (ACL 6000) (K961991) | Instrumentation Laboratory CO | 1996-09-04 |
| IMNI HOT PACKS (K955788) | Omni Therm, Inc. | 1996-09-04 |
| MYELOTEC MYELOSCOPE (K960194) | Myelotec, Inc. | 1996-09-04 |
| GYREX V-EP (K962618) | Elscint, Inc. | 1996-09-04 |
| GATED MIBI 3-D EJECTION FRACTION PROCESSING (K961597) | Trionix Research Laboratory, Inc. | 1996-09-04 |
| MICROVASIVE BALLOON GASTROSTOMY TUBE KIT (K962375) | Boston Scientific Corp | 1996-09-04 |
| EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS (K962519) | Behring Diagnostics, Inc. | 1996-09-04 |
| SELF PROPELLED ROBOTIC WHEEL (SPRW) (K950025) | Datatran, Inc. | 1996-09-03 |
| SURESCAN (K962242) | Clinicon Corp. | 1996-09-03 |
| SIREMOBIL COMPACT (K963093) | Siemens Medical Solutions USA, Inc. | 1996-09-03 |
| 3D-SPINE (K962377) | Skill Technologies, Inc. | 1996-09-03 |
| SYNTHES DORSAL DISTAL RADIUS PLATE (DDRP) SYSTEM (K962616) | Synthes (Usa) | 1996-09-03 |
| ORTHO-ONE (K962946) | Bisco, Inc. | 1996-09-03 |
| DERMAPLEX HYDROGEL WOUND DRESSING (2X2,4X4,4X8,6X10) (K962439) | Richard Hamer Assoc., Inc. | 1996-09-03 |
| SOFT TISSUE AUGMENTATION TUBE (S.T.A.T.) (K962496) | Tissue Technologies, Inc. | 1996-09-03 |
| GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES (K962401) | W. L. Gore & Associates, Inc. | 1996-09-03 |
| SELECT SHOULDER COCR HUMERAL STEM COMPONENT (K962315) | Intermedics Orthopedics | 1996-09-03 |
| LFS LIPOGEL ASSAY KIT (K960785) | Zaxis, Inc. | 1996-09-03 |
| PULPDENT RESILUTE II (K962383) | Pulpdent Corp. | 1996-09-03 |
| DURASIL (MODIFICATION) (K961410) | The S. F. Group, Inc. | 1996-09-03 |
| SUNRISE CURING LAMP (K962192) | Sunrise Technologies, Inc. | 1996-09-03 |
| UNIMED COATED NEEDLE ELECTRODE/COATED BLADE ELECTRODE/COATED BALL ELECTRODE (K962935) | Unimed Surgical Products, Inc. | 1996-09-03 |
| DSL 9100 IGF-II IRMA (K962758) | Diagnostic Systems Laboratories, Inc. | 1996-08-30 |
| VARELISA HELICOBACTER PYLORI ANTIBODIES (K953873) | Elias U.S.A., Inc. | 1996-08-30 |
| RETICULOCYTE METHOD (K954607) | Bayer Corp. | 1996-08-30 |
| VIDAS CREATINE KINASE MB ASSAY 30-421 (K962549) | Biomerieux Vitek, Inc. | 1996-08-30 |
| S-41 & S-41S VIDEO IMAGING SYSTEM (K962020) | Del Medical Systems Corp. | 1996-08-30 |
| GREINER VACUETTE BLOOD COLLECTION TUBE W/LITHIUM HEPARIN & GEL SEPARATOR (K960857) | Greiner America, Inc. | 1996-08-30 |
| GRAM NEGATIVE IDENTIFICATION PLUS CARD (K962609) | Biomerieux Vitek, Inc. | 1996-08-30 |
| SEALEX EXTRA ROOT CANAL SEALER (K962885) | Baladent | 1996-08-30 |
| OPTICON FEMALE URINARY INCONTINENCE CATHETER FOR CONTINUOUS DRAINAGE (K961697) | Medical Device Intl., Inc. | 1996-08-30 |
| E. HISTOLYTICA TEST (K955895) | Techlab, Inc. | 1996-08-30 |
| ACCUSIGN BZO-RAPID ONE-STEP BENZODIAZEPINE ASSAY (K962672) | Princeton BioMeditech Corp. | 1996-08-30 |
| ETEST FOR AZTREONAM (K962794) | Ab Biodisk | 1996-08-30 |
| SYNTHES MANDIBLE DISTRACTOR (K962272) | Synthes (Usa) | 1996-08-30 |
| ELECSYS CALCHECK HCG (K963165) | Boehringer Mannheim Corp. | 1996-08-30 |
| ROBISON & SMITH SURGICAL PACKS (K955586) | Robison & Smith, Inc. | 1996-08-30 |
| VALLEYLAB COATED ELECTRODES (K962044) | Valleylab, Inc. | 1996-08-30 |
| GREINER VACUTTE BLOOD COLLECTION TUBE W/ CLOT ACTIVATOR & GEL SEPARATOR (K960858) | Greiner America, Inc. | 1996-08-30 |
| COBAS CORE IMMUNOCHEMISTRY SYSTEM (K962231) | Roche Diagnostic Systems, Inc. | 1996-08-30 |
| FRESHFROZENCELLS (K962311) | Diagnostic Hybrids, Inc. | 1996-08-29 |
| PROSTATE SPECIFIC ANTIGEN (RSA) CONTROL MODDULE (PSACM) (K962975) | Diagnostic Products Corp. | 1996-08-29 |
| P.F.C. CERAMIC HIP HEAD (K962248) | Johnson & Johnson Professionals, Inc. | 1996-08-29 |
| A4907 LENS CLEANING SHEATH (K961860) | Olympus America, Inc. | 1996-08-29 |
| SPLINE DENTAL IMPLANT SYSTEMS (K962106) | Calcitek, Inc. | 1996-08-29 |
| SANICURE DISPOSABLE CURING PROBE (K962405) | Efos Canada, Inc. | 1996-08-29 |
| STORZ D7116 MICROVIT VITRECTOMY CUTTER EXTENSION (K960003) | Storz Instrument Co. | 1996-08-29 |
| FRESHFROZEN CELLS, HEP-2 (K962782) | Diagnostic Hybrids, Inc. | 1996-08-29 |
| EZ SURE ONESTEP EARLY PREGNANCY TEST (K962580) | Excel Scientific, Inc. | 1996-08-29 |
| IMMULITE ACTH CONTROL MODULE (LACCM) (K963240) | Diagnostic Products Corp. | 1996-08-29 |
| MITYVAC DIRECTIONAL VACUUM EXTRACTOR, DISPOSABLE (K960549) | Neward Enterprises, Inc. | 1996-08-29 |
| CAMBRIDGE HEART HI-RES ECG ELECTRODE (K962115) | Cambridge Heart, Inc. | 1996-08-29 |
| KSEA VAPORIZATION ELECTRODES (K961702) | Karl Storz Endoskop GmbH | 1996-08-29 |
| VENTRICULAR CATHETER SET (K962097) | Cook, Inc. | 1996-08-29 |
| FRESHCELLS, HEP-2 (K962780) | Diagnostic Hybrids, Inc. | 1996-08-29 |
| DERMTOME BLADE (K962371) | Dsp Worldwide | 1996-08-29 |
| LIBBE RECTAL TUBE (FORMERLY A YANKAUER SUCTION TUBE) (K962259) | Tiller Mind Body, Inc. | 1996-08-29 |
| CORPAK REPLACEMENT GASTROSTOMY DEVICE STOMACORE (K935512) | Corpak Co. | 1996-08-29 |
| FRESH CELLS MULTI-WELL & SHELL VIAL CULTURES (K962306) | Diagnostic Hybrids, Inc. | 1996-08-29 |
| D.O.R.C. MICRODIATHERMY SYSTEM (K962135) | Dutch Ophthalmic USA, Inc. | 1996-08-29 |
| SELECT SHOULDER COCR HUMERAL STEM COMPONENT (K962289) | Intermedics Orthopedics | 1996-08-29 |
| TROJAN POLYURETHANE CONDOM (MODIFICATION) (K955672) | Carter Products | 1996-08-29 |
| CERVICAL MUCOUS ASPIRATION CATHETER (K960263) | Cook Urological, Inc. | 1996-08-29 |
| OCULIGHT GL (K960971) | Iriderm Div. | 1996-08-28 |
| 3304 PULSE OXIMETER (K962156) | Bci Intl., Inc. | 1996-08-28 |
| PORTLAND TROCARS (K962193) | Surgical Innovations Plc | 1996-08-28 |
| SAFE MATE I.V. FLUID DELIVERY SETS (K962802) | Biological & Environmental Control Laboratories | 1996-08-28 |
| MODEL ALPHA BEHIND-THE-EAR HEARING INSTRUMENT (K962228) | Ototech Intl., Inc. | 1996-08-28 |
| LOGIQ A200 DIAGNOSTIC ULTRASOUND SYSTEM (K960700) | GE Medical Systems | 1996-08-28 |
| BIO-PLEXUS NEEDLE DISPOSAL CONTAINER (K960933) | Bio-Plexus, Inc. | 1996-08-28 |
| REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE Y-CONNECTOR) (K954623) | Gambro Healthcare | 1996-08-28 |
| STOPCOCK MANIFOLD GANGS (K962581) | Baxter Healthcare Corp | 1996-08-28 |
| EZ-FIX MIDSHAFT HUMERAL INTRAMEDULLARY ROD SYSTEM (K962553) | Biodynamic Technologies, Inc. | 1996-08-28 |
| MEDILOG STRESSLINK (K951128) | Oxford Medical, Inc. | 1996-08-28 |
| PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR (K962856) | Deknatel, Inc. | 1996-08-28 |
| SAFE MATE I.V. EXTENSION SETS (K962801) | Biological & Environmental Control Laboratories | 1996-08-28 |
| SELECT SHOULDER CONCENTRIC HUMERAL HEAD COMPONENTS (K962224) | Intermedics Orthopedics | 1996-08-28 |
| KSEA UNIMAT PLUS (K962898) | KARL STORZ Endoscopy-America, Inc. | 1996-08-27 |
| DEI MODEL 20 EEG (K961718) | Discovery Engineering Intl., Inc. | 1996-08-27 |