| INDIGO MEDICAL MODEL IDL 830 & MODEL IDL 830E LASER SYSTEMS FOR GENERAL GYNECOLOGICAL APPLICATIONS (K963081) | Indigo Medical, Inc. | 1997-02-21 |
| TUM-E-VAC (K962850) | Ethox Corp. | 1997-02-21 |
| VASOTHERM (K962243) | Ehti Medical Corp. | 1997-02-21 |
| FLEXI-SITE (E203-01)/ FLEXI-FIT (E300) (K964055) | Epic Medical Equipment Services, Inc. | 1997-02-21 |
| HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR (K964719) | Hudson Respiratory Care, Inc. | 1997-02-21 |
| CPI MODEL 6240 50 PSI NEBULIZER COMPRESSOR (K964994) | Contemporary Products, Inc. | 1997-02-21 |
| CHARTR EP (K960097) | Ics Medical Corp. | 1997-02-21 |
| TRI-FLOW THREE WAY STOPCOCK (K961982) | North, Inc. | 1997-02-21 |
| PRISM XPVT SYSTEM (210823) (K964712) | Philips Medical Systems (Cleveland), Inc. | 1997-02-21 |
| THEE THERMASTIM (K962703) | Ehti Medical Corp. | 1997-02-21 |
| EAGLE 4000 PATIENT MONITOR (K964750) | Marquette Electronics, Inc. | 1997-02-21 |
| LYPHOCHEK COAGULATION CONTROL (K964963) | Bio-Rad | 1997-02-20 |
| HEMAGEN CMV IGG KIT (K944438) | Hemagen Diagnostics, Inc. | 1997-02-20 |
| ACCUPACK PREGNANCY TEST (K964633) | Genix Biotek, Inc. | 1997-02-20 |
| ABBOTT TESTPACK PLUS HCG COMBO WITH OBC (K965116) | Abbott Laboratories | 1997-02-20 |
| SEALITE SCIENCES, INC. AQUALITE PROLACTIN (K970188) | Sealite Sciences, Inc. | 1997-02-20 |
| MODEL 7700 QUANTUM PRESSURE SUPPORT VENTILATOR PSV (K962517) | Healthdyne Technologies, Inc. | 1997-02-20 |
| VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55) (K964982) | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-02-20 |
| IRON REAGENT (K964913) | Derma Media Lab., Inc. | 1997-02-20 |
| GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD) (K964061) | W. L. Gore & Associates, Inc. | 1997-02-20 |
| TUMOR MARKER CONTROL (K965114) | Diagnostic Products Corp. | 1997-02-20 |
| HUMAN CHORIONIC GONADOTROPIN CALIBRATOR (K970396) | Dade Chemistry Systems, Inc. | 1997-02-20 |
| IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES (K970198) | Scimedx Corp. | 1997-02-20 |
| SUPREME II METER (K963544) | Chronimed, Inc. | 1997-02-20 |
| PRECISION G BLOOD GLUCOSE TESTING SYSTEM (K963676) | Medisense, Inc. | 1997-02-20 |
| ACCUMETER H. PYLORI TEST (K965099) | Chemtrak, Inc. | 1997-02-20 |
| THE ADVANCED OSMOMETER (3900) (K965036) | Advanced Instruments, Inc. | 1997-02-20 |
| FLEXIBLE CYSTOSCOPE (K964037) | Applied Fiberoptics, Inc. | 1997-02-20 |
| QUICKPAC II ONE STEP MARIJUANA (THC) TEST (K963207) | Drial Consultants, Inc. | 1997-02-20 |
| SUNSOFT (METHAFILCON A) SOFT (HYDROPHILIC) DAILY WEAR CONTACT LENS (K964696) | Sunsoft Corp. | 1997-02-20 |
| ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM (K962475) | Transfusion Technologies Corp. | 1997-02-20 |
| HEMATACHEK (K964452) | Richmond Diagnostics, Inc. | 1997-02-20 |
| ROSTAM APPLICATOR TAMPON/ROSTAM NON APPLICATOR TAMPON (K965064) | Rostam , Ltd. | 1997-02-20 |
| MAXI LD PTA BALLOON CATHETER (K963000) | Cordis Corp. | 1997-02-20 |
| CEMENTED CALCAR REPLACEMENT FEMORAL STEM (K964795) | Johnson & Johnson Professionals, Inc. | 1997-02-19 |
| PATIENT SPECIFIC IMPLANT HIP FEMORAL COMPONENT (K970346) | Kairos Orthopaedics | 1997-02-19 |
| SPACEMAKER SERIAL SURGICAL BALLOON DISSECTOR, WITH CANNULA, WITH VISUALIZATION AND WITH VISUALIZATION AND CANNULA (K962702) | General Surgical Innovations | 1997-02-19 |
| ATLAS 2.0 & HITACHI 2.0 (A TRADE NAME SUBJECT TO CHANGE) (K961073) | Atlantis Diagnostics Intl., Inc. | 1997-02-19 |
| ANTERIOR DYNAMIZED SYSTEM (K953978) | Acromed Corp. | 1997-02-19 |
| BARD FLEXIBLE ENDOSCOPY INJECTION SYSTEM (651019) (K970110) | Bard Medical Div. | 1997-02-19 |
| NIHON KOHDEN OLG-100A POCKETCAP POCKET CO2 MONITOR WITH ACCESSORIES (K964305) | Nihon Kohden America, Inc. | 1997-02-19 |
| STABLELOC II EXTERNAL FIXATOR (K965029) | Acu Med, Inc. | 1997-02-19 |
| DORNIER MEDILAS FIBER TOME LASER (K964760) | Dornier Medtech America, Inc. | 1997-02-19 |
| RMI DUAL FLUID IRRIGATING SYRINGE (K964833) | Research Medical, Inc. | 1997-02-19 |
| COMBISON 530 DIAGNOSTIC ULTRASOUND SCANNER (K940942) | Medison America, Inc. | 1997-02-19 |
| VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION) (K964665) | Carbomedics, Inc. | 1997-02-19 |
| VITROS CHEMISTRY PRODUCTS UPRO SLIDES (K964960) | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-02-18 |
| STRATEC LIA II ANALYZER (K961142) | Nichols Institute Diagnostics | 1997-02-18 |
| STABILIZER SOFT TISSUE ANCHOR MODEL NUMBER TA1005, TA1008, ANCHOR INSERTER/SUTURE ORGANIZER MODEL NUMBERS AI1005, AI1008 (K965111) | R. Thomas Grotz, M.D., Inc. | 1997-02-18 |
| OLYMPUS ACID PHOSPHATASE REAGENT (K963640) | Olympus America, Inc. | 1997-02-18 |
| UNIMED COATED LAPAROSCOPIC/ARTHROSCOPY/SUCTION-IRRIGATION ELECTRODE (K970066) | Unimed Surgical Products, Inc. | 1997-02-18 |
| BIPOLAR SHOULDER PROSTHESIS-SHELL(RD-113130/33, BIANGULAR MODULAR HEAD(RD-113101/41/42,BIOMODULAR MODULAR HEAD(RD-113143 (K960363) | Biomet, Inc. | 1997-02-18 |
| RAPISEAL PATCH (K964857) | Fusion Medical Technologies, Inc. | 1997-02-18 |
| PROTECT ALL BLOOD PRESSURE CUFF COVER (K964648) | Protect All, Inc. | 1997-02-18 |
| ELECSYS ESTRADIOL ASSAY (K965109) | Boehringer Mannheim Corp. | 1997-02-18 |
| ACCUCURE 3000 (K964486) | Lasermed, Inc. | 1997-02-18 |
| ADVANCED QUALITY PREGNANCY TEST (K970008) | Bionike, Inc. | 1997-02-18 |
| MODELS EXL AND EXS EXTREMITY COIL SET (K964668) | Mri Devices Corp. | 1997-02-18 |
| SAS PREGNANCY STRIP (K965253) | Sascie | 1997-02-18 |
| BAERVELT PARS PLANA GLAUCOMA IMPLANT (K955455) | Pharmacia Iovision, Inc. | 1997-02-18 |
| SAS SERUM/URINE HCG (K965250) | Sascie | 1997-02-18 |
| THYROID CALIBRATOR (K970389) | Dade Chemistry Systems, Inc. | 1997-02-18 |
| ALT/SGPT (K965134) | Derma Media Lab., Inc. | 1997-02-18 |
| FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWIRE(REGULAR SHAFT/STIFF SHAFT) NO MARKING (K964955) | Flexmedics | 1997-02-14 |
| CYGNUS ELECTROSURGICAL TIP CLEANER (K965086) | Madison Polymeric Engineering | 1997-02-14 |
| ALPHA MICRON 20/40 MICROAGGREGATE FILTER (K970225) | Alpha Therapeutic Corp. | 1997-02-14 |
| TENET MLTI-POSITIONING SURGICAL STIRRUP SYSTEM (K963505) | Tenet Medical Engineering | 1997-02-14 |
| SOFTOUCH (K964684) | Sahar Technologies, Inc. | 1997-02-14 |
| TRUSTEX COLA FLAVORD CONDOM (K964598) | Line One Laboratories | 1997-02-14 |
| JIAWANG PRE-POWDERED VINYL EXAMINATION GLOVES (K964800) | Shanghai Jiawang Industrial Co. , Ltd. | 1997-02-14 |
| EVENFLO NATURAL MOTHER ELECTRIC BREAST PUMP KIT (K960727) | Evenflo Co., Inc. | 1997-02-14 |
| BENTLEY MANUALLY OPERATED WHEELCHAIR (K970311) | Pdg Product Design Group, Inc. | 1997-02-14 |
| INFRASONICS ADULT VENTILATOR TRENDING OPTION (K964543) | Nellcor Puritan Bennett, Inc. | 1997-02-14 |
| MMB METHOD (K970343) | Dade Chemistry Systems, Inc. | 1997-02-14 |
| BALDUR VINYL POWDERED GLOVES (K963441) | Hti Trading Group | 1997-02-14 |
| AMSEAL SURGICAL FACE MASK (K964358) | American Seal Co. | 1997-02-14 |
| CHIRON DIAGNOSTICS ACS: 180 CARBAMAZEPINE ASSAY (K964765) | Chiron Diagnostics Corp. | 1997-02-14 |
| VENTANA ANTI-CD8 PRIMARY ANTIBODY (K941784) | Ventana Medical Systems, Inc. | 1997-02-14 |
| SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M (K961246) | St. Jude Medical, Inc. | 1997-02-14 |
| VYGON BIONECTOR WITH EXTENSION SET (K963981) | Vygon Corp. | 1997-02-14 |
| O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE (K965201) | Trinity Laboratories, Inc. | 1997-02-14 |
| VENTANA ANTI-CD4 PRIMARY ANTIBODY (K941604) | Ventana Medical Systems, Inc. | 1997-02-14 |
| TRUSTEX CHOCOLATE FLAVORED CONDOM IN BLACK COLOR (K964599) | Line One Laboratories | 1997-02-14 |
| DSXL DIFFUSION SPIROMETER (K961252) | Inair , Ltd. | 1997-02-14 |
| PROD. NO. 01-132 - SUTURE REMOVAL KIT (K964827) | Continental Medical Laboratories, Inc. | 1997-02-14 |
| GI SUPPLY PARACENTESIS PUMP (K970186) | Gi Supply | 1997-02-14 |
| OASIS HUMIDIFIER (K964653) | Respironics, Inc. | 1997-02-14 |
| GRASEBY ANDERSEN'S, INTEGRITY S700 (K963131) | Graseby Andersen | 1997-02-14 |
| DENTINSENSE B/C (K965138) | Centrix, Inc. | 1997-02-14 |
| RUNYON LARGE VOLUME PARACENTESIS KIT (K970187) | Gi Supply | 1997-02-14 |
| VASOVIEW BALLOON DISSECTION SYSTEM (K964171) | Origin Medsystems, Inc. | 1997-02-14 |
| BEMIS TWO GALLON SHARPS CONTAINER (K965248) | Bemis Mfg. Co. | 1997-02-14 |
| OASIS (K964658) | Sonotech, Inc. | 1997-02-14 |
| SEALITE SCIENCES AQUALITE FSH (K970085) | Sealite Sciences, Inc. | 1997-02-14 |
| S*E*M*M* SET FOR MOTO DRIVE WISAP #7689 SSM (MODIFICATION) (K960640) | Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh | 1997-02-14 |
| SPEEDBAND MULTIPLE BAND LIGATOR (K964079) | Boston Scientific Corp | 1997-02-13 |
| EXETER MESH (K963940) | Howmedica, Inc. | 1997-02-13 |
| PEDIATRIC LIMB HOLDER (K963466) | Deroyal Industries, Inc. | 1997-02-13 |
| VERSYS HIP SYSTEM--FIBER METAL TAPER HIP PROSTHESIS (K964769) | Zimmer, Inc. | 1997-02-13 |
| SD-610M(ALSO KNOWN AS STANDARD TENS, SD-609M,SD-611M, GLC-I STANDARD) (K963729) | Skylark Device Co., Ltd. | 1997-02-13 |