| MODEL DELTA, OM OXYGEN CONCENTRATOR (K952268) | Caire, Inc. | 1995-08-11 |
| MODIFIED HUMAN TUBAL FLUID (MHTF) WITH/WITHOUT PENICILLIN G DOLIUM, WITH/WITHOUT STREPTOMYCIN SULFATE (K951835) | Life Technologies, Inc. | 1995-08-11 |
| VRS 3 WALL STAND (K953336) | Philips Medical Systems (Cleveland), Inc. | 1995-08-11 |
| ROYAL SHIELD PINK & BLUE COLORED NON-STERILE LATEX EXAMINATION GLOVES (K952589) | Shield Gloves Manufacturer (M) Sdn Bhd | 1995-08-11 |
| BLOOD UREA NITROGEN REAGENT SYSTEM (K952742) | Medical Diagnostic Technologies, Inc. | 1995-08-11 |
| SAFESKIN (K952793) | Safeskin Corp. | 1995-08-11 |
| DIA SCREEN REAGENT STRIPS (K952971) | Genesis Labs, Inc. | 1995-08-11 |
| ANESTHESIA FACE MASK (K953295) | Mallinckrodt Medical | 1995-08-11 |
| CHAMPION PHYSIOACOUSTICC RECLINER-TRANSPORTER CHAIR (K951414) | Champion Mfg. Corp. | 1995-08-11 |
| BRANEMARK SYSTEM BALL ATTACHMENT SYSTEM (K952676) | Nobelpharma USA, Inc. | 1995-08-11 |
| CLEAR HUB SPINAL NEEDLE, 18, 20, 22, 25 GA. (K951949) | Baxter Healthcare Corp | 1995-08-11 |
| PREPERITONEAL DISTENTION BALLOON SYSTEMS (MODIFICATION) (K953561) | Origin Medsystems, Inc. | 1995-08-11 |
| DX1 (K951227) | Creative Biomedics, Inc. | 1995-08-11 |
| BOSTON MEDICAL LATEX EXAM GLOVES (K952695) | Shun Thai Rubber Gloves Industry Co., Ltd. | 1995-08-11 |
| ACROMED PEDICLE SCREW (K951116) | Acromed Corp. | 1995-08-11 |
| UNIVERSIX 190 (K953402) | Philips Medical Systems (Cleveland), Inc. | 1995-08-11 |
| DUPONT DIMENSION TOTAL PROTEIN METHOD (K950920) | Dupont Medical Products | 1995-08-11 |
| AUTOJECT 2 (K945660) | Owen Mumford USA, Inc. | 1995-08-11 |
| ACCUSPORT LACTATE MONITORING SYSTEM LACTATE TEST STRIPS ACCUSPORT MONITOR (K951331) | Boehringer Mannheim Corp. | 1995-08-11 |
| FORMULATION HWS-256 EPA REG. NO. 47371-129 (K953010) | Huntington Laboratories, Inc. | 1995-08-11 |
| JEDMED SPECTRUM ENT CABINET (K953457) | Jedmed Instrument Co. | 1995-08-11 |
| AMIGO GRAND TOUR (K952112) | Amigo Mobility Intl., Inc. | 1995-08-11 |
| FORMULATION HWS-128 EPA REG. NO. 47371-130 (K953009) | Huntington Laboratories, Inc. | 1995-08-11 |
| EPIDURAL NEEDLE (K942863) | Spinal Specialties, Inc. | 1995-08-11 |
| HEWLETT-PACKARD MODEL M1264B CATHSTATION (K952173) | Hewlett-Packard Co. | 1995-08-11 |
| XENON GAS BREATHING CIRCUIT (K952223) | Intertech Resources, Inc. | 1995-08-11 |
| ROYAL SHIELD NON-STERILE BLUE COLORED BUBBLE GUM SCENTED LATEX EXAMINATION GLOVES (K952591) | Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc. | 1995-08-11 |
| NEEDLE SAFETY COVER (K950098) | Hammer-Plane, Inc. | 1995-08-11 |
| DX1-PORTABLE (K951157) | Creative Biomedics, Inc. | 1995-08-11 |
| INTRAMEDULARY FIXATION ROD (K951740) | Acu Med, Inc. | 1995-08-11 |
| COMMUNITY BALANCE PERFORMANCE MONITOR OR COMMUNITY BPM (K951771) | Sms Technologies, Ltd. | 1995-08-11 |
| THEOPHYLLINE ENZYME IMMUNOASSAY (K952596) | Diagnostic Reagents, Inc. | 1995-08-11 |
| SAFESKIN (K952851) | Safeskin Corp. | 1995-08-11 |
| AUTO SUTURE* CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM** (K952748) | United States Surgical, A Division of Tyco Healthc | 1995-08-10 |
| STRYKER OPERATING LAPAROSCOPE (K943100) | Stryker Endoscopy | 1995-08-10 |
| EZ-COMP (K952353) | Adm, Inc. | 1995-08-10 |
| DILATATION CATHETER, BALLOON (K952968) | Boston Scientific Corp | 1995-08-10 |
| USCI INPUT INTRODUCER SET (K940092) | Usci, Div. C.R. Bard, Inc. | 1995-08-10 |
| WAVICIDE(R) -01 (K914749) | Wave Energy Systems, Inc. | 1995-08-10 |
| PLASMA ARC CURING SYSTEM (K952333) | American Dental Technologies, Inc. | 1995-08-10 |
| ACU-HALT (K945374) | Eva-Health USA, Inc. | 1995-08-09 |
| SERIM HISENSE TEST KIT (K952215) | Serim Research Corp. | 1995-08-09 |
| ALCON SERIES 20000 LEGACY PHACOEMULSIFIER (K952213) | Alcon Laboratories | 1995-08-09 |
| STRICKLAND TRAPEZIAL IMPLANT (K951471) | Wrightmedicaltechnologyinc | 1995-08-09 |
| DURACON BASEPLATES (K936008) | Howmedica Corp. | 1995-08-09 |
| SECURE-SITE (K941098) | Op-Co Medical Products , Ltd. | 1995-08-09 |
| OKAMOTO CONDOM (K952393) | Okamoto USA, Inc. | 1995-08-09 |
| OSTEONICS RESTORATION MONOLITHIC HIP STEM (K951291) | Osteonics Corp. | 1995-08-09 |
| MEDRAD QWIK-FIX MRI DISPOSABLE KIT (K943189) | Medrad, Inc. | 1995-08-09 |
| MED-TEC REDISET (K952189) | Medtec, Inc. | 1995-08-09 |
| ALALYSIS PACKAGE FOR DENTAL APPLICATIONS FOR XPEED, XPRESS, XVISION (K953164) | Toshiba America Medical Systems, In.C | 1995-08-09 |
| PERIPUMP (K934552) | Deschutes Medical Products, Inc. | 1995-08-09 |
| TRACHEOSTOMY CARE KIT (K952416) | Medi-Flex Hospital Products, Inc. | 1995-08-09 |
| HIP JOINT FEMORAL (HEMI-HIP) METAL/POLYMER CEMENTED OR UNCEMENTED PROSTHESIS (K953510) | Encore Orthopedics, Inc. | 1995-08-09 |
| SIGNA PROFILE (K945730) | GE Medical Systems | 1995-08-09 |
| ECTRA LIGAMENT RELEASE SYSTEM (K953387) | Smith & Nephew Dyonics, Inc. | 1995-08-09 |
| UNSCENTED MENSTRUAL LINER (K953488) | Paragon Trade Brands, Inc. | 1995-08-09 |
| UNSCENTED MENSTRUAL SHIELD (K953487) | Paragon Trade Brands, Inc. | 1995-08-09 |
| KARL STORZ ENDOSCOPY POWDER BLOWER (K952443) | KARL STORZ Endoscopy-America, Inc. | 1995-08-09 |
| ARROW MULTIPOLAR INTRACARDIAC ELECTRODE CATHETERS (K945229) | Arrow Intl., Inc. | 1995-08-08 |
| GENESIS POSTERIOR STABILIZED (P/S) KNEE SYSTEM (K946088) | Smith & Nephew Richards, Inc. | 1995-08-08 |
| RUSCH ENDOTRACHEAL TUBE STYLET (K952100) | Rusch, Inc. | 1995-08-08 |
| BUXTON BUILT STERILIZER, BUXTON BUILT RECONDITIONED STERILIZER (K951273) | Buxton Medical Servic Corp. | 1995-08-08 |
| AXSYM SALICYLATE (K951290) | Abbott Laboratories | 1995-08-08 |
| STRYKER COMMAND2 OFFICE CONSOLE (K953071) | Stryker Instruments | 1995-08-08 |
| BECKMAN ARRAY TOBRAMYCIN (TOB) REAGENT (K952568) | Beckman Instruments, Inc. | 1995-08-08 |
| TRANSIT-2 INFUSION CATHETER (K950910) | Cordis Neurovascular, Inc. | 1995-08-08 |
| PULM O2 SUCTION CATHETER TRAYS (K953226) | Premium Plastics, Inc. | 1995-08-08 |
| HENNERT SA (K952734) | Hennert S.A. | 1995-08-08 |
| TRUEFILL PVA PARTICLES (K951314) | Cordis Neurovascular, Inc. | 1995-08-08 |
| STELKAST ALL POLYETHYLENE ACETABULAR CUP (K953169) | Stelkast Company | 1995-08-08 |
| CURASOL GEL WOUND DRESSING (K953450) | Dpt Laboratories, Ltd. | 1995-08-07 |
| SIEMENS SONOLINE VERSA (K945773) | Siemens Medical Solutions USA, Inc. | 1995-08-07 |
| LIMELIGHT (K953079) | Pulpdent Corp. | 1995-08-07 |
| SILON SILICONE TEXTILE COMPOSITE (K952546) | Bio Med Sciences, Inc. | 1995-08-07 |
| HOMEVUE WOUND MONITORING SYSTEM (K945807) | Homevue Health Systems, Inc. | 1995-08-07 |
| SPI-SECRET PERSONAL INSTRUMENT CIC (K952986) | Midwest City Hearing Aid Center | 1995-08-07 |
| MLI SET (K952392) | Medical Technologies of Georgia | 1995-08-07 |
| EX-111 WOUND DRESSING (K952907) | Variseal Manufacturing Corp. | 1995-08-07 |
| MAGNESIUM REAGENT (K952426) | Schiapparelli Biosystems, Inc. | 1995-08-07 |
| SUNGLASSES (NON-PRESCRIPTION) (K953473) | Cbi Dist. | 1995-08-07 |
| ALANINE AMINOTRANSFERASE REAGENT SYSTEM (K952744) | Medical Diagnostic Technologies, Inc. | 1995-08-07 |
| PERSONAL ALARM SYSTEM (PAS) (K944961) | Cytoprobe Corp. | 1995-08-07 |
| REPLICA TOTAL HIP SYSTEM (K951741) | Osteo-Technology Intl., Inc. | 1995-08-07 |
| REDI NURSE SYSTEM (RNS) PRE-FILLED 60CC IRRIGATION SYRINGE W/STERILE SODIUM CHLORIDE SOLUTION (K952406) | Contour Fabricators of Florida, Inc. | 1995-08-07 |
| ROYAL FLASH (K952939) | Royal Flash Enterprise Co. , Ltd. | 1995-08-07 |
| TITANIUM TSRH(R) SPINAL SYSTEM (SCREWS) (K946348) | Sofamor Danek USA,Inc. | 1995-08-07 |
| REDI NURSE SYSTEM (RNS) PRE-FILLED 10CC, 30CC, 60CC SYRINGE W/STERILE WATER (K952407) | Contour Fabricators of Florida, Inc. | 1995-08-07 |
| BIO-OSS (K952617) | Geistlich-Pharma | 1995-08-07 |
| THE REUSABLE SPACEMAKER SURGICAL BALLOON DISSECTOR & CANNULA (K952278) | General Surgical Innovations | 1995-08-07 |
| POLYKOTE (K953299) | Intl. Trade Management Co. | 1995-08-07 |
| HYPOALLERGENIC POWDERED AMBIDEXTROUS PATIENT EXAMINATION GLOVES (K945766) | Ansell, Inc. | 1995-08-07 |
| TRANSAN, TRANSPARENT FILM DRESSING, TRANSPARENT WOUND DRSSING (K952449) | Medical Device Development Co. | 1995-08-07 |
| OPTX 20/20 (K953413) | Neoptx, Inc. | 1995-08-07 |
| BIOFIX BIOABSORABABLE SELF-REINFORCED POLY-L-LACTIDE, THREADED FIXATION ROD (K952471) | Bioscience, Inc. | 1995-08-07 |
| PRECISE HOSPITAL FOAM CLEANER DISINFECTANT (K951512) | Caltech Industries, Inc. | 1995-08-07 |
| SPACEMAKER SURGICAL BALLOON DISSECTOR WITH CANNULA & THE SPACEMAKER II SURGICAL BALLOON DISSECTOR WITH CANNULA (K952444) | Adjacent Surgical, Inc. | 1995-08-07 |
| MODEL INT/DL40I MICRO COMPUTER CONTROLLER FOR POWER WHEELCHAIRS (K950724) | Invacare Corp. | 1995-08-07 |
| ELMER (K952118) | Biological Technology Corp. | 1995-08-07 |
| LACTATE DEHYDROGENASE REAGENT SYSTEM (K952747) | Medical Diagnostic Technologies, Inc. | 1995-08-07 |