| IL TEST(TM) DAT CAL/CONTROL SET B (K913740) | Instrumentation Laboratory CO | 1991-10-21 |
| AUDIOTONE MODEL A-95 BEHIND-THE-EAR HEARING AID (K914477) | Miracle-Ear, Inc. | 1991-10-21 |
| LYME STAT M TEST KIT (K904652) | Whittaker Bioproducts, Inc. | 1991-10-21 |
| EVACUATION/IRRIGATION/ELECROSURGICAL DEVICE (K912492) | ETHICON, Inc. | 1991-10-21 |
| PYLORISET (K904655) | Orion Diagnostica, Inc. | 1991-10-21 |
| GLOBALCARE EMS (K913444) | Globalcare Intl., Inc. | 1991-10-21 |
| IMPLARETTE (K911655) | Implant Innovations International, Inc. | 1991-10-21 |
| ATRAUMATIC STANDARD SPROTTE NEEDLE (K911260) | Pajunk GmbH | 1991-10-21 |
| MICROTEK MEDICAL'S SOUND STIKS (K913276) | Microbio-Medics, Inc. | 1991-10-21 |
| IL TEST(TM) DAT CAL/CONTROL SET C (K913741) | Instrumentation Laboratory CO | 1991-10-21 |
| MODEL MGB-301 DIAPHRAGM FILM 24 X 30 CM (K912180) | Instrumentarium Imaging, Inc. | 1991-10-21 |
| CARDIO 500 (K913754) | Kontron Elektronik GmbH | 1991-10-21 |
| ACT-II BEHIND THE EAR HEARING AID (K914418) | Telex Communications, Inc. | 1991-10-21 |
| GOLDEN THERMAL(R) (K914182) | Seabrook Medical Systems, Inc. | 1991-10-18 |
| MEGA CONTINUOUS EPIDURAL ANESTHESIA KIT (K912445) | Mega Medical, Inc. | 1991-10-18 |
| OXYGEN MASKS 81420, 81421, 81471 & 81461 (K913383) | Specialty Packaging Producs, Inc. | 1991-10-18 |
| CORDIS PTCA GUIDING CATHETER, MODIFICATION (K913783) | Dow Corning Wright | 1991-10-18 |
| CORDIS 5.2 FRENCH SUPER TORQUE PLUS CARDIO CATH (K914007) | Cordis Corp. | 1991-10-18 |
| AM-PAK (K912436) | Cns, Inc. | 1991-10-18 |
| MF-500, MODIFICATION (K911144) | Elcot, Inc. | 1991-10-18 |
| DOX TAMPERPROOF SPECIMEN CONTAINER SYSTEM (K913967) | Doxtech, Inc. | 1991-10-18 |
| QBC E-Z PREP (K913399) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-10-18 |
| POLAR PUMP, MODEL 500 (K913729) | Breg, Inc. | 1991-10-18 |
| AXIOM TOTAL KNEE SYSTEM, A/P CURVED TIBIAL INSERT (K912894) | Orthomet, Inc. | 1991-10-18 |
| HYBRID FIT TOTAL HIP SYSTEM (K913246) | Kirschner Medical Corp. | 1991-10-18 |
| WOUND CARE TRAY A (K913480) | Catalina Biomedical Corp. | 1991-10-18 |
| MODEL 80 HEARING AID DISPENSING SYSTEM (K913245) | 3M Company | 1991-10-18 |
| ANNULUS VALVULOTOME (K912636) | Cardio Source | 1991-10-18 |
| PRESSURE SORE MANAGEMENT KIT (K912116) | Medical Device Inspection Co., Inc. | 1991-10-18 |
| INFANT/PEDIATRIC RESUSCITATION CIRCUIT W/APL (K911465) | Vital Signs, Inc. | 1991-10-18 |
| NASAL OXYGEN CANNULA, 81585, 81587 & 81589 (K913421) | Specialty Packaging Producs, Inc. | 1991-10-18 |
| BIOKIT RPR (K910541) | Biokit USA, Inc. | 1991-10-18 |
| ANNULUS DISPOSABLE VALVULOTOME (K912635) | Cardio Source | 1991-10-18 |
| HEMOCHRON(R) KACT (K913861) | International Technidyne Corp. | 1991-10-18 |
| AVI MODEL 840D DUAL CHANNEL INFUSION PUMP (K912589) | 3M Avi, Inc. | 1991-10-17 |
| HOMECLINIC ONE STEP PREGNANCY TEST (K914254) | Vanguard Biomedical Corp. | 1991-10-17 |
| BI-TEMP TEMPERATURE MONITOR TM-201D (K913083) | Respiratory Support Products, Inc. | 1991-10-17 |
| AUTO SUTURE(R) POWERED ENDOSCOPIC TA(R) STAPLER (K913832) | United States Surgical, A Division of Tyco Healthc | 1991-10-17 |
| 3-D ACCUSCAN FACIAL IMPLANTS (K913761) | Implantech Associates, Inc. | 1991-10-17 |
| FIRST RESPONSE(R) ONE-STEP (K914304) | Armkel, LLC | 1991-10-17 |
| MODELS E2502B/E2525 REUSABLE HANDSWITCHING PENCILS (K914400) | Valleylab, Inc. | 1991-10-17 |
| PHARMASEAL THORACENTESIS TRAY W/UNIV DRAINAGE SET (K910693) | Baxter Healthcare Corp | 1991-10-17 |
| MODULEX RTP SYSTEM (K913017) | Computerized Medical Systems, Inc. | 1991-10-17 |
| SIMON NITINOL FILTER, MODIFICATION (K912144) | Nitinol Medical Technologies, Inc. | 1991-10-17 |
| AVI MODEL 400D INFUSION PUMP (K912590) | 3M Avi, Inc. | 1991-10-17 |
| HOTLINE FLUID WARMER (K911383) | Level 1 Technologies, Inc. | 1991-10-17 |
| BI-TEMP TEMPERATURE MONITOR, MODEL TM-400D (K912280) | Respiratory Support Products, Inc. | 1991-10-17 |
| VLC GLASS IONOMER (K913836) | Dentsply Intl. | 1991-10-17 |
| MEDTRONIC UNIPOLAR, POLY PAC LEAD-BARR COAT COILS (K913288) | Medtronic Vascular | 1991-10-17 |
| AUTO SUTURE(R) POWERED ENDOSCOPIC GIA(TM) STAPLER (K913802) | United States Surgical, A Division of Tyco Healthc | 1991-10-17 |
| MEGA MYELOGRAM KIT (K913141) | Megadyne Medical Products, Inc. | 1991-10-17 |
| AUTO SUTURE TITANIUM SKIN AND FASCIA STAPLES (K914130) | United States Surgical, A Division of Tyco Healthc | 1991-10-17 |
| I.V. INSTANT TIMER (K913076) | The Master Medical Corp. | 1991-10-17 |
| PEDIA PALS (K911650) | Pedia Pals, Inc. | 1991-10-17 |
| COMPAC A, ELITE A, ELITE A PLUS, SURGICA A (K913569) | Hgm Medical Laser Systems, Inc. | 1991-10-17 |
| PROBASE HOT AND PROBASE COLD (K913655) | Ivoclar North America, Inc. | 1991-10-17 |
| OSTEO BONE PLATED (K913271) | Fred C. Bryson | 1991-10-17 |
| MODEL #911 STEALTH MULTI PADS (K912621) | Cardiotronics, Inc. | 1991-10-16 |
| MODEL #110 STEALTH-TRODE CHILD DEFIB PADS (K911456) | Cardiotronics, Inc. | 1991-10-16 |
| SUB-4(TM), PERIPHERAL DILATATION CATHETER (K913689) | Boston Scientific Corp | 1991-10-16 |
| WRISTRECORDER CARDIAC EVENT RECORDING SYSTEM (K913600) | Ralin Laboratories, Inc. | 1991-10-16 |
| IVT GUIDING CATHETER (K911869) | Intensive Technology, Inc. | 1991-10-16 |
| POLARIS, ORAL INDICATION (K912063) | Pfizer Laser Systems | 1991-10-16 |
| FIAX LYME M TEST KIT (K904893) | Whittaker Bioproducts, Inc. | 1991-10-16 |
| MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER (K905403) | Cook Pacemaker Corp. | 1991-10-16 |
| CARD GUARD, MODELS CG-6000 & CG-7000 (K910884) | Card Guard Scientific Survival , Ltd. | 1991-10-16 |
| MODEL #100 SHOCK-TRODE CHILD DEFIB PADS (K911455) | Cardiotronics, Inc. | 1991-10-16 |
| MODEL 100 CENTRAL STATION (K913193) | Protocol Systems, Inc. | 1991-10-16 |
| CORDIS CATH SHEATH INTRO SYST PLUS W/UNISTASIS VAL (K913801) | Cordis Corp. | 1991-10-16 |
| DORNIER LASER LITHOTRIPTER IMPACT (K913191) | Dornier Medtech America, Inc. | 1991-10-16 |
| GYROVIEW-HR (K913029) | Philips Medical Systems, Inc. | 1991-10-15 |
| SATURATION/HEMATOCRIT MONITOR SYSTEM (K910421) | Medtronic Vascular | 1991-10-15 |
| VITALOGRAPH SPIROTRAC III (K912412) | Vitalograph , Ltd. | 1991-10-15 |
| DATASCOPE PASSPORT MONITOR (K911598) | Datascope Corp. | 1991-10-15 |
| MEDICAM LAPAROSCOPY ENDOSCOPES (K912933) | Kirschner Medical Corp. | 1991-10-15 |
| DUCAL SIDE SHIELD SUNGLASS (K913745) | Ducal Trading Corp. | 1991-10-15 |
| AXION 5, MODIFICATION (K911814) | Ventura Medical Electronics | 1991-10-15 |
| TRUE/FLEX TIBIAL RODS WITH CAP (K912710) | Applied Osteo Systems, Inc. | 1991-10-15 |
| CHALLENGE 4010 ONE CHANNEL WIDE PULSE STIMULATOR (K904360) | Maximum Performance Technologies, Mpts, Inc. | 1991-10-15 |
| MARKSMAN ARTERIAL BLOOD GAS SYRINGE (K910970) | Martech Medical Products, Inc. | 1991-10-15 |
| COLLAGEN SHIELD FOR ACUTE CARE (K913148) | Vitaphore Corp. | 1991-10-15 |
| PHILIPS ANGIOPRO (K911888) | Philips Medical Systems North America, Inc. | 1991-10-15 |
| TEAM-MC (K905672) | Henley Intl. | 1991-10-15 |
| COMPUTER ASSIST STEREOTACTIC SURG SYST, MODIFIED (K911750) | Medical Instrumentation & Diagnostics Corp.(Midco) | 1991-10-15 |
| WIZARD STERILIZED ELECTROEPILATION NEEDLE (K911983) | Skin Deep, Inc. | 1991-10-15 |
| CERAVITAL MIDDLE EAR IMPLANT (K913619) | Friedrichsfeld Medizintechnik AG | 1991-10-15 |
| ULTRASOUND STETHOSCOPE(R) INTRADOP(R) (K912033) | Medadonics, Inc. | 1991-10-15 |
| NIDEK MODEL NT-1000 (K913189) | Nidek, Inc. | 1991-10-15 |
| RADIOGRAPHIC FILM MARKING SYSTEM (K913478) | Lorad Medical Systems, Inc. | 1991-10-15 |
| OPTIMOL RESPIRATORY HUMIDIFICATION SYSTEM (K911770) | Automatic Liquid Packaging, Inc. | 1991-10-15 |
| OHMEDA STYLE CHECK UNITS (FEMALE COUPLERS) (K912763) | Medical Fittings, Inc. | 1991-10-15 |
| FASTLOK (STAPLE & BUCKLE) FIXATION SYSTEM (K913461) | Neoligaments, Ltd. | 1991-10-15 |
| HOME MEDICAL KIT - FOR LITTLE HURTS (K912684) | Great West Medical Equipment, Inc. | 1991-10-15 |
| B-D(TM) MICROFINE(TM) IV PEN INJECTOR CAT. #328204 (K912330) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-10-11 |
| ABBOTT QUICKSTART TOTAL BILIRUBIN (TBIL) #5A21 (K913307) | Em Diagnostic Systems, Inc. | 1991-10-11 |
| HAP BIO-GROOVE TOTAL HIP PROSTH (BIO-INTERFACES) (K912370) | Biomet, Inc. | 1991-10-11 |
| POLARIS, GASTROENTEROLOGY/UROLOGY/PULMONARY, GI/GU (K911925) | Pfizer Laser Systems | 1991-10-11 |
| POLARIS (K910341) | Pfizer Laser Systems | 1991-10-11 |
| KINEMAX PLUS TIBIAL INSERT (K913188) | Howmedica Corp. | 1991-10-11 |
| VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY (K905211) | Vitek Systems, Inc. | 1991-10-11 |