| ARC SERIES (K954581) | Continental X-Ray Corp. | 1995-12-21 |
| PURE ADVANTAGE NITRILE HYPOALLERGENIC PATIENT EXAMINATION GLOVES (K954574) | Tillotson Healthcare Corp. | 1995-12-21 |
| PURE ADVANTAGE POWDER FREE NITRILE HYPOALLERGENIC PATIENT EXAMINATION GLOVES (K954573) | Tillotson Healthcare Corp. | 1995-12-21 |
| SIERRA BATTERY SEALED LEAD ACID BATTERY SYSTEM (K955095) | Sierra Battery, Inc. | 1995-12-21 |
| OPTUS BRONCHOSCOPES (K945268) | Optus, Inc. | 1995-12-21 |
| PARAGON IMPLANT SYSTEM (K953101) | Core-Vent Bio-Engineering, Inc. | 1995-12-21 |
| THERMOPLASTIC SHIELD (K954456) | Medtec, Inc. | 1995-12-21 |
| IMMULITE SHBG (MODIFICATION) (K955440) | Diagnostic Products Corp. | 1995-12-21 |
| CD3 FITC/CD8 R-PE MONOCLONAL ANTIBODY COMBINATION (K950916) | Caltag Laboratories, Inc. | 1995-12-21 |
| STERILE ISOTONIC SALINE & STERILE WATER (K954442) | Medcare Custom Packaging, Inc. | 1995-12-21 |
| EXL-15DP & 20-DP LINAC (K952108) | Mitsubishi Intl. Corp. | 1995-12-21 |
| CD3 FITC/CD4 R-PE MONOCLONAL ANTIBODY COMBINATION (K950918) | Caltag Laboratories, Inc. | 1995-12-21 |
| ROCHE CONTROL SERUM N (K954655) | Roche Diagnostic Systems, Inc. | 1995-12-21 |
| CD3 FITC/CD8 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION (K950917) | Caltag Laboratories, Inc. | 1995-12-21 |
| CEDIA T UPTAKE ASSAY (K954807) | Boehringer Mannheim Corp. | 1995-12-21 |
| MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION) (K954600) | Staar Surgical Co. | 1995-12-21 |
| EASY BREATHING NASAL STRIPS (K955233) | Corbett Lair, Inc. | 1995-12-21 |
| ROCHE CONTROL SERUM P (K954656) | Roche Diagnostic Systems, Inc. | 1995-12-21 |
| CD3 TRI-COLOR/CD4 R-PE/CD8 FITC MONOCLONAL ANTIBODY COMBINATION (K951073) | Caltag Laboratories, Inc. | 1995-12-21 |
| TARGETT PATCH (K952606) | Cutting Edge Technologies, Inc. | 1995-12-21 |
| MIT ONE STEP PREGNANCY TEST (K953486) | 3c Diagnostics, Inc. | 1995-12-21 |
| CARTO SYSTEM (K954395) | Biosense, Ltd. | 1995-12-21 |
| OTOSCAPE (K953814) | Soundscape Technologies, Inc. | 1995-12-21 |
| DOCUMENT TDM ULTRA UNASSAYED CONTROL (K955155) | Casco Standards | 1995-12-20 |
| WAKO AUTOKIT APO B (K954657) | Wako Chemicals USA, Inc. | 1995-12-20 |
| AUTO SUTURE SUTURE CLOSURE (K954853) | United States Surgical, A Division of Tyco Healthc | 1995-12-20 |
| VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) (K954150) | Green Field Medical Sourcing, Inc. | 1995-12-20 |
| TOTAL BILIRUBIN PROCEDURE (K955300) | Data Medical Associates, Inc. | 1995-12-20 |
| CD3 FITC/CD4 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION (K950919) | Caltag Laboratories, Inc. | 1995-12-20 |
| NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER (K953608) | Meadox Medicals, Div. Boston Scientific Corp. | 1995-12-20 |
| PROSYS BEDSIDE DRAINAGE BAG (K953767) | Convatec, A Division of E.R. Squibb & Sons | 1995-12-20 |
| TEST, RHEUMATOID FACTOR (K955086) | Polymedco, Inc. | 1995-12-20 |
| HM-SPIRO (K951718) | Hill-Med, Inc. | 1995-12-20 |
| BAGRIGHT RESUSCITATOR (K954296) | Medical Marketing Concepts | 1995-12-20 |
| LYFO(TM) DIFFERIENTAL DISK-PYR (K954812) | Microbiologics, Inc. | 1995-12-20 |
| ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA (K954515) | Pyramid Biological Corp. | 1995-12-20 |
| 3D SURGICAL ENDOSCOPY SYSTEM FOR GENERAL SURGERY (K943307) | Olympus America, Inc. | 1995-12-20 |
| AMERLITE MAB FT4 ASSAY (K955097) | Kodak Clinical Diagnostics, Ltd. | 1995-12-20 |
| OLYMPIC INFANT THERMOMETER (K954434) | Olympic Medical Corp. | 1995-12-20 |
| IT-727 (ALSO KNOWN AS IT-610, IT-600 AND DYNAPHOR II (K946337) | Skylark Device Co., Ltd. | 1995-12-20 |
| ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEM (K951495) | Bio-Rad Laboratories, Inc. | 1995-12-20 |
| COURIER BALLOON DILATATION CATHETER (K953569) | Boston Scientific Corp | 1995-12-20 |
| 3D SURGICAL ENDOSCOPY SYSTEM FOR UROLOGY (K943304) | Olympus America, Inc. | 1995-12-20 |
| CLAMP ASSEMBLY (K953599) | J.B.S., S.A. | 1995-12-19 |
| GO INTRAMEDULLARY NAIL LOCKING SCREW (K954511) | Genesis Orthopedics, Inc. | 1995-12-19 |
| RIGID NEUROVIEW ENDOSCOPE (K954899) | Neuro Navigational Corp. | 1995-12-19 |
| PROTEC X-RAY DETECTABLE GAUZE SPONGE (K955322) | Derivados DE Gasa, S.A. DE C.V. | 1995-12-19 |
| RIA LATEX CONDOM WITH SPERMICIDE, RIA COLOR CONDOM WITH SPERMICIDE (K945930) | Line One Laboratories & Trading Co. | 1995-12-19 |
| INSEMI-CATH II (K954398) | Cook Urological, Inc. | 1995-12-19 |
| BIOGRAN BIOACTIVE GLASS SYNTHETIC BONE GRAFT MATERIAL (K952922) | Orthovita Co. | 1995-12-19 |
| VASCUTEK GELWEAVE VASCULAR GRAFT (K952293) | Vascutek, Ltd. | 1995-12-19 |
| KIS II LG HEX SCREW & CYLINDER IMPLANTS (K953558) | The Implant Center of the Palm Beaches | 1995-12-19 |
| MEDOX CHAMPION COMPACT NEBULIZER (K954327) | Medox Corp. | 1995-12-19 |
| CARDIOVIT AT-1C, AT-2C (K953396) | Schiller America, Inc. | 1995-12-19 |
| CYBER III OPTION UM, UC312, UC10, UCIC (K955359) | Qualitone | 1995-12-19 |
| IMAGN(TM) 2000 SYSTEM (K945756) | Buckman Co., Inc. | 1995-12-19 |
| SENTRY(TM) ANTERIOR/POSTERIOR SPINAL SYSTEMS (K936294) | Sofamor Danek Mfg., Inc. | 1995-12-19 |
| MEPORE (6X7) (K954274) | Scott Health Care | 1995-12-19 |
| OLYMPUS HIGH FLOW INSUFFLATION UNIT (K953162) | Olympus America, Inc. | 1995-12-19 |
| PROTEC GAUZE SPONGE (K955321) | Derivados DE Gasa, S.A. DE C.V. | 1995-12-19 |
| SPERMICIDALLY LUBRICATED CONDOM (K940047) | Ansell, Inc. | 1995-12-19 |
| NEO-MED DLS-1100 (K954931) | Neo-Laboratories, LLC | 1995-12-18 |
| ECTRA II LIGAMENT RELEASE SYSTEM (K954627) | Smith & Nephew Dyonics, Inc. | 1995-12-18 |
| INCL ENDOSCOPE (K955471) | Sofamor Danek USA,Inc. | 1995-12-18 |
| MILL-ROSE ROTATABLE POLYPECTOMY SNARE (K951600) | Mill-Rose Laboratory | 1995-12-18 |
| REAADS ANTI-PHOSPHATIDYLSERINE QUANTITATIVE TEST KIT (K952287) | Reaads Medical Products, Inc. | 1995-12-18 |
| INFUSION SET (K950970) | Surgiplast , Ltd. | 1995-12-18 |
| NEUROVIEW COAXIAL BIPOLAR ELECTRODE (K955467) | Neuro Navigational Corp. | 1995-12-18 |
| PS MEDICAL IPI VASCULAR ACCESS CATHETER (K954409) | Pudenz-Schulte Medical Research Corp. | 1995-12-18 |
| SPECIFIC ALLERGEN MODULES FOR THE ALASTAT MICROPLATE ALLERGEN-SPECIFIC IGE SYSTEM (K954566) | Diagnostic Products Corp. | 1995-12-18 |
| ZOMED MODEL 20 & 30 ELECTROSURGICAL PROBES (K954965) | Zomed Intl. | 1995-12-18 |
| ILT SURGICAL LASER (K954460) | Ion Laser Technology | 1995-12-18 |
| ORATEC INTERVENTIONS MODEL TAC 1000 MONOPOLAR CAUTERY PROBE (K954439) | Oratec Interventions, Inc. | 1995-12-18 |
| SERIM PYLORITEK TEST KIT (K953632) | Serim Research Corp. | 1995-12-18 |
| VL2600 HANDSWITCHING PENCIL WITH HOLSTER (K955109) | Valleylab, Inc. | 1995-12-18 |
| C-REACTIVE PROTEIN LATEX KIT (K954447) | Randox Laboratories, Ltd. | 1995-12-18 |
| WAKO AUTOKIT CH50 (K954145) | Wako Chemicals USA, Inc. | 1995-12-18 |
| EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN (K954933) | Johnson & Johnson Clinical Diagnostics, Inc. | 1995-12-18 |
| PACI-TEMP, PACIFIER WITH DIGITAL THERMOMETER (K952073) | Intelligent Product Limited Co. | 1995-12-18 |
| SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER (K950042) | Accurate Surgical Instruments Co. | 1995-12-15 |
| FIBERFLO HOLLOW FIBER CARTRIDGE WATER FILTERS (K954349) | Minntech Corp. | 1995-12-15 |
| ENZYME IMMUNOASSAY ANA SCREENING TEST KIT (K954723) | Helix Diagnostics, Inc. | 1995-12-15 |
| SQUARE ONE SAFETY SYRINGE (K955030) | Square One Medical, LP | 1995-12-15 |
| TEVES ECM PLUS THERMOCOUPLE (K951768) | Advanced Medical Concepts, Inc. | 1995-12-15 |
| AWESMOSIS (K945066) | Applied Water Engineering, Inc. | 1995-12-15 |
| SIMS DELTEC ANTI-SIPHON VALVE (K954870) | Sims Deltec, Inc. | 1995-12-15 |
| ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER (K950201) | Sherwood Medical Co. | 1995-12-15 |
| SCINITREX (POWDER FREE NITRILE EXAMINATION GLOVES) (K952051) | Wembley Rubber Products (M) Sdn Bhd | 1995-12-15 |
| AURORA SURGICAL DIODE LASER SYSTEM W/ACCESSORIES (K954316) | Premier Laser Systems, Inc. | 1995-12-15 |
| T CLASS HYPERBARIC FACILITIES (K954387) | Reimers Systems, Inc. | 1995-12-15 |
| ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT (K954700) | Helix Diagnostics, Inc. | 1995-12-15 |
| KENTEMP (K953465) | Kentron Health Care, Inc. | 1995-12-15 |
| IMAGETITER INSTRUMENT, ANA TEST KIT & CALIBRATOR SERUM (K952490) | Roche Image Analysis Systems | 1995-12-15 |
| SCINITREX POWER FREE BLUE NITRILE EXAMINATION GLOVES (K952154) | Wembley Rubber Products (M) Sdn Bhd | 1995-12-15 |
| PER-Q-CATH MID-LINE (K954422) | Gesco Intl., Inc. | 1995-12-15 |
| SCINITREX (POWDER FREE GREEN NITRILE EXAMINATION GLOVES (K951938) | Wembley Rubber Products (M) Sdn Bhd | 1995-12-15 |
| MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION) (K953866) | Medtronic Vascular | 1995-12-15 |
| ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION) (K954092) | Medtronic Vascular | 1995-12-15 |
| AIA-PACK CORT ASSAY (K954591) | Tosoh Medics, Inc. | 1995-12-15 |
| OLYMPUS FG-45/46-1 GRASPING FORCEPS (K955049) | Olympus America, Inc. | 1995-12-15 |