| CONICAL OBTURATOR (K954459) | Phx Technologies Corp. | 1995-10-23 |
| DISSECTING OBTURATOR (K954463) | Phx Technologies Corp. | 1995-10-23 |
| MEHTA BRONCHIAL BIOSPY DRILL (K954693) | United States Endoscopy Group, Inc. | 1995-10-23 |
| CENTRALITE BACKPOINTER (K954414) | Diacor, Inc. | 1995-10-23 |
| CHEMSTRIP CRITERION URINE ANALYZER (K954024) | Boehringer Mannheim Corp. | 1995-10-23 |
| CONMED ELECTROSURGICAL GROUNDING PAD (K954633) | Conmedcorp | 1995-10-23 |
| NIOMED SHOE COVERS (K952897) | Amerasia Corp. | 1995-10-23 |
| LUMITROL CONTROLLER, LUMITROL HAND-CONTROLLED ELECTROSURGICAL PENCIL WITH BLADE ELECTRODE (K953992) | Lmi Lightwave Medical Industries , Ltd. | 1995-10-23 |
| SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE & INSTRUMENT SET (K954193) | Surgical Dynamics, Inc. | 1995-10-23 |
| 5F ENVOY GUIDING CATHETER (MODIFICATION) (K954251) | Cordis Neurovascular, Inc. | 1995-10-23 |
| CONTAMINATION CONTAINMENT DRAPE (K954212) | Engineering Controls For Medicine | 1995-10-23 |
| OSOM PREGNANCY TEST (K954178) | Wyntek Diagnostics, Inc. | 1995-10-23 |
| DISTENTION BALLOON (K953377) | Origin Medsystems, Inc. | 1995-10-23 |
| PROBE (K954476) | Phx Technologies Corp. | 1995-10-23 |
| LUNAR DPX DENSITOMETER (K953032) | Lunar Corp. | 1995-10-23 |
| NELLCOR SYMPHONY N-3100 BLOOD PRESSURE MONITOR (K953472) | Nellcor, Inc. | 1995-10-20 |
| IL682, CO-OXIMETER (K945677) | Instrumentation Laboratory CO | 1995-10-20 |
| TRILOGY ACETABULAR SHELL & LINERS 36MM (K953490) | Zimmer, Inc. | 1995-10-20 |
| PH-DETECT TEST (K952178) | Diagnostic Reagents, Inc. | 1995-10-20 |
| BREATHE RIGHT NASAL STRIP (K953772) | Cns, Inc. | 1995-10-20 |
| OPTICLONE(TM CD3 FITC/CD19 PE MONOCLONAL ANTIBODIES (K946335) | Immunotech, Inc. | 1995-10-20 |
| QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM (K953264) | Wrightmedicaltechnologyinc | 1995-10-20 |
| THROMBOPLASTIN-LI REAGENT (K951820) | Helena Laboratories | 1995-10-20 |
| QUICKVUE IN-LINE ONE STEP STREP A TEST (MODIFICATION) (K954257) | Quidel Corp. | 1995-10-20 |
| DIRECTIGEN 1-2-3 GROUP A STREP TEST (K951542) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995-10-20 |
| KARL STORZ PRESSURE CUFF FOR USE WITH THE KSEA HYDROMAT PUMP (K951105) | KARL STORZ Endoscopy-America, Inc. | 1995-10-20 |
| DISPOSABLE HME/FILTER (K954194) | Engstrom Medical | 1995-10-20 |
| PROTEIN C DEFICIENT PLASMA (K945857) | George King Bio-Medical, Inc. | 1995-10-20 |
| O.B. APPLICATOR TAMPONS (K953638) | Personal Products Co. | 1995-10-20 |
| LAPAROSCOPIC TROCAR OBTURATOR, 5MM, 10/11MM, 10/12MM (K953903) | Core Dynamics, Inc. | 1995-10-20 |
| HYS-SURGIMAT (K934866) | W.O.M. World of Medicine GmbH | 1995-10-20 |
| OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT (K953437) | Olympus America, Inc. | 1995-10-20 |
| ZIRCONIA CERAMIC FEMORAL HEAD (K944689) | Wrightmedicaltechnologyinc | 1995-10-20 |
| ACCESS PROLACTIN ASSAY (MODIFICATION) (K954680) | Bio-Rad Laboratories, Inc. | 1995-10-20 |
| VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT (K940003) | Buckman Co., Inc. | 1995-10-19 |
| TECA PREMIERE (K953732) | Medelec , Ltd. | 1995-10-19 |
| POWDERFREE LATEX GLOVE (K953986) | Steriltx | 1995-10-19 |
| BUHLMANN ANGIOSTENSIN II RIA (K954299) | Buhlmann Laboratories AG | 1995-10-19 |
| CORDIS HORIZONTAL-VERICAL VALVE SYSTEM (K944595) | Cordis Corp. | 1995-10-19 |
| BOEHRINGER AUTOVAC(R) 7900 SERIES (K945775) | Boehringer Laboratories | 1995-10-19 |
| CELL-DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (K951496) | Abbott Laboratories | 1995-10-19 |
| CPR MICROMASK (K951483) | Plasco, Inc. | 1995-10-19 |
| INFINITECH HIGH INTENSITY XENON LIGHT SOURCE SYSTEM (K951627) | Infinitech, Inc. | 1995-10-19 |
| EPILATOR (K952117) | Burke Neutech, Inc. | 1995-10-19 |
| TRY-IN GEL (K954643) | Sybron Dental Specialties, Inc. | 1995-10-19 |
| 6200 VITAL SIGNS MONITOR (K953415) | Bci Intl., Inc. | 1995-10-19 |
| ROYAL SHIELD NON-STERILE POWDER-FREE RUBBER DAMS (K952628) | Elastomade Accessories Sdn Bhd | 1995-10-19 |
| EAGLE 3000 PATIENT MONITOR (K952474) | Marquette Electronics, Inc. | 1995-10-19 |
| XENON NOPPVA (K954561) | KARL STORZ Endoscopy-America, Inc. | 1995-10-19 |
| AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE, TWO PASTE BONDING SYSTEM (K954374) | American Dental Products, Inc. | 1995-10-19 |
| MEDI-OXIDE STERILZATION POUCH FROM MEDI-PLUS (K953749) | Curwood, Inc. | 1995-10-19 |
| ELX800UV (K953572) | Bio-Tek Instruments, Inc. | 1995-10-19 |
| DECOMAT 4656 (K950566) | Getinge Disinfection, Inc. | 1995-10-19 |
| PISTON SYRINGE (K951025) | Pharmacia, Inc. | 1995-10-19 |
| EASI-JECTOR CONTROL SYSTEM (K954189) | North, Inc. | 1995-10-19 |
| AMERICAN DENTAL PRODUCTS PASTE-PRIMER ADHESIVE ORTHODONTIC BONDING SYSTEM W/FLUORIDE (K954373) | American Dental Products, Inc. | 1995-10-19 |
| DPX TISSUE QUANTIFICATION OUTPUT (K935454) | Lunar Corp. | 1995-10-19 |
| BIOFEEDBACK SYSTEM FOR SPEECH DISORDERS (K942651) | Casa Futura Technologies | 1995-10-19 |
| POLYSORB II COATED SYNTHETIC ABSORBABLE SUTURE (K953869) | United States Surgical, A Division of Tyco Healthc | 1995-10-18 |
| NOBLESCOPE NEUROENDOSCOPE SYSTEM & ACCESSORIES (K953554) | Nobles-Lai Engineering, Inc. | 1995-10-18 |
| GALVANIC SKIN RESPONSE DEVICE (K943101) | Global Ent. | 1995-10-18 |
| EASY BREATHING NASAL STRIPS (K954252) | Corbett Lair, Inc. | 1995-10-18 |
| LIHTAN 532 LASER (K951117) | Buckman Co., Inc. | 1995-10-18 |
| SYMMETRY SMALL VESSEL BALLOON DILATATION CATHETER (K953602) | Boston Scientific Corp | 1995-10-18 |
| CANDELA CRYOSYSTEM CS-5 (K953294) | Candela Laser Corp. | 1995-10-18 |
| PHILIPS BV 300 SERIES (K953910) | Philips Medical Systems North America, Inc. | 1995-10-18 |
| AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORD (K953889) | American Biosurgical, Inc. | 1995-10-18 |
| LUMISYS DICOM TOOKLIT (K953371) | Lumisys, Inc. | 1995-10-18 |
| PERCENT OXYGEN SENSOR (K952736) | Analytical Industries, Inc. | 1995-10-18 |
| KODAK AUTOMIXER II PLUS (K954484) | Eastman Kodak Company | 1995-10-18 |
| STEREX STERILE DISPOSALE ELECTROLYSIS NEEDLE FOR USE IN EPILATION (K952611) | Sterex Electrolysis Intl., Ltd. | 1995-10-18 |
| XE-LITE (K954263) | Ophthalmic Technologies, Inc. | 1995-10-18 |
| RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD) COIL (K953533) | Terumo Medical Corp. | 1995-10-18 |
| DOOSAN DSP 3800 AUTOMATIC X-RAY FILM PROCESSOR (K954345) | Doosan Corp. | 1995-10-18 |
| BLA-800A (K954310) | Toshiba Medical Systems | 1995-10-18 |
| WIDEX SENSO DIGITAL (PX) (K954526) | Widex Hearing Aid Co., Inc. | 1995-10-18 |
| BEBIG INACTIVE OPHTHALMIC APPLICATORS FOR IODINE 125 SEEDS (K945983) | Bebig Trade, Inc. | 1995-10-18 |
| MIDAS REX DRILL ATTACHMENTS & TWIST DRILLS (K954076) | Midas Rex Pneumatic Tools, Inc. | 1995-10-18 |
| ACCUPUMP 901 (MODEL NUMBERS 50 & 100) (K953382) | Pharmaceutical Infusion Technologies, Inc. | 1995-10-17 |
| SONOGEL (K953468) | Sonotech, Inc. | 1995-10-17 |
| PP-SPF1 / PP-SPF2 (K951665) | Patriot Products, Inc. | 1995-10-17 |
| INDURENT GEL (K935892) | Zhermack Dental Production | 1995-10-17 |
| SNOR-X MOUTH GUARD (K954324) | Snorex, Inc. | 1995-10-17 |
| MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYSTEM (K950073) | Shared Systems, Inc. | 1995-10-17 |
| QD BILATERAL BREAST COIL (K953262) | Hitachi Medical Systems America, Inc. | 1995-10-17 |
| MEDTEC AUTOBLOT 2000 (K951753) | Medtec, Inc. | 1995-10-17 |
| MODIFIED VERSAPORT (K954108) | United States Surgical, A Division of Tyco Healthc | 1995-10-17 |
| INCARE PRS 9300 PELVIC FL THERA SYST/TREAT URI INC (K930530) | Hollister, Inc. | 1995-10-17 |
| PLUM XL INFUSION PUMP (MODIFICATION) (K953660) | Abbott Laboratories | 1995-10-17 |
| BOBES SLIT LAMP (K945445) | Bobes S.A. | 1995-10-17 |
| EML105 ELECTROLYTE METABOLITE ANALYZER (K952621) | Radiometer America, Inc. | 1995-10-17 |
| AMERICAN DENTAL PRODUCTS TWO PASTE ADHESIVE ORTHODONTIC BONDING SYSTEM W/FLUORIDE (K954372) | American Dental Products, Inc. | 1995-10-17 |
| TRI-STAR UNIVERSAL I/A PHACO PAK (K953359) | Tri-Star Ophthalmic | 1995-10-17 |
| URODYNAMICS TUBING AND INFUSION SETS (K954341) | Life-Tech Intl., Inc. | 1995-10-17 |
| CRYOPRESS (K951769) | Grimm Scientific Industries, Inc. | 1995-10-16 |
| ECOTABS (K950587) | Msb , Ltd. | 1995-10-16 |
| VENTURI VENTILATOR (K943412) | Cardiopulmonary Corp. | 1995-10-16 |
| I-SPOUSE (K953089) | Products For Medicine | 1995-10-16 |
| MICROSURGE VERESS NEEDLE (K954520) | Microsurge, Inc. | 1995-10-16 |
| ERBOTOM ICC 300 (K953738) | Erbe Electromedizin GmbH | 1995-10-16 |