| CONDOM (RUBBER), LUBRICATED, EXTRA STRENGTH (K970767) | Custom Services Intl., Inc. | 1997-06-02 |
| SILICONE PUTTY EAR PLUGS (K971517) | Bentec Medical, Inc. | 1997-06-02 |
| DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEM (K970446) | Althin Medical AB an Affiliate of Baxter Intl | 1997-06-02 |
| QUIKSTRIP ONE STEP AMPHETAMINE TEST (K971218) | Drial Consultants, Inc. | 1997-05-30 |
| MDX 2000, DIGITAL ANALYZER (K970824) | Shotwell & Carr, Inc. | 1997-05-30 |
| QUANTA LITE IGG GLIADIN ELISA (K964985) | Inova Diagnostics, Inc. | 1997-05-30 |
| DOUBLE-HOLE PENCILE-POINT SPINAL NEEDLE (DHPP SPINAL NEEDLE) (K951928) | Csen , Ltd. | 1997-05-30 |
| IGA ANTI-GLIADIN (IGA-AGA) ANTIBODY TEST KIT (K964341) | Immco Diagnostics, Inc. | 1997-05-30 |
| DRIED GRAM-NEGATIVE MIC/COMBO PANELS (K971376) | Dade Microscan, Inc. | 1997-05-30 |
| DUPEL II BUFFERED IONTOPHORESIS ELECTRODES (K970491) | Empi | 1997-05-30 |
| LIQUICHEK URINE TOXICOLOGY CONTROL - LEVEL S1, S2, S3 (K971691) | Bio-Rad | 1997-05-30 |
| COMBINED END-MULTIPLE LATERAL HOLES EPIDURAL CATHETER (CEMLH EPIDURAL CATHETER) (K951927) | Csen , Ltd. | 1997-05-30 |
| IGG ANTI-GLIADIN (IGG-AGA) ANTIBODY TEST KIT (K964344) | Immco Diagnostics, Inc. | 1997-05-30 |
| VARIOLINK II (K971372) | Ivoclar North America, Inc. | 1997-05-29 |
| ACUPUNCTURE NEEDLES (K964861) | C.A.M. Supply, Inc. | 1997-05-29 |
| CK REAGENT (K971396) | Carolina Liquid Chemistries Corp. | 1997-05-29 |
| TYMPANOSTOMY VENTILATION TUBE (K971454) | Ikonos Corp. | 1997-05-29 |
| DMA TRIGLYCERIDES PROCEDURES (K971113) | Data Medical Associates, Inc. | 1997-05-29 |
| QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA( (K964767) | R&D Systems, Inc. | 1997-05-29 |
| TAS PT-NCTEST CONTROLS (K971748) | Cardiovascular Diagnostics, Inc. | 1997-05-29 |
| HR12000 ULTRASOUND SYSTEM (K961229) | International Ultrasound Corp. | 1997-05-29 |
| PATHFINDER SUNGLASSES (K971495) | Coil | 1997-05-29 |
| CARDIAC SCORING FOR CT SCANNERS (K970980) | Elscint, Inc. | 1997-05-29 |
| SMART - GLOVE POWDER FREE LATEX EXAMINATION GLOVE (K971403) | Sj Medical Products (M) Sdn Bhd | 1997-05-29 |
| GYROSCAN T5-NT, GYROSCAN T10-NT AND GYROSCAN ACS-NT RELEASE 5 SERIES (K963990) | Philips Medical Systems, Inc. | 1997-05-29 |
| CHOL OR CHOLESTEROL (K971345) | Carolina Liquid Chemistries Corp. | 1997-05-29 |
| CTS-200 WITH EZU-PL21 TRANSDUCER (K963068) | Shantou Institute of Ultrasonic Instuments | 1997-05-29 |
| SONOLINE VERSA 555 DIAGNOSTIC ULTRASOUND SYSTEM (K962142) | Siemens Medical Solutions USA, Inc. | 1997-05-29 |
| 511 KEV COLLIMATOR (K964438) | Trionix Research Laboratory, Inc. | 1997-05-29 |
| ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE VANISHPOINT SYRINGE (K970803) | Retractable Technologies, Inc. | 1997-05-29 |
| B2 MICROGLOBULIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (K964791) | Bayer Corp. | 1997-05-29 |
| CTS-285 WITH EZU-PL21 AND EZU-PC3B TRANSDUCERS (K963065) | Shantou Institute of Ultrasonic Instuments | 1997-05-29 |
| FRIGIDERM FRIGISPRAY (K971216) | Dermatologic Lab & Supply, Inc. | 1997-05-29 |
| USCI MAINSTAY GUIDING CATHETER (K971034) | C.R. Bard, Inc. | 1997-05-28 |
| KASHA VISUAL FIELD SYSTEM (K971156) | Kasha Software, Inc. | 1997-05-28 |
| ARTHROCARE MONOPOLAR ELECTROSURGERY LOOP (K970526) | Arthrocare Corp. | 1997-05-28 |
| THERATON 1000E (K964607) | Theratronics, Inc. | 1997-05-28 |
| Cordis Endeavor Infusion Catheter (K970842) | Cordis Corp. | 1997-05-28 |
| DURALASTIC I AND DURALASTIC II (K971480) | Allied Biomedical Corp. | 1997-05-28 |
| ULTRAVERSE PTA CATHETER (K964881) | Vas-Cath, Inc. | 1997-05-28 |
| EARCHECK PRO (K970685) | Mdi Instruments, Inc. | 1997-05-28 |
| SYNTHES (USA) COMPACT AIR DRIVE II (CAD II) (K971544) | Synthes (Usa) | 1997-05-28 |
| OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ACCESSORIES (K970797) | Olympus America, Inc. | 1997-05-28 |
| WRIGHT 1000 MONOPLACE HYPERBARIC SYSTEM (K952545) | Wright Industries | 1997-05-28 |
| CLINITRON RITE-HITE (K964223) | Hill-Rom, Inc. | 1997-05-28 |
| NOTEBOOK IMAGER (K961104) | Digirad Corp. | 1997-05-28 |
| UHS MICRONET PROGRAMMABLE HEARING AIDS MODELS 901,902,903,906,909/PROGRAMMER (K970828) | United Hearing Systems, Inc. | 1997-05-28 |
| QUANTIKINE IVD STFR ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) (K970718) | R&D Systems, Inc. | 1997-05-27 |
| IMMULITE PYRILINKS-D (K971312) | Diagnostic Products Corp. | 1997-05-27 |
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY # GL825-P (K971213) | Alexander Mfg. Co. | 1997-05-27 |
| NON-STERILE ISOLATION GOWN (K970814) | American Seal Co. | 1997-05-27 |
| KSEA CO2 ENDOFLATOR (K963423) | Karl Storz Endoscopy | 1997-05-27 |
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL8108 (K971237) | Alexander Mfg. Co. | 1997-05-27 |
| UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) (K971477) | Trace America, Inc. | 1997-05-27 |
| QUANTEX ASO-CRP-RF CONTROL (K971777) | Instrumentation Laboratory CO | 1997-05-27 |
| ORTHOCHUCK (K964252) | Buckman Co., Inc. | 1997-05-27 |
| URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) (K971485) | Trace America, Inc. | 1997-05-27 |
| CYBERJET LOCAL ANESTHESIA SYSTEM (K964802) | Intra Vantage, Inc. | 1997-05-27 |
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL4018 (K971212) | Alexander Mfg. Co. | 1997-05-27 |
| ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M7) (K970786) | Alexander Mfg. Co. | 1997-05-27 |
| LSVP INTERNATIONAL HOT BIOPSY FORCEPS (K971204) | Lsvp Intl., Inc. | 1997-05-27 |
| COMEG OPTICAL STONE CRUSHING FORCEPS, COMEG VISUAL OBTURATORS FOR UROLOGY, COMEG OPTICAL BIOPSY FORCEPS (K971202) | Comeg Endoskopie GmbH | 1997-05-27 |
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL825 (K971234) | Alexander Mfg. Co. | 1997-05-27 |
| CONVERTORS SMS DRAPES (K970554) | Allegiance Healthcare Corp. | 1997-05-27 |
| LIFECORE O-RING ABUTMENT;LIFECORE DALLA BONA ABUTMENT (K970776) | Lifecore Biomedical, Inc. | 1997-05-27 |
| AUTO HDL CHOLESTEROL CALIBRATOR (K970933) | Pointe Scientific, Inc., | 1997-05-23 |
| #ES-32 SUCTION CATHETER 32 FR. (K970890) | Tri-Med Specialties, Inc. | 1997-05-23 |
| CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES) (K971584) | Clarus Medical Systems, Inc. | 1997-05-23 |
| VINYL PATIENT EXAMINATION GLOVE, POWDER-FREE (K971415) | Shanghai Foremost Plastic Industrial Co., Ltd. | 1997-05-23 |
| MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT (K971658) | Jay H. Geller | 1997-05-23 |
| ATRION MEDICAL AUTOGENOUS TISSUE COLLECTOR (K971100) | Atrion Medical Products, Inc. | 1997-05-23 |
| LIBERTY PLUS SYSTEM(PFS-300)/VAGINAL PROBE, LIBERTY PLUS(PFS-044) (K970077) | Utah Medical Products, Inc. | 1997-05-23 |
| ENDO SMARTCAP (100501) (K971125) | Endo Smart Cap Co. | 1997-05-23 |
| SYNCHRON SYSTEMS ALKALINE PHOSPHATASE REAGENT, CHOLINESTERASE REAGENT, GAMMA-GLUTAMYL TRANSFERASE REAGENT, LACTATE DEHYD (K971333) | Beckman Instruments, Inc. | 1997-05-23 |
| CENTOCOR CA 15-3 RIA MODEL NO. 800-033 (K963803) | Centocor, Inc. | 1997-05-23 |
| RUSCH ENTERAL FEEDING TUBE (K963779) | Rusch, Inc. | 1997-05-23 |
| VINYL PATIENT EXAMINATION GLOVE, POWDERED (K971423) | Shanghai Foremost Plastic Industrial Co., Ltd. | 1997-05-23 |
| MILL-ROSE DISPOSABLE POLYPECTOMY SNARE (K971275) | Mill-Rose Laboratory | 1997-05-23 |
| STELA MODEL BJ44 AND BJ45 PACING LEADS (K963738) | Ela Medical, Inc. | 1997-05-23 |
| OCCLUSION CLAMP** DEVICE (K964251) | United States Surgical, A Division of Tyco Healthc | 1997-05-23 |
| BETTER-BLADDER (BB) (K964337) | Circulatory Technology, Inc. | 1997-05-23 |
| STA D-DI CALIBRATOR KIT (K964718) | American Bioproducts Co. | 1997-05-23 |
| INTER-OP POROUS REVISION SHELL WITH SEALABLE SCREWHOLES (K970705) | Sulzer Orthopedics, Inc. | 1997-05-22 |
| FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF SUB-TROCHANTERIAN FRACTURES (K970257) | Ferguson Medical | 1997-05-22 |
| BIO-ANCHOR (K963369) | Linvatec Corp. | 1997-05-22 |
| FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF PER-TROCHANTEROAM FRACTURES (K970280) | Ferguson Medical | 1997-05-22 |
| FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHSIS OF UNSTABLE FEMORAL NECK FRACTURES (K970258) | Ferguson Medical | 1997-05-22 |
| MEMOREG (K971155) | Heraeus Kulzer, Inc. | 1997-05-22 |
| DEROYAL INDUSTRIES, INC. DISPOSABLE BIPOLAR ELECTROSURGICAL CABLE (K970993) | Deroyal Industries, Inc. | 1997-05-22 |
| DSL ACTIVE T3 EIA (K971270) | Diagnostic Systems Laboratories, Inc. | 1997-05-22 |
| ML DISPOSABLE ALK TUBING (K971173) | Med-Logics, Inc. | 1997-05-22 |
| NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILES (K971319) | Tycom Dental | 1997-05-22 |
| AMBUVAC (K971548) | Kinetic Concepts, Inc. | 1997-05-22 |
| OSMOCYTE WOUND MANAGER SHEET DRESSING (K965143) | Procyte Corp. | 1997-05-22 |
| 3-CCD DIGITAL CAMERA (K970605) | Envision Medical Corp. | 1997-05-22 |
| KIRWAN MODEL 28 1000 BIPOLAR COAGULATOR (K971341) | Kirwan Surgical Products, Inc. | 1997-05-22 |
| INSTRUMENT HOLDER (K970900) | Contour Fabricators, Inc. | 1997-05-22 |
| VECTORVISION (K962939) | Brainlab, Inc. | 1997-05-22 |
| AYURVEDIC TONGUE CLEANER (K971025) | Calello Martinez P.C. | 1997-05-22 |
| NEO-CARE LUMBER PUNCTURE KIT (K970997) | Klein-Baker Medical, Inc. | 1997-05-22 |