| IMMULITE RUBELLA IGG (K963613) | Diagnostic Products Corp. | 1997-04-02 |
| ULTRA-BLEND PLUS (K970113) | Ultradent Products, Inc. | 1997-04-02 |
| VISTA ILLUMINATION SYSTEM (K970217) | Vista Medical Technologies, Inc. | 1997-04-02 |
| CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-2/P-3/P-4/P-5) (K964989) | Critical Device Corp. | 1997-04-02 |
| LIQUID CSF(LCR)1, LIQUID CSF(LCR)2 (K970979) | Chiron Diagnostics Corp. | 1997-04-02 |
| SLEEP STUDY ANALYSIS (SSA) VERSION 96.10 (K963631) | Omega Results | 1997-04-02 |
| CONTROLLED PROCESS RELEASE OF FLEXLENS (HEFILCON A) (K970312) | Flexlens, Inc. | 1997-04-02 |
| MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE (K970308) | Mentor Urology, Inc. | 1997-04-02 |
| NEO-PICC (K970434) | Klein-Baker Medical, Inc. | 1997-04-01 |
| ONCE-A-DAY BOWIE AND DICK TEST PACK. (K961156) | Propper Mfg. Co., Inc. | 1997-04-01 |
| LINAC SCALPEL FLOORSTAND (K964517) | Surgical Navigation Technologies, Inc. | 1997-04-01 |
| OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PR (K964107) | Oscor Medical Corp. | 1997-04-01 |
| JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009 (K970035) | Graham-Field, Inc. | 1997-04-01 |
| CH-502A & CH520B DIGITAL FINGER SPHYGMOMANOMETER (K954547) | Citizen Watch Co., Ltd. | 1997-04-01 |
| EBI X FIX DYNAFIX MINI EXTERNAL FIXATION SYSTEM (K970290) | Ebi, L.P. | 1997-04-01 |
| REGENT BIOGEL SURGICAL GLOVE, BIOGEL M GLOVE (K970924) | Regent Medical | 1997-04-01 |
| FPT NEBULIZER (K970010) | Fluid Propulsion Technologies, Inc. | 1997-04-01 |
| BENCHMARK TRANSFER TEST (K954730) | P.K. Morgan , Ltd. | 1997-04-01 |
| DIOLITE 532 (K964074) | Iriderm Div. | 1997-04-01 |
| UPSCAN 120 (K970450) | Merlin Engineering Works, Inc. | 1997-04-01 |
| D SERIES ELECTRODE (K970603) | Cmc Sense-It, Inc. | 1997-04-01 |
| APEX MEDICAL CORP. PORTABLE INTERFERENTIAL STIMULATION DEVICE (K952683) | Wholesale Medical Imports, Inc. | 1997-04-01 |
| PROSTYLE INTRA (K970975) | Planmeca Oy | 1997-04-01 |
| UMBILICAL CLAMP AND CUTTER (K963428) | R.O.S.T. Medical Development, Inc. | 1997-04-01 |
| TRX POWER TILT AND RECLINE SYSTEM (K970521) | Motion Concepts | 1997-03-31 |
| STERI-OSS TIODIZED SCREW (K964739) | Steri-Oss, Inc. | 1997-03-31 |
| PLANCON MICROLAMELLAR KERATOME (SINGLE PIECE KERATOME HEAD WITH ACCESSORIES) (K970377) | Plancon Instruments | 1997-03-31 |
| MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300 (K970479) | Medtronic Minimed | 1997-03-31 |
| MULTI-CHANNEL COMPRESSION BTE (SD) (K970262) | Miracle-Ear, Inc. | 1997-03-31 |
| ELECTRIC SURGICAL IRRIGATION SYSTEM - DUAL CONTROLLER UNIT (K963843) | Micro Motors, Inc. | 1997-03-31 |
| INTRAVIA CONTAINER, EMPTY (K964853) | Baxter Healthcare Corp | 1997-03-31 |
| PERFECT CHOICE PROPHY PASTE WITH 10% CARBAMIDE PEROXIDE (K962370) | Challenge Products, Inc. | 1997-03-31 |
| AUDALLION II HEARING SYSTEM (K970215) | Resound Corp. | 1997-03-31 |
| FUJI MEDICAL LASER IMAGER MF PRINT SERVER MF-PS667 (K970349) | Fujifilm Medical System U.S.A., Inc. | 1997-03-31 |
| ACRYPAK FOLDER (K965185) | Alcon Laboratories | 1997-03-31 |
| ALEXANDER MANUFACTURING COMPANY PRCHARGEABLE BATTERY (K970268) | Alexander Mfg. Co. | 1997-03-31 |
| PT-PAC PORTABLE HEATING PAD (K963887) | Anthony A. Chiurco | 1997-03-31 |
| E. CAM PROFILE ATTENUATION CORRECTION (K963983) | Siemens Corp. | 1997-03-31 |
| VITROTEC TRUE LIGHT ENDOILLUMINATOR (100-S) (K964555) | Vitrotec, Inc. | 1997-03-31 |
| STYLE EYES OPTICS (K970744) | Anti-Ray, Inc. | 1997-03-31 |
| EYE TRAY (K970722) | Trinity Laboratories, Inc. | 1997-03-31 |
| ACCESSPOINT, MED E-MAIL, DICOM READER (K963936) | Biosound, Inc. | 1997-03-31 |
| KALGINATE IMPRESSION MATERIAL (K970594) | Teledyne Water Pik | 1997-03-31 |
| FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU (K964441) | Gynecare Innovation Center | 1997-03-28 |
| E0520-TRIGGER SWITCH AND CORD/E0521-TRIGGER SWITCH (K970140) | Valleylab, Inc. | 1997-03-28 |
| ARTOSCAN M (K963262) | Biosound, Inc. | 1997-03-28 |
| CRYOGEN CRYOSURGICAL SYSTEM (K964971) | Cryogen, Inc. | 1997-03-28 |
| BIO-BINKI (K961782) | Biomni Medical Systems, Inc. | 1997-03-28 |
| C.E. VASCULAR MACHINE (K960840) | C.E. Diagnosis, Inc. | 1997-03-28 |
| DUAL LUMEN EMBOLECTOMY CATHETER (K970762) | Applied Medical Resources | 1997-03-28 |
| SWIFT DELIVERY PRODUCT #002-VAC EX CUP W/VAC REL VALVE (K970170) | Richard G. Lindsay | 1997-03-28 |
| NASALFLAIR (K951944) | Airways Ltd., Inc. | 1997-03-28 |
| MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME) (K970565) | Biopsys Medical, Inc. | 1997-03-28 |
| FOCUS PV BALLOON DILATATION CATHETER (K963688) | Cardiovascular Dynamics, Inc. | 1997-03-28 |
| ULTRATOMERX (K970053) | Boston Scientific Corp | 1997-03-28 |
| AIRCAST VENAFLOW SYSTEM (MODIFICATION) (K961676) | Aircast, Inc. | 1997-03-28 |
| CUFFED OROPHARYNGEAL AIRWAY (COPA) (K955721) | Mallinckrodt Medical | 1997-03-28 |
| PIP LOW PROFILE SCAVENGING SYSTEM(260 AND 261)/UNIVERSAL LOW PROFILE SCAVENGING SYSTEM(260-U AND 261-U) (K965239) | Accutron, Inc. | 1997-03-28 |
| REXTON MODEL 48 AND 49PP (K970537) | Rexton, Inc. | 1997-03-28 |
| B-D ULTRA-FINE II SHORT 31G X 5/16 PEN NEEDLE (K970737) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1997-03-28 |
| HYDROCOOL DUAL CONDUCTOR POLYMER GEL (30101-001/CORDED DISPERSIVE ELECTRODE-SENSING (K970130) | Medtrex, Inc. | 1997-03-28 |
| AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX (K963293) | Augustine Medical, Inc. | 1997-03-28 |
| COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEM (K971057) | Cogent Light Technologies, Inc. | 1997-03-28 |
| GYREX 2T-PRESTIGE (K970005) | Elscint, Inc. | 1997-03-28 |
| COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002) (K965214) | Coeur Laboratories, Inc. | 1997-03-28 |
| SCIMED CHOICE FAMILY OF PTCA GUIDE WIRES (K970244) | Scimed Life Systems, Inc. | 1997-03-28 |
| UNIVERSAL LOW PROFILE NASAL HOODS(1250,1275,1350,1450,1475,1550) (K970046) | Accutron, Inc. | 1997-03-28 |
| PARAMAX TRIGLYCERID REAGENT (K964346) | Dade Intl., Inc. | 1997-03-28 |
| FAST TRACT TRANSTRACHEAL PROCEDURE KIT (K970018) | L.W. Ward and Assoc., Inc. | 1997-03-28 |
| GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM (K962687) | Nichols Institute Diagnostics | 1997-03-28 |
| ERCP CANNULA (K963051) | United States Endoscopy Group, Inc. | 1997-03-28 |
| SELECTA-TIP LAPAROSCOPIC SCISSORS (K970826) | Microline Pentax, Inc. | 1997-03-28 |
| AESCULAP MODULAR MONOPOLAR ELECTRODES (K970541) | Aesculap, Inc. | 1997-03-28 |
| INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099) (K964021) | Baxter Edwards | 1997-03-27 |
| CONVERTORS IMPERVIOUS SHOE COVERS (K970815) | Allegiance Healthcare Corp. | 1997-03-27 |
| TEETHMATE F-1 (K965091) | Kuraray Company, Ltd. | 1997-03-27 |
| AQUASIL RIGID SMART WETTING IMPRESSION MATERIAL (K970433) | Dentsply Intl. | 1997-03-27 |
| JIAWANG POWDER-FREE VINYL EXAMINATION GLOVES (K970111) | Shanghai Jiawang Industrial Co. , Ltd. | 1997-03-27 |
| PNEUMO-MATIC INSUFFLATION NEEDLE (K970788) | Apple Medical Corp. | 1997-03-27 |
| POINT OF USE II SHARPS-A-GATOR (K964387) | Graphic Controls Corp. | 1997-03-27 |
| POLY-MED (K970625) | Shinemound Enterprise, Inc. | 1997-03-27 |
| EKONIC DENTAL/MEDICAL MASK (MD 610) (K970440) | Ekonic Company, Ltd. | 1997-03-27 |
| NIPRO DISPOSABLE SOLUTION INFUSION SET (K970076) | Nipro Medical Corp. | 1997-03-27 |
| BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM (K965131) | Wampole Laboratories | 1997-03-26 |
| DEPUY MOTECH TITANIUM MOSS MIAMI SPINAL SYSTEM (K964024) | Depuy, Inc. | 1997-03-26 |
| AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER (K970340) | Bellab | 1997-03-26 |
| WIDEX SENSO DIGITAL (CIC) (K970904) | Widex Hearing Aid Co., Inc. | 1997-03-26 |
| MAGNESIUM (K964915) | Derma Media Lab., Inc. | 1997-03-26 |
| DOCTORS REVIEW SYSTEM (K970402) | Digisonics, Inc. | 1997-03-26 |
| MAGNO ALARM (K960849) | Cardiac Assist Devices, Inc. | 1997-03-26 |
| BACFIX SPINAL FIXATION SYSTEM (K964404) | Spinal Concepts, Inc. | 1997-03-26 |
| LEVEL 10 HDI (K961459) | Advanced Technology Laboratories, Inc. | 1997-03-26 |
| MODEL 8800 ASPIRATOR (K963775) | Medical Specifics, Inc. | 1997-03-26 |
| BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM (K965129) | Wampole Laboratories | 1997-03-26 |
| ORBSHOT KERATOMETER (K964891) | Orbtek, Inc. | 1997-03-26 |
| VICTORY EYEWEAR CO (K970538) | Victory Eyewear Co., Ltd. | 1997-03-25 |
| IRRIGATION/ASPIRATION POLYPECTOMY (K970356) | United States Endoscopy Group, Inc. | 1997-03-25 |
| FIXATION PIN OR ROD (K970036) | United States Surgical, A Division of Tyco Healthc | 1997-03-25 |
| BENTLEY QUICK-PRIME HEMOCONCENTRATOR WITH DURAFLO TREATMENT (K963203) | Baxter Healthcare Corp | 1997-03-25 |
| EXTRACTORRX (K970052) | Boston Scientific Corp | 1997-03-25 |