| THE C-FIT FEMORAL HIP SYSTEM (K965019) | Corin USA | 1997-03-25 |
| SPACELABS MEDICAL 12-LEAD DIAGNOSTIC ECG ANALYSIS OPTION (K962970) | Spacelabs Medical, Inc. | 1997-03-25 |
| SYNTHES TITANIUM (TI) ALLOY HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM (K963325) | Synthes (Usa) | 1997-03-25 |
| MENICON Z BIFOCAL DESIGN LENS/MENICON Z TRIFOCAL DESIGN LENS (K970019) | Menicon U.S.A., Inc. | 1997-03-25 |
| HEDGES CORNEAL WETTING PAK (K970161) | Hedges Cwp, Inc. | 1997-03-25 |
| CORE AND COIL ASSEMBLY GUIDEWIRE (K970994) | Lake Region Mfg., Inc. | 1997-03-25 |
| INNOVASIVE 2.8MM AND 3.5MM ROC LF SUTURE BONE FASTENER (K970089) | Innovasive Devices, Inc. | 1997-03-25 |
| AVANTA ORTHOPAEDICS TENDON SPACER (K964359) | Avanta Orthopaedics, Inc. | 1997-03-25 |
| ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION) (K954301) | Abbott Laboratories | 1997-03-24 |
| BILE ACIDS REAGENT SET (K970120) | Teco Diagnostics | 1997-03-24 |
| CONMED: STAT 2 AND STAT 2 PUMPETTE EXTENSION SETS AND MASTERFLOW AND MASTERFLOW PUMPETTE PRIMARY SETS (K964844) | Conmedcorp | 1997-03-24 |
| SPINNAKER (K965189) | Target Therapeutics | 1997-03-24 |
| JELENKO NO.1 (CODE NAME RD-0601) (K970068) | J.F. Jelenko & Co., Inc. | 1997-03-24 |
| CHIRON DIAGNOSTICS ACS:180TU P (K970539) | Chiron Diagnostics Corp. | 1997-03-24 |
| CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM WITH CLINICAL TRANSPORT MEDIA (CARY-BLAIR OPTION) (K970597) | Medical Packaging Corp. | 1997-03-24 |
| AXSYM B12 (K965186) | Abbott Laboratories | 1997-03-24 |
| IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENT (K964257) | Beckman Instruments, Inc. | 1997-03-24 |
| ELECSYS PROGESTERONE ASSAY (K964841) | Boehringer Mannheim Corp. | 1997-03-24 |
| WRIGHT PLASTER OF PARIS BONE VOID FILLER KIT (SUBJECT TO REVISION) (K963587) | Wrightmedicaltechnologyinc | 1997-03-24 |
| TOXO IGG ELISA TEST (K962343) | Gull Laboratories, Inc. | 1997-03-24 |
| THERMAPREP PLUS OVEN (K970134) | Tulsa Dental Products, Ltd. | 1997-03-21 |
| CES INFUSION CATHETER (K965181) | Cordis Neurovascular, Inc. | 1997-03-21 |
| FEMTEX 100% COTTON DENTLE TOUCH TAMPONS (K970232) | Regu-Tech Assoc., Inc. | 1997-03-21 |
| METAGEN ALL POLY ACETABULAR CUP SYSTEM (K964003) | Metagen, LLC | 1997-03-21 |
| SMITH & NEPHEW IMAGES ARTHROSCOPE/ENT ENDOSCOPE (K970247) | Smith & Nephew, Inc. | 1997-03-21 |
| ACRYDERM GEL WOUND DRESSING (K970693) | Acrymed, Inc. | 1997-03-21 |
| DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM (K970721) | Johnson & Johnson Medical, Inc. | 1997-03-21 |
| TRUFILL PVA PARTICLES (K965174) | Cordis Neurovascular, Inc. | 1997-03-21 |
| EPI-SCOPE OPTION FOR Q SERIES CT SYSTEMS (K962010) | Philips Medical Systems (Cleveland), Inc. | 1997-03-21 |
| ALLCLENZ WOUND CLEANSER (K965120) | Dpt Laboratories, Ltd. | 1997-03-21 |
| DEPUY ACE AIM TITANIUM TIBIAL NAIL (K970202) | Depuy Ace Medical Co. | 1997-03-21 |
| ALGOPLAQUE HYDROCOLLOID DRESSING (K970518) | Laboratoires Urgo S.A. | 1997-03-21 |
| PHILIPS EASY DIAGNOST (K970640) | Philips Medical Systems North America, Inc. | 1997-03-21 |
| LIBERTY VALVE (K964690) | Cleveland Medical Devices, Inc. | 1997-03-21 |
| TUSTEX FLAVORED CONDOMS (K970633) | Line One Laboratories | 1997-03-21 |
| DECISION SUPPORT SYSTEM (FOR RADIATION ONCOLOGY) (K964167) | Multidata Systems International Corp. | 1997-03-21 |
| ELLIPSE 4 (K964522) | Andromeda Medizinische Systeme GmbH | 1997-03-21 |
| KREATIV KURING LIGHT SYSTEM (K962376) | Kreativ, Inc. | 1997-03-21 |
| FUKUDA DENSHI MODEL LX-3240 ECG & RESPIRATORY TRANSMITTER (K963057) | Fukuda Denshi USA, Inc. | 1997-03-21 |
| FUJI COMPUTED RADIOGRAPHY FCR/DICOM GATEWAY UNIT CR-DM666 (K970293) | Fujifilm Medical System U.S.A., Inc. | 1997-03-21 |
| CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4 (K963698) | International Biophysics Corp. | 1997-03-20 |
| SIMAR, INC. SURGICAL DRESSING (K970020) | Simar, Inc. | 1997-03-20 |
| SUPERLIGHT (K964954) | Wheelcare Scooters, Inc. | 1997-03-20 |
| CMS ACCUPROBE 610, 620, 630, 640, 650, 660, 670, 680 (K964336) | Cryomedical Sciences, Inc. | 1997-03-20 |
| SURE CORE BIOPSY KIT (K963813) | Interventional Concepts, Inc. | 1997-03-20 |
| IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT (K964877) | Impra, Inc. | 1997-03-20 |
| CANNULA (K965121) | Origin Medsystems, Inc. | 1997-03-20 |
| POWERED WHEELCHAIR (K962565) | Orthofab, Inc. | 1997-03-20 |
| HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES (K965132) | Mallinckrodt Medical | 1997-03-20 |
| TRANSTRACHEAL CATHETER (ACC. RAVUSSIN). (K955461) | VBM Medizintechnik GmbH | 1997-03-19 |
| LATEX EXAM GLOVE WITH HYPOALLERGENIC LABELING (POWDERED) (K960842) | Crocker Industrial Resources Sdn. Bhd. | 1997-03-19 |
| OMNITECH RESECTOSCOPE ROLLER ELECTRODE (K965093) | Omnitech Systems, Inc. | 1997-03-19 |
| NIKKISO CO, LTD., FLX10GW, 12GW, 15GW, 18GW & 21GW HEMODIALYZERS (K953996) | NIKKISO CO., LTD. | 1997-03-19 |
| ASCEND BALLOON DAILATION CATHETER (K970041) | Cook Urological, Inc. | 1997-03-19 |
| CUTTERSIL COMFORT (K965163) | Heraeus Kulzer, Inc. | 1997-03-19 |
| IMMUNOCHEMISTRY SYS URINE TRANSFERRIN REAGENT (K963976) | Beckman Instruments, Inc. | 1997-03-19 |
| PROMED 55-G SOFT DAILY WEAR CONTACT LENS (K970615) | Biomed Devices Corp. | 1997-03-19 |
| TUOHY EPIDURAL NEEDLES (K961152) | Hakko Shoji Co., Ltd. | 1997-03-19 |
| CHASE CORONARY SINUS PERFUSION CANNULA (K964199) | Chase Medical, Inc. | 1997-03-19 |
| ENZYMUN-TEST PSA (K965085) | Boehringer Mannheim Corp. | 1997-03-19 |
| CUTTERSIL COMFORT HARDENER (K965165) | Heraeus Kulzer, Inc. | 1997-03-19 |
| NEUROLOGICAL OR CRANI TRAYS (PACKS) (K932221) | Associated Medical Products Co. | 1997-03-19 |
| CRYOSIL SILICONE GEL SHEETING (K964047) | Biodermis Corp. | 1997-03-19 |
| EXTRA TENS (RI-2500) NEO TENS (RI-2000E) (K963507) | Comtek Intl., Corp. | 1997-03-19 |
| CHASE TWO STAGE VENOUS RETURN CATHETER (K964195) | Chase Medical, Inc. | 1997-03-19 |
| VOLUME CONTROL SYRINGE MODEL VCD-SYR-10 (K962141) | B.Braun Medical, Inc. | 1997-03-19 |
| PHILIPS SONO DIAGNOST 800 (K963706) | Hewlett-Packard Co. | 1997-03-19 |
| SPINAL NEEDLES (K961151) | Hakko Shoji Co., Ltd. | 1997-03-19 |
| WALLACH INTEGRATION UNIT (K963348) | Wallach Surgical Devices, Inc. | 1997-03-19 |
| COMEG ENDOSCOPY GRASPING FORCEPS (K970489) | Comeg Endoscopy | 1997-03-19 |
| GIOTTO HIGH TECH (H.T.) MAMMOGRAPHIC SYSTEM (K953902) | Medical Marketing Intl., Inc. | 1997-03-19 |
| THE SWIRLER NEBULIZER (K952910) | Amici, Inc. | 1997-03-19 |
| SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE (K951728) | Mira, Inc. | 1997-03-19 |
| STAINLESS STEEL CORTAC CORTICAL ELECTRODE(2111)/PLANTINUM CORTAC CORTICAL ELECTRODE (K964224) | Pmt Corp. | 1997-03-19 |
| AARON VAC 2 (K952558) | Aaron Medical Industries | 1997-03-19 |
| NARKOMED GS ANESTHESIA SYSTEM (K963994) | Draeger Medical, Inc. | 1997-03-19 |
| DAKOTA SMITH, NICOLE MILLER SUNGLASSES (K965125) | California Design Studio, Inc. | 1997-03-19 |
| REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142 (K963347) | Instrumentation Industries, Inc. | 1997-03-19 |
| T1 CONTROL HIGH SPEED DENTAL HANDPIECE (K965238) | Siemens AG | 1997-03-19 |
| CAHSE AORTIC ROOT CANNULA (K964198) | Chase Medical, Inc. | 1997-03-19 |
| MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT (K960766) | Meadox Medicals, Div. Boston Scientific Corp. | 1997-03-19 |
| SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATE (K965190) | Accumed Intl., Inc. | 1997-03-19 |
| HYDROPREP GEL (K964737) | D.O. Weaver Co. | 1997-03-19 |
| NIDEK CYBERSCAN (K970017) | Nidek, Inc. | 1997-03-18 |
| MOSS MIAMI SPINAL SYSTEM (K962628) | Depuy, Inc. | 1997-03-18 |
| VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050) (K970643) | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-03-18 |
| INTERCEPTRE LAPAROSCOPIC INSTRUMENTS (K970151) | Smith & Nephew, Inc. | 1997-03-18 |
| COMBIPROT EMERGENCY ENFUSION DEVICE (K970359) | B.Braun Medical, Inc. | 1997-03-18 |
| SYSMEX CA-1000/SYSMEX CA-5000 (K964946) | Sysmex Corp. | 1997-03-18 |
| PATIENT EXAMINATION GLOVES (POWDER FREE-NON STERILE) (K970613) | Sti Medical Sdn Bhd | 1997-03-18 |
| NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T4- ESTIMATE KIT (K962408) | Nichols Institute Diagnostics | 1997-03-18 |
| VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15) (K965142) | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-03-18 |
| AMSINO URINARY DRAINAGE BAG (K964745) | Amsino Intl., Inc. | 1997-03-18 |
| MEDTRONIC ALGOLINE INTRASPINAL CATHETER SYSTEM (K965251) | Medtronic Vascular | 1997-03-18 |
| ELECSYS TESTOSTERONE ASSAY (K964889) | Boehringer Mannheim Corp. | 1997-03-18 |
| RACE CAR TYMPANOMETER WITH AUDIOMETER(AE-RCAUD I/QUIK TYMP 1(AE-QUIK 1)/QUICK TYMP 2(AE-QUIK 2) (K970279) | American Electromedics Corp. | 1997-03-18 |
| COMPAT GASTROSTOMY/JEJUNOSTOMY FEEDING TUBE KIT(088000) (K965087) | Sandoz Nutrition | 1997-03-18 |
| CMV ANTIGEN CONTROL SLIDES (K964875) | Viral Antigens, Inc. | 1997-03-18 |
| THROMBONOSTIKA F1.2 (K964934) | Organon Teknika Corp. | 1997-03-18 |
| S.P. 100 (K970696) | Lsi Intl., Inc. | 1997-03-18 |