| ENDO SMARTCAP (100501) (K971125) | Endo Smart Cap Co. | 1997-05-23 |
| RUSCH ENTERAL FEEDING TUBE (K963779) | Rusch, Inc. | 1997-05-23 |
| MILL-ROSE DISPOSABLE POLYPECTOMY SNARE (K971275) | Mill-Rose Laboratory | 1997-05-23 |
| BETTER-BLADDER (BB) (K964337) | Circulatory Technology, Inc. | 1997-05-23 |
| 3-CCD DIGITAL CAMERA (K970605) | Envision Medical Corp. | 1997-05-22 |
| INSTRUMENT HOLDER (K970900) | Contour Fabricators, Inc. | 1997-05-22 |
| PAN (CHIBA ASPIRATING NEEDLE) (K970872) | Gallini Intl., Inc. | 1997-05-21 |
| SYMPHONY NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K963254) | Boston Scientific Corp | 1997-05-21 |
| TR NEEDLE (K970871) | Gallini Intl., Inc. | 1997-05-21 |
| DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM ALTRATOUCH 1000 DIALYSATE DELIVERY SYSTEM (K964922) | Althin Medical AB an Affiliate of Baxter Intl | 1997-05-21 |
| ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.) (K970875) | American Medical Devices, Inc. | 1997-05-20 |
| UROSTYM (K962009) | Laborie Medical Technologies, Ltd. | 1997-05-20 |
| VISTA SINGLE CHIP VIDEO CAMERA (K971373) | Vista Medical Technologies, Inc. | 1997-05-20 |
| ULTRAFLEX DIAMOND (K962899) | Boston Scientific Corp | 1997-05-20 |
| CLARUS MODEL 5197 SIGHTLITE (K971455) | Clarus Medical Systems, Inc. | 1997-05-20 |
| FREEDOM TRAVELLER (K964825) | Impact Case Technologies, Inc. | 1997-05-19 |
| MANAN V.S. ACCESS NEEDLE/SET (K963767) | Manan Medical Products, Inc. | 1997-05-16 |
| OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE (K970716) | Opticon Medical, Inc. | 1997-05-16 |
| ALEXANDER MANUFACTURING RECHARGEABLE BATTERY (M1/T) (K970799) | Alexander Mfg. Co. | 1997-05-14 |
| MBI CO-AXIAL ILLUMINATED RETINAL PICK (K964553) | M.B. Industries, Inc. | 1997-05-13 |
| MBI ILLUMINATED RETINAL PICK (K964405) | M.B. Industries, Inc. | 1997-05-13 |
| MEDISYSTEMS TRANDUCER PROTECTOR (K970536) | Medisystems Corp. | 1997-05-12 |
| T-RX RETRIEVAL FORCEPS (K970982) | Tri-Med Specialties, Inc. | 1997-05-09 |
| VAPOR-TECH SLED ELECTRODE (K970717) | Northgate Technologies, Inc. | 1997-05-08 |
| ANGLED TIP POLYPECTOMY SNARE (K970945) | United States Endoscopy Group, Inc. | 1997-05-07 |
| SYNTEC, INC. DISPOSABLE BARE END FIBER (K971338) | Syntec, Inc. | 1997-05-06 |
| ENDOLIGHT FIBEROPTIC REGULAR MONOFILAMENT AND FINE MONOFILAMENT (K970878) | American Medical Devices, Inc. | 1997-05-06 |
| O'REGAN LIGATOR (K963166) | Patrick J. O'Regan | 1997-05-05 |
| SH-1 SURGICAL HOLDER FOR TELESCOPE (K960068) | Olympus America, Inc. | 1997-05-05 |
| FIEGERT ENDOTECH CYSTOSCOPE (K970892) | Fiegert, Inc. | 1997-05-05 |
| APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE (K971498) | Applied Medical Resources | 1997-05-05 |
| BARD MEMOTHERM TRANSHEPATIC BILIARY ENDOPROSTHESIS (K963782) | C.R. Bard, Inc. | 1997-05-02 |
| COBE CENTRYSYSTEM 14 PES HEMODIALYZERS (K955592) | Cobe Renal Care, Inc. | 1997-04-30 |
| WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS (K964119) | Boston Scientific Scimed, Inc. | 1997-04-28 |
| KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET (K970969) | The Kendal Co. | 1997-04-23 |
| SMITH & NEPHEW MIS INSTRUMENTS (K970949) | Smith & Nephew Endoscopy, Inc. | 1997-04-23 |
| COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIES (K970764) | Comeg Endoscopy | 1997-04-22 |
| RESECTOSCOPE CUTTING LOOP ELECTRODE (K964365) | Omnitech Systems, Inc. | 1997-04-22 |
| MINNOVA PELVIC FLOOR STIMULATION SYSTEM (K970307) | Empi | 1997-04-22 |
| COMFORT CATH CHOICE MALE EXTERNAL CATHETER (K970966) | Sierra Laboratories, Inc. | 1997-04-22 |
| INNERDYNE STEP TROCAR EXPANABLE PORT, OPEN STEP (K970754) | Innerdyne, Inc. | 1997-04-21 |
| GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS (K955487) | Cobe Renal Care, Inc. | 1997-04-18 |
| VS-100 VIDEO SIGMOIDOSCOPE (K970382) | Welch Allyn, Inc. | 1997-04-17 |
| VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE-SMALL (K970602) | Hollister, Inc. | 1997-04-15 |
| 3 DIMENSIONAL VIDEO ENDOSCOPE (K970214) | Oktas | 1997-04-14 |
| VISTA MINI CAMERA SYSTEM (K970369) | Oktas | 1997-04-14 |
| DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER (K962814) | Denver Biomaterials, Inc. | 1997-04-14 |
| OLYMPUS NA-10J-1 ASPIRATION NEEDLE (K970563) | Olympus America, Inc. | 1997-04-11 |
| MICROVASIVE GOLD PROBE (K970278) | Boston Scientific Corp | 1997-04-11 |
| AESOP SYSTEM AND ACCESSORIES (K963126) | Computer Motion, Inc. | 1997-04-07 |
| URODYNAMIC ANALYSIS MODULE (K963330) | Synectics Medical, Inc. | 1997-04-03 |
| 12 URETEROSCOPES/URETERO-RENOSCOPES (K963855) | Richard Wolf Medical Instruments Corp. | 1997-04-03 |
| STONE DISLODGER, BASKET (K970121) | Boston Scientific Corp | 1997-04-02 |
| VISTA ILLUMINATION SYSTEM (K970217) | Vista Medical Technologies, Inc. | 1997-04-02 |
| MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE (K970308) | Mentor Urology, Inc. | 1997-04-02 |
| VITROTEC TRUE LIGHT ENDOILLUMINATOR (100-S) (K964555) | Vitrotec, Inc. | 1997-03-31 |
| MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME) (K970565) | Biopsys Medical, Inc. | 1997-03-28 |
| ULTRATOMERX (K970053) | Boston Scientific Corp | 1997-03-28 |
| COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEM (K971057) | Cogent Light Technologies, Inc. | 1997-03-28 |
| ERCP CANNULA (K963051) | United States Endoscopy Group, Inc. | 1997-03-28 |
| PNEUMO-MATIC INSUFFLATION NEEDLE (K970788) | Apple Medical Corp. | 1997-03-27 |
| IRRIGATION/ASPIRATION POLYPECTOMY (K970356) | United States Endoscopy Group, Inc. | 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 |
| CORE AND COIL ASSEMBLY GUIDEWIRE (K970994) | Lake Region Mfg., Inc. | 1997-03-25 |
| LIBERTY VALVE (K964690) | Cleveland Medical Devices, Inc. | 1997-03-21 |
| ELLIPSE 4 (K964522) | Andromeda Medizinische Systeme GmbH | 1997-03-21 |
| SURE CORE BIOPSY KIT (K963813) | Interventional Concepts, Inc. | 1997-03-20 |
| 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 |
| COMEG ENDOSCOPY GRASPING FORCEPS (K970489) | Comeg Endoscopy | 1997-03-19 |
| AMSINO URINARY DRAINAGE BAG (K964745) | Amsino Intl., Inc. | 1997-03-18 |
| COMPAT GASTROSTOMY/JEJUNOSTOMY FEEDING TUBE KIT(088000) (K965087) | Sandoz Nutrition | 1997-03-18 |
| KENDALL DUAL LUMEN CATHETER (K963446) | Kendall Healthcare Products Co. Div.Of Tyco Health | 1997-03-18 |
| FLEXIFLO FLOCATOR SMALL BOWEL FEEDING SYSTEM (K950017) | Ross Products | 1997-03-14 |
| MANAN D BAG (K961986) | Manan Medical Products, Inc. | 1997-03-13 |
| PERSONAL CATHETER (K970704) | Rochester Medical Corp. | 1997-03-13 |
| MEDVISION PERSONAL MONITOR (K961343) | Medvision, Inc. | 1997-03-13 |
| INTEGRATED VISUALIZATION SYSTEM (K970598) | Urohealth, Inc. | 1997-03-12 |
| KSEA URETERO-RENO-FIBERSCOPE AND NEPHRO-FIBERSCOPE (K970427) | Karl Storz Endoscopy | 1997-03-11 |
| SMARTGUIDE (K963894) | Ferguson Medical | 1997-03-11 |
| GASTROSCOPE AND COLONOSCOPE NOZZLE REPLACEMENT KITS (K970372) | Precision Endoscopy of America, Inc. | 1997-03-11 |
| NIPRO ARTERIAL & VENOUS BLOOD TUBING SET FOR HEMODIALYSIS (K954676) | Nissho Corp. | 1997-03-04 |
| FLEXILOG 3000 (K964589) | Oakfield Instruments, Ltd. | 1997-03-04 |
| PILLING WECK 2 PIECE TAKE-APART INSTRUMENTS (K965176) | Pilling Weck Group | 1997-03-04 |
| IMAGER TORQUE CATHETER (K965229) | Boston Scientific Corp | 1997-03-04 |
| BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS (K964871) | Biosearch Medical Products, Inc. | 1997-03-03 |
| STRYKER SAPHENOUS VEIN HARVEST SCOPE (K964930) | Stryker Endoscopy | 1997-02-28 |
| BARD DIRECTOR GUIDEWIRE (000560) (K964780) | C.R. Bard, Inc. | 1997-02-26 |
| HOLLISTER RETRACTED PENIS POUCH (K970443) | Hollister, Inc. | 1997-02-25 |
| ENDOCARE MONOPOLAR ELECTRODE (K965118) | Endocare, Inc. | 1997-02-25 |
| TUM-E-VAC (K962850) | Ethox Corp. | 1997-02-21 |
| GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD) (K964061) | W. L. Gore & Associates, Inc. | 1997-02-20 |
| FLEXIBLE CYSTOSCOPE (K964037) | Applied Fiberoptics, Inc. | 1997-02-20 |
| SPACEMAKER SERIAL SURGICAL BALLOON DISSECTOR, WITH CANNULA, WITH VISUALIZATION AND WITH VISUALIZATION AND CANNULA (K962702) | General Surgical Innovations | 1997-02-19 |
| BARD FLEXIBLE ENDOSCOPY INJECTION SYSTEM (651019) (K970110) | Bard Medical Div. | 1997-02-19 |
| FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWIRE(REGULAR SHAFT/STIFF SHAFT) NO MARKING (K964955) | Flexmedics | 1997-02-14 |
| VASOVIEW BALLOON DISSECTION SYSTEM (K964171) | Origin Medsystems, Inc. | 1997-02-14 |
| SPEEDBAND MULTIPLE BAND LIGATOR (K964079) | Boston Scientific Corp | 1997-02-13 |