| EMS SWISS LITHOCLAST LITHOTRIPTER (K963285) | Electro Medical Systems SA | 1997-02-13 |
| TROCAR CANNULA (K963115) | United States Surgical, A Division of Tyco Healthc | 1997-02-12 |
| ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TA (K964561) | Bioenterics Corp. | 1997-02-11 |
| HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2) (K960817) | Transonic Systems, Inc. | 1997-02-11 |
| TANDEMRX (K970054) | Boston Scientific Corp | 1997-02-10 |
| PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) (K946279) | Cobe Renal Care, Inc. | 1997-02-10 |
| LIBERTY RECTAL PELVIC FLOOR EXERCISER (K964526) | Utah Medical Products, Inc. | 1997-02-10 |
| SUTURE APPLICATOR (K964672) | Laurus Medical Group | 1997-02-07 |
| RUSCH SUPRAPUBIC TRAY (K970021) | Rusch, Inc. | 1997-02-07 |
| KENDALL CURITY URETERAL CATHETER (K964899) | Kendall Healthcare Products Co. Div.Of Tyco Health | 1997-02-07 |
| ULTRASOUND GASTROSCOPE GF TYPE UM30P (K963023) | Olympus America, Inc. | 1997-02-07 |
| COBE HEMODYNAMIC RECIRCULATION MONITOR (K954003) | Cobe Renal Care, Inc. | 1997-02-06 |
| SYMPACATH HYDROGEL COATED FOLEY (K964575) | Rusch Intl. | 1997-02-04 |
| MICROGYN RESECTION LOOP, COAGULATING ELECTRODE, CISS SHEATH ELECTRODE, LOOP ELECTRODE KIT AND COAGULATING ELECTRODE KIT (K962653) | Microgyn Corp. | 1997-02-04 |
| FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY) (K964892) | Gynecare Innovation Center | 1997-02-04 |
| CUTANEOUS COMPRESSION DEVICE FOR USE IN HEMODIALYSIS (K964041) | Robert R. Stevens | 1997-01-30 |
| WILSON-COOK BILIARY INTRODUCER WITH ASPIRATION BIOPSY NEEDLE (K961897) | Wilson-Cook Medical, Inc. | 1997-01-29 |
| PH ANALYSIS MODULE (K961346) | Synectics-Dantec | 1997-01-29 |
| DILATION CATHETER, BALLOON (K965067) | Boston Scientific Corp | 1997-01-28 |
| SOLOS, CIDEO CAMERA REPLACEMENT CABLE, 800/900 SERIES (K970056) | Woodbine Optical Corp. | 1997-01-28 |
| FLEXIBLE URETEROSCOPE (K964482) | Applied Fiberoptics, Inc. | 1997-01-24 |
| INNOVA COMFORTPULSE VAGINAL ELECTRODE (199204)/INNOVA COMFORTPULSE SMALL VAGINAL ELECTRODE(199205) (K964577) | Empi | 1997-01-24 |
| A LITHOTRIPTER-COMPATIBLE BASKET (K964937) | Boston Scientific Corp | 1997-01-24 |
| PRESCOTT'S LIGHT SOURCE MODEL NO. II-150 (K964586) | Iba/Griffith | 1997-01-17 |
| INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL DISCISION OF PERFORATING VINS ESDP, MODEL 8781 (K964258) | Richard Wolf Medical Instruments Corp. | 1997-01-16 |
| DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM W/SINGLE NEEDLE SINGLE LUMEN OPTION (K955384) | Althin Medical AB an Affiliate of Baxter Intl | 1997-01-10 |
| BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE (K963950) | Bioderm, Inc. | 1997-01-10 |
| CAP-AID (IMPROVED) (K964580) | Nebel, Inc. | 1997-01-10 |
| NON-SHIELDED SURGICAL TROCAR AND SLEEVE (K963760) | Ethicon Endo-Surgery, Inc. | 1997-01-08 |
| LSI VIDEOSCOPIC DISPLAY SYSTEM (K963919) | Lsi Solutions | 1997-01-08 |
| CELL RECOVERY SYSTEM (K965037) | Medical Device Technologies, Inc. | 1997-01-08 |
| VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOSCOPE WITH ENDOSHEATH SYSTEM (K964326) | Vision-Sciences, Inc. | 1997-01-03 |
| TZ (K964777) | Gallini Intl., Inc. | 1997-01-03 |
| OLYMPUS SUBCUTANEOUS ENDOSCOPY SYSTEM (K963184) | Olympus America, Inc. | 1996-12-31 |
| INJECTO FLUSH (K964120) | Robert J. Jynch, Jr. | 1996-12-30 |
| ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS (K962309) | Althin Medical AB an Affiliate of Baxter Intl | 1996-12-27 |
| CONTINUOUS FLOW SYSTEM, CFS-1 PUMP SYSTEM (4-700-00) (K964196) | Northgate Technologies, Inc. | 1996-12-23 |
| OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (UROLOGY) (K962474) | Olympus America, Inc. | 1996-12-20 |
| VITLITE (TR7700) (K963417) | Escalon Trek Medical | 1996-12-20 |
| AUTO SUTURE* ABBI* SYSTEM (K963825) | United States Surgical, A Division of Tyco Healthc | 1996-12-20 |
| BARD COAGULATING RESECTOR MODEL (3552XX; XX=01,02,03,04,05 OR 06) (K962538) | C.R. Bard, Inc. | 1996-12-17 |
| RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET (K963993) | Rusch, Inc. | 1996-12-17 |
| LITHOVAC SUCTION/ASPIRATION PROBE (K964111) | Electro Medical Systems SA | 1996-12-16 |
| VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V100 (K964100) | Vision-Sciences, Inc. | 1996-12-16 |
| C-MOUNT OBJECTIVE LENS F = 17 MM, STEAM-STERILIZABLE: MODEL 85 261.172, C-MOUNT OBJECTIVE LENS F = 21 MM, STEAM-STERILIZ (K964173) | Richard Wolf Medical Instruments Corp. | 1996-12-13 |
| MANAN D BAG (K963849) | Manan Medical Products, Inc. | 1996-12-13 |
| KARL STORZ FRIMBERGER VARIOGUIDE (K962212) | KARL STORZ Endoscopy-America, Inc. | 1996-12-13 |
| REUSABLE TROCAR WITH SLEEVE (COMMON) (K964123) | Pilling Weck Group | 1996-12-12 |
| COURIER BALLOON DILATATION CATHETER (K963691) | Boston Scientific Corp | 1996-12-12 |
| OES UROLOGY (K950719) | Olympus America, Inc. | 1996-12-11 |
| ACTIS (VENOUS FLOW CONTROLLER) (K962915) | Vivus, Inc. | 1996-12-10 |
| EXPANDACELL ANTI-FOG INSTRUMENT WIPE (WITH ALCOHOL)/(WITHOUT) (K964334) | Shippert Medical Technologies Corp. | 1996-12-09 |
| VIRAPUMP II (MODELS AND MODEL M) (K961607) | Viatro, Corp. | 1996-12-06 |
| MEDICAL DEVICE TECHNOLOGIES, INC.ULTRA (K962969) | Medical Device Technologies, Inc. | 1996-12-06 |
| AMS AMBICOR PENILE PROSTHESIS (K963328) | American Medical Systems, Inc. | 1996-12-04 |
| SPECTRA SCIENCE BIOPSY FORCEPS (K963517) | Spectrascience, Inc. | 1996-12-02 |
| FLEXIBLE MINI-FIBERSCOPES (K962172) | Richard Wolf Medical Instruments Corp. | 1996-12-02 |
| AUTO SUTURE* MODIFIED ENDOSCOPIC FASCIA STAPLER** DEVICE (K963999) | United States Surgical, A Division of Tyco Healthc | 1996-11-27 |
| ISAN STERNAL-ILIAC ASPIRATION BIOPSY NEEDLE (K962570) | Gallini Intl., Inc. | 1996-11-27 |
| BIOMID BONE MARROW BIOPSY NEEDLE (K962569) | Gallini Intl., Inc. | 1996-11-27 |
| ACRI ILIAC CREST ASPIRATION BIOPSY NEEDLES (K962568) | Gallini Intl., Inc. | 1996-11-25 |
| ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER (K963397) | Boston Scientific Corp | 1996-11-25 |
| RETRIEVAL SNARE (K963750) | Boston Scientific Corp | 1996-11-22 |
| ENDO VIP (K963323) | Richard Wolf Medical Instruments Corp. | 1996-11-21 |
| DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE (K963344) | Vision-Sciences, Inc. | 1996-11-21 |
| SPEED-CUT (K961407) | Gallini Intl., Inc. | 1996-11-21 |
| UNI-GARD QUIK CATH(SIZES 8 FRENCH THROUGH 18)UG 10008,10010,10012,10014,10016,10018 (K961906) | Spectrum Medsystems Corp. | 1996-11-19 |
| BARD HIGH FLOW PAPILLOTOME (K963484) | Bard Interventional Products Div. | 1996-11-19 |
| NAVARRE PERCUTANEOUS BILIARY DRAINAGE (K955110) | Navarre Biomedical , Ltd. | 1996-11-07 |
| REUSABLE TROCAR WITH SLEEVE (COMMON) (K963815) | Pilling Weck Group | 1996-11-05 |
| FLEXILOG LS 13921 (K961895) | Oakfield Instruments, Ltd. | 1996-11-04 |
| ENDOCAM (K963046) | Corin USA | 1996-11-01 |
| KARL STORZ REMORGIDA FORCEPS (K962083) | KARL STORZ Endoscopy-America, Inc. | 1996-11-01 |
| COMBILINES HEMODIALYSIS BLOOD TUBING SET (K962081) | National Medical Care, Medical Products Div., Inc. | 1996-11-01 |
| ASTA-CATH (K961361) | A+ Products | 1996-10-31 |
| BARD TIGER GUIDEWIRE MODEL 000540 (K962178) | C.R. Bard, Inc. | 1996-10-29 |
| ETHICON ENDOSUTURE SYSTEM (K963329) | ETHICON, Inc. | 1996-10-25 |
| PROSYS SAMEC LA (K963265) | Convatec, A Division of E.R. Squibb & Sons | 1996-10-25 |
| OLYMPUS B-5/B-7 SERIESBALLOON CATHETER (K962925) | Olympus America, Inc. | 1996-10-25 |
| WHITE SUN LIGHT SOURCE MODEL #: XL300 AND #: XL175 (K963227) | Products For Medicine | 1996-10-23 |
| MICROGYN PLUS STIMULATION DEVICE (K963222) | Hollister, Inc. | 1996-10-23 |
| SKINNY,FRANSEEN,WESCOTT NEEDLES (K962907) | Baxter Healthcare Corp | 1996-10-23 |
| BARD EAGLE INFLATION DEVICE (K962611) | Ryder Intl. Corp. | 1996-10-21 |
| DPS 4 DIALYZER PREPARATION SYSTEM (K955299) | Seratronics, Inc. | 1996-10-21 |
| AQ HYDROPHILIC DILATORS (K961904) | Cook Urological, Inc. | 1996-10-18 |
| S-357 VIDEO IMAGING SYSTEM (K962684) | Del Medical Systems Corp. | 1996-10-15 |
| TX BIOPSY NEEDLE (K962905) | Gallini S.R.L. | 1996-10-11 |
| MINIATURE LAPAROSCOPE SET (MINI LAP) (K962799) | Richard Wolf GmbH | 1996-10-11 |
| BIOPSY INTRODUCER NEEDLE (K963390) | Baxter Healthcare Corp | 1996-10-10 |
| ED-3410, VIDEO DUODENOSCOPE (K963056) | Pentax Precision Instrument Corp. | 1996-10-10 |
| BARD V-MAX ROLLER BAR (3551XX;XX=01,02,03,04,05, OR 06) (K961841) | C.R. Bard, Inc. | 1996-10-09 |
| BARD A-TRAC UROLOGICAL BALLOON DILATION CATHETER (K962921) | C.R. Bard, Inc. | 1996-10-09 |
| MINNTECH MINNIFILTER PLUS HEMOFILTER AND TUBING SET (K962707) | Minntech Corp. | 1996-10-09 |
| HEARTPORT THORACIC SURGICAL TROCARS: (TOST-4-3, TOSTL-6-3, TON-4-2 AND TONL-6-2 (K961463) | Heartport, Inc. | 1996-10-08 |
| EG-3400, VIDEO GASTROSCOPE (K962897) | Pentax Precision Instrument Corp. | 1996-10-04 |
| DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE (K962676) | United States Endoscopy Group, Inc. | 1996-10-04 |
| COMPAT NASOJEJUNAL FEEDING TUBE (K961664) | Sandoz Nutrition | 1996-10-04 |
| URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) (K962652) | Customed, Inc. | 1996-10-04 |
| EVAP-ELECTRODES TYPES 8423, 8427, 8410 & 8413 ELECTROSURGICAL VAPORIZATION OF SOFT TISSUE (K953983) | Richard Wolf Medical Instruments Corp. | 1996-10-02 |
| FLEXIFLO POLYG GASTOSTOMY TUBE (K963113) | Abbott Laboratories | 1996-10-02 |