| ADAPTOR HR-3000 REUSE (K841153) | Colorado Medical, Inc. | 1984-07-16 |
| ERIKA NEGATIVE PRESS. ARTERIAL BLOOD (K842436) | Erika, Inc. | 1984-07-13 |
| HAEMATURIA CATHETERS (K841511) | Warne Surgical Products, Ltd. | 1984-07-12 |
| PLUME FISTULA NEEDLE (K841791) | Hospal Medical Corp. | 1984-07-09 |
| AMER. PHARMASEAL SILICONIZED LATEX (K841544) | American Pharmaseal Div. Ahsc | 1984-07-09 |
| JEJUNOSTOMY SET FOR TUBE FEEDING (K841428) | Burron Medical Products, Inc. | 1984-07-09 |
| OSTOMY FREEDOM KIT (K841173) | Ellenberg Assoc. | 1984-07-09 |
| CYSTO-AID (K841197) | E-Z-Em, Inc. | 1984-07-09 |
| FOREIGN BODY PROTECTOR (K841258) | Jayco Pharmaceuticals | 1984-07-09 |
| CURITY RIG FOLEY CATH TRAY (K841169) | The Kendal Co. | 1984-07-06 |
| HOSPAL BIOSPAL SCU/CAVH KIT (K841152) | Hospal Medical Corp. | 1984-07-06 |
| RECTAL IRRIGATION TUBE (K841289) | Hdc Corp. | 1984-07-06 |
| HEMO-RO WATER PURIFICATION SYS (K841403) | Millipore Corp. | 1984-07-06 |
| RENATRON (K842258) | Renal Systems, Inc. | 1984-07-06 |
| DIALYSATE ADDITIVES (K842294) | Dialysis Products, Inc. | 1984-06-28 |
| MEDILOG PH1 (K840934) | Oxford Medilog, Inc. | 1984-06-28 |
| ENDOPORT EROCAR (K841716) | Endotherapeutics | 1984-06-28 |
| FORMA-FAS-TEST (K833128) | Chemical Detection & Experimentation | 1984-06-27 |
| C.A.P.D. AUTOMATIC HEATER PDH 200 (K842305) | Medionics International , Ltd. | 1984-06-25 |
| ULTRAMAX (K832705) | Medicorp, Inc. | 1984-06-25 |
| DOUBLE LUMEN SUBLCAVIAN-FEMORAL (K841530) | Medical Components, Inc. | 1984-06-25 |
| FILTRYZER HOLLOW FIBER ARTIF. KIDNEY (K831175) | Erika, Inc. | 1984-06-22 |
| FILTRYZER HOLLOW FIBER ARTIF. KIDNEY (K831176) | Erika, Inc. | 1984-06-22 |
| TORAY INDUSTRIES FILTRYZER HOLLOW FIBER (K831173) | Erika, Inc. | 1984-06-22 |
| FILTRYZER HOLLOW FIBER ARTIFICIAL KID- (K831174) | Erika, Inc. | 1984-06-22 |
| ANGIOSCOPY CATHETER (K834547) | American Edwards Laboratories | 1984-06-11 |
| KIDNEY TRANSPLANT CATHETER (K840687) | Warne Surgical Products, Ltd. | 1984-06-07 |
| ENTEROSCOPE (K840722) | Trimedyne, Inc. | 1984-06-07 |
| UROLOGICAL CATHETER & ACCESSORIES (K841727) | Research Medical, Inc. | 1984-06-07 |
| GORE-TEX CATHETER (K840864) | W. L. Gore & Associates, Inc. | 1984-06-01 |
| HEMOPERFUSION SYSTEM TP-400 (K840532) | Extracorporeal Medical Specialities, Inc. | 1984-05-30 |
| LITHOTRIPTOR ELECTRODE 4.5F (K834228) | Monaghan Medical Corp. | 1984-05-25 |
| CONCENTRATE CONDUCTIVITY METER (K841543) | Renal Systems, Inc. | 1984-05-22 |
| DILATION BALLOON CATHETER (K834413) | Hobbs Medical, Inc. | 1984-05-22 |
| GASTROSTOMY FEEDING TUBE (K841330) | Microvasive | 1984-05-22 |
| MAKS CENTRAL DELIVERY SYS-11-200 ETC (K840859) | Erika, Inc. | 1984-05-22 |
| YAG LASER 8000 GASTROINTESTINAL BLEE (K840144) | Cooper Medical Corp. | 1984-05-18 |
| BBL GASPAK POUCH (K841307) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-05-14 |
| KOLLMANN URETHRAL DILATOR (K841386) | Imm Enterprises , Ltd. | 1984-05-09 |
| UROLOGICAL KIT W/STERILE, WATER-FILL (K841485) | Medline Industries, Inc. | 1984-05-09 |
| WESTON RECTAL SNARE (K841387) | Imm Enterprises , Ltd. | 1984-05-09 |
| SWEEN-A-PEEL PERISTOMAL WAFERS (K840723) | Sween Corp. | 1984-05-07 |
| TRANSFER TROLLEY (K841396) | Setma, Inc. | 1984-05-07 |
| STA-POTENT SYSTEM (K841257) | Nu-Potent | 1984-05-02 |
| ACTIVE LIFE ONE-PIECE CLOSED-END POUCH (K840568) | Convatec, A Division of E.R. Squibb & Sons | 1984-05-02 |
| RENAPAK CONCENTRATE MIXING SYS. (K840182) | Renal Systems, Inc. | 1984-05-02 |
| ACTIVE LIFE ONE-PIECE STOMA CAP (K840567) | Convatec, A Division of E.R. Squibb & Sons | 1984-05-02 |
| ENTEROCYSIS TUBE W/GUIDE WIRE & CONNECT (K840752) | E-Z-Em, Inc. | 1984-05-02 |
| URO-MALE INCONTINENCE CATHETER (K841224) | Gil-Med Industries C/O Kegan & Kegan, Ltd. | 1984-05-02 |
| COMFEEL PROTECTIVE FILM (K833567) | Coloplast A/S | 1984-05-02 |
| DIALYSIS ADMIN. SET - I.V. (K840654) | Cp Medical | 1984-05-02 |
| URINARY MONITORING SYS 240 (K840917) | Vital Metrics, Inc. | 1984-05-01 |
| WEIGHTED FEEDING TUBE W/PRE-INSERTED (K841014) | Ethox Corp. | 1984-05-01 |
| SINGLE LUMEN SUBCLAVIAN CANNULA (K840197) | Shiley, Inc. | 1984-04-25 |
| BLOOD MONITOR BMM 10-4 (K831404) | Gambro, Inc. | 1984-04-25 |
| HEMOFILTRATION CATHETER HF-100 (K840322) | Vas-Cath of Canada , Ltd. | 1984-04-24 |
| HEMOCATH (K840415) | Quinton, Inc. | 1984-04-20 |
| DRAINAGE STENT (K834468) | Microvasive | 1984-04-20 |
| TOPS DISPOS. INFUSION SET/HEMODIALYSIS (K841119) | Top Surgical Manufacturers Co. | 1984-04-20 |
| DIALYSIS TRAY (K841124) | Medcare Products | 1984-04-20 |
| CENTRY 2000 DIALYSIS CONTROL UNIT (K840680) | Cobe Laboratories, Inc. | 1984-04-20 |
| CHEMLYTE (K834395) | Diachem Laboratories | 1984-04-20 |
| REAL FIBER OPTIC URETERAL TRANSILLUMIN (K834576) | Douglas Manufacturer Co. | 1984-04-20 |
| MMG FOLEY CATHETER (K840839) | Medical Technologies of Georgia | 1984-04-17 |
| BIOPSY FORCEPS (K840818) | American Endoscopy, Inc. | 1984-04-13 |
| MULTIPLE SYS-URINE DRAINAGE-CLOSED (K840284) | Luth Corp. | 1984-04-13 |
| HEMODIAL CONCENTRATE (K834587) | Moana Productions, Inc. | 1984-04-13 |
| RECTAL BALLOON CATHETERS (K841036) | Inmed Corp. | 1984-04-13 |
| MINIGARD DISPOSABLE LINERS (K840755) | Ipco Corp. | 1984-04-13 |
| MULTIPLE BAG, LEG (K840283) | Luth Corp. | 1984-04-13 |
| MILLER-ABBOTT TUBE (K841033) | Inmed Corp. | 1984-04-13 |
| BLAKEMORE TUBE (K841038) | Inmed Corp. | 1984-04-13 |
| URETERAL DILATOR (K840746) | American Edwards Laboratories | 1984-04-13 |
| MAXISHIELD INCONTINENCE CARE SYSTEM (K840754) | Ipco Corp. | 1984-04-13 |
| LABORIE FIBREOPTIC LIGHT CABLE (K840605) | Tridak Division of Indicon, Inc. | 1984-04-13 |
| AMBEZE DISPOSABLE INCONTINENCE PANTS (K840753) | Ipco Corp. | 1984-04-13 |
| CANTOR TUBE (K841039) | Inmed Corp. | 1984-04-13 |
| DEAVER T-DRAIN & CATTEL T-DRAIN (K841034) | Inmed Corp. | 1984-04-13 |
| ULTRA BAKER JEJUNOSTOMY TUBE (K841035) | Inmed Corp. | 1984-04-13 |
| IRRIGATION SYSTEM (K840268) | Coloplast A/S | 1984-04-05 |
| USCI ENDOPROSTHESIS (K834574) | C.R. Bard, Inc. | 1984-04-05 |
| ENTERNAL Y EXTENSION SET RECORDER (K840656) | Corpak Medsystems | 1984-04-04 |
| BANGORT LIFESTYLE COLOSTOMY POUCHES (K841029) | Howmedica Corp. | 1984-04-04 |
| DIETO CONTAINER FOR ENTERNAL NUTRIT (K840916) | Gil-Med Industries C/O Kegan & Kegan, Ltd. | 1984-04-04 |
| OP-CON SURG. INSTRUMENT #3 (K834171) | Imm Enterprises , Ltd. | 1984-04-04 |
| MC 2000 OSTOMY POUCHES (K840269) | Coloplast A/S | 1984-04-02 |
| FILTRODER FILTERS (K840267) | Coloplast A/S | 1984-04-02 |
| BIOSPAL 2400S (K840812) | Hospal Medical Corp. | 1984-04-02 |
| BIOSPAL 3000S (K840811) | Hospal Medical Corp. | 1984-04-02 |
| SURGITEK ALL SILICONE INFECTION DOUBJ (K833782) | Surgitek | 1984-04-02 |
| HOSPAL MODEL H1210 (K840814) | Hospal Medical Corp. | 1984-04-02 |
| BIOSPAL 1200S (K840813) | Hospal Medical Corp. | 1984-04-02 |
| FLEXI-FLATE PENILE IMPLANT (K834347) | Surgitek | 1984-04-02 |
| PARALLEL DUAL LUMEN SUBCLAVIAN CANNULA (K834358) | Vas-Cath of Canada , Ltd. | 1984-04-02 |
| MC 2002 OSTOMY POUCHES & SKIN FLANGES (K840265) | Coloplast A/S | 1984-04-02 |
| NIGHT TRAINER (K834311) | Maddak, Inc. | 1984-03-30 |
| POLYP-SAVER SLEVE (K840800) | Jayco Pharmaceuticals | 1984-03-23 |
| BLOOD CONCENTRATOR 140 (K840543) | Gambro, Inc. | 1984-03-23 |
| AMICON DIAFILTER 40. HEMOFILTER (K840449) | Medical Device Consultants, Inc. | 1984-03-23 |
| ECHO MM1000 (K834447) | Mesa Medical, Inc. | 1984-03-23 |