| SCIMED REBEL PTCA CATHETER (P860019/S137) | Scimed Life Systems, Inc. | 1998-04-15 |
| VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (N50510/S080) | Biomerieux Vitek, Inc. | 1998-04-14 |
| MEDTRONIC SYNCHROMED INFUSION SYSTEM (P860004/S040) | Medtronic, Inc. | 1998-04-13 |
| LYNX CONTOUR CORONARY BALLOON DILATATION CATHETER(A NEW MODEL OF THE FACT CATHETER). (P970052/S001) | Endologix, Inc. | 1998-04-08 |
| SELUTE PICOTIP STEROID ELUTING LEAD (P950001/S003) | Boston Scientific | 1998-04-08 |
| HFV INFANT STAR VENTILATOR (P880013/S008) | Nellcor Puritan Bennett, Inc. | 1998-04-07 |
| SCIMED REBEL PTCA CATHETER (P860019/S138) | Scimed Life Systems, Inc. | 1998-04-06 |
| PERCLOSE PROSTAR XL 10 FRENCH PVS SYSTEM (P960043/S006) | Abbott Vascular, Inc. | 1998-04-06 |
| E P TECH EPT-1000 CARDIAC ABLATION SYSTEM (P920047/S009) | Boston Scientific Corp | 1998-04-06 |
| ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR (P910066/S007) | Djo, LLC | 1998-04-03 |
| OSTEONICS CONSTRAINED ACETABULAR INSERT (P960047/S001) | Howmedica Osteonics Corp. | 1998-04-02 |
| NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P890027/S044) | Cochlear Americas | 1998-04-01 |
| NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S075) | Cochlear Americas | 1998-04-01 |
| AUTODELFIA HAFP TEST KIT (P970037) | Revvity, Inc. | 1998-03-31 |
| ITAFLUOROFOCON A AND B (P860022/S051) | Bausch & Lomb | 1998-03-31 |
| IPAFLUOROFOCON A AND B (P860022/S050) | Bausch & Lomb | 1998-03-31 |
| DELTA(R) PACEMAKER SYSTEM (VIGOR SSI AND DDD MODELS ONLY) (P840068/S034) | Boston Scientific | 1998-03-27 |
| MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM (P960009/S001) | Medtronic, Inc. | 1998-03-27 |
| MERIDIAN AND DISCOVERY PACEMAKER SYSTEMS (P940031/S012) | Boston Scientific | 1998-03-27 |
| MEDSTONE STS(TM) LITHOTRIPTER (P870015/S029) | Medstone Intl., Inc. | 1998-03-27 |
| ST. JUDE MEDICAL MECHANICAL HEART VALVE SJM MASTERS SERIES WITH SILZONE (P810002/S046) | ABBOTT MEDICAL | 1998-03-24 |
| USCI APOLLO RELY SP OVER-THE-WIRE BALLOON DILATATION CATHETER WITH HYDRO/PEL COATING AND MINIQUET DEVICE (P790017/S065) | Medtronic, Ireland | 1998-03-23 |
| MONOSTRUT CARDIAC VALVE PROSTHESIS (P970002/S001) | Alliance Medical Technologies, Inc. | 1998-03-23 |
| NEUROCONTROL FREEHAND SYSTEM(R) (P950035/S001) | Biocontrol Technology, Inc. | 1998-03-20 |
| VISX STAR S2 EXCIMER LASER SYSTEM (P930016/S006) | Amo Manufacturing USA, LLC | 1998-03-20 |
| TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADS (P960013/S001) | ABBOTT MEDICAL | 1998-03-19 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S011) | Howmedica Corp. | 1998-03-18 |
| CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT (ADULT) FLEX LEAD ELECTRODE (P940022/S004) | Advanced Bionics Corp. | 1998-03-17 |
| CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) FLEX LEAD ELECTRODE (P960058/S003) | Advanced Bionics | 1998-03-17 |
| PROVISC VISCOELASTIC MATERIAL (P890047/S011) | Alcon Research, Ltd. | 1998-03-17 |
| RES-Q(TM) MICRON ICD SYSTEM (P940008/S009) | Boston Scientific | 1998-03-17 |
| ARROW MODEL 3000-16 CONSTANT FLOW IMPLANTABLE PUMP WITH BOLUS SAFETY VALVE (P890055/S004) | Intera Oncology | 1998-03-17 |
| VISCOAT VISCOELASTIC SOLUTION (P840064/S019) | Alcon Laboratories | 1998-03-17 |
| NEUROCYBERNETIC PROTHESIS SYSTEM (P970003/S009) | LivaNova USA, Inc. | 1998-03-13 |
| ACS SWAP-IT GUIDE WIRE EXCHANGE DEVICE CATHETER (P810046/S186) | Advanced Cardiovascular Systems, Inc. | 1998-03-13 |
| VENTAK AV II DR AICD (P960040/S003) | Boston Scientific | 1998-03-13 |
| ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S025) | Abiomed Cardiovascular, Inc. | 1998-03-13 |
| PRAKTIS (P950014/S011) | Urologix, Inc. | 1998-03-13 |
| DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS (P950037/S001) | Biotronik, Inc. | 1998-03-13 |
| NEUROCYBERNETIC PROTHESIS SYSTEM (P970003/S008) | LivaNova USA, Inc. | 1998-03-13 |
| HULKA CLIP FOR TUBAL OCCLUSION (P870080/S001) | Richard Wolf Medical Instruments Corp. | 1998-03-12 |
| SAHARA CLINICAL BONE SONOMETER (P970017) | Hologic, Inc. | 1998-03-12 |
| EBI BONE HEALING SYSTEM(R) (P790002/S015) | Ahp Eos Buyer, Inc. | 1998-03-12 |
| SVS APEX PLUS EXCIMER LASER WORKSTATION AND EMPHASIS DISC (P930034/S009) | Alcon Laboratories, Inc. | 1998-03-11 |
| PROSTATRON MAXIS (P950014/S013) | Urologix, Inc. | 1998-03-10 |
| TANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY/TANDEM-MP FREE PSA IMMUNOENZYMETRIC ASSAY (P970038) | Beckman Coulter, Inc. | 1998-03-10 |
| THERMACHOICE UTERINE BALLOON THERAPY(UBT) SYSTEM (P970021/S001) | Gynecare, Inc. | 1998-03-06 |
| NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S074) | Cochlear Americas | 1998-03-06 |
| NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P890027/S043) | Cochlear Americas | 1998-03-06 |
| MEDSTONE STS(TM) LITHOTRIPTER (P870015/S028) | Medstone Intl., Inc. | 1998-03-05 |
| TRIPTER-X1 SERIES SHOCKWAVE LITHOTRIPTERS (P920034/S002) | Medirex, Inc. | 1998-03-05 |
| DIAPHRAGMATIC PACEMAKER PHRENIC NERVE STIMULATOR (P860026/S004) | Avery Biomedical Devices, Inc. | 1998-03-03 |
| VISCOAT(R) (P840064/S020) | Alcon Laboratories | 1998-03-03 |
| MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER (P920032/S004) | Pace Medical | 1998-02-27 |
| UVAR PHOTOPHORESIS SYSTEM (P860003/S029) | Therakos Development Limited | 1998-02-26 |
| SEPRAFILM BIORESORBABLE MEMBRANE (P950034/S005) | Baxter Healthcare Corporation | 1998-02-25 |
| IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R) (P910019/S005) | Intensive Technology, Inc. | 1998-02-23 |
| CHAMPION WRAP PTCA CATHETER (P930012/S009) | Progressive Angioplasty Systems, Inc. | 1998-02-23 |
| MICRO STENT TM II, MICRO STENT TM II XL, GFX TM, GFX TM XL (P970035/S002) | Medtronic, Ireland | 1998-02-23 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM CONTRACT STERILIZER (P900056/S023) | Boston Scientific Corp | 1998-02-23 |
| ABSORBABLE DUSTING POWDER (N80023/S001) | Kellerandheckman | 1998-02-20 |
| UROLOGIC TARGIS SYSTEM (P970008/S005) | Urologix, LLC | 1998-02-20 |
| FACT, ARC, LYNX AND GUARDIAN BALLOON CORONARY DILATATION CATHETERS (P970052) | Endologix, Inc. | 1998-02-20 |
| AMO(R) VITRAX(R) VISCOELASTIC SOLUTION (P880031/S012) | Abbott Medical Optics, Inc. | 1998-02-19 |
| TDX CYCLOSPORINE AND METABOLITES SERUME ASSAY (P890025/S010) | Abbott Laboratories | 1998-02-13 |
| DERMAGRAFT-TC(TM) (P960007/S005) | Shire Regenerative Medicine | 1998-02-12 |
| NEW JERSEY LCS TOTAL KNEE SYSTEM (P830055/S053) | Depuy, Inc. | 1998-02-12 |
| TELESCOPE PTCA BALLOON CATHETER (P790017/S064) | Medtronic, Ireland | 1998-02-12 |
| NEEDLE-EASE MODEL 3500 (P960044/S001) | Millenium Medical Supply, Inc. | 1998-02-11 |
| INTERCEED TC7 ABSORBABLE ADHESION BARRIER (P880047/S005) | ETHICON, Inc. | 1998-02-09 |
| IPAFLUOROFOCON A AND B (P860022/S049) | Bausch & Lomb | 1998-02-06 |
| BAK INTERBODY FUSION SYSTEM (P950002/S005) | Zimmer Spine, Inc. | 1998-02-06 |
| ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S026) | Abiomed Cardiovascular, Inc. | 1998-02-02 |
| MODEL UV65 SERIES ANTERIOR CHAMBER LENSES (P880070/S007) | Abbott Medical Optics, Inc. | 1998-02-02 |
| CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM (P910023/S030) | ABBOTT MEDICAL | 1998-02-02 |
| CHAMPION WRAP PTCA CATHETER (P930012/S008) | Progressive Angioplasty Systems, Inc. | 1998-02-02 |
| VENTAK AV DDD FAMILY OF AICD SYSTEMS (P960040/S005) | Boston Scientific | 1998-02-02 |
| CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM (P910023/S032) | ABBOTT MEDICAL | 1998-02-02 |
| ANGIO-SEAL(TM)[1] HEMOSTATIC PUNCTURE CLOSURE DEVICE (P930038/S007) | Terumo Medical Corporation | 1998-02-02 |
| MODEL 809A POSTERIOR CHAMBER INTRAOCULAR LENS (P810055/S066) | Advanced Medical Optics, Inc. | 1998-02-02 |
| MEDTRONIC.KAPPA 400 SERIES PACEMAKERS (P970012) | Medtronic, Inc. | 1998-01-30 |
| MOMENTUM PACERS (P910020/S020) | Boston Scientific | 1998-01-30 |
| IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R) (P910019/S003) | Intensive Technology, Inc. | 1998-01-29 |
| PASSIVE PLUS DX ENDOCARDIAL STEROID ELUTING, PASSIVE-FIXATION PACING LEADS (P960030) | ABBOTT MEDICAL | 1998-01-29 |
| NEUROCYBERNETIC PROTHESIS SYSTEM (P970003/S004) | LivaNova USA, Inc. | 1998-01-29 |
| POSTERIOR CHAMBER INTRAOCULAR LENSES (TIER A SUBMISSION) (P830056/S078) | Carl Zeiss Meditec, AG | 1998-01-29 |
| VISX EXCIMER LASER SYSTEM MODELS B AND C (P930016/S005) | Amo Manufacturing USA, LLC | 1998-01-29 |
| MODEL 9802 E REVEAL INSERTABLE LOOP RECORDER SOFTWARE (P890003/S052) | Medtronic, Inc. | 1998-01-29 |
| ENDURANCE BONE CEMENT (P960001/S003) | Depuy, Inc. | 1998-01-27 |
| ACS TX 2000 VP CORONARY DILATATION CATHETER CAHTETERS (P810046/S182) | Advanced Cardiovascular Systems, Inc. | 1998-01-27 |
| DUPEN LONG TERM EPIDURAL CATHETER (P860064/S009) | C.R. Bard, Inc. | 1998-01-26 |
| VENTAK MINI HE AND VENTAK MINI III AICD TM SYSTEMS (P910077/S022) | Boston Scientific | 1998-01-23 |
| PROSTATRON MAXIS (P950014/S012) | Urologix, Inc. | 1998-01-22 |
| THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P870072/S006) | Thoratec Laboratories Corp. | 1998-01-21 |
| ITREL SPINAL CORD STIMULATION SYSTEM (P840001/S041) | Medtronic Neuromodulation | 1998-01-20 |
| LCS(R)TOTAL KNEE SYSTEM (P910016/S009) | Depuy, Inc. | 1998-01-15 |
| LCS(R)TOTAL KNEE SYSTEM (P910016/S010) | Depuy, Inc. | 1998-01-15 |
| NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S073) | Cochlear Americas | 1998-01-12 |
| NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P890027/S042) | Cochlear Americas | 1998-01-12 |
| UROLOGIC TARGIS SYSTEM (P970008/S002) | Urologix, LLC | 1998-01-09 |