| MODEL 3100A HIGH FREQUENCY OCILLATORY VENTILATOR (P890057/S009) | ZOLL Medical Corporation | 1997-07-08 |
| HYALGAN(R) (P950027/S001) | Fidia Farmaceutici S.P.A. | 1997-07-08 |
| UNIZYME(TM) ENZYMATIC CLEANER (P960024/S001) | Ciba Vision Corporation | 1997-07-03 |
| OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER (P820001/S023) | Alcon Laboratories | 1997-07-03 |
| CONTACLAIR MULTI-PURPOSE SOLUTION (P910074/S001) | Eureka Laboratories, Inc. | 1997-07-03 |
| ACS RX LIFESTREAM (P810046/S175) | Advanced Cardiovascular Systems, Inc. | 1997-07-03 |
| BAUSCH & LOMB(R) RENU(R) MULTI-PURPOSE SOLUTION (P860023/S012) | Bausch & Lomb, Inc. | 1997-07-03 |
| ULTRA CARE (TM) NEUTRALIZING TABLET (P850088/S036) | Advanced Medical Optics, Inc. | 1997-07-03 |
| GUARDIAN(R) ATP II IMPLANTABLE CARDIOVERTER/DIFIB. (P940024) | Telectronics Pacing Systems, Inc. | 1997-07-03 |
| STERILE SALINE PRESERVED SOLUTION (P850070/S010) | Automatic Liquid Packaging, Inc. | 1997-07-02 |
| MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK (P900061/S033) | Medtronic Cardiac Rhythm Disease Management | 1997-07-02 |
| SORBIC ACID PRESERVED LENS LUBRICANT (P850075/S009) | Paco Pharmaceutical Services, Inc. | 1997-07-02 |
| OPTI-FREE SUPRACLENS (P820001/S022) | Alcon Laboratories | 1997-07-02 |
| SORBIC ACID PRESERVED DAILY CLEANER (P850076/S009) | Paco Pharmaceutical Services, Inc. | 1997-07-02 |
| CHARTER LABS SALINE SOLUTION (P840069/S007) | Paco Pharmaceutical Services, Inc. | 1997-07-02 |
| ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 81573 (P830034/S034) | Alcon Laboratories | 1997-07-02 |
| CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM (P910023/S026) | ABBOTT MEDICAL | 1997-07-01 |
| TRILOGY DR+ PULSE GENERATOR MODELS 2360L AND 2364L PULSE GENERATORS MODELS 2360L AND 2364L (P880086/S037) | ABBOTT MEDICAL | 1997-06-30 |
| BAK INTERBODY FUSION SYSTEM (P950002/S004) | Zimmer Spine, Inc. | 1997-06-30 |
| ECONOLITH(TM) LITHOTRIPTER (P950043/S001) | Medispec, Ltd. | 1997-06-30 |
| APS II 3003 PROGRAMMER WITH MODEL 3203A FUNCTION PACK (P880006/S025) | St. Jude Medical, Inc. | 1997-06-30 |
| AFP PACING SYSTEM (P830045/S053) | St. Jude Medical, Inc. | 1997-06-30 |
| UV-ELASTIC POSTERIOR CHAMBER IOL FOR LENS MODEL AA-4207VFHAMBER IOL'S (P880091/S010) | Staar Surgical Co. | 1997-06-30 |
| SEPRAFILM BIORESORBABLE MEMBRANE (P950034/S006) | Baxter Healthcare Corporation | 1997-06-30 |
| ORACLE MEGASONICS FIVE-64 PTCA CATHETER (P910031/S016) | Abbott Vascular Devices | 1997-06-27 |
| MEDTRONIC WIKTOR PRIME CORONARY STENT DELIVERY SYSTEM (P960010) | Medtronics Interventional Vascular | 1997-06-27 |
| CLARION MULTI-STRATEGY COCHLEAR IMPLANT (P960058) | Advanced Bionics | 1997-06-26 |
| ORTHOLOGIC 1000 BONE GROWTH STIMULATOR (P910066/S004) | Djo, LLC | 1997-06-25 |
| PAPNET (R) TESTING SYSTEM (P940029/S003) | Bd Diagnostics | 1997-06-25 |
| E P TECH EPT-1000 CARDIAC ABLATION SYSTEM (P920047/S007) | Boston Scientific Corp | 1997-06-24 |
| HIGH FREQUENCY VENTILATOR (P880013/S007) | Nellcor Puritan Bennett, Inc. | 1997-06-24 |
| MODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S006) | Covidien | 1997-06-24 |
| PERIOGARD PERIODONTAL TISSUE MONITOR (P960031) | Xytronyx, Inc. | 1997-06-23 |
| STERILE SALINE PRESERVED SOLUTION (P850070/S009) | Automatic Liquid Packaging, Inc. | 1997-06-20 |
| SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)EXTENDED WEAR CONTACT LENS (P850077/S024) | CooperVision, Inc. | 1997-06-20 |
| TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADS (P960013) | ABBOTT MEDICAL | 1997-06-20 |
| BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS (P960053) | Stryker Corporation | 1997-06-19 |
| S-ROM POLY-DIAL CONSTRAINED LINER (P960054) | Depuy, A Johnson & Johnson Co. | 1997-06-19 |
| ALBUNEX(R) ALBUMIN (HUMAN) 5%, SONICATED (P900059/S004) | Molecular Biosystems, Inc. | 1997-06-17 |
| WALLSTENT(R) ILIAC ENDOPROSTHESIS (P940019/S003) | Boston Scientific Scimed, Inc. | 1997-06-16 |
| OSTEONICS CONSTRAINED ACETABULAR INSERT (P960047) | Howmedica Osteonics Corp. | 1997-06-13 |
| MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK (P900061/S032) | Medtronic Cardiac Rhythm Disease Management | 1997-06-12 |
| VISX EXCIMER LASER SYSTEM MODELS B AND C (P930016/S004) | Amo Manufacturing USA, LLC | 1997-06-12 |
| NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P890027/S038) | Cochlear Americas | 1997-06-11 |
| NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S070) | Cochlear Americas | 1997-06-11 |
| EBI BONE HEALING SYSTEM(R) (P790002/S018) | Ahp Eos Buyer, Inc. | 1997-06-11 |
| LEOCOR SABLE(TM) PTCA CATHETER (P890001/S018) | Leocor, Inc. | 1997-06-11 |
| ACS TX2000 VP CORONARY DILITATION CATHETER (P810046/S174) | Advanced Cardiovascular Systems, Inc. | 1997-06-11 |
| SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S116) | Scimed Life Systems, Inc. | 1997-06-11 |
| NEW JERSEY LCS TOTAL KNEE SYSTEM (P830055/S055) | Depuy, Inc. | 1997-06-11 |
| LEOCOR PICO-ST (P890001/S019) | Leocor, Inc. | 1997-06-09 |
| SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S119) | Scimed Life Systems, Inc. | 1997-06-09 |
| IOL MODELS MZ60PD AND MZ60MD (P840060/S027) | Alcon Laboratories | 1997-06-06 |
| SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S122) | Scimed Life Systems, Inc. | 1997-06-05 |
| ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S022) | Abiomed Cardiovascular, Inc. | 1997-06-04 |
| SEREINE WETTING & SOAKING SOLU. (NEW PRESERVATIVE) (P870051/S006) | Trp Company | 1997-06-02 |
| SEREINE CONTACT LENS CLEANER (NEW PRESERVATIVE) (P870050/S006) | Trp Company | 1997-06-02 |
| PRO OSTEON IMPLANT 500 CORALLINE HYDROXYPATITE BONE VOID FILLER (FORMERLY INTERPORE 500) (P860005/S007) | Interpore Intl. | 1997-05-30 |
| THE WRAP(PTCA) CATHETER (P930012/S006) | Progressive Angioplasty Systems, Inc. | 1997-05-29 |
| CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM (P910023/S028) | ABBOTT MEDICAL | 1997-05-29 |
| MODEL 809A POSTERIOR CHAMBER INTRAOCULAR LENS (P810055/S067) | Advanced Medical Optics, Inc. | 1997-05-28 |
| HYALGAN(R) (P950027) | Fidia Farmaceutici S.P.A. | 1997-05-28 |
| ABBOTT IMX(R) HAVAB(R)-M (P790019/S009) | Abbott Laboratories | 1997-05-28 |
| CARBOMEDICS PROSTHETIC HEART VALVE (CPHV) (P900060/S014) | Corcym S.r.l. | 1997-05-27 |
| PORT-A-CATH(R) EPIDURAL IMPLANTABLE ACCESS SYST (P900052/S004) | Smiths Medical Asd, Inc. | 1997-05-23 |
| TCI HEARTMATE(R) 1000A IP LVAS (P920014/S006) | Thoratec Corp | 1997-05-22 |
| CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM (P910023/S024) | ABBOTT MEDICAL | 1997-05-22 |
| SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)EXTENDED WEAR CONTACT LENS (P850077/S023) | CooperVision, Inc. | 1997-05-19 |
| LIFE PULSE HIGH FREQUENCY VENTILATOR ENDOTRACHEAL TUBE ADAPTER (P850064/S012) | Bunnell, Inc. | 1997-05-16 |
| ABBOTT AXSYM AFP (P820060/S011) | Abbott Laboratories | 1997-05-16 |
| ALCON WETTING, SOAKING, CONDITIONING, AND DISINFECTING SOLUTION ID 84392 (P830071/S008) | Alcon Laboratories | 1997-05-15 |
| NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S069) | Cochlear Americas | 1997-05-15 |
| DURASOFT 3 (PHEMFILCON A) UV OPTIFIT TORIC AND SPHERICAL CONTACT LENSES (P830037/S040) | Alcon Laboratories, Inc. | 1997-05-15 |
| OPTI-ZYME ENZYMATIC CLEANER (P820001/S021) | Alcon Laboratories | 1997-05-15 |
| ACUVUE(R) (ETAFILCON A) EXTENDED WEAR CONTACT LENS (CLEAR AND TINTED WITH UV BLOCKER) (N18033/S030) | Vistakon, Johnson & Johnson Vision Products, Inc. | 1997-05-14 |
| ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK(TM) (P900056/S020) | Boston Scientific Corp | 1997-05-13 |
| ACS CORONARY DILATATION CATHETERS (INDICATION) (P810046/S170) | Advanced Cardiovascular Systems, Inc. | 1997-05-13 |
| GIANTURCO-ROUBIN CORONARY FLEX-STENT(TM) 12MM LONG (P910030/S005) | Cook, Inc. | 1997-05-12 |
| ACS RX COMET CORONARY DILATION CATHETER (P810046/S171) | Advanced Cardiovascular Systems, Inc. | 1997-05-12 |
| PDS II (POLYDIOXANOE) SUTURE DYED & UNDYED (N18331/S027) | ETHICON, Inc. | 1997-05-12 |
| BAK INTERBODY FUSION SYSTEM (P950002/S002) | Zimmer Spine, Inc. | 1997-05-09 |
| ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR (P910066/S005) | Djo, LLC | 1997-05-09 |
| ULTRAVIOLET-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS (P910056/S006) | Bausch & Lomb, Inc. | 1997-05-07 |
| CHIROFLEX(TM)MODEL C10UB ULTRAVIOLET-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS (P910058/S009) | Bausch & Lomb, Inc. | 1997-05-07 |
| H55 HYDROPHILIC CONTACT LENS/OCUFILCON D 55% HYDRO. CONTACT LENSES FOR EXTENDED WEAR (P890023/S005) | The Cooper Companies | 1997-05-06 |
| VENTAK PRX AICD,SYSTEM FOR THE RHYTHMLINE TM TRANSTELPHONIC INTERROGATION SYSTEM MINI HC AICD, VENTAK II AICD (P910077/S018) | Boston Scientific | 1997-05-06 |
| DORNIER COMPACT S) AND DORNIER LITHOTRIPTER (STATIONARY & TRANSPORTABLE (P840008/S058) | Dornier Medtech America, Inc. | 1997-05-05 |
| MODEL 3100A HIGH FREQUENCY OCILLATORY VENTILATOR (P890057/S008) | ZOLL Medical Corporation | 1997-05-02 |
| ANGIO-SEAL(TM)[1] HEMOSTATIC PUNCTURE CLOSURE DEVICE (P930038/S005) | Terumo Medical Corporation | 1997-05-01 |
| THOR PTCA DILATATION CATHETERS WITH 10 MM AND 40 MM LONG BALLOONS (P880003/S066) | Cordis Corp. | 1997-04-30 |
| NEW JERSEY LCS TOTAL KNEE SYSTEM (P830055/S054) | Depuy, Inc. | 1997-04-30 |
| PTCA DILATATION CATHETERS FOR VALOR AND VALOR XL PTCA (P880003/S065) | Cordis Corp. | 1997-04-30 |
| NATURAL-KNEE(R) WITH CSTI(TM) (P940002/S001) | Sulzermedica | 1997-04-30 |
| PROSTAR 9 FR. PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM (P960043) | Abbott Vascular, Inc. | 1997-04-30 |
| MODEL 9602 PROGRAMMER (P880038/S034) | St. Jude Medical, Inc. | 1997-04-29 |
| MODEL 1256D META MV CARDIAC PULSE GENERATOR (P900070/S019) | St. Jude Medical, Cardiac Rhythm Management Divisi | 1997-04-29 |
| MODEL 9602 PROGRAMMER (P820018/S072) | St. Jude Medical, Inc. | 1997-04-29 |
| UROLUME(TM)ENDOURETHRAL WALLSTENT(R) PROSTHESIS (P920023/S003) | Boston Scientific Corp | 1997-04-29 |
| MFL5000 & DORNIER LITHOTRIPTERS (STATIOINARY & TRANSPORTABLE) (P840008/S057) | Dornier Medtech America, Inc. | 1997-04-29 |
| MODEL 1256D META MV CARDIAC PULSE GENERATOR (P900070/S018) | St. Jude Medical, Cardiac Rhythm Management Divisi | 1997-04-29 |