| PM 2002 CC PROLINE (K970812) | Planmeca Oy | 1997-08-05 |
| PARI PEP THERAPY SYSTEM (K972042) | Pari Holding Co. | 1997-08-05 |
| UNIGLOVES (K971731) | Uni-Glove (Usa), Inc. | 1997-08-05 |
| AMPLAID 460 (K971747) | Amplifon S.P.A. | 1997-08-05 |
| MEMORY STAPLE (20 SIZES AVAILABLE) (K964226) | Landos, Inc. | 1997-08-05 |
| MAGNETOM PROJECT 047 SYSTEM (NUMARIS 3.5 SOFTWARE) (K971684) | Siemens Medical Solutions USA, Inc. | 1997-08-05 |
| ELECTRO-LITE ELITE POWERED WHEELCHAIR (K970575) | Damaco | 1997-08-05 |
| V-12 LONG LIFE 675 HEARING AID (K972755) | Vista Labs | 1997-08-05 |
| 40 CC SUMO (K971673) | Boston Scientific Corp | 1997-08-05 |
| ANTI-TUMOR EXPERT SYSTEM (ATES) FOR RADIATION THERAPY TREATMENT PLANNING (K963451) | Topslane | 1997-08-05 |
| BSM BONE SUBSTITUTE MATERIAL KIT (K962548) | Etex Corp. | 1997-08-05 |
| ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM (K970508) | Shimadzu Medical Systems | 1997-08-04 |
| PLASMA CATECHOLAMINE KIT (K972167) | Bioanalytical Systems, Inc. | 1997-08-04 |
| RHINOCELL NASAL PACKINGS (K972459) | Boston Medical Products, Inc. | 1997-08-04 |
| RANDOX ASSAYED SPECIFIC PROTEIN CONTROL (K972608) | Randox Laboratories, Ltd. | 1997-08-04 |
| METHADONE EIA ASSAY (K972526) | Diagnostic Reagents, Inc. | 1997-08-04 |
| AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL DUSSELDORF, DRESDEN AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL TUBINGEN (K972585) | Heinz Kurz GmbH Medizintechnik | 1997-08-04 |
| BELL PROSTHESIS (PARTIAL) (K972492) | Heinz Kurz | 1997-08-04 |
| GOLDEN EAGLE (K971043) | Golden Technologies, Inc. | 1997-08-01 |
| DRIED GRAM-NEGATIVE MIC/COMBO PANELS (K972180) | Dade Microscan, Inc. | 1997-08-01 |
| UREA (K971309) | Derma Media Lab., Inc. | 1997-08-01 |
| INNOFLUOR GENTAMICIN ASSAY SYSTEM (K972331) | Oxis Intl., Inc. | 1997-08-01 |
| GLUCOSE REAGENT (K970664) | Derma Media Lab., Inc. | 1997-08-01 |
| QUICKSTICK ONE STEP HCG PREGNANCY TEST (K972682) | Phamatech | 1997-08-01 |
| N-ASSAY TIA APO A1/B MULTI CALIBRATOR (K964294) | Crestat Diagnostics, Inc. | 1997-08-01 |
| MODIFICATION OF EST CULTURE SYSTEM II - MYCO (K972756) | Accumed Intl., Inc. | 1997-08-01 |
| RELIEFBAND TENS UNIT (MODIFICATION) (K961050) | Maven Labs, Inc. | 1997-08-01 |
| GRAFT PATCH (K970561) | Organogenesis, Inc. | 1997-08-01 |
| N-ASSAY TIA APO B TEST KIT (K964296) | Crestat Diagnostics, Inc. | 1997-08-01 |
| UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026) (K971992) | Uromed Corp. | 1997-08-01 |
| CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TEST (K972160) | Trinity Laboratories, Inc. | 1997-08-01 |
| IMPROVEMENTS TO THE MEHL RUBY LASER (K971814) | Mehl/Biophile Intl., Inc. | 1997-08-01 |
| REGANES SPINAL NEEDLE (VARIOUS) (K971645) | Avid N.I.T., Inc. | 1997-08-01 |
| DOUBLE LUMEN PICC (K970926) | B.Braun Medical, Inc. | 1997-08-01 |
| N-ASSAY TIA APO A1 TEST KIT (K964292) | Crestat Diagnostics, Inc. | 1997-08-01 |
| PHONAK EPICA (K972105) | Phonak, Inc. | 1997-08-01 |
| ELITE H-D VINYL POLYSILOXANE IMPRESSION MATERIALS .PUTTY SOFT/NORMAL SETTING /PUTTY SOFT/FAST SETTING (K972239) | Zhermack S.P.A. | 1997-08-01 |
| INFINITECH MULTI-SPOT SLIT LAMP LASER ADAPTER (K971950) | Infinitech, Inc. | 1997-08-01 |
| MEDI-DYNE GUIDING CATHETER (K970401) | Medi-Dyne, Inc. | 1997-08-01 |
| SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD (K965187) | Sparta Surgical Corp. | 1997-08-01 |
| PORT-NEB (K971933) | Medic-Aid , Ltd. | 1997-08-01 |
| AEROQUIP SAFESTART IV CATHETER (K970669) | Aeroquip Medical Products | 1997-08-01 |
| GOLDEN HAWK (K971050) | Golden Technologies, Inc. | 1997-08-01 |
| SYNTHES(USA)TITANIUM LOCKING PLATE SYSTEM(TILPS) (K970048) | Synthes (Usa) | 1997-08-01 |
| HAND HELD MEDISPACER (K972237) | Thayer Medical Corp. | 1997-07-31 |
| AEROQUIP SAFESTART (TM) IV CATH (TM) SYSTEM (K970644) | Aeroquip Medical Products | 1997-07-31 |
| ALTERNATING PRESSURE AIR FLOTATION MATTRESS (K972153) | Decubiti Concepts, Inc. | 1997-07-31 |
| INTUITIVE SURGICAL MONARCH LAPAROSCOPIC MANIPULATOR (K965001) | Intuitive Surgical, Inc. | 1997-07-31 |
| VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000) (K972100) | Advanced Care Medical Products | 1997-07-31 |
| EVT EXPANDABLE SHEATH (K970470) | Guidant Cardiac and Vascular Surgery | 1997-07-31 |
| MEDIVISION ARTHROSCOP (K971996) | Medivision Scope Service Center, Inc. | 1997-07-31 |
| ENDOSCOPIC VENTRICULAR CATHETER (K971617) | Integra Neurocare, LLC | 1997-07-31 |
| IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK (K971832) | M-Pact Worldwide Management Corp. | 1997-07-31 |
| TMS COMFORT SERIES NASAL CPAP MASK (K964092) | Tiara Medical Systems, Inc. | 1997-07-31 |
| AUDIFON H24 AGC/AUDIFON H25 AGC/AUDIFON H30 AGC (K972550) | Trutone | 1997-07-31 |
| APOLLO KNEE FEMORAL SPACERS (K971770) | Sulzer Orthopedics, Inc. | 1997-07-31 |
| DIGOXIN DG-II FPIA REAGENT SET (K972794) | Sigma Diagnostics, Inc. | 1997-07-31 |
| BENZ B36 (KOLFOCON B) RIGID GAS PERMEABLE (HYDROPHOBIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FROM LENS BLANK) (K963744) | Benz Research and Development Corp. | 1997-07-31 |
| BENZ B17 (KOLFOCON A) RIGID GAS PERMEABLE (HYDROPHOBIC DAILY WEAR CONTACT LENS (CLEAR AND TINTED, LATHE-CUT FROM LENS BL (K963512) | Benz Research and Development Corp. | 1997-07-31 |
| NEVADA EYEWORKS, LUIGI LANATTA SUNGLASSES (K972590) | Lbi U.S.A. | 1997-07-31 |
| MEDI-TECH 5 FRENCH NIGHTHAWK SELECTIVE ANGIOGRAPHIC CATHETERS (K970207) | Boston Scientific Corp | 1997-07-31 |
| IMPLANTABLE CLIP (K970793) | United States Surgical, A Division of Tyco Healthc | 1997-07-30 |
| FASTAK SUTURE ANCHOR (11.7MM)/(7.5MM) (K971723) | Arthrex, Inc. | 1997-07-30 |
| CODA AUTOMATED EIA ANALYZER (K972024) | Bio-Rad | 1997-07-30 |
| PHONAK MICROZOOM P 2 (K972097) | Phonak, Inc. | 1997-07-30 |
| INTRACAVITY NEEDLE GUIDE KIT (K955668) | Arlanda Medicinska Instrument Co. AB | 1997-07-30 |
| VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSION (K971791) | Louisville Laboratories, Inc. | 1997-07-30 |
| TINA-QUANT FERRITIN ASSAY (K964282) | Boehringer Mannheim Corp. | 1997-07-30 |
| STANDARD ENDOSCOPE (K972056) | Laser-Optik-Systeme GmbH & Co. KG | 1997-07-30 |
| WHITESIDE BIOMECHANICS, INC. ZIRCONIA CERAMIC FEMORAL HEAD (K971721) | Whiteside Biomechanics, Inc. | 1997-07-30 |
| ZIRCONIA CERAMIC FEMORAL HEAD (12/14 TAPER) (K971752) | Zimmer, Inc. | 1997-07-30 |
| OSTEOLOCK ACETABULAR SHELL SYSTEM (K971854) | Howmedica Corp. | 1997-07-30 |
| AUDIFON H20 PC/AUDIFON H32 PP (K972552) | Trutone | 1997-07-30 |
| SIGMA DIAGNOSTICS VALPROIC ACID FPIA REAGENT SET, SIGMA DIAGNOSTICS VALPROIC ACID FPIA CALIBRATORS (K972132) | Sigma Diagnostics, Inc. | 1997-07-30 |
| OSTEO CANNULATED SCREW SYSTEM (K971800) | Osteonics Corp. | 1997-07-30 |
| VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION (K971802) | Louisville Laboratories, Inc. | 1997-07-30 |
| DUAL ROD ANTERIOR FIXATOR SYSTEM (K963780) | Sofamor Danek USA,Inc. | 1997-07-30 |
| ARGLAES FILM DRESSING (K970566) | Maersk Medical, Ltd. | 1997-07-29 |
| POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED) (K972195) | Absolute Synthetic Technologies Malaysia Sdn. Bhd. | 1997-07-29 |
| OVATION HDP (K972373) | Orsonique, Inc. | 1997-07-29 |
| VELOS CONSTANCY CHECK DEVICE, MODEL 55-145 (K970384) | Aktina Medical Physics Corp. | 1997-07-29 |
| GE LOGIQ 700 DIAGNOSTIC ULTRASOUND SYSTEM (K964886) | GE Medical Systems | 1997-07-29 |
| WELCON HUE-VU URINARY DRAINAGE BAG (K971764) | Welcon, Inc. | 1997-07-29 |
| GALLINI COAXIAL INTRODUCER (K972266) | Gallini U.S., LLC | 1997-07-29 |
| HEMODIALYSIS VENOUS BLOOD TUBING SET OR SIMILAR TRADE NAME (K971687) | National Medical Care, Inc. | 1997-07-29 |
| COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903) (K971597) | Coloplast Corp. | 1997-07-29 |
| MEDICAL Z, S.A. MEDIGEL Z SCAR MANAGEMENT GEL (K971916) | Medical Z, S.A. | 1997-07-29 |
| RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT (K971571) | Waters Instruments, Inc. | 1997-07-29 |
| BRACHYSTEPPER STEPPING UNIT, BRACHYSTEPPER NEEDLE GUIDE TEMPLATE, BRACHYSTAND SUPPORT AND MANUAL ADJUSTMENT ACCESSORY (K972672) | Barzell-Whitmore Maroon Bells, Inc. | 1997-07-29 |
| VISTA UNIVERSAL HANDPIECE (K972252) | Odyssey Technologies, Inc. | 1997-07-29 |
| HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C) (K971671) | Heidelberg Engineering | 1997-07-29 |
| P3 UNIVERSAL PHACO HANDPIECE (K972253) | Odyssey Technologies, Inc. | 1997-07-29 |
| DERMAMEND HYDROGEL GAUZE DRESSING (K972336) | Dermarx Corp. | 1997-07-29 |
| BONE AND MARROW COLLECTION SYSTEM KIT (K971782) | Biomedical Ent., Inc. | 1997-07-29 |
| WIRELESS EEG RECORDING SYSTEM MODEL W32 (K963195) | Cme Telemetrix, Inc. | 1997-07-29 |
| STRYKER INTERPULSE HANDPIECE SET, SPLASH SHIELDS, IRRIGATION AND SUCTION TIPS, RECHARGEABLE BATTERY PACK (K972069) | Stryker Instruments | 1997-07-29 |
| SCAR CARE (K971009) | Target Health, Inc. | 1997-07-29 |
| MYRINGOTOMY TUBE (K972126) | Mednet Locator, Inc. | 1997-07-29 |
| SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM (K970920) | Siemens Medical Solutions USA, Inc. | 1997-07-29 |
| VG 200 VIDEO GASTROSCOPE (K971734) | Welch Allyn, Inc. | 1997-07-29 |