| BIOSPHERE SUTURE ANCHOR (K963396) | Instrument Makar, Inc. | 1997-05-06 |
| FLOSSBRUSH WITH FLUORIDE (K964976) | Flossbrush Interdental Cleaner and Applicator | 1997-05-06 |
| SAFESKIN POWDERED EXAMINATION GLOVE (K970899) | Safeskin Corp. | 1997-05-06 |
| CUSTOM OPTICAL SUNGLASS FRAMES (K970895) | Custom Optical Frames, Inc. | 1997-05-06 |
| BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS (K970698) | Polymer Technology Corp. | 1997-05-06 |
| SILOC SYSTEM (K970848) | Heraeus Kulzer, Inc. | 1997-05-06 |
| CORDIS OPTA5 PTA BALLOON CATHETER (K970620) | Cordis Corp. | 1997-05-06 |
| TRANSJUGULAR ACCESS SET (K964034) | AngioDynamics, Inc. | 1997-05-06 |
| BARAKKA, INFERNO, STERLING, AND/OR ONE (K970944) | Sentinal Importing Corp. | 1997-05-06 |
| SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT) (K971466) | Carolina Liquid Chemistries Corp. | 1997-05-06 |
| SANI-SHIELD (K970104) | Dw Industries, Inc. | 1997-05-06 |
| HWA MAO OPTICAL SUNGLASSES (NON-PRESCRIPTION) (K970476) | Hwa Mao Optical Co., Ltd. | 1997-05-06 |
| AUTOMIX PLUS, 3+3, MICROMIX COMPOUNDING SYSTEM; (K955622) | Baxter Healthcare Corp | 1997-05-06 |
| EVEREST SUNGLASSES (K970315) | Ycc International Corp. | 1997-05-06 |
| CYGNUS INSTRUMENT PROTECTORS (K964256) | Madison Polymeric Engineering | 1997-05-06 |
| ANSPACH LUBRICATING SYSTEM II (K970530) | The Anspach Effort, Inc. | 1997-05-05 |
| MEDILOG FD4 (K970902) | Oxford Instruments Medical Systems | 1997-05-05 |
| PRESS-FIT HIP STEM (K964178) | Encore Orthopedics, Inc. | 1997-05-05 |
| MODIFIED USSC* POLYSORB SUTURE (K970863) | United States Surgical, A Division of Tyco Healthc | 1997-05-05 |
| VIDAS ROTAVIRUS ASSAY (K965092) | Biomerieux Vitek, Inc. | 1997-05-05 |
| TRISTAR LP TORCAR WITH LOW PROFILE THREADED SLEEVE (K965045) | Ethicon Endo-Surgery, Inc. | 1997-05-05 |
| O'REGAN LIGATOR (K963166) | Patrick J. O'Regan | 1997-05-05 |
| ELECTROSURGICAL ELECTRODE (K970987) | Fusion Medical Technologies, Inc. | 1997-05-05 |
| SH-1 SURGICAL HOLDER FOR TELESCOPE (K960068) | Olympus America, Inc. | 1997-05-05 |
| STANDARD & EXTENDED BLADE/NEEDLE/BALL;MODIFIED STANDARD & EXTENDED BLADE/NEEDLE (K971187) | Aaron Medical Industries | 1997-05-05 |
| DISPOSABLE VITRECTOMY PROBE (K970673) | Altex Vision | 1997-05-05 |
| FIEGERT ENDOTECH CYSTOSCOPE (K970892) | Fiegert, Inc. | 1997-05-05 |
| CENTAURI (K932683) | Premier Laser Systems, Inc. | 1997-05-05 |
| SHADOWFORM (K964972) | I.Z.I. Medical Products Corp. | 1997-05-05 |
| MICROSPAN INSEMINATION SYSTEM (K970750) | Imagyn Medical, Inc. | 1997-05-05 |
| IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130) (K963054) | Genbio | 1997-05-05 |
| APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE (K971498) | Applied Medical Resources | 1997-05-05 |
| CENTAURI (K933841) | Premier Laser Systems, Inc. | 1997-05-05 |
| BEHRING COAGULATION SYSTEM (K970431) | Behring Diagnostics, Inc. | 1997-05-05 |
| HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES (K964625) | Intervascular, Inc. | 1997-05-05 |
| SEALED LEAD ACID BATTERY PACK (K970234) | Portable Power Systems, Inc. | 1997-05-02 |
| BONE SOURCE HYDROXYAPATITE (K970400) | Orthofix, Inc. | 1997-05-02 |
| PROFORM GENERAL APPLICATION CEMENTED FEMORAL COMPONENT (K970490) | Stelkast Company | 1997-05-02 |
| DIGIT-GRIP WITH LCD (DGR002) (K970870) | Nk Biotechnical Corp. | 1997-05-02 |
| BARD MEMOTHERM TRANSHEPATIC BILIARY ENDOPROSTHESIS (K963782) | C.R. Bard, Inc. | 1997-05-02 |
| EBI SPINELINK SYSTEM (K964797) | Electro-Biology, Inc. | 1997-05-02 |
| DRIED GRAM-NEGATIVE MIC/COMBO PANELS (K970676) | Dade Intl., Inc. | 1997-05-02 |
| PRECISE IMPRESSION KIT (K970952) | Starkey Laboratories, Inc. | 1997-05-02 |
| IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120 (K963055) | Genbio | 1997-05-02 |
| LD-L REAGENT (K971398) | Carolina Liquid Chemistries Corp. | 1997-05-02 |
| WILLIAMS SOUND, PERSONAL FM, HEARING HELPER (K970687) | Williams Sound, LLC | 1997-05-02 |
| GREINER VACUETTE BLOOD COLLECTION TUBE (K971221) | Greiner America, Inc. | 1997-05-02 |
| WILLIAMS SOUND, PERSONAL FM, HEARING HELPER (K970665) | Williams Sound, LLC | 1997-05-02 |
| ACPII ANTERIOR CERVICAL PLATE SYSTEM (K970806) | Sofamor Danek USA,Inc. | 1997-05-02 |
| MITRA IMAGING, INC. FILM EXPRESS SCANNING SOFTWARE (K970652) | Mitra Imaging, Inc. | 1997-05-02 |
| XOMED SILICONE BLOCK/STRIP (K970910) | Xomed, Inc. | 1997-05-02 |
| TRANSMEDICA MODEL 100 DIGITAL ELECTRONIC STETHOSCOPE (K963418) | Transmedica, Inc. | 1997-05-02 |
| WILLIAMS SOUND, PERSONAL FM SYSTEM, HEARING HELPER (K970974) | Williams Sound, LLC | 1997-05-02 |
| AMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGES (K962807) | American Surgical Sponges | 1997-05-02 |
| BASIS FLEXIBLE TIP DIGITAL THERMOMETER (K971045) | Polymedica Industries, Inc. | 1997-05-02 |
| RIS SCANVIEW SYSTEM (RSVS) (K970641) | Radiology Information Systems, Inc. | 1997-05-02 |
| ALB OR ALBUMIN (K971445) | Carolina Liquid Chemistries Corp. | 1997-05-02 |
| SAFE-CONNECT VIAL DISPENSING SPIKE (K970789) | Faulding Medical Device Co. | 1997-05-01 |
| FUKADA DENSHI DYNASCOPE MODEL DS-5300 PATIENT MONITOR (K964187) | Fukuda Denshi USA, Inc. | 1997-05-01 |
| ETEST SUBMISSION FOR AZITHROMYCIN/S. PNEUMONIAE (K970473) | Ab Biodisk | 1997-05-01 |
| FREEPIX/PIXPACS DICOM/HTTP GATEWAY (K970174) | Pixelinks, Inc. | 1997-05-01 |
| SAFE-CONNECT Y-SITE ADAPTER CATALOG NO. 681518 (K971266) | Faulding Medical Device Co. | 1997-05-01 |
| INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY (K963289) | Incstar Corp. | 1997-05-01 |
| (MODIFIED) ETEST PACKAGE INSERT (K964236) | Ab Biodisk | 1997-05-01 |
| CHANNEL BALLOON CATHETER (K970379) | Boston Scientific Corp | 1997-05-01 |
| AMIKACIN (K970210) | Ab Biodisk | 1997-05-01 |
| STRYKER 2115 REPLACEMENT BATTERY (2115) (K970378) | Implant Resource, Inc. | 1997-04-30 |
| COBE CENTRYSYSTEM 14 PES HEMODIALYZERS (K955592) | Cobe Renal Care, Inc. | 1997-04-30 |
| IMTEC/TITANIUM MESH (K970841) | Imtec Corp. | 1997-04-30 |
| 3M SUSTEL DENTAL SYSTEM (K970500) | 3M Company | 1997-04-30 |
| IMPLEX BIPOLAR HIP SYSTEM (K970447) | Implex Corp. | 1997-04-30 |
| TARGIS ALLOY #7 (K970963) | Ivoclar North America, Inc. | 1997-04-30 |
| BCW POWER ADVANTAGE WHEELCHAIR (K970743) | Wheelchairs of Kansas | 1997-04-30 |
| NATURAL-KNEE II REVISION FEMORAL SPACER LUGS (K970498) | Intermedics Orthopedics | 1997-04-30 |
| MD-1A GALVANIC UNIT (K964208) | R. A. Fischer Co. Corp. | 1997-04-30 |
| TUNA 5 CATHETER (K965199) | Vidamed, Inc. | 1997-04-30 |
| DEPUY ACE TROCHANTERIC SIDE PLATE (K970503) | Depuy Ace Medical Co. | 1997-04-30 |
| TARGET VITAL-PORT VASCULAR ACCESS SYSTEM (K970442) | Med Institute, Inc. | 1997-04-30 |
| AURA TEK FDP (K970353) | Perimmune, Inc. | 1997-04-30 |
| INNOVASIVE ROCLET BONE TUNNEL AUGMENTATION DEVICE (K970423) | Innovasive Devices, Inc. | 1997-04-30 |
| CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM (K962788) | Gaymar Industries, Inc. | 1997-04-30 |
| PERMOBIL CHAIRMAN L/CS 8 (K960951) | Permobil AB | 1997-04-30 |
| PCM 2000; ISOLAIR APR MODEL 2735 (K970448) | Tecnol Medical Products, Inc. | 1997-04-30 |
| PEGGED ACETABULAR COMPONENT (K970501) | Biomet, Inc. | 1997-04-30 |
| TEFGEN - LS (K965205) | American Custom Medical, Inc. | 1997-04-30 |
| TITANIUM ALLOY BONE SCREWS (K970549) | Aesculap, Inc. | 1997-04-30 |
| HYFRECATOR 2000 (K970493) | Aspen Labs | 1997-04-30 |
| BIOSCOPE SD TENS, ARISTA SD PLUS, AP-102080T (K970429) | Apex Medical Corp. | 1997-04-29 |
| IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENT (K964695) | Beckman Instruments, Inc. | 1997-04-29 |
| ALIGNMENT INSTRUMENT (K970345) | Richard Wolf Medical Instruments Corp. | 1997-04-29 |
| BK-A; BK-B; BK-IS SEALING CAP (K970204) | Biotronik, Inc. | 1997-04-29 |
| PMT ACCESSORY DEPTHALON ELECTRODE ANCHOR BOLT (2103-23-XX) (K970418) | Pmt Corp. | 1997-04-29 |
| MEDRAD DISPOSABLE SYRINGES (K964642) | Medrad, Inc. | 1997-04-29 |
| QUICKIE POWER WHEELCHAIRS P200 SERIES (K963385) | Quickie Designs, Inc. | 1997-04-28 |
| ALPHATEC EXTERNAL FIXATION SYSTEM (K964400) | Alphatec Mfg., Inc. | 1997-04-28 |
| QUICKIE P100 SERIES (K963382) | Quickie Designs, Inc. | 1997-04-28 |
| IMMULITE CANNABINOIDS (K963916) | Diagnostic Products Corp. | 1997-04-28 |
| WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS (K964119) | Boston Scientific Scimed, Inc. | 1997-04-28 |
| FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM (K971141) | Dade Chemistry Systems, Inc. | 1997-04-28 |
| QUICKIE P300 SERIES (K963381) | Quickie Designs, Inc. | 1997-04-28 |