| BAYLIS PAIN MANAGEMENT GENERATOR MODEL: PMG-115 (FOR DOMESTIC USE), PMG-230 (FOR INTERNATIONAL USE) (K002565) | Baylis Medical Co., Inc. | 2001-05-03 |
| ADJUSTABLE LARGE FIXATOR SYSTEM (K010344) | Synthes (Usa) | 2001-05-03 |
| MODIFICATION TO TISSUELINK BIPOLAR FORCEPS (K010661) | Tissuelink Medical, Inc. | 2001-05-03 |
| KILEJIAN CIRCUMCISOR (K010867) | Iris Surgical, LLC | 2001-05-03 |
| TISSUE MARKER (K001807) | Advanced Uroscience, Inc. | 2001-05-03 |
| SANARUS CORE TISSUE BIOPSY SYSTEM (K003528) | Endocare, Inc. | 2001-05-03 |
| COOK IVF CRYOPRESERVATION KIT AND THE COOK IVF THAW KIT (K011157) | Cook Urological, Inc. | 2001-05-03 |
| SEEDNET, MODELS FP6T5, FP5T5, FP5T3 (K010991) | Galil Medical , Ltd. | 2001-05-03 |
| POWDERFREE COLORED LATEX EXAMINATION GLOVES (PINK, BLUE, GREEN, AND WHITE) WITH PROTEIN CONTENT LABELING CLAIM (50 MICR0 (K010483) | Pt. Medisafe Technologies | 2001-05-03 |
| SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000 (K003458) | Clinical Innovations, Inc. | 2001-05-03 |
| LAGLOVE BRAND NITROPRENE POWDER FREE EXAMINATION GLOVES (MADE OF NITRILE-NEOPRENE CO-POLYMER) (K010863) | La Glove (M) Sdn. Bhd. | 2001-05-03 |
| NEUROPLUS, MODEL A10040, A10041, A10042, A10043 (K010638) | Vermont Medical, Inc. | 2001-05-03 |
| KOALA CLAMP (K010695) | Maternus, Inc. | 2001-05-03 |
| SYNTHES (USA) MIDFACE DISTRACTOR (K010499) | Synthes (Usa) | 2001-05-03 |
| BIPOLAR PENCIL, MODEL 3901-002, 3900-002 (K010487) | Medtronic PS Medical | 2001-05-03 |
| BIOUNIVERSAL PDF (K011022) | Ivoclar North America, Inc. | 2001-05-02 |
| PTA-OS SIZING BALLOON, MODEL 360 (K003320) | NuMED, Inc. | 2001-05-02 |
| SIII ALARM AMPLIFIER (K011088) | Stockert Instrumente GmbH | 2001-05-02 |
| MODULAR FOOT SYSTEM - 2.7 MM MODULE (K010321) | Synthes (Usa) | 2001-05-02 |
| KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR (K010346) | KARL STORZ Endoscopy-America, Inc. | 2001-05-02 |
| RAICHEM CREATININE URINE STANDARD (K011126) | Hemagen Diagnostics, Inc. | 2001-05-02 |
| HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870A (K003819) | Agilent Technologies, Inc. | 2001-05-02 |
| KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010 (K011115) | Heinz Kurz GmbH Medizintechnik | 2001-05-02 |
| ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR) (K010322) | Orthodyne, Inc. | 2001-05-02 |
| D.SIGN 96 (K011023) | Ivoclar North America, Inc. | 2001-05-02 |
| SURE CHECK OVULATION PREDICTOR (K010244) | Chembio Diagnostic Systems, Inc. | 2001-05-02 |
| SYNETEC (K002817) | Ela Medical, Inc. | 2001-05-02 |
| VASCULAR ASSIST (K002186) | Huntleigh Healthcare, Inc. | 2001-05-02 |
| GLOBAL BY <GENX> BLASTOCYST MEDIA (K010183) | <Genx> Intl., Inc. | 2001-05-02 |
| ECLIPSE 6.5 (K010975) | Varian Medical Systems, Inc. | 2001-05-02 |
| MACROPORENS CRANILOC (K002334) | Macropore Biosurgery, Inc. | 2001-05-02 |
| WEISS RETINAL CANNULA (K010305) | Micron Surgical, Inc. | 2001-05-02 |
| WHITE MTA MATERIAL (K011009) | Dentsply International | 2001-05-02 |
| MODIFICATION TO THE EMIT II PLUS COCAINE METABOLITE ASSAY (K011162) | Syva Co., Dade Behring, Inc. | 2001-05-02 |
| TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315; INTEGRA CATALOG # 2148323 (K003064) | Roche Diagnostics Corp. | 2001-05-01 |
| MAXITEX DUPLEX POWDER FREE LATEX STERILE SURGEON GLOVES PROTEIN LABELING CLAIM (50 MICRGRAMS OR LESS) (K010438) | Terang Nusa Sdn Bhd | 2001-05-01 |
| SPHYGMOCOR MX MODEL SCOR-MX (K002742) | Pwv Medical Pty, Lt. | 2001-05-01 |
| WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION (K003402) | Welcon, Inc. | 2001-05-01 |
| COOLTOUCH VARIA ND:YAG LASER SYSTEM; COOLTOUCH VARIA-II ND:YAG LASER SYSTEM (K010316) | Cooltouch Corp. | 2001-05-01 |
| ABBOTT ACCLAIM ENCORE, MODEL 12237 (K011096) | Abbott Laboratories | 2001-05-01 |
| ULTRA CARE 2 LATEX EXAMINATION GLOVES MADE FROM ALLOTEX (ENZYME TREATED) NATURAL RUBBER LATEX WITH A PROTEIN CONTENT LAB (K002718) | Tillotson Healthcare Corp. | 2001-05-01 |
| MAXITEX DUPLEX STERILE LATEX POWDERED SURGEON GLOVES WITH PROTEIN LABELING CLAIM (100 MICROGRAMS OR LESS) (K010439) | Terang Nusa Sdn Bhd | 2001-05-01 |
| LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION) (K010284) | Laserscope | 2001-05-01 |
| DRX 2000 (K010292) | Axiom Worldwide, Inc. | 2001-05-01 |
| POWDER FREE NITRILE EXAMINATION GLOVE (K011012) | Contract Latex Dippers Sdn Bhd | 2001-05-01 |
| SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 (K010494) | Dade Behring, Inc. | 2001-05-01 |
| AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154 (K011093) | Agilent Technologies, Inc. | 2001-05-01 |
| APPLICATOR TIP/DUAL SPRAYER KIT (K010708) | Interpore Cross Intl. | 2001-04-30 |
| TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600 (K004038) | Scantibodies Laboratory, Inc. | 2001-04-30 |
| COBE HC 700 MIDI HEMOCONCENTRATOR (K003023) | Hospal Industrie | 2001-04-30 |
| ORTHO CONTROL FEMALE URINARY CONTROL DEVICE (K010365) | Personal Products Co. | 2001-04-30 |
| VACUETTE SPEEDY QUICK-RELEASE HOLDER (K003812) | Greiner Vacuette North America, Inc. | 2001-04-30 |
| POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD CLAMP, NON-STERILE, MODEL 385 (K010835) | Busse Hospital Disposables, Inc. | 2001-04-30 |
| ALIEN RX MICRO CANNULA, MODEL 4530 (K010993) | Boston Scientific Corp | 2001-04-30 |
| SIMPLICITY WING INFUSION SET (K010886) | Sterling Medivations, Inc. | 2001-04-30 |
| LIFESTYLES, CONTEMPO OR PRIVATE LABEL, MALE LATEX CONDOM WITH GLYCERINE LUBRICANT (K010371) | Suretex, Ltd. | 2001-04-27 |
| PROLENE (POLYPROPYLENE) 3D PATCH, NONABSORBABLE SYNTHETIC SURGICAL MESH (K010722) | ETHICON, Inc. | 2001-04-27 |
| MIASPAS MINITTA ANTERIOR MICRO SURGICAL TRANSTHORACIC APPROACH INSTRUMENTATION (K003740) | Aesculap, Inc. | 2001-04-27 |
| SPERMICIDAL LUBRICATED MALE LATEX CONDOM (K010178) | Innolatex Sdn. Bhd | 2001-04-27 |
| SPAZZ (K010823) | Colours 'N Motion | 2001-04-27 |
| GRAFT MARKER RING (K001915) | T. Korossurgical Instruments Corp. | 2001-04-27 |
| SENOJ IMPLANT SYSTEM (K000889) | Senoj Biocare, Inc. | 2001-04-27 |
| MODIFICATION TO TISSUELINK MONOPOLAR FLOATING BALL (K010662) | Tissuelink Medical, Inc. | 2001-04-27 |
| DRYSTAR 4500 PRINTER, MODEL 4500 (K010275) | Agfa Medical Imaging | 2001-04-27 |
| MED-LOGICS DISPOSABLE ALK TUBING (K010353) | Med-Logics, Inc. | 2001-04-27 |
| LSI SOLUTIONS FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES PRODUCT (K011016) | Lsi Solutions | 2001-04-27 |
| SONICAID SYSTEM 8002 (K992607) | Oxford Instruments Medical Systems | 2001-04-27 |
| CEDARS-SINAI BPGS AND MOCO (K010509) | Smv America | 2001-04-27 |
| TRANSAMERICAN TENS (K010782) | Transamerica Medical Systems | 2001-04-27 |
| CANNULA, SURGICAL GENERAL & PLASTIC SURGERY, MODELR65-995, R65-995-1, R65-995-2, R65-997, R65-997-1 (K010789) | A & A Medical, Inc. | 2001-04-27 |
| KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEM (K003325) | Karl Storz Imaging, Inc. | 2001-04-27 |
| FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9 (K010268) | Fresenius Medical Care North America | 2001-04-27 |
| NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET (K010264) | Nipro Medical Corp. | 2001-04-27 |
| TRANSAMERICA DIGITAL EMS (K010665) | Transamerica Medical Systems | 2001-04-27 |
| HANSATOME MICROKERATOME (K010260) | Bausch & Lomb, Inc. | 2001-04-27 |
| TITANIUM CEMENT RESTRICTOR MATERIAL PLDLA (K010529) | Medtronic Sofamor Danek USA, Inc. | 2001-04-27 |
| THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200 (K010283) | Theragenics Corp. | 2001-04-26 |
| CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304 (K010417) | Nuclear Assoc., Div. Inovision LP | 2001-04-26 |
| ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER (K002627) | Atrium Medical Corp. | 2001-04-26 |
| EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229 (K010960) | Syva Co., Dade Behring, Inc. | 2001-04-26 |
| SMARTSCREW MODEL 222006...227510 (K003077) | Bionx Implants, Ltd. | 2001-04-26 |
| COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR (K004046) | Cobe Cardiovascular, Inc. | 2001-04-26 |
| BMT ANSCORE HEALTH MANAGEMENT SYSTEM (K010955) | Boston Medical Technologies, Inc. | 2001-04-26 |
| MODIFICATION TO MIRAGE (K010726) | Segami Corp., Inc. | 2001-04-26 |
| EMIT II PLUS METHADONE ASSAY, MODEL OSRE229 (K010962) | Syva Co., Dade Behring, Inc. | 2001-04-26 |
| PICCOLO CHLORIDE TEST SYSTEM (K010670) | Abaxis, Inc. | 2001-04-26 |
| FREELITE LAMBDA FREE KIT (K010440) | The Binding Site, Ltd. | 2001-04-26 |
| MEDIFACE PACS (K010259) | Mediface Co., Ltd. | 2001-04-26 |
| URS-1K (KETONE TESST) (K003987) | Teco Diagnostics | 2001-04-26 |
| TCI (TINNITUS CONTROL INSTRUMENT) (K003559) | Siemens Hearing Instruments, Inc. | 2001-04-26 |
| HARDYDISK BACITRACIN, 10MCG, MODEL Z927 (K011086) | Hardy Diagnostics | 2001-04-26 |
| ACCU-CHEK COMPACT SYSTEM, ACCU-CHEK COMPACT TEST STRIPS, ACCU-CHEK COMPACT COMPACT CONTROLS (K004010) | Roche Diagnostics Corp. | 2001-04-26 |
| MAGNUM (K010252) | Magnum Equipment LLC | 2001-04-26 |
| EMBOL-X INTRODUCER, MODEL CF00200 (K002973) | Embol-X, Inc. | 2001-04-26 |
| FREELITE KAPPA FREE KIT (K010441) | The Binding Site, Ltd. | 2001-04-26 |
| NOVAMETRIX MARQUETTE COMPATIBLE SENSORS (K010451) | Novametrix Medical Systems, Inc. | 2001-04-25 |
| ACTIVHEAL SCAR MANAGEMENT DRESSING (K010245) | Advanced Medical Solutions, Ltd. | 2001-04-25 |
| GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005 (K003206) | Proxima Therapeutics, Inc. | 2001-04-25 |
| BABY DOPPLEX 3000 MK 2 (BD3000) (K010889) | Huntleigh Healthcare, Inc. | 2001-04-25 |
| SYNTHES (USA) IMF SCREWS (K010527) | Synthes (Usa) | 2001-04-25 |