Atlas FDA

1999

3,554 FDA 510(k) clearances · Clearance year

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RecordFirmDate
TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM (K992544)Circon Corp.1999-10-26
GINRAM ENDOCIC SINGLE OVAL PORT (MODEL NO. 720195) (K992926)Ri Mos. S.R.L.1999-10-26
GOLD CORE 75 (K993175)Jeneric/Pentron, Inc.1999-10-26
ENDOREZ (K992097)Ultradent Products, Inc.1999-10-26
SKINTACT ECG ELECTRODES, S&W ECG ELECTRODES (K982521)Leonhard Lang Co.1999-10-26
SPECTRUM DESIGNS SPECTRAGEL (K992522)Spectrum Designs, Inc.1999-10-26
GOLD CORE 55 (K993173)Jeneric/Pentron, Inc.1999-10-26
INTERACOUSTICS EP 15 ABR STAND ALONE UNIT (K991853)Idem (Int'L Dist. of Electronics For Medicine)1999-10-25
INTRAOP CATHETER (K991543)I-Flow Corp.1999-10-25
HYBRID CAPTURE II CT-ID TEST (K990023)Digene Corp.1999-10-25
MICROWAVE DELIVERY SYSTEM, MODEL MMC-300 (K991456)Microwave Medical, Inc.1999-10-25
PICCOLO SODIUM TEST SYSTEM (K993211)Abaxis, Inc.1999-10-25
K-ASSAY APO AI (K993345)Kamiya Biomedical Co.1999-10-25
AMBU HAND POWER SUCTION PUMP (K992902)Ambu, Inc.1999-10-25
STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM (K991696)Stryker Instruments1999-10-25
ORATEC INTERVENTIONS VULCAN EAS ELECTROTHERMAL ARTHROSCOPY SYSTEM AND ACCESSORIES (K991140)Oratec Interventions, Inc.1999-10-25
SELECT-SUTTER MICRO BIPOLAR FORCEPS (K992760)Select Medizintechnik Hermann Sutter GmbH1999-10-25
FLEXIBLE FIBERSCOPES & ACCESSORIES (K990397)Richard Wolf Medical Instruments Corp.1999-10-25
FIRSTCLASS POWER TILT AND RECLINE SEAT SYSTEM, MODEL S400 (K992628)Teftec Corp.1999-10-25
AMIGO MODEL 680000 (AMIGO EXCITE F 350) (K992619)Amigo Mobility Intl., Inc.1999-10-25
DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM (K993294)Diamedix Corp.1999-10-25
XRT 600 R/F, WRF 0600 (K992603)Wuestec Medical, Inc.1999-10-25
FIRST CLASS POWER RECLINE SEATING SYSTEM, MODEL S500 (K992627)Teftec Corp.1999-10-25
VENTIL-A ORAL PROTECTOR (K992269)Somatics, Inc.1999-10-25
SCAREASE SHEETS & SCAREASE GEL (K991970)Pillar Surgical1999-10-25
ABBOTT AXSYM HOMOCYSTEINE (K992858)Abbott Laboratories1999-10-25
DADE BEHRING N HIGH SENSITIVITY CRP ASSAY (K991385)Dade Behring, Inc.1999-10-25
ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000 (K992796)Image-Guided Neurologics, Inc.1999-10-25
3.5 MM 90 CANNULATED LIMITED CONTACT ANGELED BLADE PLATES (3.5MM 90 CANNULATED LC-ABP) (K992837)Synthes (Usa)1999-10-25
INTELLISYSTEM II COLOR MONITOR (K993341)Merit Medical Systems, Inc.1999-10-25
HYDROCISION ARTHROJET SYSTEM WITH CAUTERY (K993009)Hydrocision, Inc.1999-10-25
STENTOR, PAGEVIEW (K992698)Stentor, Inc.1999-10-25
SORING GMBH, ARCO 3000, ARCO 2000, ARCO 1000, MBC 601, MBC 600 (K993265)Soring GmbH Medizintechnik1999-10-22
REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTS (K991026)Smith & Nephew, Inc.1999-10-22
PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEM (K993220)Puritan Bennett Corp.1999-10-22
HOWMEDICA OSTEONICS ACCP SYSTEM CORTICAL SCREWS (K993181)Howmedica Osteonics Corp.1999-10-22
SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTER (K990713)Spectranetics Corp.1999-10-22
SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD (K990637)Synthes (Usa)1999-10-22
SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17; 21G MODEL# 4910-18 (K992471)Sims Portex, Inc.1999-10-22
VENTURE IHO 100 HOME FILL COMPLETE HOME OXYGEN SYSTEM (K983627)Invacare Corp.1999-10-22
ACCUGUIDE MUSCLE INJECTION MONITOR (K990793)Medtronic Xomed1999-10-22
NRC NON-RINSE CONDITIONER (K992519)Dentsply Intl.1999-10-22
HTU3 (K984313)Hyox Systems , Ltd.1999-10-22
D/SENSE II (GREEN-OR) DENTIN DESENSITIZER (K992629)Centrix, Inc.1999-10-22
DRYASOL ACID CONCENTRATE MIX (K993212)Diasol, Inc.1999-10-22
CATHETER INNOVATIONS IMPLANTABLE PORT (K991897)Catheter Innovations, Inc.1999-10-21
BIO-MODULAR SHOULDER OFFSET HUMERAL HEADS (K992899)Biomet, Inc.1999-10-21
HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3154A (K993171)Hewlett-Packard Co.1999-10-21
JEL BIOS 18 (CODE NAME RD- 1214) (K993152)J.F. Jelenko & Co., Inc.1999-10-21
THE BRIGHT MEDICAL DILATION RETRACTOR SYSTEM (K992898)Bright Medical Instruments1999-10-21
MEDTRONIC AVE BRIDGE STENT (K993145)Medtronic Ave, Inc.1999-10-21
ZOLL M SERIES 12SL ANALYSIS OPTION (K991556)Zoll Medical Corp1999-10-21
.010 SILVERSPEED HYDROPOPHILIC GUIDEWIRE, .014 SILVERSPED HYDROPHILIC GUIDEWIRE, .016 SILVERSPEED HYDROPHILIC GUIDEWI (K993257)Micro Therapeutics, Inc.1999-10-21
PACIFIC IMPLANT TITANIUM ENDODONTIC POINT (K992582)Pacific Implant, Inc.1999-10-21
SURGEON POWDER-FREE GLOVES, LATEX, STERILE (K992679)Wear Safe Malaysia Sdn. Bhd.1999-10-21
JEL BIOS 10 (CODE NAME RD-1801) (K993136)J.F. Jelenko & Co., Inc.1999-10-21
125 IMPLANT SEEDS, MODEL STM1251 (K991280)Sourcetech Medical, LLC1999-10-20
BRAUN THERMOSCAN PRO3000 INFARED THERMOMETER (K992468)Braun GmbH1999-10-20
50 W METAL HALIDE ILLUMINATOR, VES 0501. (K992447)Angiolaz, Inc.1999-10-20
AMBIDERM LATEX EXAMINATION GLOVES (VIOLET, BLUE , GREEN, AND PINK) CONTAINING 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE (K993080)Medtexx Partners, Inc.1999-10-20
QUICKSCREEN PRO MULTI DRUG SCREEN, MODEL 9177 & 9178 (K993165)Phamatech1999-10-20
CASE 8000 EXERCISE TESTING SYSTEM (K991014)General Electric Medical Systems Information Techn1999-10-20
BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KIT (K993138)Ballard Medical Products1999-10-20
ACTIVA (K991132)Hoveround Corp.1999-10-20
TRIO 300 (K990787)Ito Co., Ltd.1999-10-20
LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295 (K990141)Light Diagnostics1999-10-19
PASCO MIC AND MIC/ID PANELS, ERYTHROMYCIN (K992647)Pasco Laboratories, Inc.1999-10-19
P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM (K992880)Sims Deltec, Inc.1999-10-19
MCL 29 DERMABLATE ER:YAG LASER SYSTEM (K992707)Aesculap-Meditec North America1999-10-19
TES-20 (K992425)Tes Electrical Electronic Corp.1999-10-19
PASCO MIC AND MIC/ID PANELS, PENICILLIN (K992646)Pasco Laboratories, Inc.1999-10-19
UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50 (K993178)Diagnostic Chemicals , Ltd.1999-10-18
N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET (K992766)Genzyme Corp.1999-10-18
EXTREME H20 (HIOXIFILICON A) SOFT CONTACT LENS (K992692)Benz Research and Development Corp.1999-10-18
FETAL ASSESSMENT CAP (K992580)Acuson Corp.1999-10-18
DERMAGRIP POWDER FREE NITRILE EXAMINATION GLOVE, NON STERILE (K990752)Wrp Specialty Products Sdn. Bhd.1999-10-18
REP CHOLESTEROL PROFILE KIT (K992971)Helena Laboratories1999-10-18
INSURE PRO TEST (K992695)Inbios Intl., Inc.1999-10-18
RAPIDONE-AMPHETAMINE TEST (K992452)American Bio Medica Corp.1999-10-18
OPAP (K991926)Opap, Inc.1999-10-18
HICHEM CALIBRATOR 1 KIT, HICHEM CALIBRATOR 2 KIT, HICHEM CALIBRATOR 3 KIT, CALIBRATION STANDARDS KIT (K992845)Elan Holdings, Inc.1999-10-18
HICHEM TOTAL PROTEIN REAGENT (K992846)Elan Holdings, Inc.1999-10-18
HEALTH-PLUS SANITEX,RELIANCE PRE-POWDERED MULTI-PLY LATEX EXAMINATION GLOVE (NATURAL RUBBER LATEX-NITRILE-CONSTRUCTION W (K992523)Pamitex Industries Sdn Bhd1999-10-18
PHILIPS GYROSCAN INTERA (*) (K992533)Philips Medical Systems North America, Inc.1999-10-18
ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM (K992723)Transfusion Technologies Corp.1999-10-18
VIP 60 (2H), MODEL 115-000-1, VIP 60 (4H), MODEL 115-000-2 (K991239)Micron Corp.1999-10-18
STRYKER T4 HOOD, STRYKER T4 ZIPPERED TOGA, STRYKER T4 PULLOVER TOGA (K993148)Stryker Instruments1999-10-15
BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT (K992394)Endotec, Inc.1999-10-15
OBC-085 BREAST ARRAY COIL (K993233)Mri Devices Corp.1999-10-15
QWH-085 WRIST ARRAY COIL (K993235)Mri Devices Corp.1999-10-15
CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS (K992591)Codman & Shurtleff, Inc.1999-10-15
DERMAGRIP POWDER FREE BLUE NITRILE EXAMINATION GLOVE, NON STERILE (K990750)Wrp Specialty Products Sdn. Bhd.1999-10-15
ACTITRAC (K992410)Individual Monitoring Systems, Inc.1999-10-15
PERIOGLAS- BIOGLASS BONE GRAFT PARTICULATE (K992416)Usbiomaterials Corp.1999-10-15
ANTI-TISSUE TRANSGLUTAMINASE (TTG)ANTIBODY TEST (K992878)Immco Diagnostics, Inc.1999-10-15
PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A (K992478)Hewlett-Packard, Healthcare Solutions Group1999-10-15
ABX PENTRA 60 HEMATOLOGY ANALYZER (K992511)Abx Diagnostics1999-10-15
LUMA-CATH FIXED CURVE EP CATHETERS (K991025)Irvine Biomedical, Inc.1999-10-15
POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES LABELING CONTENT: 100 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEI (K992870)Alliance Rubber Products Sdn. Bhd.1999-10-15
KSEA SCBCOM (K992469)Karl Storz Endoscopy1999-10-15
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