Atlas FDA

1999

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

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RecordFirmDate
KLEENHANDS POWDERED LATEX EXAMINATION GLOVES (K990527)Ssn Gloves (M) Sdn Bhd1999-04-23
GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE (K990584)Broadline Medical Industries1999-04-23
NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, BLUE COLOR. (K990486)Alliance Rubber Products Sdn. Bhd.1999-04-23
SIDEKICK INFUSION KIT (K990425)I-Flow Corp.1999-04-23
COWBOY XV (K981311)Kci New Technologies, Inc.1999-04-23
NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, GREEN COLOR (K990485)Alliance Rubber Products Sdn. Bhd.1999-04-23
RAPIDFLAP CRANIAL CLAMP (K991029)Walter Lorenz Surgical, Inc.1999-04-23
SYNTHETIC SERUM SUBSTITUTE (SSS) (K983579)Irvine Scientific Sales Co., Inc.1999-04-23
LYSTA LC CURING LIGHT, MODEL LC 2500C/BA (K991138)Lysta A/S1999-04-23
KLEENHANDS POWDERFREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (K990526)Ssn Gloves (M) Sdn Bhd1999-04-23
DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVE, NON STERILE (PROTEIN CONTENT LABELING) (K991044)Wrp Specialty Products Sdn. Bhd.1999-04-23
EBI VUECATH ENDOSCOPIC SYSTEN (K990459)Electro-Biology, Inc.1999-04-23
CHALLENGE TEST PACK (K983451)North American Science Assoc., Inc.1999-04-23
PBN DRAINAGE CATHETER GUIDEWIRES (K991097)Medical Device Technologies, Inc.1999-04-23
ARSOFT NITRILE EXAMINATION GLOVES, NON-STERILE POWDER FREE (K990427)Alliance Rubber Products Sdn. Bhd.1999-04-23
CAREVENT BLS, CAREVENT BLS+, CAREVENT ALS, CAREVENT ALS+, AND CAREVENT ATV (K991195)O-Two Systems Intl., Inc.1999-04-22
FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEM (K990214)Surgical Navigation Technologies, Inc.1999-04-22
AVIA PAIN MEDICATION DELIVERY SYSTEM (K990312)Amtec Medical1999-04-22
BI-DIRECTIONAL TUNNELER (K991027)Impra, Inc.1999-04-22
ETEST FOR CEFUROXIME (K990722)Ab Biodisk1999-04-22
ENSITE 3000 SYSTEM (K983456)Endocardial Solutions, Inc.1999-04-21
COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS (K982413)Gambro Healthcare1999-04-21
PVS BASICS (K984436)Paragon Vision Sciences1999-04-21
LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789 (K990858)Bio-Rad1999-04-21
PDQ AND PDQ-TI ABUTMENT (K990367)Vident1999-04-21
URETERAL ACCESS SHEATH SET (K990775)Applied Medical Resources1999-04-21
S575 INTRAORAL DOCKING DENTAL CAMERA (K990948)Sopro1999-04-21
SHEATHES (NON-LATEX), STERILE (K990175)Sheathing Technologies, Inc.1999-04-21
INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY (K990915)Stellar Bio Systems, Inc.1999-04-21
INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY (K990916)Stellar Bio Systems, Inc.1999-04-21
CANTOR & SILVER 5X TINTED (HIOXIFILCON A) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT WEAR CONTACT LENS, TINTED (TRANSPA (K990757)Cantor & Silver , Ltd.1999-04-21
DIABETIC NEEDLE DISPOSAL, MODEL # PMSM - 950 (K990371)Post Medical, Inc.1999-04-21
SERIM BLOOD LEAK TEST STRIP (K990206)Serim Research Corp.1999-04-21
THORAX FD AND MULTIX FD (K983732)Siemens Medical Solutions USA, Inc.1999-04-21
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TX W/FLURO OPTION (K984156)Shimadzu Medical Systems1999-04-21
FREIBURG FLAP APPLICATOR SET, PART NUMBER 089.095 (K983338)Nucletron Corp.1999-04-20
FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM (K990939)Selfcare, Inc.1999-04-20
ENDOMETRIAL SAMPLER (K990387)U.A. Medical Products, Inc.1999-04-20
PHOTOTHERAPY LAMP (K984589)Medela, Inc.1999-04-20
FLEXPLUG (K991130)Eagle Vision, Inc.1999-04-20
CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50 (K990754)Diagnostic Chemicals , Ltd.1999-04-20
EEG ELECTRODES MODEL 445 SERIES (K982053)Class A Ent.1999-04-20
QUICKDRAW VENOUS CANNULA (K981995)Heartport, Inc.1999-04-20
CARESIDE CK (K990439)Careside, Inc.1999-04-19
RADIONICS EQUI-FLOW VALVE, VENTRICULAR AND PERITONEAL CATHETER WITH EZ-COAT (K980903)Radionics, Inc.1999-04-19
MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER (K990189)Midmark Corp.1999-04-19
SMARTRECORDER, MODEL 2500 (K990199)Respironics, Inc.1999-04-19
CARESIDE CKMB (K990434)Careside, Inc.1999-04-19
HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE T (K990972)Hewlett-Packard GmbH1999-04-19
DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111 (K990159)Dynamic Technology Corp.1999-04-19
LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405 (K990928)Bio-Rad1999-04-16
SHIMADZU CEILING TUBE SUPPORT CH-30GH (K990715)Shimadzu Corp.1999-04-16
`BI I-125 BRACHYTHERAPHY SEED, MODEL 125SL & 125SH (K984446)Urocor, Inc.1999-04-16
REVISED C-REACTIVE PROTEIN (RCRP) FLEX REAGENT CARTRIDGE (K990825)Dade Behring, Inc.1999-04-16
STRAUMANN EXTRAORAL IMPLANT SYSTEM (K990458)Straumann USA1999-04-16
BEACON, MODEL 211060 (K983948)Philips Medical Systems (Cleveland), Inc.1999-04-16
DICOM IMAGE MANAGER, MODEL 3-D VISUALIZATION OPTION (K990248)Dicomit Imaging Systems Corp.1999-04-16
S-38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, THE ESSTECH PS & SV (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS (K990281)Nissel , Ltd.1999-04-16
REVISED C-REACTIVE PROTEIN CALIBRATOR (K990824)Dade Behring, Inc.1999-04-16
KINGLI ACUPUNCTURE NEEDLE (K990406)United Pacific Co., Ltd.1999-04-16
COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETER (K983830)Mallinckroot, Inc.1999-04-16
CONVERTORS SURGICAL GOWNS (K991034)Allegiance Healthcare Corp.1999-04-16
NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCESSORIES (K990031)Nihon Kohden America, Inc.1999-04-16
BIPOLAR FORCEPS, KLEPPINGER INSERT, MODEL #'S 8393.741,8393.771,8394.741,8394.771 (K990147)Richard Wolf Medical Instruments Corp.1999-04-16
ACCUSIGN MTD, BIOSIGN MTD (K991080)Princeton BioMeditech Corp.1999-04-15
VIEW COM (K990759)Electromed Intl., Ltd.1999-04-15
STRAIGHT ASPIRATOR, 90 DEGREE ASPIRATOR,45 DEGREE ASPIRATOR,7 FRENCH ASPIRATOR,EXTENDED STRAIGHT ASPIRATOR,13.9 CM STRAG (K990919)Visualization Technology, Inc.1999-04-15
ACCUSIGN BAR, BIOSIGN BAR, STATUS BAR (K991018)Princeton BioMeditech Corp.1999-04-15
ALTHIN MEDICAL AB ALTRACART II (K990010)Althin Medical AB1999-04-15
ONTRAK TESTCUP M2K, MODEL CAT. 11 1849 8 (K990399)Roche Diagnostics Corp.1999-04-15
ACCUSIGN BZO, BIOSIGN BZO, STATUS BZO (K991079)Princeton BioMeditech Corp.1999-04-15
QUANTA LITE LYME IGG ELISA (K984222)Inova Diagnostics, Inc.1999-04-15
BLEASE 6200 ANAESTHESIA VENTILATOR (K982132)Blease Medical Equipment , Ltd.1999-04-15
ACCUSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP (K991076)Princeton BioMeditech Corp.1999-04-15
ACCUSIGN DOA2, DOA, BAR/BZO, BIOSIGN DOA2, BAR/BZO, STATUS DS BAR/BZO, SYVA RAPIDTEST D.A.U. 2 BAR/BZO (K991082)Princeton BioMeditech Corp.1999-04-15
MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 15CM SBF146, MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 20CM SB (K974236)Medical Components, Inc.1999-04-15
OPART (K990260)Toshiba America Mri, Inc.1999-04-15
ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K) (K990409)Roche Diagnostics Corp.1999-04-15
ACCUSIGN DOA3, DOA, BAR/BZO/MTD, BIOSIGN DOA3, BIOSIGN BAR/BZO/MTD (K991084)Princeton BioMeditech Corp.1999-04-15
ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8, THC/OPI/COC/AMP/BZO/BAR/TCA/PAP, STATUS DS DO8 (K991078)Princeton BioMeditech Corp.1999-04-15
STANDARD CT/MR APPLICATOR SET,RING CT/MR APPLICATOR SET, VAGINAL CT/MR APPLICATOR SET, FLETCHER WILLIAMSON APPLICATOR SE (K983341)Nucletron Corp.1999-04-15
NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIES (K984504)Nihon Kohden America, Inc.1999-04-15
QUANTA LITE LYME IGM ELISA (K984234)Inova Diagnostics, Inc.1999-04-15
OXYCON LENS (K990895)Concise Contact Lens Co.1999-04-14
HEADED BIO-ABSORBABLE CORKSCREW MODEL #AR-1921BU (K990361)Arthrex, Inc.1999-04-14
NEARLY ME RETOUCH SILICONE SCAR REDUCTION SHEETS (K984213)Capital Marketing Technologies, Inc.1999-04-14
MODIFICATION OF: EBI SPINELINK SYSTEM (K990999)Electro-Biology, Inc.1999-04-14
DERMACOOL (K990417)Optomed Corp.1999-04-14
NELLCOR PURITAN BENNETT, GOODKNIGHT 418G (K991150)Nellcor Puritan Bennett France Dvpt.1999-04-14
DUMEX IODOFORM PACKING STRIP (K990332)Dumex Medical Surgical Products, Ltd.1999-04-14
MEGA 4 (K982144)Mega Motion, Inc.1999-04-14
MEGA 3 (K982145)Mega Motion, Inc.1999-04-14
INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1 (K990594)Roche Diagnostics Corp.1999-04-14
INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN B (K990595)Roche Diagnostics Corp.1999-04-14
SMITH & NEPHEW HANDPORT SYSTEM (K990414)Smith & Nephew, Inc.1999-04-14
DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES MODEL AS-851 (K982134)Dynamic Technology Corp.1999-04-14
ONTRAK TESTCUP-ER M2K (K990418)Roche Diagnostics Corp.1999-04-13
UNI-FLEX RESIN (K983461)Trans-Atlantic Dental1999-04-13
WILTEK HOT BIOPSY FORCEPS (K990231)Wiltek Medical, Inc.1999-04-13
MODIFICATION TO PARTS NUMBERED CGT-SL AND CGT-SL-15 (K990845)Advanced Spine Fixation Systems, Inc.1999-04-13
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