Atlas FDA

1999

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

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RecordFirmDate
CONVERGENCE NUA FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS (K991318)Hitachi Medical Corp. of America1999-06-18
RS-4V MUSCLE STIMULATOR (K990697)Rs Medical1999-06-18
HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P.N. 4103, HYDRAGEL LDL/HDL CHOL DIRECT 0 (K990250)Morax1999-06-18
RENAL LINK (K990953)Baxter Healthcare Corp1999-06-18
HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE) (K991047)Hardcover Products, Inc.1999-06-18
CHIRON DIAGNOSTICS ACS: 180 FT3 (K991692)Chiron Diagnostics Corp.1999-06-18
DERMASTIM PLUS, PIGTAILS, FLEXSTIM SUPERFLEX, FLEXSTIM PLUS, CARBONSTIM VERTASTIM, ENDURO (K982096)Rapid Mfg. Co.1999-06-18
EXPLOR-X 70 (K991310)Villa Sistemi Medicali S.P.A.1999-06-18
DIRECT HDL-CHOLESTEROL REAGENT (K990581)Kamiya Biomedical Co.1999-06-18
DIMENSION BITE (K991008)Espe Dental AG1999-06-18
PANATOME (K991518)Imaging Sciences Intl., Inc.1999-06-18
HISPEED NX/I CT SCANNER SYSTEM (K991716)Ge Medical Systems, Inc.1999-06-18
HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM (K991671)Advanced Technology Laboratories, Inc.1999-06-18
ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM (K991179)Zeus Scientific, Inc.1999-06-17
ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501 (K991526)Imagyn Medical Technologies, Inc.1999-06-17
SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE (K991876)R&D Systems, Inc.1999-06-17
3D ANATOMICAL MESH (K990930)Santerra Medical Technology, Inc.1999-06-17
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS (K983922)Dade Microscan, Inc.1999-06-17
QUANTA LITE ANA ELISA (K991657)Inova Diagnostics, Inc.1999-06-17
MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION) (K990925)Hardcover Products, Inc.1999-06-17
ULTRA-SELECT GUIDEWIRE, HYTEK GUIDEWIRE (K991898)Microvena Corp.1999-06-16
OSTEOMED INTRAORAL DISTRACTION SYSTEM (K990944)Osteomed Corp.1999-06-16
REMOVABLE CUFF ABUTMENT (K984536)Sulzer Calcitek, Inc.1999-06-16
SSA-390A/POWER VISION 8000 (K991858)Toshiba America Medical Systems, In.C1999-06-16
ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL (K991498)Neometrics, Inc.1999-06-16
TERUMO SURFLO FLEX I.V. CATHETER AND TERUMO SURFLASH I.V. CATHETER (K991406)Terumo Medical Corp.1999-06-16
LYNX ULTRASOUND SYSTEM (K991872)Ecton, Inc.1999-06-16
XANTOPREN COMFORT (K991425)Heraeus Kulzer, Inc.1999-06-15
CADD ADMINISTRATION SET (K991599)Sims Deltec, Inc.1999-06-15
CONMED STEALTH NON-STICK ACCESSORY ELECTRODE, MODEL 138XXX (K991855)Conmedcorp1999-06-15
MODIFICATION OF: STERRAD BI TEST PACK (K991675)Advanced Sterilization Products1999-06-15
INVIGRA (K991374)Indus Medicare , Ltd.1999-06-15
CORDIS MAXI DS PTA BALLOON CATHETER (K991811)Cordis Corp.1999-06-15
CLIMAX (K991049)Medilatex Sdn. Bhd.1999-06-15
DAHEDI INSULIN INFUSION PUMP (K991376)Disetronic Medical Systems1999-06-15
CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE, CLEAR GUARD 11 W/ GAS MONITORING PORT (K990949)Intersurgical, Inc.1999-06-15
TELEMEDICINE 2000 (K991307)Card Guard Scientific Survival , Ltd.1999-06-14
MONOJECT INSULIN SYRINGE (K991758)The Kendal Co.1999-06-14
DEFLECTABLE TAC ELECTROTHERMAL PROBE (K990859)Oratec Interventions, Inc.1999-06-14
HISTOFREEZER DEVICE (K990877)OraSure Technologies, Inc.1999-06-14
K-PACK II (HYPODERMIC NEEDLE) 23G X 1, MODEL KN-2325RB, K-PACK II NEEDLE (HYPODERMIC NEEDLE) 25G X 1, MODEL KN-2525RB, K (K984576)Terumo Europe N.V.1999-06-14
BIOSENSOR HOLTER MONITOR SYSTEM SOFTWARE, MODEL 1005 (K990956)Biosensor Corp.1999-06-14
IMPLEX ALUMINA FEMORAL HEAD (K990183)Implex Corp.1999-06-11
PSI TITANIUM MICRO-LIGATION HEMOSTATIC CLIP (K991002)V. Mueller Neuro/Spine1999-06-11
SYNTHES LOCKING CALCANEAL PLATES (K991407)Synthes (Usa)1999-06-11
PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 (CLEAR) JIT (K990905)Passy-Muir, Inc.1999-06-11
CARDIOQUANT CARDIAC ASSESSMENT CONTROLS (K991447)Spectral Diagnostics, Inc.1999-06-11
MAGNA-ROM 21 KNEE SYSTEEM (K991143)Sulzer Orthopedics, Inc.1999-06-11
SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228 (K990864)Boston Scientific Corp1999-06-11
CARDIOLIGHT (K982448)Capintec, Inc.1999-06-11
SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S (K991215)Symtex Healthcare Corp.1999-06-11
PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA (K983791)Edwards Lifesciences Research Medical1999-06-11
FLEXIBLE FIBERSCOPE, MODEL 7331.001, GUIDE SECTION FOR LITHOVAC HANDPIECE, MODEL 8708.253 (K991178)Richard Wolf Medical Instruments Corp.1999-06-11
ADVANCED MEDICAL SOLUTIONS-SILICONE GEL SCAR MANAGEMENT SHEET (K991630)Advanced Medical Solutions Group Plc1999-06-11
AT HOME DRUG TEST, MODEL 9171 (K991824)Phamatech1999-06-11
LATEX EXAMINATION GLOVES, POWDER FREE WITH PROTEIN LABELING CLAIM (50 MCG OR LESS) (K991686)Arista Latindo Industrial Ltd. P.T1999-06-11
BMT ANSCORE HEALTH MANAGEMENT SYSTEM, MODEL 1.1 (K991831)Boston Medical Technologies, Inc.1999-06-11
COOPERSURGICAL INFRARED COAGULATOR (K990852)CooperSurgical, Inc.1999-06-11
SYSTEM FIVE/ECHOPAC WITH STRAIN RATE IMAGING (K991842)Ge Vingmed Ultrasound1999-06-11
DRG TITANIUM BONE PLATE (K990920)Doctor'S Research Group, Inc.1999-06-10
`INEAR WRIST COIL, MODEL 440GE-09 (K991113)Medical Advances, Inc.1999-06-10
K-ASSAY MICROALBUMIN CALIBRATOR SET (K991166)Kamiya Biomedical Co.1999-06-10
STERI-PAK LF BOWIE-DICK TEST PACK (K990246)Steritec Products Mfg Co, Inc.1999-06-10
PILLOWPOSITIVE CERVICAL PILLOW (K990871)Lifesleep Systems, Inc.1999-06-10
BROWNE MVI ETHYLENE OXIDE INDICATOR (K991418)Albert Browne , Ltd.1999-06-10
VARIANT II B-THALASSEMIA (K991127)Bio-Rad1999-06-10
AMERICAN DENTAL PRODUCTS ETCH-DETECT (K991099)American Dental Products, Inc.1999-06-10
K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET (K991467)Kamiya Biomedical Co.1999-06-10
11.5F X 6 (15CM) DUO-SPLIT CATHETER MCDS116MT, 11.5F X 8 (20CM) DUO-SPLIT CATHETER MCDS118MT (K980438)Medical Components, Inc.1999-06-10
AMORPHOUS DIAMOND COATED DRILL (K990846)Nobel Biocare Uas, Inc.1999-06-10
COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331 (K991102)Guidant Corp.1999-06-09
MICROELECTROENCEPHALOGRAPHY PROFESSIONAL SYSTEM 5000 (EEG PRO SYSTEM 5000) (K991077)Microrecording Systems Consultants, LLC1999-06-09
VITOP DRESSING (K990974)Wonder & Bioenergy Hi-Tech America, Inc.1999-06-09
BIOTEST ANTI-EBV RECOMBINANT (K983839)Biotest Diagnostics Corp.1999-06-09
ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET (K990954)Nsk Nakanishi, Inc.1999-06-09
EPI-FOAM SILICONE SHEETING (K991604)Biodermis Corp.1999-06-09
MODIFICATION OF: HERMES OPERATING ROOM CONTROL CENTER (K991734)Computer Motion, Inc.1999-06-09
MTP EXTRACTION BAG (K990912)Mtp Medical Technical Promotion GmbH1999-06-09
FUJI CATHETER, MODEL CTH001 (K983867)Windy Hill Technology, Inc.1999-06-09
FOTONA FIDELIS ER:YAG LASER SYSTEM & ACCESSORIES (K990243)Fotona D.D.1999-06-09
IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5 (K991796)Diagnostic Products Corp.1999-06-09
3402 HANDHELD PULSE OXIMETER (K991410)Bci Intl., Inc.1999-06-09
GE LOGIQ 500 (K991611)General Electric Co.1999-06-09
CADISCOPE ELECTRONIC STETHOSCOPE (K990809)Caditec AG1999-06-09
NIHON KOHDEN TG-901T CO2 SENSOR KIT WITH ACCESSORIES (K990063)Nihon Kohden America, Inc.1999-06-09
CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPHON VALVE, CADD ADMINISTRATION SET WITH 1 (K991301)Sims Deltec, Inc.1999-06-09
PUMP SEGMENT RINSE LINE W/ SLIP-ON CONNECTOR, PUMP SEGMENT RINSE LINE W/ LUER-LOCK CONNECTOR, T-CONNECTOR, SHORT, W/ SLI (K991003)Dayspring Medical, Inc.1999-06-09
K-ASSAY RHEUMATOID FACTOR (K991409)Kamiya Biomedical Co.1999-06-09
BIOTEST ANTI-EBV RECOMBINANT, EBNA IGG (K983841)Biotest Diagnostics Corp.1999-06-09
IMMULITE TURBO TROPONIN I, MODELS LSKTI1, LSKTI5 (K991795)Diagnostic Products Corp.1999-06-09
MTP UROPUMP DISPOSABLE TUBING SET (K990909)Mtp Medical Technical Promotion GmbH1999-06-09
BIOTEST ANTI-EBV RECOMBINANT, EA IGM (K983842)Biotest Diagnostics Corp.1999-06-09
DORNIER LASERTRODE FIBER (K991183)Dornier Surgical Products, Inc.1999-06-09
CAPNOCHECK II, MODEL 8400 (K991086)Bci Intl., Inc.1999-06-09
P.F.C. SIGMA POROUS MODULAR KEEL TIBIAL TRAY (K991106)DePuy Orthopaedics, Inc.1999-06-09
SOMATOM PLUS 4 WITH SLIDING GANTRY OPTION (K991600)Siemens Corp.1999-06-09
IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5 (K991797)Diagnostic Products Corp.1999-06-09
INTERSOURCE 125, MODEL 1251L (K984235)International Brachytherapy, Inc.1999-06-09
CADD-TPN ADMINISTRATION SET, MODEL 21-7071 (K991255)Sims Deltec, Inc.1999-06-09
FOUNTAIN Infusion Catheter and Occluding Guide Wire (K991619)Merit Medical Systems, Inc.1999-06-09
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