Atlas FDA

1999

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

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RecordFirmDate
VIT ENHANCER (K992943)Medical Instrument Development Laboratories, Inc.1999-12-10
CG-7000DX ECG RECORDER/TRANSMITTER (K993799)Card Guard Scientific Survival , Ltd.1999-12-10
CHEST DRAINAGE TUBING (K993062)Olson Medical Sales, Inc.1999-12-10
CUSTODIOL (K992209)Dr. Franz Kohler Chemie GmbH1999-12-10
HEPARIN IV FLUSH SYRINGE, 10 U/ML \ (K990390)Rocap Div. of Sabratek Corp.1999-12-10
SMART NAIL MODELS 521516, 521520,521525, 531516, 531520. 531525 (K993074)Bionx Implants, Ltd.1999-12-10
DRG CONVENTIONAL ELECTRONIC DIGITAL STETHOSCOPE, MODEL ECHOP 200-00 (K991714)Doctor'S Research Group, Inc.1999-12-10
BARDEX I.C. PEDIATRIC FOLEY CATHETER (K993464)C.R. Bard, Inc.1999-12-10
ENDOPEARL WITH THREADER (K993339)Linvatec Corp.1999-12-10
DRUG STOP (K991465)Texas Immunology, Inc.1999-12-10
AIRLIFE HEATED VENTILATOR AND BREATHING CIRCUITS (K993833)Allegiance Healthcare Corp.1999-12-10
ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 30 DEGREES; ENDOSCOPES, 10MM DIAMETER, 50 DEGREES (K993103)Richard Wolf Medical Instruments Corp.1999-12-10
EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM (K993822)Ebi, L.P.1999-12-10
ACTIFRESH 400 LENS (K983637)Hydron , Ltd.1999-12-10
LUMA-CATH STEERABLE EP CATHETERS (K991878)Irvine Biomedical, Inc.1999-12-10
3 CHANNEL KNEE ELECTRONIC AMPLIFIED STETHOSCOPE (K991756)Bio-Research Associates, Inc.1999-12-10
SURVIVALINK MULTIFUNCTIONAL ELECTRODE (SVL-9630) (K993072)Survivalink Corp.1999-12-10
ROCAP HEPARIN IV FLUSH SYRINGE, 100U/ML (K990308)Rocap Div. of Sabratek Corp.1999-12-10
MEMCATH UROLOGY CATHETER, MODEL 101 -000 - 006 (K993226)Memcath Technologies, LLC1999-12-10
VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT (K993821)Metron Medical Australia, Pty, Ltd.1999-12-09
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, SPINE WANDS, ORTHOWANDS, ARTHROWANDS (K992581)Arthrocare Corp.1999-12-09
MICROSTREP PLUS PANEL (K983746)Dade Microscan, Inc.1999-12-09
XOMED ENT RF SYSTEM (K993112)Xomed, Inc.1999-12-09
RUSCH BRILLANT SILICONE FOLEY (K993063)Rusch Intl.1999-12-09
AROMATIC AND FLAVORED TONGUE DEPRESSOR (K992995)Aga Plastic Ind. Com. Ltda.1999-12-09
RELIEFBAND NST DEVICE MODELS WB-2,WB-6,WB-R (K983907)Woodside Biomedical, Inc.1999-12-09
FRIALIT-2 SELECT COMPONENTS (K993095)Friadent GmbH1999-12-09
IRIDERM, MODEL APEX 800 (K992298)Iridex Corp1999-12-09
SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS (K990503)Sulzermedica1999-12-09
AUROFLUID M, ALLOY NO. 5315 (K993475)Metalor Dental USA Corp.1999-12-09
LEMAITRE EMBOLECTOMY CATHETER (K992368)Vascutech, Inc.1999-12-09
ACCU-CHEK SIMPLICITY SYSTEM (K993829)Roche Diagnostics Corp.1999-12-09
ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODELS LCS-C5, LCS-C1, CS-23C, CS-231, CS-14C, CS-141 (K993054)Ethicon Endo-Surgery, Inc.1999-12-09
QUALITROL TUMOR MARKER CONTROL, LEVELS 1 AND 2 (K993631)Seracare Technology1999-12-09
QUALITROL IMMUNOASSAY PLUS CONTROL, LEVELS 1,2 AND 3 (K992939)Seracare Technology1999-12-09
SMITH & NEPHEW BONE PLATE SYSTEM (BONE PLATES, BONE SCREWS AND ACCESSORIES) (K993106)Smith & Nephew, Inc.1999-12-09
NEXFLEX TOTAL KNEE SYSTEM (K991882)Nexmed, Inc.1999-12-08
HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K WITH EASI-ST SEGMENT MEASUREMENT, HP VIRIDIA CMS 24/26, REV K WITH (K992595)Hewlett-Packard GmbH1999-12-08
HELAX-TMS V 5.0 RADIATION THERAPY TREATMENT PLANNING SYSTEM (K993766)Helax AB1999-12-08
PAGALINOR 4 , ALLOY NO. 5440 (K993506)Metalor Dental USA Corp.1999-12-08
V-DELTA SPECIAL, ALLOY NO. 5154 (K993505)Metalor Dental USA Corp.1999-12-08
PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015 (K990643)Althin Medical AB an Affiliate of Baxter Intl1999-12-07
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 (K993299)Dade Behring, Inc.1999-12-07
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH (K993774)Acist Medical Systems1999-12-07
BARRETT'S ESOPHAGEAL CYTOLOGY DEVICE (K984168)United States Endoscopy Group, Inc.1999-12-07
VIRTUOSO-STEREOTAXIC PLANNING SOFTWARE (K991706)Stryker Corp.1999-12-07
BIONIKE AQ PHENCYCLIDINE (PCP) TEST (K993945)Bionike Laboratories, Inc.1999-12-07
PHILIPS EASYVISION WORKSTATION (K990329)Philips Medical Systems North America, Inc.1999-12-07
AED LAPAROSCOPE (K993688)National Advanced Endoscopy Devices, Inc.1999-12-06
DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 4560 (K990113)Maersk Medical A/S1999-12-06
TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM ( IN VITRO DIAGNOSTIC SYSTEM) (K993353)Bayer Corp.1999-12-06
BIOSONIC UC-70 STERILIZABLE INSTRUMENT CASSETTE (K993255)Coltene/Whaledent, Inc.1999-12-06
V-SUPRAGOLD, ALLOY NO. 5024 (K993507)Metalor Dental USA Corp.1999-12-06
SYNTHES LIGHT GUIDE (K993314)Synthes (Usa)1999-12-06
DISPOSABLE ECG MONITORING ELECTRODES, MODELS, 4420, 4440 (K990115)Maersk Medical A/S1999-12-06
V-SUPRA PLUS, ALLOY NO. 5025 (K993508)Metalor Dental USA Corp.1999-12-06
VIRIDIA INFORMATION CENTER SOFTWARE FOR M3154A OPT C22 (K993907)Agilent Technologies, Inc.1999-12-06
QUANTITATIVE SENTINEL SYSTEM (K993008)Marquette Medical Systems, Inc.1999-12-06
SMART SCREW ACL MODELS 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030 (K993073)Bionx Implants, Ltd.1999-12-06
AUTOSTAT II RHEUMATOID FACTOR IGG ELISA (K993304)Cogent Diagnotics , Ltd.1999-12-06
COLON ALERT TEST (K992759)Immunostics Inc.,1999-12-06
K-ASSAY FIBRINOGEN (K993482)Kamiya Biomedical Co.1999-12-06
SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334 (K992712)Sigma Diagnostics, Inc.1999-12-06
MANUAL BONE MARROW BIOPSY DEVICE (K993435)Promex, Inc.1999-12-06
DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570 (K990111)Maersk Medical A/S1999-12-06
OMNISONIC ENDOSCOPIC DEFLECTOR (K993445)Omnisonics Medical Technologies1999-12-06
DISPOSABLE ECG MONITORING ELECTRODES, MODEL 4110, 4140 (K990110)Maersk Medical A/S1999-12-06
OPTISTAR MR INJECTOR SYSTEM (K984088)Mallinckrodt Inc., Liebel-Flarsheim Business1999-12-06
NICHOLS ADVANTAGE CHEMILUMINESCENCE SOLUBLE TRANSFERRIN RECEPTOR IMMUNOASSAY, MODEL 62-7028 (K992188)Nichols Institute Diagnostics1999-12-06
ORA-50 S AUTOTEMP ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIES (K993854)Oratec Interventions, Inc.1999-12-06
SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094 (K992711)Sigma Diagnostics, Inc.1999-12-06
TYRODE'S SOLUTION-ACIDIFIED (K991339)Irvine Scientific Sales Co., Inc.1999-12-06
SYNERGY INTEGRAL SCREWS, MODEL NUMBERS 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,2220 (K993808)Interpore Cross Intl.1999-12-06
PROMPTFLOW (K993566)Espe Dental AG1999-12-06
BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR TROPONIN I ASSAY (K993309)Bayer Corp.1999-12-06
DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610 (K990112)Maersk Medical A/S1999-12-06
OBC-300 BREAST ARRAY COIL (K993776)Mri Devices Corp.1999-12-03
MODIFICATION TO CARTO EP NAVIGATION SYSTEM (K993729)Biosense Webster, Inc.1999-12-03
QWH-300 WRIST ARRAY COIL (K993819)Mri Devices Corp.1999-12-03
AUTOMATIC IMAGE REGISTRATION SOFTWARE, MODEL NSFU-050A (K992992)Toshiba America Medical Systems, In.C1999-12-03
PRIMUS STEAM STERILIZERS (K991575)Primus Sterilizer Co., Inc.1999-12-03
HL148 & HL168 (K990807)Health & Life Co., Ltd.1999-12-03
GLOVCO, POWDER-FREE CHLORINATED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) (K993752)Glovco (M) Sdn. Bhd.1999-12-03
COBE SMARXT HVR 4000 SURFACE MODIFIED HARDSHELL VENOUS RESERVOIR, FILTERED & NONFILTERED (K993001)Cobe Cardiovascular, Inc.1999-12-03
CATHETER INNOVATIONS IMPLANTABLE PORT (K993860)Catheter Innovations, Inc.1999-12-03
POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL CLAIM - 50 MICROGRAMS OR LESS) (K993454)Sri Johani Sdn. Bhd.1999-12-03
GYRUS HYSTEROSCOPIC RESECTOSCOPE (K993749)Gyrus Medical , Ltd.1999-12-03
BIOMAGNETIC TECHNOLOGIES MAGNES 3600 WHOLE HEAD MEG (K993708)Biomagnetic Technologies, Inc.1999-12-03
SPACELABS MEDICAL DISPOSABLE SP02 SENSOR (K981655)Spacelabs Medical, Inc.1999-12-03
AED ARTHROSCOPE (K991656)National Advanced Endoscopy Devices, Inc.1999-12-02
LC COMPOSITE (K991492)Harry J. Bosworth Co.1999-12-02
CARESIDE ANALYZER (K993634)Careside, Inc.1999-12-02
POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN LABELING CLAIM 50 MICROGRAM OR LESS (K993820)Felda Rubber Corp.1999-12-02
DELTAPAL, ALLOY NO. 5161 (K993474)Metalor Dental USA Corp.1999-12-02
DERMAGRIP POWDER-FREE LATEX SURGICAL GLOVE, STERILE (PROTEIN CONTENT LABELING 50 MICROGRAMS OR LESS) (K993214)Wrp Specialty Products Sdn. Bhd.1999-12-02
QUALITY LATEX POWDERED LATEX MEDICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 170 MICROGRAM OR LESS (K993271)Quality Latex Corp. Sdn Bhd1999-12-02
POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL OF 50 MCROGRAM OR LESS) (K993500)Besglove Medicare Sdn. Bhd.1999-12-02
MULTI-COMFORT NITRILE EXAMINATION GLOVES, (POWDER FREE) (K993127)Glovesworld Industries Sdn. Bhd.1999-12-02
ENSITE 3000 SYSTEM (K992479)Endocardial Solutions, Inc.1999-12-02
TALON ANCHOR SNAP-PAK (K993261)Mitek Products1999-12-02
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