Atlas FDA

2000

3,453 FDA 510(k) clearances · Clearance year

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RecordFirmDate
TALON BALLOON DILATION CATHETER (K000798)Boston Scientific Corp2000-06-08
CITRASATE DIALYSATE ACID CONCENTRATE LIQUID, MODELS CS-1XXX-XX, CS-XXX-XX, CS-3XXX-XX (K000792)Advanced Renal Technologies, Inc.2000-06-08
UNIVEC TWO PIECE SYRINGE (K000747)Univec, Inc.2000-06-08
AS/3 ANESTHESIA MONTIOR WITH S-ANE99(A)/L-ARK99(A) (K000815)Datex-Ohmeda2000-06-08
ALLON 2001 (K001546)Mtre Advanced Technology , Ltd.2000-06-08
FLEXAM NITRILE T AMBI EXAMINATION GLOVES WITH CHEMO CLAIM (K000813)Allegiance Healthcare Coporation2000-06-08
L720 EXAMINATION CHAIR (K001261)Luneau Gynecologie SA2000-06-08
BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM (K000836)Bionx Implants, Inc.2000-06-08
ENSITE 3000 SYSTEM, MODEL EE3000 (K001437)Endocardial Solutions, Inc.2000-06-07
SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT (K992799)Sangui Biotech, Inc.2000-06-07
SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 DIAMETER, 145CM LENGTH, SUPPORT) SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 D (K001454)Micro Therapeutics, Inc.2000-06-07
ULTRAPEN REUSABLE PENCIL, MODEL 130350 THROUGH 130353, REUSABLE ACCESSORY ELECTRODE KIT (FOR USE WITH ULTRAPEN PENCIL), (K001161)Conmedcorp2000-06-07
CIPA (ADULTS) CIPI (INFANTS) (K992932)Dmc Medical, Ltd.2000-06-07
BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR (K000702)Fresenius Medical Care North America2000-06-07
MDA D-DIMER (K000492)Organon Teknika Corp.2000-06-07
MODULAR ROTATING HINGE KNEE CROSSOVER TIBIAL BEARING COMPONENTS (K001548)Howmedica Osteonics Corp.2000-06-07
AGILENT M2636A TELEMON MONITOR (K001436)Agilent Technologies, Inc.2000-06-07
HYFRECATOR 2000 REUSABLE HAND-SWITCHING ACCESSORY HANDPIECE/FOOT-SWITCHING ACCESSORY HANDPIECE, HYFRECATOR PLUS REUSABL (K001159)Conmedcorp2000-06-07
ENDOR 2000 (K984376)T.C. Medical, Inc.2000-06-07
WINDOW CERVICAL DYNAMIC PLATE SYSTEM (K993066)Advanced Spine Technology, Inc.2000-06-07
SELF ADHERING NAVIGUS GUIDE (K001192)Image-Guided Neurologics, Inc.2000-06-07
THE APTUS, AUTOMATED APPLICATION OF THE GLIADIN IGA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY, ELISA FOR (K001393)Zeus Scientific, Inc.2000-06-07
ACTICOAT PRIMARY ANTIMICROBIAL DRESSING (K992221)Westaim Biomedical, Inc.2000-06-07
QUANTA LITE LKM-1 ELISA (K000535)Inova Diagnostics, Inc.2000-06-07
HARDYDISK CINOXACIN, 100 MCG (K001487)Hardy Diagnostics2000-06-07
THE WAND (K992404)Spintech, Inc.2000-06-06
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (MOXIFLOXACIN) (K001036)Trek Diagnostic Systems, Inc.2000-06-06
C.S.O. TONOMETER (K992835)Cso2000-06-06
BONASSE CONTACT LENS CASE (K991206)Bonasse Ent. Co., Ltd.2000-06-06
MEMCATH UROLOGY INTRODUCER SHEATH, MODEL 201 (K000767)Memcath Technologies, LLC2000-06-05
BOFOR REVISION COUP (K993874)Plus Orthopedics2000-06-05
STAT-SHELL DISPOSABLE SP02 SENSOR (K000831)Epic Medical Equipment Services, Inc.2000-06-05
AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 85700 (K000820)Endosonics Corp.2000-06-05
X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR (K993772)Terumo Medical Corp.2000-06-05
WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM (K000001)Boston Scientific Scimed, Inc.2000-06-05
CONMED TROGARD FINESSE TROCAR SYSTEM, MODEL 60-6050-XXX (K001597)Conmedcorp2000-06-05
DATEX-OHMEDA CS/3 TELEMETRY SYSTEM (K000882)Datex-Ohmeda2000-06-05
NEPHROSCOPE, 12 DEGREES; DIAPHRAGM VALVE; IRRIGATION ATTACHMENT; NEPHROSCOPE, 20 DEGREE, STRAIGHT VIEW; NEPHROSCOPE, 20 (K994223)Richard Wolf Medical Instruments Corp.2000-06-05
BESTNEB PORTABLE AEROSOL THERAPY UNIT, AP-100100 (K990435)Apex Medical Corp.2000-06-05
MEDTRONIC AVE BRIDGE X3 STENT (K000744)Medtronic Ave, Inc.2000-06-05
OPTION CARE SYSTEM FOR THE CLEANING AND DISINFECTING OF SOFT (HYDROPHILIC) CONTACT LENSES (K000998)Optisonic, Inc.2000-06-05
TRIFIX SPINAL FIXATION SYSTEM (K001627)Endius, Inc.2000-06-03
MEROGEL OTOLOGIC PACK (K001148)Xomed, Inc.2000-06-03
OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR BRONCHIAL USE (K994106)Olympus America, Inc.2000-06-02
SYNCHRON CONTROL (K001458)Beckman Coulter, Inc.2000-06-02
PHOENIX EPIDURAL & SPINAL NEEDLES (K990519)Myco Medical Supplies, Inc.2000-06-02
OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR URINARY USE (K994069)Olympus America, Inc.2000-06-02
MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM (K001427)Selfcare, Inc.2000-06-02
PHARMASEED, MODEL BT-103-2 (K993700)Syncor International, Inc.2000-06-02
OPTIRAD (K993895)Permedics, Inc.2000-06-02
DR9000 DIGITAL RADIOGRAPHY X-RAY SYSTEM (K001336)Analogic Corp.2000-06-02
VIKING OPTIMA GUIDING CATHETER (K001435)Guidant Corp.2000-06-02
AUDIOSCREENER OAE + ABR (K001058)Kedly, Inc.2000-06-02
ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668 (K001413)Biotronik, Inc.2000-06-02
AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30 (K001285)Diagnostic Chemicals , Ltd.2000-06-02
PSN HEMODIALYZER, MODELS PSN 170, PSN 210 (K001422)Baxter Healthcare Corp2000-06-02
INSTANT-VIEW MARIJUANA URINE CASSETTE TEST (K994405)Alfa Scientific Designs, Inc.2000-06-02
XPLORER 1000 (K992955)Imaging Dynamics Corp.2000-06-02
RETRAX RETRACTING NEEDLE SYRINGE, SIZE 3CC (K001017)Retrax Safety Systems, Inc.2000-06-02
COMPLETE BRAND COMFORTPLUS MULTI-PURPOSE SOLUTION (K000164)Allergan, Inc.2000-06-02
DR5000 DEDICATED CHEST X-RAY SYSTEM (K001341)Analogic Corp.2000-06-02
TRI-FIX SPINAL FIXATION SYSTEM (K000766)Endius, Inc.2000-06-01
DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM) (K000976)Instrumentarium Imaging, Inc.2000-06-01
VFSS IMAGER, MODEL SIS-300 (K000987)Lifecare Imaging Intl., Ltd.2000-06-01
KSEA MANHES PNEUMOTROCAR (K000769)KARL STORZ Endoscopy-America, Inc.2000-06-01
WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR (K001004)Wako Chemicals USA, Inc.2000-06-01
HARVEST TECHNOLOGIES DUAL LIQUID APPLICATOR, MODEL SK/S: HARVEST DUAL LIQUID APPLICATOR LK/2 (K000456)Harvest Technologies, LLC2000-06-01
STERRAD BI TEST PACK (K993775)Advanced Sterilization Products2000-06-01
MULTIX COMPACT K AND MULTIX L RADIOGRAPHIC X-RAY SYSTEMS (K001201)Siemens Medical Solutions USA, Inc.2000-06-01
HARDYDISK CEFOPERAZONE, 75 MCG (K001489)Hardy Diagnostics2000-06-01
HARDYDISK CEFONICID, 30 MCG (K001490)Hardy Diagnostics2000-06-01
IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG (K000463)Diagnostic Products Corp.2000-06-01
LASER SYSTEM MEDIOSTAR H (WITH AND WITHOUT SKIN COOLING SYSTEM) (K994116)Aesculap-Meditec North America2000-06-01
INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PELVIS COIL (K001209)Usa Instruments, Inc.2000-06-01
ELECSYS ANTI-TPO CALCHECK (K001014)Roche Diagnostics Corp.2000-06-01
WAKO HDL-C/LDL-C CALIBRATOR (K001005)Wako Chemicals USA, Inc.2000-06-01
MODIFICATION TO ACIST CL 100H (K991103)Acist Medical Systems2000-05-31
ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B (K984231)Invasatec2000-05-31
RELIANCE FAMILY OF WASHER-DISINFECTORS (K983068)STERIS Corporation2000-05-31
RUSCH EMERGENCY MASK (K993528)Rusch, Inc.2000-05-31
QUEST MPS PERFUSION ASSISTED DIRECT CORONARY ARTERY BYPASS (PADCAB) (K994274)Quest Medical, Inc.2000-05-31
SURGEN VALVE (K990331)Tiva Medical2000-05-31
FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX (K001367)St. Jude Medical, Inc.2000-05-31
NEOCARE 20 MICRON BLOOD FILTER (K000719)Whatman, Inc.2000-05-30
HM-930 ELECTROSURGICAL UNIT (K993991)Hill-Med, Inc.2000-05-30
SOVEREIGN BIPOLAR INSTRUMENTS (K001330)Aesculap, Inc.2000-05-30
EAGLE ENDO SPECIMEN RETRIEVAL BAG (K001264)Eagle Endoscopic, Inc.2000-05-30
PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL (K001108)Prime Dental Manufacturing, Inc.2000-05-30
BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER (K993010)Environmental Tectonics Corp.2000-05-30
ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, PLASMA SCALPEL GS, C (K001302)Arthrocare Corp.2000-05-30
SOMNUS DISPOSABLE TISSUE COAGULATING ELECTRODE AND SOMNUS REUSABLE CONNECTOR CABLE (K000720)Somnus Medical Technologies, Inc.2000-05-30
SPIRAL IMAGING OPTION (K000802)GE Medical Systems2000-05-26
BEHRING COAGULATION SYSTEM (BCS) (K000973)Dade Behring, Inc.2000-05-26
INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (REVAS) (K992668)Innerdyne, Inc.2000-05-26
SURGITRON IEC II (K001253)Ellman Intl., Inc.2000-05-26
BARZELL-WHITMORE MAROON BELLS, INC. COLO-RECTAL MOVER, MODEL 3900 (K000960)Barzell-Whitmore Maroon Bells, Inc.2000-05-26
HYSTEROSCOPE OPERATING SHEATH AND INSERT, MODEL 8988.031/.041/.231/.241 (K000673)Richard Wolf Medical Instruments Corp.2000-05-26
MEDIVISION I-VIEW PERSONAL VIDEO DISPLAY (K000669)Medivision Endoscopy2000-05-26
OPTIMUM WETTING AND REWETTING DROP (K001428)Lobob Laboratories, Inc.2000-05-26
QUICKSCREEN PRO DRUG CUP, MODEL 9195X (K001397)Phamatech2000-05-26
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