Atlas FDA

1999

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

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RecordFirmDate
PBS 1X- DULBECCO'S PHOSPHATE BUFFERED SALINE SOLUTION (K991342)Irvine Scientific Sales Co., Inc.1999-07-08
VIEWPOINT TOOLS- STERRAD (K983764)Philips Medical Systems (Cleveland), Inc.1999-07-08
SPERM MAINTENANCE MEDIUM WITH GLYCEROL (K991337)Irvine Scientific Sales Co., Inc.1999-07-08
FCI CRAWFORD PROBE INTUBATION SETS (K991238)Fci Ophthalmics, Inc.1999-07-08
THERMOPLATE (K991263)Tokai Hit Co., Ltd.1999-07-08
ISOLATE, ISOLATE CONCENTRATE, ISOLATE STOCK SOLUTION (K991341)Irvine Scientific Sales Co., Inc.1999-07-08
C-LEG (3C100) (K991590)Otto Bock Orthopedic Industry, Inc.1999-07-08
ATLAS MONITOR (K984033)Welch Allyn, Inc.1999-07-08
EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM (K991211)Reynolds Medical , Ltd.1999-07-08
QUALISYS PSA IMMUNOASSAY (K990234)Qualisys Diagnostics, Inc.1999-07-08
MTI 1 ML SYRINGE (K991225)Micro Therapeutics, Inc.1999-07-08
SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC) (K991235)Ludlow Technical Products1999-07-08
VOLUSION SMALL PARTS TRANSDUCER, MODEL S-VNW 5-10, VOLUSION ABDOMINAL TRANSDUCER, MODEL S-VAW 4-7 (K992155)Medison America, Inc.1999-07-08
STAINLESS STEEL SOFT SUTURE WIRE (K990355)Bregma International Trading Company , Ltd.1999-07-08
BISTITE II SC (K991711)Tokuyama America, Inc.1999-07-07
NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL WATER EXTRAC (K991849)Seal Polymer Industries Bhd.1999-07-07
RAPIDONE - MARIJUANA TEST (K990818)American Bio Medica Corp.1999-07-07
SPECIALITY 55 MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR, SPECIALITY 55 (METHAFILCON A) (K984090)Specialty Ultravision, Inc.1999-07-07
VISER PENILE TUMESCENCE MONITOR (K991479)Laborie Medical Tech Corp.1999-07-07
N LATEX IGE MONO REAGENT (K991787)Dade Behring, Inc.1999-07-07
ADVENTURE TINTS PROSTHETIC TINTED SOFT CONTACT LENS (K992054)Adventures IN Color Technology, Ltd.1999-07-07
OCUSYSTEM ART ADVANTAGE, MODEL 995 (K991852)Surgical Design Corp.1999-07-07
SAMSUNG RAYPAX SYSTEM (K991537)Samsung Sds Co., Ltd.1999-07-06
DURAGEN DURAL GRAFT MATRIX (K982180)Integra Lifesciences Corp.1999-07-06
SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR (K991323)Smith & Nephew, Inc.1999-07-06
QUADRATURE WRIST COIL, MODEL 445PH-64 (K991434)Medical Advances, Inc.1999-07-06
LIFESTYLES XTRA PLEASURE (K983518)Ansell, Inc.1999-07-06
TAMPA HYPERBARIC MONOPLACE CHAMBER (K981938)Tampa Hyperbaric Ent.1999-07-06
IMMULITE TURBO INTACT PTH, MODEL LSKPTZ (K992105)Diagnostic Products Corp.1999-07-06
STATUS STIK, ACCUSIGN STIK (K992068)Princeton BioMeditech Corp.1999-07-06
MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION (K991955)Engineered Medical Systems1999-07-06
IMMERGE IMAGE CORRELATION (K991468)Surgical Navigation Technologies, Inc.1999-07-06
MODIFIED HAM'S F-10 WITH ALBUMIN (K991420)Irvine Scientific Sales Co., Inc.1999-07-02
FREEZING MEDIUM - TEST YOLK BUFFER (TYB) WITH GLYCEROL, REFRIGERATION MEDIUM - TEST YOLK BUFFER 9TYB) (K991421)Irvine Scientific Sales Co., Inc.1999-07-02
DD URETERAL STENT, INTEGRAL STENT (K982974)Rusch Intl.1999-07-02
WEBRAD COMPUTED RADIOGRAPHY QUALITY ASSURANCE WORKSTATION (K991626)Analogic Corp.1999-07-02
MODIFICATION TO GAMMA GUIDANCE SYSTEM (K983768)Radiation Monitoring Devices, Inc.1999-07-02
RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-014 (K991170)Edwards Lifesciences Research Medical1999-07-02
MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION (K991953)Engineered Medical Systems1999-07-01
RICHTER LIPOPLASTY CANNULAS AND ACCESSORIES (K990602)Tecsa Technical Services1999-07-01
HEDROCEL ACETABULAR CAGE SYSTEM (K983837)Implex Corp.1999-07-01
SYNTHES CERVIFIX SYSTEM (K990965)Synthes (Usa)1999-07-01
OPUS TROPONIN I CALIBRATOR (K991176)Dade Behring, Inc.1999-07-01
EXCELL 22 (K991539)Mwi, Inc.1999-07-01
BIO-INTERFERENCE SCREW (K990454)Innovasive Devices, Inc.1999-07-01
SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854 (K991169)Biotronik, Inc.1999-07-01
BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDER-FREE) (K991939)Brightway Holdings Sdn. Bhd.1999-07-01
BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEM (K992058)Biomet, Inc.1999-07-01
NITRILE EXAMINATION GLOVE, POWDERED, BLUE (K991821)Ning BO Yujiang Rubber & Plastic Co.1999-07-01
AUTO-PEEP MEASUREMENT DEVICE, MODEL # KC 9-P (K983631)Instrumentation Industries, Inc.1999-07-01
CRYO-MONO CRYOGRNIC SYSTEM (K991122)Influence, Inc.1999-07-01
MODIFICATION TO TRUZONE PEAK FLOW METER (K991212)Monaghan Medical Corp.1999-07-01
ANESFLOW-DUAL DRIP IV INFUSION SET (K990496)Innovative Design Assoc.1999-07-01
OPUS TROPONIN I (CTN) TEST MODULES (K991177)Dade Behring, Inc.1999-07-01
WALKMED 300, WALKMED 350, WALKMED IC, WALKMED PCA, WALKMED PLUS (K991275)Mckinley, Inc.1999-07-01
DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE (K991457)Shanghai Palomar Mountain Industries, Inc.1999-07-01
THERMAL ANGEL (K984640)Estill Medical Technologies, Inc.1999-07-01
TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02 (K991666)A.P. Total Care, Inc.1999-06-30
ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM (K991576)Bayer Corp.1999-06-30
MODIFICATION TO 'RAPID DRUG SCREEN' 9-PANEL (K992033)American Bio Medica Corp.1999-06-30
COLORPOINT 1720 MEDICAL IMAGERS AND VIDEO CAPTURE BOX CX-1000 SERIES (K991282)Seiko Instruments USA, Inc.1999-06-30
DIFOTI SYSTEM (K991098)Electro-Optical Sciences, Inc.1999-06-30
CHIRON DIAGNOSTICS ACS: 180 FOLATE (K991582)Chiron Diagnostics Corp.1999-06-30
GLUCOMETER ELITE TEST STRIPS (K991242)Bayer Corp.1999-06-30
AST/SGOT (K991663)A.P. Total Care, Inc.1999-06-30
MCKINLEY SP DISPOSABLE INFUSION PUMP (K990461)Mckinley, Inc.1999-06-30
FLUOREX ULTRA (FLUSILFOCON E) RIGID GAS PERMEABLE CONTACT LENS (K991781)G.T. Laboratories, Inc.1999-06-29
FLUOREX 700 -UV (FLUSILFOCON A), FLUOREX 500-UV (FLUSILFOCON B) AND FLUOREX 300-UV (FLUSILFOCON C) RIGID GAS PERMEABLE C (K991780)G.T. Laboratories, Inc.1999-06-29
O.B. APPLICATOR TAMPONS, O.B. TAMPONS (K991118)Personal Products Co.1999-06-29
W-55 (METHAFILCON A) CLEAR AND VISIBILITY TINTED LENS BLANK AND HORIZON 55 SOFT (CLEAR) AND HORIZON 55 WESTINT (TINTED) (K992010)Westcon Contact Lens Co., Inc.1999-06-29
SPYROGEL HYDROGEL WOUND AND BURN DRESSING SA (K991287)Advanced Medical Solutions Group Plc1999-06-29
SHADOW TRAYS (K991107)Mick Radio-Nuclear Instruments, Inc.1999-06-29
K-SYSTEMS WORK STATIONS, TYPE L-13W, L-13E, L-13ES, L-13ET, L-13EM, L-23, L-23E, L-24, L-24E, L-25, L-25E, L-26, L-26E,L (K991229)Henning Knudsen Engineering A/S1999-06-29
GRIT BLASTED HUMERAL STEM (K991603)Encore Orthopedics, Inc.1999-06-29
ORIBRUSH - WITH PROTECTIVE TIP - B001 (K991595)Orifice Medical AB1999-06-29
ORIBRUSH - STANDARD - B002 (K991593)Orifice Medical AB1999-06-29
OSTEONICS ALUMINA C-TAPER HEAD, OSTEONICS TRIDENT POLYETHYLENE INSERTS (K991952)Howmedica Osteonics Corp.1999-06-29
COAGULOOP (K991314)American Medical Systems, Inc.1999-06-29
OMNI-FIX, HUMERAL NAIL (K991405)Turnkey Intergration USA, Inc.1999-06-29
GYRUS ENDOUROLOGY SYSTEM (K990628)Gyrus Medical , Ltd.1999-06-29
AMIB7 (K990198)Alliance Medical, Inc.1999-06-29
FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS (K984586)Fresenius Hemotechnology, Inc.1999-06-29
DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING (K991061)Dermaphylyx, Inc.1999-06-28
BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE (K984162)Nobelpharma USA, Inc.1999-06-28
GENTLE TOUCH UV (NETRAFILCON A) SOFT CONTACT LENSES (K991000)Wesley Jessen Corp.1999-06-28
POLYSLIT IFE KIT (K990998)Helena Laboratories1999-06-28
BIONIKE AQ BARBITURATE TEST (K990280)Bionike, Inc.1999-06-28
COLOR BUFFED ANSWER CEMENTED FEMORAL (K991987)Biomet, Inc.1999-06-28
MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR SET (K990705)Medamicus, Inc.1999-06-28
THE ACME MEDICAL AESTHETIC ND:YAG LASER (K991234)Acme Medical, Inc.1999-06-28
SYNERGY ADJUSTABLE LENGTH ROD (K990057)Interpore Cross Intl.1999-06-28
OVERLANDER PEV 2000 (K983497)Raye'S, Inc.1999-06-27
INDEPENDENCE 624 (K990122)Eagle Parts & Products, Inc.1999-06-25
DAUM MRI/CONVENTIONAL BIOPSY KIT (K991366)Daum GmbH1999-06-25
GREINER MINICOLLECT LITHIUM HEPARIN GEL BLOOD COLLECTION TUBE (K991843)Greiner Meditech, Inc.1999-06-25
HERMES CONTROL CENTER, WITH CONTROL OF THE AESOP 3000HR (HERMES READY). (K991444)Computer Motion, Inc.1999-06-25
PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST (K984346)Meridian Diagnostics, Inc.1999-06-25
6F HYDROLYSER THROMBECTOMY CATHETER (K990771)Cordis Corp.1999-06-25
ARROW FWD POWER WHEELCHAIR (K991168)Invacare Corp.1999-06-25
ORTHOSLICE OS1000 SERIES; PANORAMIC ORTHOSLICE OS 1000: OS1000, OS1000E PANORAMIC AND CEPHALOMETRIC ORTHOSLICE OS1000C, (K991455)Trophy Radiologie1999-06-25
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