Atlas FDA

1995

5,487 FDA 510(k) clearances · Clearance year

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RecordFirmDate
CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE (K952562)Cardio Metrics, Inc.1995-08-29
ELLMAN LAPTRODE (K953440)North American Technical Services Corp.1995-08-29
KIRSCHNER(R) MODULAR II-C(TM) TOTAL SHOULDER SYSTEM (K940537)Kirschner Medical Corp.1995-08-29
BECTON DICKINSON BLUNT STEEL CANNULA (K944931)Bd Becton Dickinson Vacutainer Systems Preanalytic1995-08-29
ELASTIC IMPRESSION CREAM (K952422)Teledyne Water Pik1995-08-29
LAPPING TOOL KIT (K953103)Steri-Oss, Inc.1995-08-29
MEROCEL REINFORCED SILICONE SHEETS (K953013)Merocel Corp.1995-08-29
H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) (K953034)Ackrad Laboratories1995-08-29
PERMUALUTE INDIRECT RESTORATIVE BONDING PRIMERS (K953527)Ultradent Products, Inc.1995-08-29
CHEMOGUARD, P2 HIRISK (K952274)Biosafety Systems, Inc.1995-08-29
EASY PNEUMATIC CROWN AND BRIDGE REMOVER (K951299)Dentco, Inc.1995-08-29
QUANTA LITE ACA SCREEN (HRP) (K953291)Inova Diagnostics, Inc.1995-08-29
WYNTEK OSOM HCG-URINE TEST (K953383)Wyntek Diagnostics, Inc.1995-08-29
BAIR HUGGER MODEL 600 UNIT, BLANKETS (K950416)Augustine Medical, Inc.1995-08-29
LAP WASH SYSTEM: REUSEABLE LENS WASHER & IRRIGATING SHEATH (K953243)Devmed Group, Inc.1995-08-28
SAFESKIN SUPRA (K953015)Safeskin Corp.1995-08-28
SHIATSU MASTER MASSAGER CUSHION (K952916)Kinsei Shiatsu, Inc.1995-08-28
MODIFIED LUXAR LX-20 FAMILY CO2 LASER SYSTEM (K953074)Luxar Corp.1995-08-28
PRG BUTTON (K946140)Applied Medical Technologies1995-08-28
ULTRADENT FLOWABLE COMPOSITE (K953525)Ultradent Products, Inc.1995-08-28
UNITRON MODEL IKON AOHPL (K953646)Unitron Industries, Inc.1995-08-28
W&H MICRO AIR MOTOR LT25 (K944713)A-Dec, Inc.1995-08-28
LATEX PATIENT EXAMINATION GLOVE POWDERFREE LAMINATED COPOLYMER (K951018)Siam Sempermed Corp., Ltd.1995-08-28
FILTRESSE, SMOKE FILTRATION SYSTEM, 115 VAC & 230 VAC (K952981)Utah Medical Products, Inc.1995-08-28
SNIP INPUT COMPRESSION CLASS A (K953631)Midwest City Hearing Aid Center1995-08-28
PADLESS ELECTROSURGICAL PENCIL (K952792)Lca, Inc.1995-08-28
GDLH POSTERIOR SPINAL SYSTEM (K950596)Sofamor Danek USA,Inc.1995-08-28
STRYKER STERI-SHIELD SURGICAL APPAREL (K944393)Stryker Corp.1995-08-28
BIO-OSS (K952618)Geistlich-Pharma1995-08-28
CAPNO-FLO REGULATOR, CAPNO-FLO (K952512)Kirk Specialty Systems1995-08-28
DIALYZER REPROCESSING SYSTEM (K944492)G.E.M. Water Systems1995-08-28
COMP=FLOW (K952662)Jeneric/Pentron, Inc.1995-08-28
BIO-OSS CERAMIC (K952619)Geistlich-Pharma1995-08-28
SILICONE ELASTOMER MALAR IMPLANT (K952707)Spirit Ridge Technologies1995-08-28
MINIPIEZON (K953026)Electro Medical Systems SA1995-08-28
DHD METERED DOSE INHALER (MDI) SPACER (MODIFICATION) (K953206)Dhd Diemolding Healthcare Div.1995-08-28
PROTHESIS, CHIN, INTERNAL (K952709)Spirit Ridge Technologies1995-08-28
QUADRALASE (MICROQUARTZ MEDICAL ADJUSTABLE SIDE-FIRING LASER FIBER) (K952974)Microquartz Medical, Inc.1995-08-28
SPIRIT RIDGE SILICONE CARVING BLOCK (K952706)Spirit Ridge Technologies1995-08-28
CITRACE HOSPITAL GERMICIDAL DEODORIZER (K952405)Caltech Industries, Inc.1995-08-28
MICROQUATZ MEDICAL LINEAR MODULATOR ACCESSORY (K953174)Microquartz Medical, Inc.1995-08-28
AM-YAG (K950825)American Lasers, Inc.1995-08-28
MOSS(R) STEEL BREAKAWAY(R) INTRODUCER (K945480)Harry A. Schlakman1995-08-28
SCHWARTZ ELECTRO-OPTICS, INC. TRILASE LASER SYSTEM (K952554)Schwartz Electro-Optics, Inc.1995-08-28
PECTORALIS IMPLANT (K952708)Spirit Ridge Technologies1995-08-28
DCURASOL GEL WOUND DRESSING (K953816)Dpt Laboratories, Ltd.1995-08-28
BOSWORTH RESIN II (K953119)Bosworth Co.1995-08-28
TRI-CEN GERMICIDAL DETERGENT (K951020)Central Solutions, Inc.1995-08-28
IMAGYN ENDOSCOPE SHEATH (K951974)Imagyn Medical, Inc.1995-08-28
FRIEDRICH ELECTRONIC AIR CLEANER (K944305)Friedrich Air Conditioning Co., Inc.1995-08-28
SAFESKIN SUPRA (K952993)Safeskin Corp.1995-08-28
SPIRIT RIDGE NASAL IMPLANT (K952705)Spirit Ridge Technologies1995-08-28
DISPATCH HOSPITAL CLEANER DISINFECTANT WITH BLEACH (K952336)Caltech Industries, Inc.1995-08-28
ADI STERILE GAUZE SPONGES (K953501)Asia Dynamics, Inc.1995-08-28
CENTURY BATHING SYSTEM (K930665)Arjo-Century, Inc.1995-08-28
DEGUBOND ULTRA (K953344)Degussa AG1995-08-25
OXYLOG 2000 (K943531)Drager, Inc.1995-08-25
HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT (K953544)Gibeck, Inc.1995-08-25
SB ANCHOR (K942889)Orthopaedic Biosystems, Ltd.1995-08-25
SMARTSAT PULSE OXIMETRY ANALYZER (K952327)Clinical Dynamics Corp.1995-08-25
W&H AIR MOTOR A25 (K944711)A-Dec, Inc.1995-08-25
ACE BONE SCREW TACKING KIT (K951510)Ace Surgical Supply Co., Inc.1995-08-25
HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE (K953491)Gibeck, Inc.1995-08-25
AURAFLEX TG-AB AND TPO-AB (K951320)Organon Teknika Corp.1995-08-25
W&H MICRO MOTOR E25 (WITHOUT LIGHT) (K944712)A-Dec, Inc.1995-08-25
CYTO-STAT/COULTER CLONE CD3-ECD/T4-RD1/T8-FITC MONOCLONAL ANTIBOEY REAGENT (K950742)Coulter Corp.1995-08-25
PULPDENT DENTASTIC II (K953272)Pulpdent Corp.1995-08-25
GAMMACELL 3000 ELAN (K952291)Nordion International, Inc.1995-08-25
W&H CORSAIR SCALER (K944714)A-Dec, Inc.1995-08-25
ORIMS DIGITAL ANGIOGRAPHY SYSTEM (K952480)Midwest Ophthalmic Instruments, Inc.1995-08-25
LIGHTED FLEXGUIDE (MODIFICATION) (K953677)Scientific Sales Intl., Inc.1995-08-25
TAMPON, UNTREATED (K950194)Hygieia Healthcare , Ltd.1995-08-25
MAPWIRE J-TIP SENSOR GUIDEWIRE (K952626)Navion Biomedical Corp.1995-08-25
LMT BONE ANCHOR (K953764)Li Medical Technologies, Inc.1995-08-25
EXPANDED RANGE OF SUTURE SIZES OGDEN ANCHORS: 7.4MM AND 5.5MM (K951232)American Medical Electronics, Inc.1995-08-25
WARM N WET HMEF W/LUER ADAPTER (K953620)Hospitak, Inc.1995-08-25
PARAGON POSTERIOR SPINAL SYSTEM (K950955)Sofamor Danek USA,Inc.1995-08-25
DENTASTIC ONE-STEP (K953301)Pulpdent Corp.1995-08-25
UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM (K943725)Synthes Spine1995-08-25
EEE (K953540)Edentec Corp.1995-08-25
NEWPORT ELECTRONIC MANOMETER (K941308)Newport Medical Instruments, Inc.1995-08-25
PULPDENT TOUCHDOWN (K953217)Pulpdent Corp.1995-08-25
HEAD IMMOBILIZATION APPARATUS (K941118)Northwest Medical Physics Center1995-08-25
AURAFLEX TPO-AB (K952607)Organon Teknika Corp.1995-08-25
HAND EXTRACTOR HECTOR (K953109)Karl Storz Endoscopy1995-08-25
WARM N WET HME W/LUER ADAPTER (K953619)Hospitak, Inc.1995-08-25
STRYKER DROP APPLICATOR, KITS, SPRAY APPLICATOR KIT, TIPS (K950824)Stryker Corp.1995-08-25
FLOW-THERME, WISAP #7642 (K952508)Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh1995-08-25
CUPRALLOY (K952670)Wykle Research, Inc.1995-08-25
ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT (K952253)Helix Diagnostics, Inc.1995-08-24
OPUS T3 (K953160)Behring Diagnostics, Inc.1995-08-24
DEVILBISS MODEL 5500 (K946095)Devilbiss Health Care, Inc.1995-08-24
LYFO(TM) DIFFERENTIAL DISK (K951889)Microbiologics, Inc.1995-08-24
CSF LIQUID CEREBROSPINAL FLUID CONTROL (K952877)Medical Analysis Systems, Inc.1995-08-24
SWISS LITHOCLAST LITHOTRIPTER (K951531)Electro Medical Systems SA1995-08-24
TOX PERFECT B TUBES AND REAGENTS (K952501)Chimera Research & Chemical, Inc.1995-08-24
CENTRA HEART STATION (K935589)Marquette Electronics, Inc.1995-08-24
ROLLER ELECTRODE (K951863)Olympus America, Inc.1995-08-24
ASEPTECH PORTABLE RO+ SYSTEM (K924695)Dayton Water Systems1995-08-24
OLYMPUS RHEUMATOID FACTOR IMMUNOTURBIDIMETRIC REAGENT (K953520)Olympus America, Inc.1995-08-24
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Every clearance here is in the API, with alerts when new ones post.