Atlas FDA

1999

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

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RecordFirmDate
LAPARO CO2-PNEU AUTOMATIC INSUFFLATOR WITH 30L FLOW RATE,AND VIDEO-SCREEN DISPLAY, HIGH FLOW INSUFFLATION TUBE WITH HEAT (K991906)Richard Wolf Medical Instruments Corp.1999-11-23
N LATEX FERRITIN (K993273)Dade Behring, Inc.1999-11-23
SIRSCAN (K991473)Intelligence Artificielle Applications1999-11-23
NIL, SURGEON'S GLOVE - POWDER FREE (K993349)Sri Anusham Rubber Industries Pvt., Ltd.1999-11-23
K-ASSAY IGA (K993213)Kamiya Biomedical Co.1999-11-23
AX WORKSTATION DR-VIEWER SOFTWARE OPTION (K992925)Siemens Corp.1999-11-23
EBI SPINELINK SYSTEM (K992920)Ebi, L.P.1999-11-23
STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTS (K990512)Stoeckert Instrumente1999-11-23
EASY-JET DEVICE (K972383)A.Stein - Regulatory Affairs Consulting1999-11-23
STERILE HYDROGEL (K993119)Dumex Medical Surgical Products, Ltd.1999-11-23
PIONEER SILICOAT STERNAL CABLE (K993286)Pioneer Surgical Technology1999-11-23
TURBO 7000 SHAVER AND DRILL CONSOLE; TURBO 7000 HANDPIECES; ESSENTIAL SHAVER/BURRS; (K992994)Gyrus Ent LLC1999-11-23
CARDIASURE CARDIAC MARKERS CONTROL (K993723)Quantimetrix Corp.1999-11-23
PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS (K992242)Pillar Surgical, Inc.1999-11-22
FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000 (K993046)Fibra Sonics, Inc.1999-11-22
STAK-CHEX PLUS RETICS (K992887)Streck Laboratories, Inc.1999-11-22
3D1 MICROPOSITIONING HEADSTAGE (K993501)Scientific Tools, Inc.1999-11-22
ENDOSPINE OPERATING TUBE AND TELESCOPE BRIDGE (K993540)KARL STORZ Endoscopy-America, Inc.1999-11-22
PILLAR MALAR IMPLANT (K992240)Pillar Surgical, Inc.1999-11-22
CASCADE LIQUID COAGULATION CONTROL LEVELS 1, 2, AND 3 (K992829)Medical Analysis Systems, Inc.1999-11-22
DISETRONIC PEN P100 (K993666)Disetronic Medical Systems1999-11-22
SUTURE CLINCH (K992852)Applied Medical Resources1999-11-22
PILLAR CHIN IMPLANT (K992239)Pillar Surgical, Inc.1999-11-22
XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46 (K992125)Norland Medical Systems, Inc.1999-11-22
OXY-GLIDE ROOT CANAL CLEANSER & LUB. (K992919)Super Glide, Inc.1999-11-19
IBC VENT VALVE, MODEL 1400 (K992964)International Biophysics Corp.1999-11-19
ALARMVIEW SYSTEM (K992848)Data Critical Corp.1999-11-19
COMFIT POWDER FREE NITRILE EXAMINATION GLOVE, STERILE (K993311)Wrp Asia Pacific Sdn. Bhd.1999-11-19
I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY PACK, PHACOEMULSIFICATION PACK, ADMIINISN (K990292)Ophthalmic Consultants, Inc.1999-11-19
EXACTECH ACUMATCH INTEGRATED HIP SYSTEM A-SERIES POROUS COATED ACETABULAR COMPONENT (K993082)Exactech, Inc.1999-11-19
OSTEO-PIN MEMBRANE FIXATION PIN (K990537)Luitpold Pharmaceuticals, Inc.1999-11-19
HI BOND NON-PRECIOUS CERAMIC ALLOY (K992881)Matech, Inc.1999-11-19
POWDER FREE GLOVES (POLYMER COATED) (K993183)Pan-Century Rubber Products Sdn. Bhd.1999-11-19
OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (100 MICROGRAMS OR LESS) (K993479)Omnigrace (Thailand) , Ltd.1999-11-19
WICHITA FUSION NAIL FULLY THREADED SELF-TAPPING SCREW (K993603)Howmedica Osteonics Corp.1999-11-19
DISPOSABLE PVC POWDERED SYNTHETIC EXAMINATION GLOVES (K993049)Shanghai Antares Industries, Inc.1999-11-19
NIL, NITRILE EXAMINATION GLOVE - POWDER FREE (K993348)Sri Anusham Rubber Industries Pvt., Ltd.1999-11-19
SULZER VASCUTEK EPTFE VASCULAR PROSTHESIS (K992832)Sulzermedica1999-11-19
LORENZ DISTRACTION SYSTEM (K992952)Walter Lorenz Surgical, Inc.1999-11-19
MED-4000 (K993823)Micro Current Technology, Inc.1999-11-19
EBI XFIX DFS WRISTFIX SYSTEM (K993649)Ebi, L.P.1999-11-19
VERSALOK LOW BACK FIXATION SYSTEM (K992885)Osteotech, Inc.1999-11-19
CROSSFIRE SYSTEM 12 ACETABULAR INSERTS (K993352)Howmedica Osteonics Corp.1999-11-19
MASIMO SET/QUARTZ 2500 PULSE OXIMETER AND ACCESSORIES (K993555)Masimo Corp.1999-11-19
STRYKER LEIBINGER RESORBABLE FIXATION SYSTEM (K993061)Stryker Instruments1999-11-19
NIL, NITRILE EXAMINATION GLOVE - POWDERED (K993347)Sri Anusham Rubber Industries Pvt., Ltd.1999-11-19
OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE; POLYMER COATED WITH PROTEIN CLAIM (50 MICROGRAMS OR LESS) (K993419)Omnigrace , Ltd.1999-11-19
PORT-A-CATH II TRANS-ARTERIAL PERCUTANEOUS SYSTEM (K992697)Sims Deltec, Inc.1999-11-18
AURORA SL (K993285)Premier Laser Systems, Inc.1999-11-18
Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM (K992874)Wr Medical Electronics Co.1999-11-18
OPTILITE IX LASER SURGERY ACCESSORIES (K992866)Convergent Laser Technologies1999-11-18
CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER (K990290)Biomet, Inc.1999-11-18
11 GAUGE PROBE, STEREOTACTIC, 14 GAUGE PROBE, STEREOTACTIC,14 GAUGE PROBE, ULTRASOUND, HOUSING STEREOTACTIC,HOUSING, ULT (K992813)Ethicon Endo-Surgery, Inc.1999-11-18
NELLCOR PURITAN BENNETT ACHIEVA VENTILATOR AND REPORT GENERATOR (K990177)Nellcor Puritan Bennett, Inc.1999-11-18
OMEGA TRAC, MODEL Z100 (K993160)Teftec Corp.1999-11-18
TRAPIS (TRANSPERINEAL PROSTATE IMPLANT SIMULATOR), VERSION 1.5 (K990475)Kps & Assoc., Inc.1999-11-18
HAEMONETICS LN 193 DISPOSABLE SET, FOR USE WITH THE HAEMONETICS CELLSEVER HAEMOLITE 2 FAMILY OF AUTOLOGOUS BLOOD RECOVER (K993581)Haemonetics Corp.1999-11-18
COLORMAX COLOR VISION ENHANCEMENT LENSES (K984219)Color Vision Technologies, Inc.1999-11-18
RCI FIXATION SCREWS (WITH ASSORTED SIZES) (K992945)Smith & Nephew, Inc.1999-11-18
STAR TEMPORARY WOUND COVER (K983753)Osteogenics, Inc.1999-11-18
MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION (K991786)General Electric Medical Systems Information Techn1999-11-18
AVOCET ACUSURE SYSTEM (K991286)Avocet Medical, Inc.1999-11-18
CUSTOM PROSTHETIC (HEFILCON A) SOFT LENS (K992950)Prosthetic Soft Lens Corp.1999-11-18
ONE-STEP DOUBLE-CHEK PREGNANCY TEST (K992915)Biomedical Products Corp.1999-11-18
WATER PURIFICATION COMPONENTS AND SYSTEMS HEMODIALYSIS (K983239)Rasco1999-11-18
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM (K992510)Boston Scientific Corp1999-11-18
PATIENT NITRILE EXAMINATION GLOVES POWDER FREE CHLORINATED (K992678)Wear Safe Malaysia Sdn. Bhd.1999-11-17
NON-STERILE POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM (70 MICROGRAMS OR LESS PER (K993326)Seal Polymer Industries Bhd.1999-11-17
PHACOLASE ER: YAG LASER (K991993)Aesculap-Meditec GmbH1999-11-17
SEAL & PROTECT PROTECTIVE SEALANT FOR EXPOSED DENTINE (K992822)Dentsply Intl.1999-11-17
LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET (K993669)DiaSorin, Inc.1999-11-17
NON-STICK BIPOLAR FORCEPS (K992931)Silverglide Surgical Technologies1999-11-17
IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6 (K993251)Diagnostic Products Corp.1999-11-17
CASHMERE NON-STERILE POWDERED NITRILE EXAMINATION GLOVES BLUE AND GREEN (K993133)Seal Polymer Industries Bhd.1999-11-17
CASHMERE NON-STERILE BLUE POWDERED NITRILE EXAMINATION GLOVESBLUE AND GREEN) (K993134)Seal Polymer Industries Bhd.1999-11-17
MODIFIED BLOOD RECIPIENT SET (K993120)Baxter Healthcare Corp1999-11-17
MODIFICATION TO RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005126-13, 1005128-13, 1005130-13, 1005132-13, 1005134-13, (K993588)Guidant Corp.1999-11-17
HEMASEAL & CIDE (K990779)Advantage Dental Products, Inc.1999-11-17
LASEREX ND:YAG OPHTHALMIC LASER (LQ2106), ALCON ND:YAG OPHTHALMIC LASER (3000LE), LASEREX ND:YAG OPHTHALMIC LASER, MODEL (K992824)Ellex Medical Pty, Ltd.1999-11-17
MODIFIED LONG LENGTH GAMMA NAIL (K993670)Howmedica Osteonics Corp.1999-11-16
SPECTRANETICS 0.014 SUPPORT CATHETER, MODEL 518-016, SPECTRANETICS 0.018 SUPPORT CATHETER, MODEL 518-017 (K991059)Spectranetics Corp.1999-11-16
ETEST FOR QUINUPRISTIN/DALFOPRISTIN (K992993)Ab Biodisk1999-11-16
HOWMEDICA OSTEONICS FEMORAL HEADS (K993601)Howmedica Osteonics Corp.1999-11-16
MODIFIED BMP TROCHANTERIC PLATES (K993510)Biomet, Inc.1999-11-16
E Z CHAIR (K993298)Premier Designs1999-11-16
QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3 (K993715)Seracare Technology1999-11-16
RICROKERATOME BLADE (K992978)Surgistar, Inc.1999-11-16
SABRE (K993177)Sle Limited1999-11-16
SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEM (K992793)Better Water, Inc.1999-11-16
XIA SPINAL SYSTEM C-C ADAPTOR (K992792)Howmedica Osteonics Corp.1999-11-16
BONE BULLET SUTURE ANCHOR (K991024)Linvatec Corp.1999-11-16
UNI-GRAFT K DV PATCH (K992776)Atrium Medical Corp.1999-11-16
FIRST STEP UNICOMPARTMENTAL KNEE SYSTEM (K992287)Howmedica Osteonics Corp.1999-11-16
SILHOUETTE SPINAL FIXATION SYSTEM (K993067)Sulzer Spine-Tech1999-11-16
SPECTRUM LIBRE WHEELCHAIR (K993640)Freedom Designs, Inc.1999-11-16
UNIMED DISPOSABLE HAND AND FOOT-SWITCHING PENCILS WITH HOLSTER AND 1BLADE AND TIP CLEANER, UNIMED DISPOSABLE HAND AND F (K993647)Unimed Surgical Products, Inc.1999-11-16
MINIMED COM-STATION, HARDWARE-7301; SOFTWARE-7311 (K993012)Medtronic Minimed1999-11-15
P10 SPECIAL (K993344)North American Alloys, Inc.1999-11-15
ADHERE CONDITIONER, ADHERE PRIMER, ADHERE LC ADHESIVE, ADHERE DC ADHERE DC ACTIVATOR, ADHERE CYLANATE (K992838)Biomat Sciences, Inc.1999-11-15
BRAHMS DIAGNOSTICA DYNOTEST ANTI-TPO (K992791)Brahms Diagnostica, LLC1999-11-12
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Every clearance here is in the API, with alerts when new ones post.