Atlas FDA

2002

3,685 FDA 510(k) clearances · Clearance year

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RecordFirmDate
SALUTE, MODEL 3022 (K014286)Onux Medical, Inc.2002-03-08
DIEGO POWERED DISSECTOR AND DRILL SYSTEM (K020594)Gyrus Ent LLC2002-03-08
ACTICHROME HEPARIN (ANTI-FXA), MODEL 832 (K013318)American Diagnostica, Inc.2002-03-08
MODIFICATION TO CORLINK AUTOMATED ANASTOMOTIC DEVICE (K020470)Bypass , Ltd.2002-03-08
DERMASTAR ER:YAG LASER SYSTEM (K014057)Asclepion-Meditec AG2002-03-08
POWDER FREE (POLYMER COATED) NON CHLORINATED WHITE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICS (K013267)Siam Sempermed Corp., Ltd.2002-03-08
BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR (K012960)Biogenex Laboratories2002-03-08
SAS VALUE HCG (K020438)Sa Scientific, Inc.2002-03-08
MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM (K013677)Usfilter/Ionpure, Inc.2002-03-08
FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH) (K014072)Disc-O-Tech Medical Technologies, Ltd.2002-03-08
ACT 11 MP VENTRICULAR CATHETER (K013005)Innerspace, Inc.2002-03-08
MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS (K013662)Quantimetrix Corp.2002-03-08
EDWARDS LIFESCIENCES SWAN-GANZ MONITORING CATHETER WITH OLIGON MATERIAL (K014054)Edwards Lifesciences, LLC2002-03-08
NEWGEN/UNIVERSAL MANDIBULAR SYSTEM (K014263)Stryker Instruments2002-03-08
BIOTECH MANUAL WHEELCHAIR B900 SUPER LIGHT WHEELCHAIR (K020472)Taiwan Armada Enterprise Co., Ltd.2002-03-08
MASTERGRAFT RESORBABLE CERAMIC GRANULES (K012506)Medtronic Sofamor Danek USA, Inc.2002-03-07
NON-EUGENOL TEMPORARY CEMENT (K020158)J. Morita USA, Inc.2002-03-07
OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMAX SENSORS AND CABLES (AKA ACCESSORIES) (K012891)Nellcor Puritan Bennett, Inc.2002-03-07
IMUBIND PLASMA PAI-1 ELISA,MODEL 822 (K013168)American Diagnostica, Inc.2002-03-07
COOLTOUCH AND COOLTOUCH-II ND:YAG LASER SYSTEMS (K014035)Cooltouch Corp.2002-03-07
MEDELA SYMPHONY BREAST PUMP, MODEL 024 (K020518)Medela, Inc.2002-03-07
VIATRONIX V3D COLON (K020658)Viatronix, Inc.2002-03-07
BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145 (K014075)Baylis Medical Co., Inc.2002-03-07
TRUFILL DCS DETACHABLE COIL AND FRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS DETACHABLE COIL SYSTEM (K014041)Cordis Neurovascular2002-03-07
XTD THROMBECTOMY CATHETER, XX CM, MODEL# CT000500X; XTD CONTROL CONSOLE, MODEL # CT0006001; XTD COLLECTION BOTTLE, MODEL (K013473)Xtrak Medical, Inc.2002-03-06
DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T (K020156)Axis-Shield Diagnostics, Ltd.2002-03-06
ELECSYS ANTI-TG CALCHECK (K020369)Roche Diagnostics Corp.2002-03-06
MICROSCAN SYNERGIES PLUS (K020511)Dade Microscan, Inc.2002-03-06
TOWEL DRAPE, MODELS 4409, 4410 (K012957)Dynarex Corp.2002-03-06
REBILDA SC (K014111)Voco GmbH2002-03-06
ULTRA TOUCH POWDERED LATEX EXAMINATION GLOVES (K020359)Ar Alliance Healthcare Sdn. Bhd.2002-03-06
PRIME ECG SYSTEM (K012414)Meridian Medical Technologies, Inc.2002-03-06
MICROAIRE 1000E SYSTEM (K014060)Microaire Surgical Instruments, Inc.2002-03-05
SPL-50 SPIROLYSER (K010761)Fim Medical2002-03-05
ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822 (K014204)K-Jump Health Co., Ltd.2002-03-05
INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE (K013653)Hollister, Inc.2002-03-05
CHLORINATED POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH ALOE VERA (K013774)Supermax Sdn Bhd2002-03-05
TROJAN PASSION BERRY GEL (K013433)Armkel, LLC2002-03-05
ANGELTOUCH VENTED IV ADMINISTRATION SET (K012189)Angiplast Private , Ltd.2002-03-05
SILK TOUCH POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) (K013821)Top Quality Mfg., Inc.2002-03-05
LASERPRO 16 (K020243)Eradlink, Inc.2002-03-05
AKTINA MEDICAL PHYSICS RADIATION THERAPY WEDGES (K014081)Aktina Medical Physics Corp.2002-03-05
ASTOFLO (K020060)Nats Corp.2002-03-05
STAURENGHI WIDE FIELD SCANNING LASER LENS (K014170)Ocular Instruments, Inc.2002-03-04
INTEGRAPH FLASH, MODEL CI 110 (K012732)Steritec Products, Inc.2002-03-04
CARBODISSECTING ENDOSCOPE (K013680)Endo Surgical Devices, Inc.2002-03-04
MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT) (K014044)Notal Vision, Inc.2002-03-04
SONOREAL 3D SYSTEM (K020068)Bio Medi Com2002-03-04
WRISTORE FIXATOR (K012294)Millennium Medical Technologies, Inc.2002-03-04
TEMPORARY CROWN AND BRIDGE MATERIAL (K020157)J. Morita USA, Inc.2002-03-04
ACCOLADE TMZF HA 132 DEGREE SIZE 0 HIP STEM (K020572)Howmedica Osteonics Corp.2002-03-04
ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890 (K014002)Fortune Medical Instrument Corp.2002-03-04
ENDOPATH DILATING TIP TROCAR, MODEL #512XD (K020428)Ethicon Endo-Surgery, Inc.2002-03-04
INVIGRA (K020223)Indus Medicare , Ltd.2002-03-04
O-RING PROSTHETIC ATTACHMENT (K001638)Titan Implants2002-03-04
MRI LINE MARKER (K014022)I.Z.I. Corp.2002-03-04
LIFEMATE MLA MULTI-LINE ADAPTOR; LIFEMATE SFR STERILE FLUID RESERVOIR (K011269)Nxstage Medical, Inc.2002-03-04
NEUROSPECTQUAD GAMMA CAMERA (K013353)Nuclear Cardiology Systems, Inc.2002-03-04
LATEXX MANUFACTURING NON-CHLORINATED, POLYMER COATED, POWDER-FREE RUBBER LATEX EXAMINATION GLOVE (K014087)Latexx Manufacturing Sdn.Bhd.2002-03-04
INFRARED EAR THERMOMETER, MODEL DX-707 (K013876)Jawon Medical Co., Ltd.2002-03-04
TRIDENT ELEVATED RIM LINER (K020497)Howmedica Osteonics Corp.2002-03-04
AHP-66 4:1 REDUCTION CONTRANGLE: AHP-88 8:1 REDUCTION CONTRANGLE: AHP-88MP 8:1 REDUCTION CONTRANGLE - PUSH BUTTON (K020137)Aseptico, Inc.2002-03-04
MODIFICATION TO HI-TORQUE WHISPER LS AND MS GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING (K020340)Guidant Corp.2002-03-01
SAFETOUCH (K014300)James D Rusin MD, MBA2002-03-01
KONICA DIRECT DIGITIZER REGIUS MODEL 350 (K013054)Konica Minolta Medical & Graphic, Inc.2002-03-01
AESCULAP -MIETHKE SHUNT SYSTEM (K011030)Aesculap, Inc.2002-03-01
DRG DISPOSABLE VAGINAL SPECULUM (K012535)Doctor'S Research Group, Inc.2002-03-01
REPROCESSED DISPOSABLE TROCARS (K013987)Adven Medical2002-03-01
MODIFICATION TO EBI XFIX DFS SYSTEM (K014276)Ebi, L.P.2002-03-01
MODIFICATION TO VIGIL LIPID CONTROL (K020521)Beckman Coulter, Inc.2002-03-01
MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON (K013737)Telemed Systems, Inc.2002-03-01
ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500 (K020128)Diagnostic Systems Laboratories, Inc.2002-03-01
ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORIES, ELECTROSURGICAL WANDS (K012640)Medical Instruments Technology, Inc.2002-02-28
UNITE BONDING ADHESIVE (K014142)3M Unitek2002-02-28
VENUS UNIVERSAL LIGHT CURING COMPOSITE (K020131)Heraeus Kulzer, Inc.2002-02-28
CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM (K012357)Bayer Diagnostics Corp.2002-02-28
SANDHILL SCIENTIFIC PEDIATEC PH PROBE (K013951)Sandhill Scientific, Inc.2002-02-28
GC FUJI LINING LC PASTE PAK (K020117)GC America, Inc.2002-02-28
URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM (K013819)Sierra Diagnostic, LLC2002-02-28
SOF-TACT DIABETES MANAGEMENT SYSYEM; SOF-TACT BLOOD GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS (K012975)Abbott Laboratories2002-02-28
ABX MICROS 60 HEMATOLOGY ANALYZER (K014203)Abx Diagnostics2002-02-28
INTUITIVE SURGICAL STERO VIEW ENDOSCOPIC SYSTEM (K013952)Intuitive Surgical, Inc.2002-02-28
SATARI POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) POLYMER COATED WHIT (K014110)Siam Sempermed Corp., Ltd.2002-02-28
ADVANTAGE WORKSTATION 4.1 (K020483)GE Medical Systems2002-02-28
SATARI LATEX PATIENT EXAMINATION POWDERED GLOVE SINGLE SIDE POLYMER COATED, NON STERILE, 200 MG OR LESS OF TOTAL WATER E (K014112)Siam Sempermed Corp., Ltd.2002-02-28
STAT PROFILE PHOX ANALYZER (K014295)Nova Biomedical Corp.2002-02-28
RESPIRONICS HEATED HUMIDIFIER (K012633)Respironics, Inc.2002-02-28
MODEL 9210 DELIVERY CATHETER, MODEL 9210 (K013963)Medtronic Vascular2002-02-28
JAS AMYLASE LIQUID REAGENT (K020282)Jas Diagnostics, Inc.2002-02-28
INFRARED EAR THERMOMETER, MODELS TH88 SERIES (K020504)Radiant Innovation, Inc.2002-02-28
LORENZ SELF DRILLING SCREWS (K013954)Walter Lorenz Surgical, Inc.2002-02-28
DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAINING (K020023)Dako Corp.2002-02-28
PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM (K020115)Pulpdent Corp.2002-02-28
BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88) (K013148)Biogenex Laboratories2002-02-28
OCULAR SCIENCES, INC. BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS (K020193)Cl Mcintosh2002-02-28
APPLIED GELPORT LAPAROSCOPIC HAND ACCESS DEVICE (K014047)Applied Medical Resources Corp.2002-02-28
STEALTHSTATION WITH FLUOROMERGE SOFTWARE (K020338)Medtronic Surgical Navigation Technologies2002-02-27
DEPILASE YAG LASE PLUS LASER SYSTEM (K020463)Depilase Group , Ltd.2002-02-27
PULSION FS LASER KERATOME (K013941)Intra Lase Corp.2002-02-27
1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX (K014115)Portex, Inc.2002-02-27
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