Atlas FDA

1

32,815 FDA 510(k) clearances · Device class

Sort:Newest firstOldest first

Download CSV table Client report (share link) ◉ Watch

Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.

RecordFirmDate
POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING CLAIM (K030157)Wrp Asia Pacific Sdn. Bhd.2003-02-19
ST. GEORGE TECHNOLOGY, INC PERFECTION PLUS DISPOSABLE PROPHY ANGLE (K023953)St. George Technology, Inc.2003-02-14
POWDER FREE NITRILE EXAMINATION GLOVES, PURPLE COLOR (K023072)Arista Latindo Industrial Ltd. P.T2003-02-13
ALOE VERA & VITAMIN E POWDERFREE LATEX EXAMINATION GLOVES (K023974)Top Glove Sdn. Bhd.2003-02-13
MULTIPLE PATIENT EXAMINATION GLOVES POWDERED LATEX (K022815)Pt. Smartglove Indonesia2003-02-13
WIENER LAB COLINESTERASA AA (K023992)Wiener Laboratories Saic2003-02-12
STERILE POWDERED LATEX PATIENT EXAMINATION GLOVES (K023915)Sanrea Healthcare Private Limited2003-02-11
WAKO NEFA LINEARITY SET (K030065)Wako Chemicals USA, Inc.2003-02-11
STERILE PATIENT POWDERFREE LATEX EXAMINATION GLOVES (K023910)Sanrea Healthcare Private Limited2003-02-11
MARK I THERMAL IMAGER (K023925)Ix-Dr, Inc.2003-02-11
POWDER FREE LATEX SURGEON'S GLOVES CONTAINS 50 MEGM OR LESS OF TOTAL WATER EXTRACTABLE PER GRAM (K023912)Sanrea Healthcare Private Limited2003-02-11
ACON STREP A TWIST TEST DEVICE (K023766)Acon Laboratories Co.2003-02-10
NESS CHILDREN SYSTEM (K024279)Ness-Neuromuscular Electrical Stimulation Systems2003-02-05
STARMATRIX POWDER FREE LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (K023715)Starmatrix Sdn Bhd2003-02-04
EVERGREEN NON-STERILE POWDERED NATURAL OR COLORED LATEX EXAMINATION GLOVE (K024355)Yty Industry (Manjung) Sdn Bhd2003-02-03
POWDERED VINYL EXAMINATION GLOVES (K024016)Top Glove (Zhangjiagang) Co. , Ltd.2003-02-03
LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPER (K023688)LeMaitre Vascular, Inc.2003-01-30
OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV) (K023677)Osmetech2003-01-29
SAS RSV TEST (K022845)Sa Scientific, Inc.2003-01-29
NON-DEHP, POWDER FREE VINYL EXAMINATION GLOVES (K024174)General Gloves Corp.2003-01-28
UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100 (K023764)Beckman Coulter, Inc.2003-01-28
SOFT TISSUE ANCHORING WASHERS (K030031)Accu-Speed, Incorporated2003-01-28
DISPOSBLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR (K024081)Safehealth Medical Supply Corp.2003-01-28
LINICAL PROTEIN 5 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY AND IMMAGE PROTEIN SYSTEMS (K030150)Cliniqa Corporation2003-01-28
NITRILE EXAMINATION GLOVES, POWDER FREE (K023978)Starmatrix Sdn Bhd2003-01-24
PICCOLO TRIGLYCERIDES TEST SYSTEM (K023639)Abaxis, Inc.2003-01-24
NITRILE EXAMINATION GLOVES, PRE-POWDERED (K023979)Starmatrix Sdn Bhd2003-01-24
POWDER FREE POLYMER COATED (ACRYLIC BASED) PATIENT EXAMINIATION GLOVES (K023866)Kl-Kepong Rubber Products Sdn. Bhd.2003-01-24
GOOD LUBRICATIONS (K020586)Biofilm, Inc.2003-01-24
ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3 (K030102)Bayer Healthcare, LLC2003-01-24
PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (K023977)Starmatrix Sdn Bhd2003-01-24
SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE-BLUE COLOR (K023826)Syntex Healthcare Products Co., Ltd.2003-01-24
PICCOLO TOTAL CHOLESTEROL TEST SYSTEM (K023642)Abaxis, Inc.2003-01-24
PICCOLO HDL TEST SYSTEM (K023640)Abaxis, Inc.2003-01-24
DIMISIL SCAR GEL (K023678)Aesthetic and Reconstructive Technologies, Inc.2003-01-23
TRIAGE CARDIAC CONTROLS; TRIAGE CARDIO PROFILER CONTROLS (K030089)Biosite Incorporated2003-01-23
OSTEO-CABLE SLEEVE (K024022)Biomet, Inc.2003-01-23
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS (K030067)Ortho-Clinical Diagnostics2003-01-17
TRIAGE CARDIAC CALIBRATION VERIFICATION CONTROLS, TRIAGE CARDIO PROFILER CALIBRATION VERFICICATION CONTROLS (K030088)Biosite Incorporated2003-01-17
PRE-POWDERED LATEX SURGEON'S GLOVES (K023515)Sanrea Healthcare Private Limited2003-01-16
DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES WITH SKIN-CARE INGREDIENTS (VITAMIN A, VITAMIN B, OC-LIPOIC ACID, EUCAL (K023490)Wrp Asia Pacific Sdn. Bhd.2003-01-16
MAYBE?MOM MINI OVULATION MICROSCOPE (K013582)Maybe?Mom2003-01-16
RDH-2000 (K023213)Anodia Systems2003-01-16
RSV OIA (K023779)Thermo Biostar, Inc.2003-01-14
POWDER-FREE COATED NITRILE EXAMINATION GLOVE, BLUE COLORED (K024184)Perusahaan Getah Asas Sdn. Bhd.2003-01-14
LIQUISHIELD-S (0.7G), MODEL LS 0010, LIQUISHIELD-S (2.0G), MODEL LS 0020 (K023163)Medlogic Global Limited2003-01-13
GREEN POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH PEPPERMINT FLAVOR (K024083)Supermax Glove Manufacturing Sdn Bhd2003-01-10
KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105 (K021634)King Systems Corp.2003-01-09
MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN AND CHEMOTHERAPY LABELING CLAIM (K024292)Allegiance Healthcare Corp.2003-01-09
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR (K023728)Canopus Medical Supply Co., Ltd.2003-01-07
SHANGHAI HUAMAO POWDER-FREE YELLOW VINYL EXAM GLOVES (K024154)Shanghai Huamao Gloves Co., Ltd.2003-01-06
VALIDATE CHEM 10 CALIBRATION VERIFICATION TEST SET, MODEL 110 (K023410)Maine Standards Co.2003-01-06
ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101 (K023373)Gvi Technology Partners2003-01-03
IMMUNOCARD STAT! E. COLI O157 PLUS (K023599)Meridian Bioscience, Inc.2003-01-03
POWDER FREE POLYMER COATED GREEN NEOPRENE SURGICAL GLOVES, STERILE (K024130)Wrp Asia Pacific Sdn. Bhd.2002-12-30
BALDUR BRAND VINYL POWDER-FREE EXAMINATION GLOVES (K022091)Tangshan Zhonghong Pulin Group Co., Ltd.2002-12-30
GALAXY SERIES WHEELCHAIR (K023993)Evermed Corp.2002-12-27
MASTEL 1 FOLDER IMPLANTATION SYSTEM (K022723)Mastel Precision, Inc.2002-12-26
AMMONIA ASSAY FOR THE ADVIA 1650 (K023841)Bayer Diagnostics Corp.2002-12-24
QUICKCHECK LIQUID CHEMISTRY CONTROL (ASSAYED AND UNASSAYED), LEVELS 1, 2, AND 3 (K023731)Consolidated Technology2002-12-24
RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER (K023784)Hemagen Diagnostics, Inc.2002-12-24
NON-STERILE, POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING, VITAMIN E AND PROTEIN CLAIM (K024106)Siam Sempermed Corp., Ltd.2002-12-20
TILITE EVO (K024055)Tisport, LLC2002-12-20
NON-STERILE, POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING, ALOE, VITAMIN E AND PROTEIN CLAIM (K024121)Siam Sempermed Corp., Ltd.2002-12-20
MAS CARDIOIMMUNE TL LOW LEVEL LIQUID ASSAYED CARDIAC MARKER CONTROL, DADE CARDIAC TL LOW LEVEL LIQUID ASSAYED CARDIAC MA (K023669)Medical Analysis Systems, Inc.2002-12-19
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, VIOLET COLOR (K024025)Kossan Latex Industries(M)Sdn Bhd2002-12-18
DFA RESPIRATORY VIRUS SCREENING & ID KIT (K022713)Diagnostic Hybrids, Inc.2002-12-18
POWDER-FREE NITRILE EXAM GLOVES, COLOR: BLUE (K023702)Ningbo Tianshun Rubber Products Co., Ltd.2002-12-18
ANDREWS INTRODUCER, MODEL ASI01 (K023173)Andrews Surgical Innovations, Ltd.2002-12-18
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR (K024026)Shanghai PM Plastics Enterise Co., Ltd.2002-12-18
DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (K024102)Allegiance Healthcare Corp.2002-12-18
ST AIA-PACK TESTOSTERONE ASSAY (K023091)Tosoh Medics, Inc.2002-12-17
MAS T-MARKER, LEVEL 1,2 AND 3, DADE SPECIAL-T MARKER, LEVEL 1,2 AND 3 (K023867)Medical Analysis Systems, Inc.2002-12-17
ENVIRON-NP DISPOSABLE VINYL EXAM GLOVES, POWDERED (K023560)Shanghai Palomar Mountain Industries, Inc.2002-12-17
KERATOME BLADE 200200 & 600600 (K020482)Micro Specialties, Inc.2002-12-16
MILLENNIUM SERIES MANUAL WHEELCHAIRS (K024030)Evermed Corp.2002-12-12
SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE (K023232)Smartpractice2002-12-11
MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS CONTROL (K023928)Medical Analysis Systems, Inc.2002-12-11
BD DIRECTIGEN EZ RSV KIT (K022133)Becton, Dickinson & CO2002-12-10
WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA (K023550)Wiener Laboratories Saic2002-12-09
LINICAL RF-CRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS (K023661)Cliniqa Corporation2002-12-06
POWDER FREE LATEX EXAM GLOVES, POLY COATED NATURAL AND/OR COLORED, WITH PROTEIN LABELING (<50UN/G) (K023577)Yty Industry (Manjung) Sdn Bhd2002-12-06
GIZMO (K023574)Freedom Designs, Inc.2002-12-04
MOTEX LATEX EXAMINATION GLOVES, POWDER-FREE (K020837)Shanghai Motex Healthcare Co., Ltd.2002-12-02
DERMAGRIP-P POWDER FREE PINK NITRILE EXAMINATION GLOVES, NON-STERILE (K023517)Wrp Asia Pacific Sdn. Bhd.2002-12-02
SST SALIVA SUPPORTING TABLETS (K023046)Sinclair Pharmaceuticals, Ltd.2002-12-02
EVER-MORE POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVES (K023523)Ever-More Latex Products Sdn Bhd2002-11-29
EVER-MORE POWDER-FREE LATEX EXAMINATION GLOVES, BLUE COLOR (K023522)Ever-More Latex Products Sdn Bhd2002-11-29
ELECSYS PROBNP CALCHECK (K020883)Roche Diagnostics Corp.2002-11-29
EVER-MORE POWDER-FREE LATEX EXAMINATION GLOVES (K023524)Ever-More Latex Products Sdn Bhd2002-11-29
MY BREAST FRIEND, BREAST SELF-EXAM PAD (K023390)Mbf Sales, LLC2002-11-26
VALIDATE CHEM 9 CALIBRATION VERIFICATION TEST SET, MODEL 109 (K023352)Maine Standards Co.2002-11-22
QUICKLAB RSV (K021789)Integrated Biotechnology Corp.2002-11-20
INSOUND XT SERIES HEARING AID (K021867)Insound Medical, Inc.2002-11-19
TILITE YG AND TILITE YGS (K023606)Tisport2002-11-19
FREEFORM BLUE POWDERFREE NITRILE EXAMINATION GLOVES (K022671)Hartalega Sdn Bhd2002-11-18
IDI-STREP B ASSAY (K022504)Infectio Diagnostic, Inc.2002-11-18
PTS PANELS LIPID PANEL TEST STRIPS (K023558)Polymer Technology Systems, Inc.2002-11-15
MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB (K022982)Med-Logics, Inc.2002-11-15
BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES (K022900)John O. Butler Co.2002-11-14
← Previous Next →

Track 1 automatically

Every clearance here is in the API, with alerts when new ones post.