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
OX-SOX, MODEL C, D, E, (K062300)Pattient Safety Innovations, Llp2006-11-27
CARDIAC MARKERS CONTROL AND CALIBRATION VERIFICATION CONTROL SET (K062593)Compass Bioscience2006-11-22
ENAMEL PRO (K062166)Premier Dental Products Co.2006-11-21
D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT (K061101)Diagnostic Hybrids, Inc.2006-11-20
TRU-MR LARYNGOSCOPE SET (K062523)Truphatek International, Ltd.2006-11-17
NITRILE POWDER FREE EXAMINATION GLOVES (GREEN) (K063046)Hartalega Sdn Bhd2006-11-17
RAPIRUN H. PYLORI ANTIBODY DETECTION KIT (K052716)Otsuka Pharmaceutical Co., Ltd.2006-11-16
SDIF DENTAL CHAIR WITH OPERATIVE UNIT AND ACCESSORIES (K063302)Shanghai Dental Instrument Factory2006-11-15
VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM (K063144)Ortho-Clinical Diagnostics, Inc.2006-11-13
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED) (K062884)Suqian Green Glove Co., Ltd.2006-11-09
POWDER FREE LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE (K062955)Pt. Haloni Jane2006-11-09
LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM (K062930)Alcon Research, Ltd.2006-11-08
CELLU M6 KEYMODULE I (K053225)Lpg One, Inc.2006-11-06
SYNTHETIC VINYL PATIENT EXAM GLOVES POWDER-FREE, YELLOW (K062715)Baoding Guanzhong Glove Co., Ltd.2006-11-03
SENSTOUCH POWDER FREE EXAMINATION GLOVES, NON STERILE (K061233)Pt Mahakarya Inti Buana2006-11-03
RF SURGICAL SYSTEMS INC. DETECTION SYSTEM, MODEL 100A (K062642)Rf Surgical Systems, Inc.2006-11-02
JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU (K062740)Jindell Medical Instruments Co., Ltd.2006-11-02
STERILE AND NON-STERILE POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WITH EXTRACTABLE PROTEIN CONTENT LABELING CLAIM (50 (K062917)Wear Safe Malaysia Sdn. Bhd.2006-11-02
MEDLINE SURGICAL SPONGE SCANNER (K061316)Medline Industries, Inc.2006-11-02
BREATH ALCOHOL TEST SYSTEM, MODEL AL-5000 (K061922)Sentech Korea Corp.2006-10-30
QUANTIMETRIX NICOSURE COTININE URINE CONTROL (K062942)Quantimetrix Corp.2006-10-30
STERILE POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED (K062778)Wear Safe Malaysia Sdn. Bhd.2006-10-27
CST61 HIGH SPEED TURBINE HANDPIECE (K063110)Shanghai Dental Instrument Factory2006-10-26
C. ALBICANS PNA FISH (K062461)Advandx, Inc.2006-10-25
REMCORE REMOTE CONTROLLED OXYGEN REGULATOR (K060265)Remcore, Inc.2006-10-25
KOZY COMFORT INFANT POSITIONER (K062143)Alfred E Mann Inst. For Biomedical Engineering2006-10-24
CATALYSY (K062660)Ki Mobility, LLC2006-10-24
CLINIQA LIQUID QC CARDIAC MARKER CONTROL SP, LEVELS 1,2, &3 (K062916)Cliniqa Corporation2006-10-23
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED) (K062882)Suqian Green Glove Co., Ltd.2006-10-20
MEDHOT MTI 2000 THERMAL IMAGING SYSTEM (K063047)Medhot Thermal Imaging, Inc.2006-10-19
K-SPRAY, MODEL 085-2715 (K062418)Scican2006-10-19
NASOPORE EAR, MODELS ND04, ND05 (K062540)Polyganics B.V.,2006-10-18
LIAISON EA IGG (K060204)DiaSorin, Inc.2006-10-18
POWERTOME PERIOTOME (K063007)Westport Medical, Inc.2006-10-17
AUDIT MICROCV IMMUNOASSAY LINEARITY SET (K062668)Aalto Scientific, Ltd.2006-10-16
APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM (K061413)Gen-Probe, Inc.2006-10-13
PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS (K062972)Roche Diagnostics Corp.2006-10-13
POWDERED VINYL PATIENT EXAMINATION GLOVES (K062520)Jiangsu Jaysun Glove Co., Ltd.2006-10-11
KARMA MANUAL WHEELCHAIR, MODELS S-ERGO 305 AND S-ERGO 105 (K062309)Karma Medical Products Co., Ltd.2006-10-10
URASSIST (K062061)Preferred Medical Devices, Inc.2006-10-05
POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE; POWDER FREE POLYCHLOROPRENE STERILE EXAMINATION GLOVE (K062138)Molnlycke Health Care, Inc.2006-10-05
KARMA MANUAL WHEELCHAIR, MODEL BUDGET 800 (K062311)Karma Medical Products Co., Ltd.2006-10-04
MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER (K062751)Quantimetrix Corp.2006-10-03
VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 901 (K062501)Maine Standards Co.2006-09-29
INFANT HEEL WARMER BY INTCO (K053254)Shanghai Intco Medical Supply Co., Ltd.2006-09-19
POWDERED (WHITE) VINYL PATIENT EXAMINATION GLOVES (K062655)Shijiazhuang Junfei Plastic Products Co., Ltd.2006-09-18
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K061659)Tangshan Luxiong Plastic Products Co., Ltd.2006-09-15
PREVU POINT OF CARE SKIN STEROL TEST (K062092)Premd, Inc.2006-09-15
ETHMOID SINUS SPACER (K062458)Acclarent, Inc.2006-09-15
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K061662)Tangshan Luxiong Plastic Products Co., Ltd.2006-09-15
MAMMOPAD RADIOLUCENT CUSHION (K062141)Biolucent, Inc.2006-09-13
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K062522)Jiangsu Jaysun Glove Co., Ltd.2006-09-08
QUICKVUE RSV (20 TEST KIT), MODEL 20193; (2 TEST KIT), MODEL 20199 (K061008)Quidel Corp.2006-09-08
CYL-FIL OXYGEN SYSTEM (K061785)Responsive Respiratory, Inc.2006-09-07
ZYOPTIX XP EPI SEPARATOR SYSTEM (K062465)Bausch & Lomb, Inc.2006-09-06
DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE (K062316)Dade Behring, Inc.2006-09-06
TEXTURED POWER FREE BP2000 (BUTADIENE POLYMER) EXAM GLOVES, NATURAL COLOR (K062067)Shen Wei (Usa), Inc.2006-09-06
MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL 310002 (K062230)Minrad, Inc.2006-08-31
MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, STANDARD, MODEL 310001 (K062231)Minrad, Inc.2006-08-31
HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H) (K061701)J. Morita USA, Inc.2006-08-25
N LATEX CDT (K060677)Dade Behring, Inc.2006-08-25
POWDER FREE LATEX EXAMINATION GLOVES, NATURAL OR BLUE COLOUR AND WITH PROTEIN CONTENT LABELING CLAIM (50 UG OR LESS) (K061551)Medipure Corporation (M) Sdn. Bhd.2006-08-24
DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516 (K062191)Dade Behring, Inc.2006-08-21
RELIEVA SINUS BALLOON CATHETER (K061903)Acclarent, Inc.2006-08-18
PEDI-SPIDER STRAP (K061721)Emergency Products and Research2006-08-17
JAN MAO WHEELCHAIR, MODELS JMC612-FL318EPP AND JMC612-FL418EPP (K062218)Jan Mao Industries Co., Ltd.2006-08-16
EXCEL HIGH SPEED DENTAL HANDPIECE (K061581)Orthosource, Inc.2006-08-16
ACON URINALYSIS REAGENT STRIPS (K061559)Acon Laboratories Co.2006-08-11
COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS (K053287)Roche Diagnostics Corp.2006-08-10
DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR (K061793)Dade Behring, Inc.2006-08-07
COUGAR WHEELCHAIR (K061810)R82 A/S2006-08-07
PRODRIVE SYSTEMS REPLACEMENT TURBINE (K062219)Prodrive Systems, Inc.2006-08-04
BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS (K061383)B.T.I. Biotechnology Institute, Sl.2006-08-03
POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED (BLUE AND WHITE) (K061724)Smart Glove Corp. Sdn Bhd2006-07-25
XPERT, GENEXPERT DX SYSTEM (K060540)Cepheid2006-07-25
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088 (K053446)Gen-Probe, Inc.2006-07-25
COMPACT PLUS - EXTREME - PERFECT PLUS (K052574)J.O. Suarez & Cia, Ltda2006-07-17
NON-STERILE, POWDER-FREE BLACK NITRILE EXAMINATION GLOVES (K061553)Yty Industry (Manjung) Sdn Bhd2006-07-17
HEAD BED (K060986)Steven H. Warnock, M.D.2006-07-11
VINYL CO-POLYMER POWDER FREE EXAMINATION GLOVES, BLUE COLOR (K061562)Grand Work Plastic Products Co., Ltd.2006-07-11
TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414 (K060788)Biosite Incorporated2006-07-10
POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES W/ALOE VERA, GREEN COLOR (K060785)Ever Light Plastic Products Co., Ltd.2006-07-07
ADVIA IMS CPSA CONTROL (K061137)Bayer Healthcare, LLC2006-07-06
BARRIERPLUS GOLD POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES (K053406)Barriermed Glove Co.2006-07-05
MEDCARE MECHANICAL WHEELCHAIR, MODELS MC-281S & MC-200S (K061694)Medcare Manufacturing, Inc.2006-07-05
CHOLINESTERASE GEN.2 TEST SYSTEM (K061093)Roche Diagnostics Corp.2006-07-03
THE DOUBLE GLOVE (K060030)Biobarrier, Inc.2006-06-27
TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE) (K051573)Dr. Howard Martin, P.A.2006-06-26
COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM (K061301)Copan Diagnostics, Inc.2006-06-23
BARRIERPLUS PLATINUM POWDER-FREE SYNTHETIC POLYCHLOROPRENE SURGICAL GLOVES, MODELS 12544-125490 (K061038)Barriermed Glove Co.2006-06-23
DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT (K060510)Drew Scientific , Ltd.2006-06-19
3M LIQUID BANDAGE (K053409)3M Company2006-06-19
CUTICOVER SKIN BARRIER DEVICE (K042955)D & D Holdings, LLC2006-06-19
VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668 (K061464)Ortho-Clinical Diagnostics, Inc.2006-06-15
BLUE POWDER FREE NITRILE EXAMINATION GLOVES (K052583)Hartalega Sdn Bhd2006-06-14
ASTROTILT MANUAL WHEELCHAIR (K061475)Pdg Product Design Group, Inc.2006-06-14
EASY X-TRAC SYSTEM (K060691)A. Titan Instruments, Inc.2006-06-12
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE, BLACK COLOUR) (K060402)Brightway Holdings Sdn. Bhd.2006-06-09
LATEX POWDERED EXAMINATION GLOVE (K060858)High Momentum Sdn Bhd2006-06-08
POWDERED FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K060910)Jiangsu Everyguard Plastic Products Co., Ltd.2006-06-07
← Previous Next →

Track 1 automatically

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