Atlas FDA

1

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

Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green (K180644)Hartalega Sdn Bhd2018-08-10
Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs (K180221)Smart Glove Corporation Sdn. Bhd.2018-08-08
OptiPillows EPAP Mask (K181219)Cpapnea Medical Supply2018-08-03
MolecuLight i:X (DEN180008)MolecuLight, Inc.2018-07-31
Panther Fusion GBS Assay (K181156)Diagenode2018-07-27
RxSight Insertion Device (K181401)Rxsight, Inc.2018-07-26
Dental High-speed Handpiece and Accessories (K173943)Microp Technology (Taiwan), Inc.2018-07-24
Free Testosterone AccuBind ELISA Test System (K181017)Monobind, Inc.2018-07-20
Sterile Latex Surgical Gloves, Powder Free (K171550)Sanrea Healthcare Products Pvt, Ltd.2018-07-13
High-speed Turbine Handpieces for Single Use (K172543)Beijing Dongbo Dental Handpiece Co., Ltd.2018-07-11
PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs (K173766)Shen Wei USA, Inc.2018-07-08
Nitrile Patient Examination Powder Free Glove, Textured, Black (K161085)Multisafe Sdn. Bhd.2018-07-05
Alleye (K180895)Oculocare Medical AG2018-06-27
Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs (K180646)Halyard Health2018-06-27
NeuMoDx GBS Assay (K173725)Neumodx Molecular, Inc.2018-06-26
Surgic Pro, Surgic Pro+ (K173905)Nakanishi, Inc.2018-06-19
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White) (K180505)Hartalega Sdn Bhd2018-06-14
Vinyl Examination Glove (Clear, Non-Colored) (K180861)Zhicheng Trading Co., Ltd.2018-06-13
Powder Free Vinyl Patient Examination Gloves (Yellow, White) (K180260)Shanxi Hongjin Plastic Technology Co., Ltd.2018-06-12
White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim (K180452)Riverstone Resources Sdn Bhd2018-06-12
Vinyl Examination Glove (Clear, Non-Colored) (K180849)Huifu Trading Co., Ltd.2018-06-11
Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color (K171422)Ever Global (Vietnam) Enterprise Corp2018-06-11
POWDER FREE LATEX EXAMINATION GLOVE (K173053)Professional Latex Sdn Bhd2018-06-06
Magnesium (K173294)Abbott Laboratories2018-05-18
Athena 190 (K173360)Medical Rehab Products, LLC2018-05-17
IS3 (K180527)Hiossen, Inc.2018-05-16
Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (K180476)Comfort Rubber Gloves Industries Sdn. Bhd.2018-05-15
Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange (K172867)Gmp Medicare Sdn Bhd (F25)2018-05-10
TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System (K173345)Taidoc Technology Corporation2018-05-04
Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (K172864)Maxter Glove Manufacturing Sdn Bhd2018-05-02
BacterioScan 216Dx System (K172412)Bacterioscan, Inc.2018-05-01
Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal (Tested for use with Chemotherapy Drugs) (K180696)Medline Industries, Inc.2018-04-30
Finessis Intense Polyisoprene Surgical Glove (K173304)Lucenxia Prescience AG2018-04-30
P50 Series Dental Operative Unit and Accessories (K171872)Pelton & Crane2018-04-26
Nitrile Examination Powder Free Glove, White, Black, Orange, Nitrile Examination Powder Free Gloves Tested For Use With Chemotherapy Drugs, Blue (K172923)Top Glove Sdn. Bhd.2018-04-26
Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy (K173258)Pt. Medisafe Technologies2018-04-20
KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System (K170463)I-Sens, Inc.2018-04-13
mCare Powder-free Blue Nitrile Examination Gloves (K172930)Mercator Medical (Thailand), Ltd.2018-04-13
D-Actor 200 Vibration Massage System (K173692)Storz Medical AG2018-04-13
VisuMax Femtosecond Laser (K173371)Carl Zeiss Meditec, Inc.2018-04-13
Finessis Zero Flexylon Powder Free Sterile White Surgical Glove Tested for use with Chemotherapy Drugs (K173386)Lucenxia Prescience AG2018-04-09
Mission Lipid Panel Monitoring System (K180504)ACON Laboratories, Inc.2018-03-28
Concentrix MX-AC High-Speed Handpiece (K173465)Dentalez, Inc.2018-03-28
UriSwab-Urine Collection, Transport and Preservation System (K180052)Copan Italia Spa2018-03-23
Granada Medium (K173903)Hardy Diagnostics2018-03-22
BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial (K173873)Becton, Dickinson and Company2018-03-16
Powder-free Clear Vinyl Patient Examination Gloves (K173078)Yongsheng Medical Products Co., Ltd.2018-03-09
Intellitorq (K180092)Gauthier Biomedical, Inc.2018-03-08
BreathID Hp System (K173772)Exalenz Bioscience , Ltd.2018-03-08
BreathID Hp Lab System (K173777)Exalenz Bioscience , Ltd.2018-03-08
Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (K173942)Central Medicare Sdn Bhd2018-03-05
KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black) (K171171)Koon Seng Sdn Bhd2018-02-22
U-MED Powder Free Polyethylene Examination Gloves,Blue Color (K173228)Jiangsu U-Med Rubber & Plastic Products Co., Ltd.2018-02-20
SPIWay Endonasal Access Guide (K180141)Spiway, LLC2018-02-16
Vinyl Patient Examination Glove (Yellow) (K173580)Nature Medical Products Co., Ltd.2018-02-15
Vinyl Patient Examination Glove (Yellow) (K173561)Yurun Glove Co., Ltd.2018-02-12
Gammex PI Breach Detect Powder Free Surgical Glove (K171375)Ansell Healthcare Products, LLC2018-02-06
SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES) (K171367)Sanrea Healthcare Products Pvt, Ltd.2018-01-26
CAMPYLOBACTER CHEK (K173219)Techlab, Inc.2018-01-22
CAMPYLOBACTER QUIK CHEK (K173217)Techlab, Inc.2018-01-22
Nurture Rest (K172962)Neonatal Loving Kare, Inc.2018-01-18
Aleo BME Liquid Bandage (K171148)Aleo Bme, Inc.2018-01-12
Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein (K172942)Beta Healthcare Products Pvt., Ltd.2018-01-08
STRONG Dental Handpieces (K171436)Saeshin Precision Co., Ltd.2018-01-05
Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves (K171737)Ansell Healthcare Products, LLC2017-12-29
Disposable Powder Free Vinyl Exam Glove, Clear/Yellow (K172357)Ever Growth (Vietnam) Co. , Ltd.2017-12-29
Solana GBS Assay (K173250)Quidel Corporation2017-12-21
Sofia Strep A+ FIA, Sofia 2 Analyzer (K171976)Quidel Corporation2017-12-21
PERIO-FLOW nozzle (K171174)E.M.S Electro Medical Systems S.A2017-12-18
pioli IOL Delivery System (K172228)Ast Products, Inc.2017-12-15
Composite Removable Sinus Stent System (K170913)Sts Medical2017-12-15
Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) (K173017)Anhui Kindguard Medical Supplies Technology Co., Ltd.2017-12-15
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink) (K173137)Hartalega Sdn Bhd2017-12-12
MESIRE - Balloon Sinus Dilatation System (K172737)M/S. Meril Life Sciences Private Limited2017-12-12
Crystalsert Lens Delivery System (K173480)Bausch & Lomb, Inc.2017-12-11
W&H Assistina Twin (K171553)W&H Dentalwerk Buermoos GmbH2017-12-08
Med-Hot Thermal Imaging Systems (K171928)Med-Hot Thermal Imaging, Inc.2017-12-08
Orange Non Sterile Powder Free Nitrile Examination Gloves (K172642)Central Medicare Sdn Bhd2017-11-28
THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE (K172678)Shen Wei USA, Inc.2017-11-24
Dental Low-speed Turbine Handpiece (K170236)Guangdong Jinme Medical Technology Co., Ltd.2017-11-21
Powder Free Pink Polychloroprene Copolymer Examination Gloves, Powder Free Black Polychloroprene Copolymer Examination Gloves (K171743)Smart Glove Corporation Sdn. Bhd.2017-11-17
Merits Model R106/R136 Rehab Wheelchair (K170517)Merits Healthcare Industries (Suzhou) Co., Ltd.2017-11-16
Kindguard Powder Free Vinyl Patient Examination Gloves, Light Yellow Color (K173016)Anhui Kindguard Medical Supplies Technology Co., Ltd.2017-11-15
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs (K171873)Zhonghong Pulin Medical Products Co., Ltd.2017-11-15
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (K172525)Central Medicare Sdn Bhd2017-11-13
Dental High-speed Turbine Handpiece (K170229)Guangdong Jinme Medical Technology Co., Ltd.2017-11-08
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) (K172442)Hartalega NGC Sdn. Bhd.2017-11-06
EPI K Console (K172994)Moria SA2017-10-26
STERILE VINYL EXAMINATION GLOVES, Powder Free (K170612)Primus Gloves Pvt Limited2017-10-23
Finessis Zero Flexylon Powder Free Sterile White Surgical Glove (K171987)Lucenxia Prescience AG2017-10-20
Premium Plus Prophy Air Motor (K170261)Premium Plus International Limited2017-10-19
Convaid Flyer FL12, FL13, FL14, FL15 and FL16; Convaid Flyer transit FL12T, FL13T, FL14T, FL15T and FL16T (K171017)Convaid Products, LLC2017-10-18
Chitogel Endoscopic Sinus Surgery Kit (K172179)Chitogel, Ltd.2017-10-17
SuperNO2VA Device (K163277)Revolutionary Medical Devices, Inc.2017-10-13
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use With Chemotherapy Drugs (Dawn Blue) (K171874)Hartalega Sdn Bhd2017-10-12
Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy drugs (K171782)Blue Sail Medical Co.,Ltd2017-10-12
Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and Sterile Latex Surgical Powder Free Gloves (K171279)Top Glove Sdn. Bhd.2017-10-12
Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim (K172420)Wear Safe (Malaysia) Sdn. Bhd.2017-09-29
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED) (K172015)Careglove Global Sdn. Bhd.2017-09-26
Powder-free Clear Vinyl Patient Examination Gloves (K171460)Shandong Zhiwei Medical Products, Co. , Ltd.2017-09-24
← Previous Next →

Track 1 automatically

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