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

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RecordFirmDate
chromID Strepto B agar (K163042)bioMerieux, Inc.2017-01-27
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU) (K162924)Hartalega Sdb. Bhd.2017-01-24
Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs (K161823)Wrp Asia Pacific Sdn. Bhd.2017-01-23
Titan 3 Low Speed Angle Attachments (K162397)Dentalez, Inc.2017-01-19
Atellica CH Magnesium (Mg) (K162399)Siemens Healthcare Diagnostics, Inc.2017-01-19
Precision Thin Reciprocating Blade, 0.010in. (K161514)Stryker Corporation2017-01-17
Elecsys CYFRA 21-1 CalCheck 5 (K162173)Roche Diagnostics2017-01-12
Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak (K163015)Bio-Rad Laboratories2017-01-10
Sentinel BreastScan II System (K162767)First Sense Medical, LLC2017-01-09
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) (K162818)Hartalega Sdn Bhd2017-01-09
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs (K162819)Hartalega Sdn Bhd2017-01-09
LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set (K162961)DiaSorin, Inc.2017-01-05
Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender) (K162146)Brightway Holdings Sdn. Bhd.2017-01-05
LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set (K162959)DiaSorin, Inc.2017-01-04
Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table (K162702)Stl International, Inc.2016-12-30
Kuschall K-Series Attract Manual Wheelchair (K162692)Invacare Corporation2016-12-28
Kuschall Advance Manual Wheelchair (K162696)Invacare Corporation2016-12-28
Kuschall Champion Manual Wheelchair (K162686)Invacare Corporation2016-12-28
SMARTO (K163308)Jeil Medical Corporation2016-12-27
ARIES GBS Assay (K162772)Luminex Corporation2016-12-23
CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System (K151545)Polymer Technology Systems, Inc.2016-12-22
Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs (K161215)Brightway Holdings Sdn. Bhd.2016-12-21
DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) (K162259)Zibo Daiyang Plastic Company2016-12-21
EndoVac Pure (K162436)Kerr Corporation2016-12-21
Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green) (K160928)Hartalega Sdb. Bhd.2016-12-20
Vinyl Exam Gloves, Powder Free, Clear (K161390)Zibo Hongchin Plastic and Rubber Co., Ltd.2016-12-19
Chagas Detect Plus Rapid Test (K161947)InBios International, Inc.2016-12-16
Vanguard Dental Unit (K161734)Ritter Concept GmbH2016-12-09
ESTETICA Dental Treatment Unit and Accessories (K161488)Kaltenbach & Voigt GmbH2016-12-08
APEX Manual Wheelchair (K161425)Motion Composites2016-12-05
Lenstec LC Injection system (K161776)Lenstec, Inc.2016-11-29
Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink (K161932)Terang Nusa Sdn Bhd2016-11-28
W&H Implantmed SI-1015 incl. Accessories (K161957)W&H Dentalwerk Burmoos GmbH2016-11-23
Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less (K162175)Vietglove Corporation2016-11-21
Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs (K161944)Shandong Baisheng Medical Products Co., Ltd.2016-11-21
Walk-O2-Bout (K161472)Essex Industries, Inc.2016-11-18
Discovery NM 750b Bopsy (K160933)GE Healthcare2016-11-18
Powder Free Nitrile Examination Gloves Flock-Lined, Black Color (K161074)Shen Wei (Usa), Inc.2016-11-17
Powder Free Nitrile Examination Gloves (Blue) (K162113)Nam Viet Glove Joint Stock Company2016-11-07
Puritan Fecal Opti-Swab Collection and Transport System (K162284)Puritan Medical Products, LLC2016-11-04
Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue) (K162095)Yty Industry (Manjung) Sdn Bhd2016-11-02
BreathID Hp Lab System (K162150)Exalenz Bioscience , Ltd.2016-10-31
Gammex Cut-Resistant Glove Liner (K160974)Ansell Healthcare Products, LLC2016-10-28
Multichem A1c (K162514)Technopath Manufacturing2016-10-26
Relieva UltirraNav Sinus Balloon Catheter (K161698)Acclarent, Inc.2016-10-24
DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (K161422)Wrp Asia Pacific Sdn. Bhd.2016-10-20
HDL-Cholesterol Gen.4 (K162593)Roche Diagnostics Operations (Rdo)2016-10-19
Medline Powder-Free Nitrile Exam Glove Extended Cuff (Tested for Use with Chemotherapy Dr) (K161473)Medline Industries, Inc.2016-10-19
FREND Testosterone Test System (K153577)Nanoentek USA, Inc.2016-10-14
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs (K160562)Hartalega Snd. Bhd.2016-10-13
WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head (K160410)Dental Savings Club2016-09-29
MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology (K160825)Dentsply Sirona2016-09-27
Provicol QM Plus (K161630)Voco GmbH2016-09-15
EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs (K161187)Eco Medi Glove Sdn. Bhd.2016-09-09
HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves (K160709)Halyard Health2016-09-06
EMG Pink Nitrile Examination Glove Powder Free (K161320)Eco Medi Glove Sdn. Bhd.2016-09-01
Cavilon Advanced High Endurance Skin Protectant (K153571)3M Healthcare2016-08-23
Sentinella 102, Sentinella 102 Horus (K162052)General Equipment For Medical Imaging (Oncovision-2016-08-18
EMS-200 (K153285)Meta Systems Co., Ltd.2016-08-12
Audit MicroControls Linearity DROP LQ Blood Glucose (K161874)Aalto Scientific, Ltd.2016-08-10
BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial (K161306)Becton Dickinson2016-08-08
Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove (K161006)Hartalega Sdn Bhd2016-08-04
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) (K160560)Hartalega Sdn Bhd2016-08-04
A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) (K153744)A1 Glove Sdn Bhd2016-08-04
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile (K151750)Kossan International Sdn Bhd2016-08-03
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs, Powder Free Nitrile Patient Examination Glove, White Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs (K151824)Kossan International Sdn Bhd2016-08-02
Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim (K160467)Kossan International Sdn Bhd2016-08-02
Powder free vinyl patient examination glove, colored (yellow) (K160675)Kaixing Plastic Products Co., Litd.2016-08-02
Puritan Opti-Tranz Cary-Blair Collection and Transport System (K160082)Puritan Medical Products, LLC2016-07-29
Powder Free Blue Nitrile Examination Glove (K153732)Qube Medical Product Sdn Bhd2016-07-29
POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE (K161008)Hartalega Sdn Bhd2016-07-28
SinuBand (K160101)Bioinspire Technologies, Incorporated2016-07-27
Atteris No-Sting Skin Protectant (K160684)Rochal Industries, LLC2016-07-26
Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating (K160411)Cardinal Health, Inc.2016-07-25
LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set (K161139)DiaSorin, Inc.2016-07-22
SUNCO Mechanical Wheelchair, model SKW-9003 (K153328)Danyang Sunco Machinery Co., Ltd.2016-07-20
EPIC ClearView System (DEN150004)Epic Research & Diagnostics, Inc.2016-07-15
Powder Free Grey Vinyl Examination Gloves (K161072)Zibo Flourish Trading Co., Ltd.2016-07-14
Soberlink Cellular Device and Sober Sky Web Portal (K160613)Soberlink Healthcare, LLC2016-07-14
Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating (K160875)Cardinal Health, Inc.2016-07-11
Easy-Load Lens Delivery System (K161012)Bausch and Lomb, Inc.,2016-07-06
LIAISON EBV IgM Serum Control Set (K161522)DiaSorin, Inc.2016-06-30
LIAISON CMV IgM Serum Control Set (K161526)DiaSorin, Inc.2016-06-30
ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material (K151986)Siemens Healthcare Diagnostics, Inc.2016-06-29
Vent-Os Sinus Dilation family (K160770)Sinusys Corporation2016-06-29
Synthetic Vinyl Examination Gloves, Powder-Free, Yellow (K160468)Inpro Technology Device Factory2016-06-23
EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented (K152937)Eco Medi Glove Sdn. Bhd.2016-06-23
DermaTherapy Bed Linens (K152884)Precision Fabrics Group, Inc.2016-06-20
Getinge Series Warming Cabinet (K153713)Getinge Sourcing, LLC2016-06-07
Medipure Oxygen-LC System (K153518)Praxair Distribution, Incorporated.2016-06-03
FirstSense Breast Exam (K160573)First Sense Medical, LLC2016-06-01
DCI Edge Dental Chair with Operative Unit (K151987)Dci2016-06-01
Yongchang Powder-Free Yellow Vinyl Patient Examination Gloves (K152818)Ideal Plastic Co., Ltd.2016-05-26
Noxilizer Surgical Ruler (K160501)Noxilizer, Inc.2016-05-26
Kudu (K151492)R82 A/S2016-05-20
IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers (K161082)Immunodiagnostic Systems , Ltd.2016-05-17
Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow) (K153316)Cardinal Health, Inc.2016-05-12
Standard Clamp (K153358)Standard Bariatrics2016-05-02
Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs (K151390)Maxter Glove Manufacturing Sdn Bhd2016-05-02
CueSee Hypoxic (K152553)Eurotrol B.V.2016-04-22
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