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

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RecordFirmDate
NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs (K152222)Gmp Medicare Sdn Bhd (F25)2016-04-21
Dropper hsCRP High Sensitivity CRP Control (K152117)Quantimetrix Corporation2016-04-21
GLAUCOMA COMPANION (DEN140022)Innovatex, Inc.2016-04-20
Nitrile Patient Examination gloves, Powderfree, Blue color (K143477)Primus Gloves Pvt Limited2016-04-14
JRP Wound Spreader (K152538)J.R. Parker, LLC2016-04-13
430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece (K153411)Dentalez, Inc.2016-04-08
HG Pro Nitrile Powder Free Examination Gloves (K152479)Healthy Glove Co., Ltd.2016-04-04
Powder Free Blue Nitrile Examination Glove (K153562)Vietglove Corporation2016-04-01
Halyard Black-Orange Powder-Free Nitrile Exam Glove (K153708)Halyard Health2016-03-31
Pure Tilt (K152021)Proactive Comfort, LLC2016-03-31
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU) (K151997)Hartalega NGC Sdn. Bhd.2016-03-31
SensiCare PI Surgical Gloves (K152428)Medline Industries, Inc.2016-03-31
Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating (K151778)Cardinal Health 200, Inc.2016-03-24
Glide-On Vinyl Examination Gloves (K151754)Medline Industries, Inc.2016-03-22
Powder Free Polychloroprene Examination Glove Green (K153510)Terang Nusa Sdn Bhd2016-03-21
Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) (K151845)CooperSurgical, Inc.2016-03-18
Minghao Nitrile Powder Free Patient Examination Gloves, Blue Color (K152707)Minghao Medical Products Co., Ltd.2016-03-17
Jiayuan Nitrile Powder Free Patient Examination Gloves, Blue Color (K152705)Jiayuan Medical Products Co., Ltd.2016-03-17
ImmunoCard STAT! HpSA (K153661)Meridian Bioscience, Inc.2016-03-14
Xingda Nitrile Powder Free Patient Examination Gloves, Blue Color (K152720)Xingda Medical Products Co., Ltd.2016-03-10
Nitrile Powder Free Patient Examination Gloves, Blue Color (K152712)Zhonghong Pulin Medical Products Co., Ltd.2016-03-09
Gammex PI Hybrid Surgical Gloves (K151694)Ansell Healthcare Products, LLC2016-03-09
Xinfu Powder-Free Yellow Vinyl Patient Examination Gloves (K152719)Xinfu Medical Products Co., Ltd.2016-03-01
Beactive Brace (K151476)Natures Pillows, Inc.2016-02-26
HAINING NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR (K152715)Haining Medical Products Co., Ltd.2016-02-25
LATEX EXAMINATION GLOVE POWDER FREE (K152593)Careplus (M) Sdn Bhd2016-02-25
BD BACTEC Peds Plus/F Culture Vials (plastic) (K151866)Becton, Dickinson and Company2016-02-25
IV-eye (K152088)Novarix Limited2016-02-24
Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series (K153474)Biochemical Diagnostics, Inc.2016-02-23
Weely Manual Wheelchair (K152827)Rupiani2016-02-19
Triumph Resin Dam (K151945)Denali Corporation2016-02-18
Powder Free Nitrile Patient Examination Gloves, Blue Color (K151680)Suqian Xingye Glove Co,Ltd2016-02-12
Relieva Scout Multi-Sinus Dilation System (K153341)Acclarent, Inc.2016-02-12
Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator (K151529)Siemens Healthcare Diagnostics, Inc.2016-02-11
ARCHITECT SHBG (K152185)Biokit, S.A.2016-02-11
Powder Free Nitrile Patient Examination Gloves, Black color (K152271)Suqian Xingye Glove Co,Ltd2016-02-09
Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue (K153028)Zibo Huiying Medical Products, Co. , Ltd.2016-02-05
SUNTEC Mechanical Wheelchair, model ST-WL-1000 (K152878)Danyang Suntec Auto Parts Co., Ltd.2016-02-03
AIR-FLOW handy 3.0 PLUS (K151912)E.M.S Electro Medical Systems S.A2016-02-03
SPIWay Endonasal Access Guide (K153686)Spiway, LLC2016-01-28
VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit (K153712)Radiometer America, Inc.2016-01-28
Vinyl patient examination glove, Powder Free (K153159)Xingyuan Plastic Products Co., Ltd.2016-01-26
Evogue Dental Unit (K152100)Takara Belmont Corporation2016-01-22
TAURUS C1 (K151996)Shinhung Company, Ltd.2016-01-22
Renovo Life Hard Carbon Coated Drill Bit (K151661)Renovo Life, LLC2016-01-15
ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes (K152522)Ecolab, Inc.2016-01-15
PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm (K151228)Emerson & Co. Srl2016-01-15
Direct HDL Cholesterol (HDL) (K153435)Randox Laboratories, Ltd.2016-01-08
Tellos ISQ Buddy (K143445)Tellos Medical AB2016-01-07
OTELO LL (K151104)Spineart2016-01-06
MyOn HC Manual Wheelchair (K152536)Invacare Corporation2016-01-05
Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for Use with Chemotherapy Drugs (K152542)Riverstone Resources Sdn Bhd2015-12-24
Powder Free Vinyl Patient Examination Glove (Non?-Sterile) (K150934)Lpl (Hui Zhou) Glove2015-12-21
Powder Free Vinyl Patient Examination Gloves (Green) (K152692)Supermax Plastic Products Co., Ltd.2015-12-21
ARCHITECT 2nd Generation Testosterone (K152155)Abbott Laboratories2015-12-17
Liquichek Cardiac Markers Plus Control LT (K150300)Bio-Rad Laboratories2015-12-11
Medismart ( Latex Surgeon¿s Gloves powdered ) and Medismart + (Latex Surgeon¿s Gloves Powder Free, Polymer coated with protein (K151114)St. Marys Rubbers Pvt, Ltd.2015-12-11
High Speed Handpieces and Accessories (K152146)Codent Technical Industry Co., Ltd.2015-12-08
NuVent EM Sinus Dilation System (K152121)Medtronic Xomed, Inc.2015-12-01
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) (K151679)Heze Yuze Glove Co., Ltd.2015-11-27
SensiCare Sterile Powder-Free Polymer Coated Polyisoprene Surgical glove, With Aloe Vera (Tested of Use with Chemotherapy Drugs) -Natural Color (K150238)Medline Industries, Inc.2015-11-27
LUXATOR LX HANDPIECE (K133178)Directa AB2015-11-24
Advanced Air System (K143704)W&H Dentalwerk Buermoos GmbH2015-11-23
XprESS Multi-Sinus Dilation System (K152434)Entellus Medical, Inc.2015-11-20
PassAssist LED Light Fiber (K152435)Entellus Medical, Inc.2015-11-20
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) (K151682)Daxwell, LLC2015-11-17
Finessis Zero Flexylon Powder Free Sterile White Surgical Glove (K151607)Lucenxia Prescience AG2015-11-16
Finessis Corium Flexylon Powder Free Sterile Green Surgical Gloves (K151605)Lucenxia Prescience AG2015-11-16
Annuy Latex Patient Examination Glove (powdered and powder-free); Annuy Nitrile Patient Examination Glove (powdered and powder-free) (K150612)Anhui Anyu Latex Products Co., Ltd.2015-11-16
Annuy Latex Surgeon's Gloves (Powdered and Powder Free) (K150609)Anhui Anyu Latex Products Co., Ltd.2015-11-16
Valved Safety Centesis Catheter (K150800)B.Braun Medical, Inc.2015-11-12
Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs, Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color. (K142941)Pt. Medisafe Technologies2015-11-02
MicroSTAAR Injector System Cartridges (K152357)STAAR Surgical Company2015-10-30
P.R.O. CG Manual Wheelchair (K151893)Freedom Designs, Inc.2015-10-22
NITRILE POWDER FREE EXAMINATION GLOVES-PINK, NITRILE POWDER FREE EXAMINATION GLOVES-GREEN,NITRILE POWDER FREE EXAMINATION GLOVES-ORANGE, NITRILE POWDER FREE EXAMINATION GLOVES-BLACK (K151836)Hartalega NGC Sdn. Bhd.2015-10-21
Powder Free Nitrile (Black) Examination Gloves (K151528)Gallant Quality Sdn. Bhd.2015-10-09
Podimetrics Remote Temperature Monitoring System (K150557)Podimetrics,Inc.2015-10-08
hemoFISH Masterpanel (K150031)Miacom Diagnostics GmbH2015-10-01
Cholesterol (K150654)Randox Laboratories, Ltd.2015-09-29
Contour Next Control Solution (K151742)Bayer Healthcare2015-09-23
Sensiflex Plus Sterile Latex Green Surgical Glove Powder Free with Protein Content Labeling Claim with 50ug/dm2 or less (K151392)Terang Nusa Sdn Bhd2015-09-18
Spirit (K143696)Pelton & Crane2015-09-18
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim(Blue) (K151684)Hartalega NGC Sdn. Bhd.2015-09-18
Powder Free Nitrile Examination Glove (K151208)Vrg Khai Hoan Joint Stock Company2015-09-14
KleenGel Dispenser (K143177)Kleengel, LLC2015-09-14
CT Sim Laser System (K152303)Gammex, Inc.2015-09-11
Biogel PI Micro Indicator Underglove (K150146)Molnlycke Health Care Us, LLC2015-08-31
DSS Sinusplasty Balloon Catheter (K143738)Intuit Medical Products, LLC2015-08-27
Nuocande Plastic Manual Wheelchair Model NKD L07 (K151797)Ningbo Lecount Medical Technology Co., Ltd.2015-08-25
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (white, blue, orange) (K151343)Hartalega NGC Sdn. Bhd.2015-08-24
NON-STERILE, POWER FREE NITRILE EXAMINATION GLOVES-ORANGE, GREEN, BLUE AND VIOLET COLOR (K143289)Yty Industry (Manjung) Sdn Bhd2015-08-18
Neurosplint (K143458)Neurospectrum, LLC2015-08-13
Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood Only;Alere Clearview H. pylori Whole Blood, Serum, Plasma; Alere Clearview H. pylori Whole Blood Only (K151935)Alere San Diego, Incorporated2015-08-12
Triglycerides (K150819)Randox Laboratories Limited2015-08-06
NUZONE X2G Polychloroprene Synthetic Green Surgical Gloves Powder Free, Tested for Use with Chemotherapy Drugs (K150973)Terang Nusa Snd Bhd2015-08-04
STRONG Dental Handpieces (K143418)Saeshin Precision Co., Ltd.2015-07-31
Cream Stretch Vinyl Patient Examination Glove (Non-Sterile),White Vinyl Patient Examination Glove (Non-Sterile), (K143277)Lifestyle Safety Products (Hui Zhou) Co., Ltd.2015-07-29
TENEO Dental Treatment Unit and Accessories (K151045)Sirona Dental Systems GmbH2015-07-24
Powder-Free Yellow Vinyl Patient Examination Gloves (K143347)Zibo Zhouheng Plastic Products Co., Ltd.2015-07-24
Powder-Free White Vinyl Patient Examination Gloves (K143346)Zibo Changda Plastic Products Company, Limited2015-07-22
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