| Scanostics UTI Check Application Test System (K170118) | Teco Diagnostics | 2017-09-21 |
| Powder Free Nitrile Examination Gloves (Orange) (K171541) | Comfort Rubber Gloves Industries Sdn. Bhd. | 2017-09-20 |
| Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs (K171378) | Semperit Investments Asia Pte , Ltd. | 2017-09-14 |
| AIR-FLOW PLUS Prophylaxis powder (K171189) | E.M.S Electro Medical Systems S.A | 2017-09-11 |
| Tri Auto ZX2 (K170275) | J. Morita USA, Inc. | 2017-09-11 |
| Clear Vinyl Powder-free Patient Examination Gloves (K171317) | Shandong Zhi Hong Medical Products, Co. , Ltd. | 2017-09-11 |
| Powder Free Nitrile Examination Glove (K171667) | Professional Latex Sdn Bhd | 2017-09-08 |
| MicroSTAAR Injector System Cartridges (K172375) | STAAR Surgical Company | 2017-09-06 |
| Relieva SpinPlus Nav Balloon Sinuplasty System (K171687) | Acclarent, Inc. | 2017-09-05 |
| NLZ Motor System (K163402) | Nakanishi, Inc. | 2017-08-31 |
| Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs (K170136) | Shandong Feiyang Professional Gloves Co., Ltd. | 2017-08-25 |
| Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue, Cobalt Blue) (K171104) | Yty Industry (Manjung) Sdn Bhd | 2017-08-25 |
| Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs (K171276) | Tg Medical Sdn. Bhd. | 2017-08-21 |
| Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs (K171898) | Better Care Plastic Technology Co., Ltd. | 2017-08-18 |
| Zip 4 Skin Closure Device (K170003) | Zipline Medical, Inc. | 2017-08-18 |
| s LDL-EX SEIKEN (K161679) | Denka Seiken Co., Ltd. | 2017-08-18 |
| PANA SPRAY Plus (K163483) | Nakanishi, Inc. | 2017-08-15 |
| Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip (K162729) | Cook Incorporated | 2017-08-11 |
| Xingyu Nitrile Powder Free Patient Examination Gloves, White color (K171615) | Shandong Xingyu Gloves Co., Ltd. | 2017-07-31 |
| Wheelchair (K163352) | Kunshan Hi-Fortune Health Products Co., Ltd. | 2017-07-28 |
| Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color (K162312) | Shen Wei USA, Inc. | 2017-07-25 |
| Infant Transport Mattress Warmer with Disc (K163295) | Rapid Aid Corp. | 2017-07-24 |
| NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST (K162858) | Careplus (M) Sdn Bhd | 2017-07-24 |
| Xingyu Powder Free Nitrile Patient Examination Gloves, Blue color (K171616) | Shandong Xingyu Gloves Co., Ltd. | 2017-07-20 |
| STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE (K171093) | Sanrea Healthcare Products Pvt, Ltd. | 2017-07-19 |
| OLINDA EXM (K163687) | Hermes Medical Solutions AB | 2017-07-19 |
| Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE) (K162856) | Bonart Co., Ltd. | 2017-07-18 |
| Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue (K162510) | Ug Global Resources Sdn. Bhd. | 2017-07-18 |
| Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs (K170686) | Brightway Holdings Sdn. Bhd. | 2017-07-14 |
| Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System (K163406) | ACON Laboratories, Inc. | 2017-07-11 |
| Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs (K170397) | Kossan International Sdn Bhd | 2017-07-10 |
| DilaCheck Nitrile Powder Free Examination Glove, (Sterile) (K163035) | Elm Tree Medical, Inc. | 2017-07-07 |
| EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy Drugs (K171339) | Eco Medi Glove Sdn. Bhd. | 2017-07-07 |
| On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis (K170587) | ACON Laboratories, Inc. | 2017-07-06 |
| Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (White) (K170794) | Hartalega NGC Sdn. Bhd. | 2017-06-30 |
| Powder-Free Clear Vinyl Patient Examination Gloves (K170735) | Zibo Yue Fan Medical Products Co, Ltd. | 2017-06-27 |
| Stellar LEAP (K163432) | Pdg Product Design Group, Inc. | 2017-06-27 |
| POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED (K170094) | Vietglove Corporation | 2017-06-23 |
| Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL) (K163412) | Girgis Scope, LLC | 2017-06-22 |
| Sterile Polyisoprene Powder Free Surgical Gloves (K171047) | Better Care Plastic Technology Co., Ltd. | 2017-06-22 |
| SIMPLANT Guide (K170849) | Dentsply Sirona | 2017-06-15 |
| Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White) (K170198) | Cardinal Health, Inc. | 2017-06-15 |
| Sterile Nitrile Surgical Gloves, Powder-free (K170515) | Primus Gloves Pvt Limited | 2017-06-09 |
| GenePOC GBS LB (K170557) | Genepoc, Inc. | 2017-05-25 |
| Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein (K170779) | Terang Nusa Sdn Bhd | 2017-05-24 |
| Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr (K170290) | Shen Wei USA, Inc. | 2017-05-24 |
| LATEX EXAMINATION GLOVE POWDER FREE (K161833) | Careglove Global Sdn. Bhd. | 2017-05-23 |
| Powder Free Nitrile Patient Examination Gloves, Blue (K163553) | Hebei Titans Medical Supply Technology Group., Ltd. | 2017-05-22 |
| Strep B Carrot Broth One-Step (K170586) | Hardy Diagnostics | 2017-05-22 |
| Disposable Powder Free Vinyl Exam Glove, Clear/Yellow (K170575) | Ever Global (Vietnam) Enterprise Corp | 2017-05-16 |
| Strep B Carrot Broth Kit (K170481) | Hardy Diagnostics | 2017-05-16 |
| Winner Transfer Wheelchair (K162328) | Winner SG Pte, Ltd. | 2017-05-11 |
| A-dec NLZ Electric Motor System (K163131) | Nakanishi, Inc. | 2017-05-11 |
| UniTex Non-Sterile, Powder-Free, Latex Examination Glove (K161961) | Ug Global Resources Sdn. Bhd. | 2017-05-11 |
| Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue and Violet Blue) (K170393) | Zibo Chengxun Automatic Device Co., Ltd. | 2017-05-09 |
| Resultz Lice & Egg Removal Kit (K151562) | Piedmont Pharmaceuticals, LLC | 2017-05-08 |
| POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN) (K170152) | Hartalega Sdn Bhd | 2017-05-05 |
| Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves (K160781) | Semperit Investments Asia Pte , Ltd. | 2017-05-02 |
| ABL90 FLEX, ABL90 FLEX PLUS (K170882) | Radiometer Medical Aps | 2017-04-28 |
| Randox RX Daytona Plus Magnesium (MG) (K162200) | Randox Laboratories, Ltd. | 2017-04-28 |
| BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS (K162294) | Brightway Holdings Sdn. Bhd. | 2017-04-21 |
| K3 (K152830) | Osstem Implant Co., Ltd. | 2017-04-20 |
| Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair (K162621) | Invacare Corporation | 2017-04-17 |
| Intelli-Ox (K161179) | Air Liquide Healthcare America Corporation | 2017-04-13 |
| Nova Max Uric Acid Monitoring System (K160990) | Nova Biomedical Corporation | 2017-04-11 |
| Beta-CrossLaps CalCheck 5 (K170678) | Roche Diagnostics | 2017-04-04 |
| BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM (K162186) | Brightway Holdings Sdn. Bhd. | 2017-03-31 |
| Multichem IA Plus (K162530) | Techno-Path Manufacturing | 2017-03-31 |
| THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE (K162626) | Top Quality Glove Sdn. Bhd | 2017-03-31 |
| Palm-Pro Chemo-Guard Nitrile Powder Free Examination Glove (K161929) | Dipped Products (Thailand) Limited | 2017-03-29 |
| Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (White); Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (Blue) (K162405) | Comfort Rubber Gloves Industries Sdn. Bhd. | 2017-03-28 |
| BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO (K161816) | bioMerieux, Inc. | 2017-03-28 |
| NITRILE EXAMINATION GLOVE (K163267) | Brightway Holdings Sdn. Bhd. | 2017-03-24 |
| GEN_2 and GEN_3 Mechanical Wheelchairs (K170701) | Free Wheelchair Mission | 2017-03-24 |
| Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (K163017) | Gmp Medicare Sdn. Bhd. | 2017-03-22 |
| Nix Ultra Lice Treatment Kit (K163401) | Medtech Products, Inc. | 2017-03-21 |
| Direct LDL Cholesterol (LDL) (K161691) | Randox Laboratories Limited | 2017-03-20 |
| SMARTmatic (K163239) | Kaltenbach & Voigt GmbH | 2017-03-17 |
| Audit MicroControls Linearity FD Tumor Markers II (K163629) | Aalto Scientific, Ltd. | 2017-03-10 |
| Greiner Vacuette Urine Count and Culture, Mannitol tube (K163436) | Greiner Bio-One Na, Inc. | 2017-03-06 |
| Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) (K162646) | Hartalega NGC Sdn. Bhd. | 2017-03-03 |
| MR Conditional CGA 870 (K162811) | Essex Industries, Inc. | 2017-03-02 |
| Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) (K162982) | Medline Industries, Inc. | 2017-02-27 |
| Air-Powered Handpieces and Handpiece Attachments (K162926) | W&H Dentalwerk Burmoos GmbH | 2017-02-23 |
| Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow) (K163168) | Hebei Hongtai Plastic Products Company Limited | 2017-02-23 |
| Powder Free Nitrile Examination Gloves, Black (K161099) | Pt. Maja Agung Latexindo | 2017-02-23 |
| Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue) (K163126) | Blue Sail Medical Co.,Ltd | 2017-02-22 |
| MEG-TORQ (K161500) | Micro-Nx Co., Ltd. | 2017-02-22 |
| Sofia RSV FIA on Sofia 2 analyzer (K162911) | Quidel Corporation | 2017-02-22 |
| Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E (K163041) | Pt. Medisafe Technologies | 2017-02-22 |
| ELECTROmatic (K163317) | Kaltenbach & Voigt Gmgh | 2017-02-21 |
| T-Cuff (K162365) | Terumobct, Inc. | 2017-02-16 |
| POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs (K163146) | Hebei Hongsen Plastics Technology Co, Ltd. | 2017-02-13 |
| XSmart iQ (K161213) | Dentsply Sirona | 2017-02-10 |
| UA-Cellular Complete (K170091) | Streck | 2017-02-09 |
| BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial (K161810) | Becton Dickinson | 2017-02-09 |
| Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove (K162852) | Lucenxia Prescience AG | 2017-02-08 |
| Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) (K162491) | Hartalega Sdn Bhd | 2017-02-08 |
| NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - AQUA BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - VIOLET BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK VIOLET BLUE (K162923) | Hartalega NGC Sdn. Bhd. | 2017-02-06 |
| HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (K162381) | Healthy Glove Co., Ltd. | 2017-01-31 |