| Getinge GSS67N Series Steam Sterilizer (K172159) | Maquet GmbH | 2018-01-30 |
| SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES) (K171367) | Sanrea Healthcare Products Pvt, Ltd. | 2018-01-26 |
| ClearLine IV (K171954) | Clearline MD | 2018-01-25 |
| 3M Attest Super Rapid Readout Biological Indicator, 3M Attest Auto-reader, 3M Attest Auto-reader (K173584) | 3M Company | 2018-01-22 |
| Kit Boxes and Kit Plates (K163600) | Nobel Biocare AB | 2018-01-22 |
| Nurture Rest (K172962) | Neonatal Loving Kare, Inc. | 2018-01-18 |
| AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System (K172319) | STERIS Corporation | 2018-01-18 |
| NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) (K173479) | Novo Nordisk, Inc. | 2018-01-17 |
| Kinsa QuickCare Thermometer (K173730) | Kinsa, Inc. | 2018-01-17 |
| Medline Disposable Electronic Thermometer Probe Cover (K173113) | Medline Industries, Inc. | 2018-01-17 |
| Aleo BME Liquid Bandage (K171148) | Aleo Bme, Inc. | 2018-01-12 |
| Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves (K171737) | Ansell Healthcare Products, LLC | 2017-12-29 |
| Celerity 20 HP Biological Indicator (K172474) | STERIS Corporation | 2017-12-29 |
| Disposable Powder Free Vinyl Exam Glove, Clear/Yellow (K172357) | Ever Growth (Vietnam) Co. , Ltd. | 2017-12-29 |
| Praxiject 0.9% NaCl (K171109) | Medxl, Inc. | 2017-12-21 |
| Deltaven XiV Max, Deltaven XiV Max FF (K171530) | Delta Med Spa | 2017-12-21 |
| OMNI Surgical System (K173332) | Sight Sciences, Inc. | 2017-12-21 |
| Digital thermometer(with disposable thermometer cover) (K172861) | Hangzhou Hua'An Medical&Health Instruments Co.,Ltd | 2017-12-19 |
| BD Nexiva Diffusics Closed IV Catheter Systems (K173354) | Becton Dickinson Infusion Therapy Systems, Inc. | 2017-12-15 |
| Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) (K173017) | Anhui Kindguard Medical Supplies Technology Co., Ltd. | 2017-12-15 |
| ArchFlo CT Midline (K171483) | Medcomp (Dba Medical Components, Inc.) | 2017-12-15 |
| ISP Safety Huber Needle Infusion Set (K170881) | Infusion Safety Products, Inc. | 2017-12-14 |
| DropSafe Safety Pen Needle (K170988) | Htl-Strefa S.A | 2017-12-12 |
| Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink) (K173137) | Hartalega Sdn Bhd | 2017-12-12 |
| SporView Rapid Read Biological Indicator (K172432) | Crosstex/Spsmedical, A Division of Cantel Medical | 2017-12-12 |
| Safety Blood Collection Device for Single Use (K170276) | Gemtier Medical (Shanghai), Inc. | 2017-12-11 |
| C3 Wave System (K170934) | Medical Components, Inc (Dba Medcomp_ | 2017-12-06 |
| Graft Delivery, DePuy Synthes (K173385) | Micromedics, Inc. (D/B/A Nordson Medical) | 2017-11-30 |
| Infrared thermometer (K171578) | Shenzhen Aeon Technology Co., Ltd. | 2017-11-30 |
| Orange Non Sterile Powder Free Nitrile Examination Gloves (K172642) | Central Medicare Sdn Bhd | 2017-11-28 |
| THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE (K172678) | Shen Wei USA, Inc. | 2017-11-24 |
| SALUS - Hygiene Instrument Reprocessing Container (K172292) | Scican , Ltd. | 2017-11-24 |
| Non Contact Infrared Forehead Thermometer (K170662) | Intrinity Global Limited | 2017-11-22 |
| Micro-MEC 1.8% Glutaraldehyde Monitor Strip (K172472) | STERIS Corporation | 2017-11-17 |
| SterilContainer with PrimeLine Pro Lid (K172850) | Aesculap, Inc. | 2017-11-17 |
| Powder Free Pink Polychloroprene Copolymer Examination Gloves, Powder Free Black Polychloroprene Copolymer Examination Gloves (K171743) | Smart Glove Corporation Sdn. Bhd. | 2017-11-17 |
| 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 Bhd | 2017-11-13 |
| DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + Accessories (K170900) | Intervene Group, Ltd. | 2017-11-09 |
| MHC Standard and NRFit Tip Syringes (K171131) | Mazza Healthcare, LLC | 2017-11-08 |
| IV Administration Sets (K170595) | B.Braun Medical, Inc. | 2017-11-07 |
| 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 |
| Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site (K170897) | B.Braun Medical, Inc. | 2017-11-03 |
| ORCA (tm) - Operational Rescue Containment Apparatus (K163223) | Isovac Products, LLC | 2017-11-02 |
| Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader Incubator (K163646) | Terragene S.A. | 2017-11-02 |
| Sterisheet Sterilization Wrap (K170437) | Andersen Sterilizers, Inc. | 2017-11-01 |
| Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion Set (K162812) | Unomedical A/S | 2017-11-01 |
| AN87 Dosimeter (K170439) | Andersen Sterilizers, Inc. | 2017-11-01 |
| MAUSER PG II Sharps Container (K170513) | Mauzer USA, LLC | 2017-11-01 |
| Anprolene SteriTest (K170427) | Andersen Sterilizers, Inc. | 2017-10-31 |
| Anprolene AN75 Ethylene Oxide Gas Sterilizer (K170432) | Andersen Sterilizers, Inc. | 2017-10-31 |
| AN85/AN86 EO Indicators (K170426) | Andersen Sterilizers, Inc. | 2017-10-30 |
| Tyvek Sterilization Pouches with Chevron Seal (K170429) | Andersen Sterilizers, Inc. | 2017-10-27 |
| Skylife (K170585) | Neolight, LLC | 2017-10-27 |
| Celerity ECG Cable Accessory Pack (K171931) | Medcomp (Medical Components, Inc.) | 2017-10-26 |
| iTotal Family Reusable Instrument Tray (K170226) | Conformis, Inc. | 2017-10-25 |
| DentureID Microchip (K170423) | Cmp Industries, LLC | 2017-10-25 |
| STERILE VINYL EXAMINATION GLOVES, Powder Free (K170612) | Primus Gloves Pvt Limited | 2017-10-23 |
| GRI-FILL PERISTALTIC SET (K162216) | Laboratorios Grifols, S.A. | 2017-10-19 |
| OptiScanner 5000 Glucose Monitoring System (K162042) | Optiscan Biomedical Corp. | 2017-10-16 |
| PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator (K162362) | Pms Tibbi Cihazlar Teknolojisi San VE Tic AS | 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 Bhd | 2017-10-12 |
| Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy drugs (K171782) | Blue Sail Medical Co.,Ltd | 2017-10-12 |
| Vial Adapter 15mm (K171796) | Medimop Medical Project , Ltd. | 2017-10-12 |
| Clickfine Pen Needle, Penfine Classic Pen Needle (K171984) | Ypsomed AG | 2017-10-11 |
| Bilicocoon™ Phototherapy System (K163526) | Neomedlight | 2017-10-06 |
| ri-former Predictive Thermometer (K171182) | Rudolf Riester GmbH | 2017-10-04 |
| Arisure Closed Vial Adapter (K172884) | Yukon Medical | 2017-10-03 |
| Arisure Dry Spike (K172631) | Yukon Medical | 2017-09-29 |
| Sherlock 3CG Tip Positioning System Stylet (K172397) | C.R. Bard, Inc. | 2017-09-29 |
| Digital Thermometer (K170262) | K-Jump Health Co., Ltd. | 2017-09-28 |
| QiF Blood and Fluid Warmer (K171215) | Quality IN Flow , Ltd. | 2017-09-27 |
| 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 |
| IV Fat Emulsion Administration Sets (K172544) | Baxter Healthcare Corporation | 2017-09-22 |
| SYSTEM 1E Liquid Chemical Sterilant Processing System (K170956) | STERIS Corporation | 2017-09-22 |
| Powder Free Nitrile Examination Gloves (Orange) (K171541) | Comfort Rubber Gloves Industries Sdn. Bhd. | 2017-09-20 |
| Medline Blood Collection Set (K170002) | Medline Industries, Inc. | 2017-09-19 |
| Digital Thermometer (K163518) | Joytech Healthcare Co. , Ltd. | 2017-09-19 |
| Endoscope Sterilization Tray (K170640) | Intuitive Surgical, Inc. | 2017-09-17 |
| BD Cathena Safety IV Catheter (K172506) | Becton, Dickinson and Company | 2017-09-17 |
| Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs (K171378) | Semperit Investments Asia Pte , Ltd. | 2017-09-14 |
| Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel (K171144) | Medbio, LLC | 2017-09-12 |
| 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 |
| Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml (K171805) | Conceptomed AS | 2017-09-08 |
| Carefusion NeutraClear Needle-free connector (EL-NC1000) (K171117) | Cair Lgl | 2017-09-01 |
| Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer (K163337) | Midmark Corporation | 2017-08-31 |
| Integrated Catch-up Freedom Syringe Driver Infusion System (K162613) | Repro-Med Systems, Inc. Dba Rms Medical Products | 2017-08-31 |
| ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump (K162165) | Summit Medical Products, Inc. | 2017-08-29 |
| Sapphire Sets (K171346) | Icu Medical | 2017-08-25 |
| Standard Supreme Sterilization Wrapper (K172207) | Standard Textile Co., Inc. | 2017-08-25 |
| 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 |
| CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM) (K170982) | Smiths Medical Ads, Inc. | 2017-08-24 |
| VERIFY Assert VH2O2 Self-Contained Biological Indicator (K171504) | STERIS Corporation | 2017-08-22 |
| VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator (K171587) | STERIS Corporation | 2017-08-22 |
| Zip 4 Skin Closure Device (K170003) | Zipline Medical, Inc. | 2017-08-18 |
| BD Intima II PLUS Closed IV Catheter System (K172204) | Becton, Dickinson and Company | 2017-08-17 |