510(k) Clearances in 2019 — Page 32

2,918 510(k) clearances total

Browse FDA 510(k) clearances granted in 2019. RegDataLab tracks 2,918 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2019 (page 32 of 59)
510(k) clearancesDetails
K190516 — MicroLink All-Suture Button Fixation System (Radiolucent)Conmed Corporation Jun 28, 2019
K183389 — Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical UndergloveHartalega NGC Sdn. Bhd. Jun 28, 2019
K190696 — Stryker Surgeon iD Mandible Recon PlateStryker Jun 28, 2019
K191465 — Human IgM Kit for use on SPAPlusThe Binding Site Group , Ltd. Jun 27, 2019
K191175 — ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi SystemAcist Medical Systems, Inc. Jun 27, 2019
K190017 — LiverMultiScan (LMSv3)Perspectum Diagnostics, Ltd. Jun 27, 2019
K183183 — VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical SutureETHICON, Inc. Jun 27, 2019
K190578 — SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM ConfidenceSiemens Medical Solutions USA, Inc. Jun 27, 2019
K182683 — Z-Robot Patient Positioning SystemChinan Biomedical Technology, Inc. Jun 27, 2019
K190583 — DynaFlexDyna Flex Jun 27, 2019
K183602 — SwimCount Sperm Quality TestMotilitycount Aps Jun 27, 2019
K191438 — ERBEFLO 2 Endo Quick Connect Pentax Scope Port ConnectorErbe USA, Inc. Jun 27, 2019
K190080 — Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black)Comfort Rubber Gloves Industries Sdn. Bhd. Jun 27, 2019
K182733 — Rochal Bioshield Silicone FilmRochal Industries, LLC Jun 27, 2019
K190782 — FlexGard Cut-Resistant Glove LinersLdi Corporation Jun 27, 2019
K191485 — Deflectable Brush Biopsy SetCook Incorporated Jun 26, 2019
K190299 — Elos Accurate® Customized AbutmentElos Medtech Pinol A/S Jun 26, 2019
K182851 — SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy DrugsO&M Halyard, Inc. Jun 26, 2019
K190938 — Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd. Jun 26, 2019
K190097 — Straumann CARES Screw-Retained Bridges and BarsInstitut Straumann AG Jun 26, 2019
K191128 — Vantage Titan 3T, MRT-3010, V2.5Canon Medical Systems Corporation Jun 26, 2019
K191166 — DigniCap DeltaDignitana, Inc. Jun 26, 2019
K190096 — R2GATEMegagen Implant Co., Ltd. Jun 26, 2019
K182832 — Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor SetCook Incorporated Jun 26, 2019
K191207 — Guardian Angel Rx GA2001 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. Jun 25, 2019
K190784 — BUHLMANN fCAL turboBuhlmann Laboratories AG Jun 25, 2019
K190052 — Radio Frequency Ablation SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd. Jun 25, 2019
K190743 — Venus BlissVenus Concept USA, Inc. Jun 25, 2019
K190779 — Trevo XP ProVue RetrieverStryker Jun 25, 2019
K191168 — Cepheid Xpert SA Nasal Complete Control PanelMicrobiologics, Inc. Jun 25, 2019
K191194 — CLARUSCarl Zeiss Meditec, Inc. Jun 25, 2019
K190785 — Reprocessed PentaRay Nav eco High-Density Mapping CatheterInnovative Health, LLC Jun 25, 2019
K182704 — WishBone Guided Growth SystemWishbone Medical Jun 25, 2019
K183170 — uWS-CTShanghai United Imaging Healthcare Co., Ltd. Jun 24, 2019
K190443 — MMSphereGalactic Beauty, LLC Jun 24, 2019
K190106 — Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire HandleCenterline Biomedical, Inc. Jun 24, 2019
K171304 — Maxxi Rip SensorNeurovirtual USA, Inc. Jun 24, 2019
K183032 — FUJIFILM Double Balloon Endoscope EI580BTFujifilm Corporation Jun 24, 2019
K182411 — Scooter, Model: R-100Yongkang Dingchang Industry & Trade Co., Ltd. Jun 24, 2019
K190927 — Oscillometric Blood Pressure MonitorRudolf Riester GmbH Jun 24, 2019
K190754 — Orthoss(R)Geistlich Pharma AG Jun 23, 2019
K182844 — ASAHI SASUKEAsahi Intecc Co., Ltd. Jun 22, 2019
K182960 — ReliefBandReliefband Technologies, LLC Jun 21, 2019
K191388 — FloPatch (FP110)Flosonics Medical (R/A 1929803 Ontario Corp.) Jun 21, 2019
K183595 — Aqua Medical RF Vapor SystemAqua Medical, Inc. Jun 21, 2019
K190597 — BRILLIANT EverGlow FlowColtene/Whaledent AG Jun 21, 2019
K190750 — DePuy Synthes Plates and Screws PortfolioDePuy Synthes Jun 21, 2019
K183220 — OrthoScan TAU Mini C-ArmOrthoscan, Inc. Jun 21, 2019
K183262 — EsoCheck CCD Cell Collection DeviceLucid Diagnostics, Inc. Jun 21, 2019
K182139 — AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc. Jun 21, 2019
← Previous Page 32 of 59 Next →