510(k) Clearances in 2019 — Page 7

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 7 of 59)
510(k) clearancesDetails
K192919 — Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. Nov 26, 2019
K192738 — ETEST Delafloxacin (DFX) (0.002-32 µg/mL)Biomerieux S.A. Nov 26, 2019
K192907 — Advocate PTA CatheterMerit Medical Systems, Inc. Nov 26, 2019
K192026 — Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd. Nov 26, 2019
K190911 — Physica KR Liner and SMR Reverse Humeral LinerLimacorporate Nov 26, 2019
K192946 — DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc. Nov 26, 2019
K191502 — Heraeus Peripheral GuidewireHeraeus Medical Components, LLC Nov 26, 2019
K192396 — Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc. Nov 26, 2019
K182892 — TRAUS Dental HandpiecesSaeshin Precision Co., Ltd. Nov 26, 2019
K192320 — HealthCXRZebra Medical Vision, Ltd. Nov 26, 2019
K191851 — VS3-IRMedtronic Nov 25, 2019
K190590 — Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle)Allwin Medical Devices, Inc. Nov 25, 2019
K190529 — SOZOImpediMed Limited Nov 25, 2019
K192788 — ADVIA Centaur Cortisol (COR)Siemens Healthcare Diagnostics, Inc. Nov 25, 2019
K192248 — Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc. Nov 25, 2019
K190494 — Infant IncubatorNingbo David Medical Device Co., Ltd. Nov 25, 2019
K192329 — Blue Latex Examination Powder Free GlovesJr Engineering & Medical Technologies (M) Sdn. Bhd. Nov 25, 2019
K181845 — Pivot System Sterilization caseRp Medical, Inc. Nov 25, 2019
K190760 — Cadwell Bolt SoftwareCadwell Industries, Inc. Nov 23, 2019
K182712 — DEXIS CariVu 3-in-1 by KaVoKaltenbach & Voigt GmbH Nov 23, 2019
K193041 — Hemochron Signature EliteAccriva Diagnostics, Inc. Nov 22, 2019
K192777 — ADVIA Centaur CA 15-3 assaySiemens Healthcare Diagnostics, Inc. Nov 22, 2019
K193036 — C2 CryoBalloon EndoGripPentax Medical, A Division Of Pentax Of America, Inc. Nov 22, 2019
K193017 — EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WPDRTECH Corporation Nov 22, 2019
K191103 — Parkell Desensitizer GelParkell, Inc. Nov 22, 2019
K192242 — Synergy Platform, Synergy, Infinity, VersaHDElekta Limited Nov 22, 2019
K191236 — 3M™ Attest™ Steam Chemical Integrators3M Company Nov 22, 2019
K192336 — Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc. Nov 22, 2019
K192877 — Senhance Surgical SystemTransenterix, Inc. Nov 22, 2019
K192270 — LEva Pelvic Digital Health SystemRenovia, Inc. Nov 22, 2019
K192126 — AMIStem-P Short NeckMedacta International S.A. Nov 22, 2019
K191746 — SMR TT Augmented Glenoid SystemLima Corporate S.P.A. Nov 22, 2019
K190697 — PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag)Kci USA, Inc. Nov 22, 2019
K190977 — Navina Smart System, Navina Classic SystemDentsply Sirona Nov 22, 2019
K192964 — Parcus Synd-EZ SSParcus Medical, LLC Nov 22, 2019
K190331 — Applied Medical Laparoscopic Linear CutterApplied Medical Resources Corporation Nov 22, 2019
K190518 — Color Liquid, Vita LiquidZirkonzahn Srl Nov 22, 2019
K192157 — 6450 Ultrasound systemEsaote, S.P.A. Nov 22, 2019
K192260 — everX FlowGC America, Inc. Nov 22, 2019
K193031 — EXPD 4343P, EXPD 3643PDRTECH Corporation Nov 22, 2019
K192207 — Trevo NXT ProVue RetrieverStryker Nov 22, 2019
K192508 — Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd. Nov 22, 2019
K191903 — BruxZir GT (Gum Tissue) ColorPrismatik Dentalcraft, Inc. Nov 22, 2019
K190512 — SmartBand EMR Kit, SmartBand EMR Pack, SmartSnareIntelligent Endoscopy Nov 22, 2019
K171899 — Revitalair 430FOxavita Srl Nov 22, 2019
K191075 — HealyTimewaver Production GmbH Nov 22, 2019
K192675 — VariAx FootStryker GmbH Nov 22, 2019
K191754 — Hair Growth SystemKunshan Bella Optical Technology Co., Ltd. Nov 22, 2019
K192843 — INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test MidstreamInnovita (Tangshan) Biological Technology Co., Ltd. Nov 22, 2019
K192122 — Trevo Trak 21 MicrocatheterStryker Nov 22, 2019
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