Atlas FDA

2019

2,918 FDA 510(k) clearances · Clearance year

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RecordFirmDate
OrthoScan TAU Mini C-Arm (K183220)Orthoscan, Inc.2019-06-21
ReliefBand (K182960)Reliefband Technologies, LLC2019-06-21
EsoCheck CCD Cell Collection Device (K183262)Lucid Diagnostics, Inc.2019-06-21
Aqua Medical RF Vapor System (K183595)Aqua Medical, Inc.2019-06-21
Vit Kit- Freeze NX and Vit Kit- Warm NX (K190152)Fujifilm Irvine Scientific, Inc.2019-06-21
BRILLIANT EverGlow Flow (K190597)Coltene/Whaledent AG2019-06-21
Voyager Trajectory Array Guide (V-TAG) (K191400)Mri Interventions, Inc.2019-06-21
Soniquence Bipolar Electrodes (K190336)Soniquence, LLC2019-06-20
Renovis A200 PS Knee System as part of the Renovis A200 Knee System (K190122)Renovis Surgical Technologies2019-06-20
EmBody System (K183450)Inmode MD , Ltd.2019-06-20
Campylobacter Chek (K191442)Techlab, Inc.2019-06-20
PK High Tibial Osteotomy Correction System (K182285)Paonan Biotech Co., Ltd.2019-06-20
Kubtec Mozart (Xpert42) (K183624)Kub Technologies, Inc.2019-06-20
Cepheid Xpert MRSA NxG Control Panel (K191172)Microbiologics, Inc.2019-06-20
Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate (K183354)Gx Corporation Sdn Bhd2019-06-20
VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 (K190545)Icotec AG2019-06-20
Panthera Dental Milled Bars (K183580)Panthera Dental, Inc.2019-06-20
DB-CMF (K182742)Dimensional Bioceramics, LLC2019-06-20
Powder-Free Clear Vinyl Patient Examination Gloves (K190095)Anhui Intco Medical Products Co., Ltd.2019-06-20
Campylobacter Quik Chek (K191456)Techlab, Inc.2019-06-20
The JASPER Spinal Fixation System II (K190762)Gbs Commonwealth Co., Ltd.2019-06-19
EntericBio Dx Assay (K182703)Serosep , Ltd.2019-06-19
MHD TENS (K190115)Minghuangda Electronic Co., Ltd.2019-06-19
Republic Spine Restore Cervical Interbody Fusion System (K190889)Republic Spine, LLC2019-06-19
Bioliner (K182658)Five Star Orthodontic Lab & Supply2019-06-19
Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro (K182719)Quidel Cardiovascular, Inc.2019-06-19
Multix Fusion Max (K191418)Siemens Medical Solutions USA, Inc.2019-06-19
LOQTEQ VA Foot Plates 2.5 (K182785)Aap Implantate AG2019-06-19
Hailie Sensor (K182638)Adherium (Nz), Ltd.2019-06-19
STOP U (Packed Black USA), STOP U (Packed White USA) (K182774)Pollogen, Ltd.2019-06-19
RayStation (K190387)RaySearch Laboratories AB (PUBL)2019-06-19
Aneroid Type Blood Pressure Kit (K191209)Dongguan Mars Medical Products Co., Ltd.2019-06-18
Torpedo Gelatin Foam (K183578)Biosphere Medical, S.A.2019-06-18
QLAB Advanced Quantification Software 13 (K190913)Philips Health Care2019-06-18
Stryker MIS and Footed Attachments (K191049)Stryker Corporation2019-06-18
NanoKnife System (K183385)Angiodynamics2019-06-18
Med-link Temperature Probes (K182667)Shenzhen Med-Link Electronics Tech Co., Ltd.2019-06-18
Bovine Pericardial Tissue Patch (K182493)Tisgenx2019-06-18
Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter (K182695)Cook Incorporated2019-06-17
Q-Switched Nd: YAG Laser System (K190936)Shanghai Apolo Medical Technology Co., Ltd.2019-06-17
LxHA PEEK Lateral IBF System (K190684)Innovasis, Inc.2019-06-17
Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6 (K190663)PAJUNK GmbH Medizintechnologie2019-06-17
FlowTriever Retrieval/Aspiration System (K191368)Inari Medical2019-06-17
GALILEO Spine Alignment Monitoring System (K182524)MiRus, LLC2019-06-17
IDS SHBG (K190121)Immunodiagnostic Systems , Ltd.2019-06-17
MRI Compatibility for Existing Straumann Dental Implant Systems (K190662)Straumann USA, LLC2019-06-17
Penumbra System Reperfusion Catheter JET 7 (K190010)Penumbra, Inc.2019-06-16
UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope (K183263)Unipack Medical Corporation2019-06-14
AEQUALIS FLEX REVIVE Shoulder System (K191318)Tornier, Inc.2019-06-14
Silhouette Featherlift / Silhouette Lift (K191299)Silhouette Lift, Inc.2019-06-14
ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube (K191387)Envizion Medical , Ltd.2019-06-14
Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments (K190172)Stryker2019-06-14
Moss Gastrostomy Tube, Moss Nasal Tube – Mark IV (K190414)Moss Tubes, Inc.2019-06-14
Trio-CT Triple Lumen Catheter (K183219)Medical Components, Inc. (dba MedComp)2019-06-14
Medline Digital Rectal Thermometer Sheath (K183431)Medline Industries, Inc.2019-06-14
ELECTRODES PAD (K190700)Shenzhen Bestpad Technology Development Co., Ltd.2019-06-14
CLARITY II Laser System (K183566)Lutronic Corporation2019-06-14
VIVO (K183195)Catheter Precision, Inc.2019-06-14
SeraQuest HSV Type 2 Specific IgG (K181514)Quest International, Inc.2019-06-13
Transcranial Doppler Ultrasound System (K190228)Shenzhen Delica Medical Equipment Co., Ltd.2019-06-13
Sonopet iQ Sterilization Tray (K190667)Paragon Medical2019-06-13
Treace Medical Concepts (TMC) Snap-Off Screw System (K183363)Treace Medical Concepts, Inc.2019-06-13
Electrosurgical Generator (K183564)Fulwell, LLC2019-06-13
Edwards Pressure Cable (K191089)Edwards Lifesciences, LLC2019-06-13
Restore Toothpaste (K181965)Dr. Collins, Inc.2019-06-13
HealthICH (K190424)Zebra Medical Vision, Ltd.2019-06-13
ClariCT.AI (K183460)Claripi, Inc.2019-06-13
Fiberoptix IAB (K190117)Arrow International, Inc.2019-06-13
Strome-Blitzer Cytology Balloon (K182159)Adn International, LLC2019-06-13
Oyster ACIF Cage (K182608)Silony Medical GmbH2019-06-13
XenoSure Dura Biologic Patch (K183513)LeMaitre Vascular, Inc.2019-06-13
SyMRI (K191036)Syntheticmr AB2019-06-13
ProLift® Expandable System (K191005)Life Spine, Inc.2019-06-13
Full Automatic (NIBP) Blood Pressure Monitor-HL158UB (K190133)Health & Life Co., Ltd.2019-06-13
Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags (K191341)Corinth Medtech, Inc.2019-06-13
Avid IF2 (K183692)Vision Quest Industries Inc./Dba VQ Orthocare2019-06-12
Wallace Dual Lumen Oocyte Recovery System (K191291)CooperSurgical, Inc.2019-06-12
LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600 (K172232)Ams Diagnostics2019-06-12
Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump (K182749)Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic., Ltd.2019-06-12
Viveve System 2.0 (K190422)Viveve Medical2019-06-12
On Call Express Voice Blood Glucose Monitoring System (K191038)ACON Laboratories, Inc.2019-06-12
Eon FR (K180511)Dominion Aesthetic Technologies, Inc.2019-06-12
Aquilion ONE (TSX-305A/6) V8.9 with AiCE (K183046)Canon Medical Systems Corporation2019-06-12
Lateral Plate System (K190016)Corelink, LLC2019-06-12
Argon Handset (K191064)New Deantronics Taiwan , Ltd.2019-06-12
J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle, (K190177)Ranfac Corporation2019-06-12
Medline Poly-Cath Red Polymer Urethral Catheter (K183335)Medline Industries, Inc.2019-06-12
Phasix ST Mesh with Open Positioning System (K190185)C.R. Bard, Inc.2019-06-12
Aequalis Ascend Flex Shoulder System (K190521)Tornier S.A.S.2019-06-12
RS85 Diagnostic Ultrasound System (K191115)Samsung Medison Co., Ltd.2019-06-12
HS40 Diagnostic Ultrasound System (K191055)Samsung Medison Co., Ltd.2019-06-12
PENTAX Medical ENT Video Imaging System (K183691)Pentax of America, Inc.2019-06-12
Life Sensor Cardiac Monitor (K191331)Braveheart Wireless, Inc.2019-06-12
T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System (K191271)Stryker Trauma GmbH2019-06-11
Spine & Trauma Navigation (K191285)Brainlab AG2019-06-11
Scoreflex PTA Scoring Balloon Catheter (K182713)Orbusneich Medical Trading, Inc.2019-06-11
NOVA Minimally Invasive System (K182416)Baui Biotech Co., Ltd.2019-06-11
Arthrex SwiveLock Suture Anchor (K191226)Arthrex, Inc.2019-06-11
JAMBRO Single Core A Sterilization wrap (K182656)Jiangsu Zhande Medical Supplies Co., Ltd.2019-06-11
Force Fiber Suture (K191268)Teleflex Medical Incorporated2019-06-11
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Every clearance here is in the API, with alerts when new ones post.