Atlas FDA

2024

3,129 FDA 510(k) clearances · Clearance year

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RecordFirmDate
Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N) (K233070)Chongqing Rob Linka Science and Technology Co., Ltd.2024-03-13
DEKA Loop (K234055)Deka Research and Development2024-03-13
Align Studio (K232564)Laon Medi, Inc.2024-03-12
Tranquil-C Interbody System (K240416)Nexus Spine, LLC2024-03-12
DRX-Evolution Plus System (K233381)Carestream Health, Inc.2024-03-12
Smartxide Tetra Pro (K240497)El.En S.P.A.2024-03-12
EmoLED (v. 2-USA) (K240132)Emoled, Srl2024-03-12
MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483 (K231849)Baxter Healthcare2024-03-12
Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix (K240424)Collagen Matrix, Inc.2024-03-12
Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII) (K231789)Guangzhou Xinbo Electronic Co., Ltd.2024-03-11
ARIX Cannulated Screw System (K233912)Jeil Medical Corporation2024-03-11
28mm/38D MDM X3 Insert for MDM Liner (K233724)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2024-03-11
NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2) (K231758)Luminex Molecular Diagnostics, Inc.2024-03-11
Fiber Optic Brushless Electronic Micromotor, model: iM100 (K231864)Codent Technical Industry Co., Ltd.2024-03-11
VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) (K234000)bioMerieux, Inc.2024-03-11
Caphosol® Artifical Saliva (32 doses sachet box) (K234015)Eusa Pharma (Uk) Limited2024-03-11
OTS Hip (K232140)Ortoma AB2024-03-11
SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG (K233922)Satelec - Acteon Group2024-03-11
Osteon Precision Milled Suprastructure (K233083)Implant Solutions Pty Ltd (Aka Osteon Medical)2024-03-09
Trivicta™ Hip Stem (K233758)Ortho Development Corp.2024-03-08
ALGO Pro Newborn Hearing Screener (ALGO Pro) (K233649)Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)2024-03-08
HP-OCT (HP-OCT) (K231760)Cylite Pty. , Ltd.2024-03-08
Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824) (K232826)Steris2024-03-08
Ultrasonic Gastrovideoscope (K231813)Sonoscape Medical Corp.2024-03-08
WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System (K234046)Boston Scientific Corporation2024-03-08
SENDERO Microcatheter (K240384)Okami Medical, Inc.2024-03-08
Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013) (K233943)Medtronic, Inc.2024-03-08
SleepStageML (K233438)Beacon Biosignals, Inc.2024-03-08
Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A, T14A, T16A, T19A) (K240264)Shenzhen Mlay Intelligent Technology Co., , Ltd.2024-03-08
CellFX Percutaneous Electrode System (SYS3000) (K233705)Pulse Biosciences, Inc.2024-03-08
OSSIOfiber® Threaded Trimmable Fixation Nails (K233198)OSSIO , Ltd.2024-03-08
Knee+ (K233899)Pixee Medical2024-03-08
RESCAN 700 (K233421)Carl Zeiss Meditec, AG2024-03-08
Neo ADVISE software (K230195)Comerge AG2024-03-08
Elite iQ PRO (M122K1) (K240396)Cynosure, LLC2024-03-08
Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s (K233038)Edan Instruments, Inc.2024-03-08
Esperance Distal Access Catheter (K231056)Wallaby Medical2024-03-08
STERiJECT Low Dead Space, STERiJECT The Invisible Needle (K231734)Tsk Laboratory International Japan KK2024-03-08
Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard (K231904)Co-Innovation Biotech Co., Ltd.2024-03-08
Nest VT Vitrification Device (K233177)Cook Incorporated2024-03-08
DOMINION Expandable Corpectomy System (K233359)Astura Medical2024-03-08
ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-Suture Anchor (K240407)Stryker Endoscopy2024-03-07
D·Kutting™ PTA Scoring Balloon Dilatation Catheter (K232207)Dk Medical Technology Co., Ltd.2024-03-07
0909FCC, 0909FCC-HS (K240371)Rayence Co., Ltd.2024-03-07
Safety Sliding Blood Collection Set (K232781)Jiangsu Caina Medical Co.,Ltd2024-03-07
Synthetic Bone Putty (K240458)Ventris Medical2024-03-07
Voluson Signature 20, Voluson Signature 18 (K233692)GE Medical Systems Ultrasound and Primary Care Diagnostics2024-03-07
Access Free T4 (K240273)Beckman Coulter, Inc.2024-03-06
Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector (K232004)Medivators (A Subsidiary of Steris Corporation)2024-03-06
Defendo Single Use Cleaning Adapter for Olympus Endoscopes (K240352)STERIS Corporation2024-03-06
Choledochoscope System (K231497)Shenzhen HugeMed Medical Technical Development Co., Ltd.2024-03-06
“BioGend” Interbody Fusion System 001 Cage (K233075)Biogend Therapeutics Co., Ltd.2024-03-06
Insulin Syringe (K233794)Spm Medicare Pvt. , Ltd.2024-03-06
EdgeFlow UH10 (K231677)Edgecare, Inc.2024-03-06
DVT Motion Pneumatic Compression Device (K232270)Koge Micro Tech Co., Ltd.2024-03-06
Disposable Bipolar Forceps (K232703)Jiangsu Hope Biomedical Science & Technology Co., Ltd.2024-03-06
BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device (K233021)Care Fusion2024-03-06
e-SDF (K240619)Kids-E-Dental Llp2024-03-06
FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine) (K240351)Assure Tech., LLC2024-03-06
evoDrill Cranial Perforator (K231403)Evonos GmbH & Co. KG2024-03-06
Autofuse (K233572)Pymedix2024-03-06
Momcozy Wearable Breast Pump (BP137); Momcozy Wearable Breast Pump (BP141) (K233880)Shenzhen Root Innovation Technology Co., Ltd.2024-03-06
CurrentBody Skin RF (K232424)El Global Trade, Ltd.2024-03-06
Gynethotics™ Pessary (K231786)Cosm Medical2024-03-06
DGA Abutment (K231210)Modern Dental Laboratory (Dg) Co., Ltd.2024-03-05
HTx Disposable Hysteroscope System (K231260)Suzhou AcuVu Medical Technology Co., Ltd.2024-03-05
Cerament Bone Void Filler (K240459)Bonesupport AB2024-03-05
Medline Open-back Level 3 Protective Gown (K233526)Medline Industries, LP2024-03-05
NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615) (K240404)Novabone Products, LLC2024-03-05
TERA HARZ CLEAR (K240597)Graphy, Inc.2024-03-05
BASIS FLOW II (K233859)YAMAHACHI DENTAL MFG., Co.2024-03-05
Argo Knotless GENESYS Anchor (K240090)Conmed Corporation2024-03-05
Stelo Glucose Biosensor System (K234070)Dexcom, Inc.2024-03-05
Vyvo (K231288)Vyvo Technology Corp.(Vt)2024-03-04
XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4) (K233877)Magic Mobility2024-03-04
Medical Diode Laser Systems (K230047)Gigaalaser Company , Ltd.2024-03-04
Overjet Caries Assist-Pediatric (K233738)Overjet, Inc.2024-03-04
ReBOSSIS (K240453)Orthorebirth Co., Ltd.2024-03-04
Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, aka Synguard C+ Nitrile Exam Gloves (K231365)Anhui Intco Medical Products Co., Ltd.2024-03-01
OxiplexTS200 (K232385)Iss Medical, Inc.2024-03-01
Insignis™ Syringe Infusion System (K232328)Innovative Health Sciences, LLC2024-03-01
BoneMRI (K233030)Mriguidance B.V.2024-03-01
LIAISON PLEX Respiratory Flex Assay (K233410)Luminex Corporation2024-03-01
Zfx Abutments (K231915)Zfx GmbH - A Company of Zimvie2024-03-01
IMAGEnet6 Ophthalmic Data System (K232828)Topcon Corporation2024-03-01
GORE® PROPATEN® Vascular Graft (K240083)W. L. Gore & Associates, Inc.2024-03-01
S21 OTC Transcutaneous Electrical Nerve Stimulator (K233095)Micro Current Technology, Inc.2024-03-01
DEKA Infusion System, DEKA Administration Set (K232316)Deka Research and Development2024-03-01
MiroDry Wound Matrix (K240277)Reprise Biomedical, Inc.2024-03-01
Muscle Stimulator (K231648)Shenzhen Yiran Intelligent Co., Ltd.2024-03-01
NUNA LUX (NUNL528) (K233862)Premier North America, Inc.2024-03-01
Access Intact PTH (K232791)Beckman Coulter, Inc.2024-03-01
Probe Covers (YF-001, YF-002) (K240023)Shenzhen YI Fang Blister Packaging Co., Ltd.2024-03-01
Gynatrof (K232040)Tyros Biopharma, Inc.2024-03-01
Nihon Kohden NKV-550 Series Ventilator System (K231778)Nihon Kohden Orangemed, LLC2024-03-01
iCAS-LV (K231690)Highrad , Ltd.2024-03-01
Powder Free Nitrile Examination Gloves (Blue), Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs (K240051)Lingshi Hongruida Health Protection Technology Co., Ltd.2024-02-29
Balloon Inflation System (K232842)Ningbo Hicren Biotechnology Co., Ltd.2024-02-29
PlazMagik (K230837)Agnes Medical Co., Ltd.2024-02-29
MAGNETOM Cima.X Fit (K232765)Siemens Medical Solutions USA, Inc.2024-02-29
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Every clearance here is in the API, with alerts when new ones post.