Atlas FDA

2024

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

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RecordFirmDate
Hearing Aid Feature (HAF) (DEN230081)Apple, Inc.2024-09-12
CINA-CSpine (K240942)Avicenna.Ai2024-09-12
Glidewell™ 3DP Denture Base Resin (K241493)Prismatik Dentalcraft, Inc.2024-09-12
Electric wheelchair (C001) (K242136)Zhejiang Hfizer Medical Equipment Co., Ltd.2024-09-12
Extremity All Suture System (K241695)Field Orthopaedics2024-09-12
Elucid PlaqueIQ (K241524)Elucid Bioimaging, Inc.2024-09-12
Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2 (K231982)Qura S.R.L2024-09-12
VitalFlow Set with Balance Biosurface (K240880)Medtronic, Inc.2024-09-12
Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518) (K240787)Biotronik, Inc.2024-09-12
Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) (K240271)Linshom Medical, Inc.2024-09-11
Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with 46 Chemotherapy Drugs, the Opioid Fentanyl citrate, simulated Gastric Acid, Fentanyl in Gastric Acid, the tranquilizer Xylazine, and Xylazine in Fentanyl citrate (Blue) (K241745)Ksg Medicare Sdn. Bhd.2024-09-11
FETOLY-HEART (K241380)Diagnoly2024-09-11
Signus Tetris™ St; Signus Tetris™ R St (K241438)Signus Medizintechnik GmbH2024-09-11
Rx Knee System (K240683)Signature Orthopaedics Pty, Ltd.2024-09-11
Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2) (K241004)Huizhou Lvb Maternal and Infant Supplies Co., Ltd.2024-09-11
C&B NFH Hybrid (K232559)Arum Dentistry Co., Ltd.2024-09-11
SonoBlock; SonoBlock II (K241954)PAJUNK GmbH Medizintechnologie2024-09-11
Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System (LK128C); Ultrasound Imaging System (LK128M); Ultrasound Imaging System (LK128PA); Ultrasound Imaging System (LK128E); Ultrasound Imaging System (LU700C); Ultrasound Imaging System (LU700L); Ultrasound Imaging System (LU710L); Ultrasound Imaging System (LU710LH); Ultrasound Imaging System (LU710C); Ultrasound Imaging System (LU710M); Ultrasound Imaging System (LU710PA); Ultrasound Imaging (K241161)Leltek, Inc.2024-09-11
HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors (K241010)Depuy Mitek2024-09-11
Pounce XL Thrombectomy System (PTS-1011-7F135) (K241362)Surmodics,Inc.2024-09-11
Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for GE Systems) (10135910) (K234064)Surgical Instrument Service and Savings, Inc.2024-09-10
LumiNE US; Lumi (K240094)Augmedit B.V.2024-09-10
Tornier Humeral Reconstruction System (Tornier HRS) (K241609)Stryker Corporation (Tornier, Inc.)2024-09-10
ProPel SG3™ Surgical Gown (K241214)Standard Textile Co., Inc.2024-09-10
Option ELITE Vena Cava Filter System (352506070E 352506100E) (K242612)Argon Medical Devices, Inc.2024-09-10
Mobility Scooter (K240990)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd2024-09-10
8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 Reloads (K241638)Intuitive Surgical, Inc.2024-09-10
See-Mode Augmented Reporting Tool, Thyroid (SMART-T) (K240697)See-Mode Technologies Pte, Ltd.2024-09-09
Overjet Image Enhancement Assist (K241681)Overjet, Inc.2024-09-09
TENS & EMS Stimulator (MHD-1083) (K241678)Shenzhen Minghuangda Electronics Co., Ltd.2024-09-09
ADAS 3D (K240791)Adas3D Medical S.L.2024-09-09
Pitkar Spinal Pedicle Screw System (K240233)S.H.Pitkar Orthotools Pvt. , Ltd.2024-09-09
Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM, Y6S MU, Y6S OG, Y6S CH,Y6S PN,Y6S NK, Y6S PG, Y6S TG, Y6S OE) (K241205)Shenzhen Ulike Smart Electronics Co., Ltd.2024-09-09
TriALTIS™ Spine System (K242042)Medos International SARL2024-09-09
FoLix (K242349)Lumenis Be, Ltd.2024-09-09
Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF) (K242394)Rayence Co., Ltd.2024-09-09
Latex Examination Glove Powder Free (Ocean Blue and Natural White) (K240266)Sri Trang Gloves (Thailand) Public Company Limited2024-09-09
PM2 System and ECGuide Connector (K240486)Piccolo Medical, Inc.2024-09-08
Nordica PV Cryo Mapping Catheter (K233900)Synaptic Medical Corporation2024-09-06
ACS® LD FB Knee System (K234044)Implantcast GmbH2024-09-06
MSC SFM (K232543)Yocon Biology Technology Company2024-09-06
FemChec Controlled Saline-Air Device (FCD-250) (K241693)Femasys, Inc.2024-09-06
SafeCross Vascular Introducer System (4001) (K240600)East End Medical I, LLC2024-09-06
IB3D™ PL Spinal System (K241164)Medicrea International S.A.S. (Medtronic)2024-09-06
Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF) (K232996)Shanghai Iatrical-Ti Technologies CO , Ltd.2024-09-06
uAI Portal (K240411)Shanghai United Imaging Intelligence Co., Ltd.2024-09-06
T2 Plus (K233806)Osstem Implant Co., Ltd.2024-09-06
VISULAS combi (K233911)Carl Zeiss Meditec, AG2024-09-06
Access Syphilis (K241427)Beckman Coulter, Inc.2024-09-06
Withings Sleep Rx (K231667)Withings2024-09-06
nextaro® va, 15mm, 5µm (K241976)Sfm Medical Devices GmbH2024-09-06
Mucosal Impedance Measurement System (K233974)Alandra Medical Sapi DE CV2024-09-06
MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer (K241552)Mentor Worldwide, LLC2024-09-06
COPRO 3 (K241672)Amt Engineering Co., Ltd.2024-09-06
Orchid Safety Release Valve™ (K241415)Linear Health Sciences, LLC2024-09-06
TMC Compression Implant System (K242415)Treace Medical Concepts2024-09-06
COSINE™ Spacer (K234035)Globus Medical, Inc.2024-09-06
DD Hybridlayer (multicolored zirconia) (K241579)Dental Direkt GmbH2024-09-06
Luvis Chair (LC700C) (K233921)Dentis Co., Ltd.2024-09-06
Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140) (K232692)Intradin (Shanghai) Machinery Co., Ltd.2024-09-05
Cold Sore Device (QPZ-03) (K241155)Shenzhen Nuon Medical Equipment Co., Ltd.2024-09-05
ICX-Implant System (K231566)Medentis Medical GmbH2024-09-05
Novum IQ Syringe Pump (40800BAXUS) (K242390)Baxter Healthcare Corporation2024-09-05
Fine Osteotomy™ (K241356)Bodycad Laboratories, Inc.2024-09-05
Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System with Nanotechnology (K241605)Nanovis, LLC2024-09-05
TRAQinform IQ (K233998)Aiq Global, Inc.2024-09-05
Electric wheelchair (W3902) (K241723)Zhejiang Richall Medical Technology Co., Ltd.2024-09-05
ProGear® Surgical Mask with Oxafence®, Model AV82030 (K231741)Prestige Ameritech2024-09-05
Electric wheelchair (N3901) (K241721)Zhejiang Richall Medical Technology Co., Ltd.2024-09-05
URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video Processor) (K240203)Dyne Medical Group, Inc.2024-09-05
Tamper Evident Cap (K231095)International Medical Industries, Inc.2024-09-04
BE Plus PRO, Neurotravel LIGHT (K242305)Eb Neuro S.P.A.2024-09-04
Modular Medical MODD1 Insulin Delivery System (K240158)Modular Medical, Inc.2024-09-04
Velacur (K233977)Sonic Incytes2024-09-04
NextDent Jet Denture Base; NextDent Jet Denture Teeth (K241071)Vertex-Dental B.V.2024-09-04
Qraycam PRO (K221275)AIOBIO Co., Ltd.2024-09-04
DreamClear (K240646)Somnomed Technologies Inc., Doing Business AS Remware2024-09-04
Mini Screws (K231502)Proimtech Saglik Urunleri Anonim Sirketi2024-09-04
FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP (K240142)Fujifilm Corporation2024-09-04
SignalNED System (Model RE) (K242306)Forest Devices, Inc.2024-09-04
Litho 60; Litho 100; Litho 150 (K242251)Quanta System Spa2024-09-03
Indigo® Aspiration System – Aspiration Catheter 6X (K242319)Penumbra, Inc.2024-09-03
EVOS Patella Plates (K240487)Smith & Nephew2024-09-03
Eminent Spine Scoliosis Deformity Pedicle Screw System (K242069)Eminent Spine2024-09-03
SOMATOM On.site (K241295)Siemens Medical Solutions USA, Inc.2024-09-03
ShapeIT (SI014135) (K241611)Imds Operations B.V.2024-09-03
K5 (K233805)Osstem Implant Co., Ltd. Chair Business2024-09-03
Arthrex VAL and VAL KreuLock™ Compression Screw System (K241592)Arthrex, Inc.2024-08-31
ODI-Tech (K241393)Odi Medical AS2024-08-30
JetBoots PRO Plus (K241256)Therabody, Inc.2024-08-30
Ultrasound Transducer Cover (K241662)Vitrolife Sweden AB2024-08-30
Talee, Talee PostOp (K241957)Invent Medical USA, LLC2024-08-30
Vave Wireless Ultrasound System (K241051)Vave Health, Inc.2024-08-30
BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808) (K231969)Dongguanshi Yiyingmei Technology Co., Ltd.2024-08-30
Kingcera Dental Zirconia Blank (K241602)Hunan Qinghao Puzhong Technology Co., Ltd.2024-08-30
Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA) (K241318)Adaptiiv Medical Technologies, Inc.2024-08-30
Conformity Stem Extension Line (K242249)United Orthopedic Corporation2024-08-30
Velmeni for Dentists (V4D) (K240003)Velmeni, Inc.2024-08-30
embecta Insulin Delivery System (K234027)Embecta Medical I, LLC2024-08-30
syngo.via MI Workflows; Scenium; syngo MBF (K242275)Siemens Medical Solutions USA, Inc.2024-08-30
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Every clearance here is in the API, with alerts when new ones post.