Atlas FDA

2024

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

Sort:Newest firstOldest first

Download CSV table Client report (share link) ◉ Watch

Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.

RecordFirmDate
Contour Hand/Wrist (Q7000232) (K233652)Quality Electrodynamics2024-02-16
VasQ (K240119)Laminate Medical Technologies , Ltd.2024-02-16
VedDilator ^TM (3-Stage Balloon Dilation Catheter) (K232245)Jiangsu Vedkang Medical Science and Technology Co., Ltd.2024-02-15
Contour Shoulder (K233656)Quality Electrodynamics2024-02-15
MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color Doppler Ultrasound System (P25 Expert); P12 Plus Digital Color Doppler Ultrasound System (P12 Plus); P11 Plus Portable Digital Color Doppler Ultrasound System (P11 Plus); P9 Plus Ultrasound Diagnostic System (P9 Plus); P3 Plus Ultrasound Diagnostic System (P3 Plus) (K231659)Medisono2024-02-15
Breathing circuit bacterial/viral filter (K222917)Shaoxing Haitech Medical Products Co., Ltd.2024-02-15
Medical Monitor (21HQ613D) (K240130)Lg Electronics.Inc2024-02-15
SONIK MONARK 100 (K234036)Neuro Spinal Innovation, Inc.2024-02-15
COPAL® exchange G hip spacer; COPAL® G+V (K234028)Heraeus Medical GmbH2024-02-15
EpiMonitor (K232915)Empatica S.r.l.2024-02-15
InVision™ 1.5 Surgical Theatre (K240157)Deerfield Imaging, Inc.2024-02-15
Bronchoscope System (K231107)Hunan Endoso Life Technology Co., Ltd.2024-02-15
FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration) (K233483)Cardio Flow Inc.,2024-02-15
EMPHASYS™ Dual Mobility System (K231522)Depuy Ireland UC2024-02-15
PBC Separator with Selux AST System (K223493)Selux Diagnostics, Inc.2024-02-15
Radiography 7000 M (K233678)Philips Medical Systems Dmc GmbH2024-02-14
airVata™ (K240427)Gelb Practice Solutions, Inc.2024-02-14
Azure (K231514)Daeshin Enterprise Co., Ltd.2024-02-14
Transorb™ Self-Gripping Resorbable Mesh (K233661)Sofradim Production2024-02-13
Apex Locator (K231990)Cefla S.C.2024-02-13
VerteLoc Spinal System (K231134)Signature Orthopaedics Pty, Ltd.2024-02-13
EXPD 4343S (K232082)DRTECH Corporation2024-02-13
Black Nitrile Powder Free Patient Examination Glove, Non Sterile (K233740)W.A. Rubbermate Co., Ltd.2024-02-13
EPi-Ease Epicardial Access Device (EAS) (K233959)AtriCure, Inc.2024-02-13
Easi-Vue® embolic microspheres System (K234123)Abk Biomedical, Inc.2024-02-13
QOCA® image Smart RT Contouring System (K231855)Quanta Computer, Inc.2024-02-13
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System (K233788)Philips Ultrasound, LLC2024-02-13
Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu (K233954)B&E Korea Co., Ltd.2024-02-13
M.U.S.T. Pedicle Screw System - Extension (K234048)Medacta International S.A.2024-02-13
SCOUT MD Surgical Guidance System (K231468)Merit Medical System, Inc.2024-02-12
Mimics Cardiac Planner (K233217)Materialise NV2024-02-12
Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile) (K233401)Eieling Technology Limited2024-02-12
NerveTape (K233533)Biocircuit Technologies, Inc.2024-02-12
SPY Cystoscope/Hysteroscope (K233635)Stryker Endoscopy2024-02-12
Univers Revers CA Head and Adapter (K233260)Arthrex, Inc.2024-02-12
EMS/TENS Massager Device (K233040)Shenzhen Imdk Medical Technology Co., Ltd.2024-02-12
Endoscopic Video Image Processor, Single-Use Video Hysteroscope (K232003)Guangzhou Red Pine Medical Instrument Co., Ltd.2024-02-12
Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W) (K233092)Chongqing Rob Linka Science and Technology Co., Ltd.2024-02-12
PainFreeze II (K232674)Nuance Medical, LLC2024-02-12
I.T.S. INS Proximal Femur Nail (K233134)I.T.S. GmbH2024-02-12
Facial Toning device (UIC-189); Facial Toning device (UIC-589) (K233667)Body Trim Industrial Co., Ltd.2024-02-12
Aurora (K231355)Ensodata2024-02-09
Infrared Thermometer: Model YJ600 (K232473)Zhuhai Yueja Medical Device Technology Co., Ltd.2024-02-09
CATS-L Tonometer™ Prism (K234037)Cats Tonometer, LLC2024-02-09
Neteera 130H-Plus Vital Sign Monitoring Sensor (K231733)Neteera Technologies , Ltd.2024-02-09
AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18G (K232072)H.S Hospital Service S.P.A2024-02-09
Fine Osteotomy™ (K240066)Bodycad Laboratories, Inc.2024-02-09
VERZA™ High Speed Drills (K233638)Globus Medical, Inc.2024-02-09
V-STRUT® Vertebral Implant (K240084)Hyprevention2024-02-09
Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested For Use With Chemotherapy Drugs and Fentanyl Citrate (K240072)Luliang Hongruida Health Protection Technology Co., Ltd.2024-02-09
WSA Self-Fitting Hearing Aid Gen 2 (K233464)Wsaud A/S2024-02-09
DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) (K240098)STERIS Corporation2024-02-09
VenaCore Thrombectomy Catheter (46-101) (K234034)Inari Medical, Inc.2024-02-09
ZapStim Controller Application (Z1023) (K233631)Revital Lab, Inc.2024-02-09
Aid-U (K231662)Iaid2024-02-08
Leksell GammaPlan (LGP) (K232854)Elekta Solutions AB2024-02-08
HealthFLD (K233080)Nano-X AI , Ltd.2024-02-08
T-FIT (K231913)Techwin Co., Ltd.2024-02-08
neuro42 MRI System (K232644)Neuro42, Inc.2024-02-08
Access SHBG (K233480)Beckman Coulter, Inc.2024-02-08
Ion 3D (K240086)SurGenTec, LLC2024-02-08
eQUANT System (K231536)Avails Medical, Inc.2024-02-08
Z1 Hip System (K233476)Orchard Medical Development2024-02-08
Alma Harmony (K233024)Alma Lasers, Inc.2024-02-08
T2Bacteria® Panel (K233184)T2biosystems, Inc.2024-02-08
XVbeam2000 (K233914)Shenzhen Xpectvision Technology Co., Ltd.2024-02-08
SINC Support Catheter (K233350)Reflow Medical, Inc.2024-02-08
Vecttor VT-300 (K231575)Artaflex, Inc.2024-02-08
Concentriq Dx (K230839)Proscia, Inc.2024-02-08
Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M) (K240069)Endolumik2024-02-08
Lexa MINI (RIS-303, RIS-305) (K233504)W&H Sterilization S.R.L.2024-02-08
FUJIFILM Endoscope Model EB-710XT (K240075)FUJIFILM Healthcare Americas Corporation2024-02-07
Purema® H Hemoconcentrator (EtO Sterilized) (K232171)Tecnoideal America2024-02-07
Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K232764)Eco Medi Glove Sdn. Bhd.2024-02-07
F&P Optiflow+ Duet Nasal Cannula (K231956)Fisher & Paykel Healthcare, Ltd.2024-02-07
Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom (K240064)Wontech Co., Ltd.2024-02-07
Sleep Apnea Feature (DEN230041)Samsung Electronics Co., Ltd.2024-02-06
INNOVERSE Spinal System (K233960)Innosys Co., Ltd.2024-02-06
Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) (K233221)Metro Optics of Austin, Inc.2024-02-06
Hawkeye Control Unit with Eyas Endoscope (K233115)E Surgical, LLC2024-02-06
BÜHLMANN fCAL® turbo and CALEX® Cap (K232057)Bühlmann Laboratories AG2024-02-06
MAGEC Spinal Bracing and Distraction System (K233593)Nuvasive Specialized Orthopedics, Incorporated2024-02-06
Cryojet Plus (SHE-ACP001-1) (K233416)Beijing Sano Laser S&T Development Co.,Ltd2024-02-06
5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S, G516S) (K233897)Shenzhen Beacon Display Technology Co., Ltd.2024-02-06
FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test Midstream (K233174)Assure Tech. (Hangzhou) Co, Ltd.2024-02-05
PREVENT Kit (K232379)Clear Choice Therapeutics2024-02-05
Viz HDS, Viz Volume Plus, Viz ICH+ (K232363)Viz. Ai, Inc.2024-02-05
Ziehm Vision RFD (K240099)Ziehm Imaging GmbH2024-02-05
Flow-Nail (K234075)Flow-Fx, LLC2024-02-05
EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA, EZS24A and EZS24TA); OptiSite Arterial Perfusion Cannulae (OPTI16, OPTI18, OPTI20 and OPTI22); EndoReturn Arterial Cannulae (ER21B and ER23B); (K233895)Edwards Lifesciences2024-02-05
Central Monitoring System (MFM-CMS) (K232694)Edan Instruments, Inc.2024-02-05
Smart Fit Knee 3.0T (K233600)Philips Healthcare (Suzhou) Co., Ltd.2024-02-05
Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ (K234013)Bone Solutions, Inc.2024-02-05
X-trodes System M (K232210)X-Trodes2024-02-04
CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) (K232890)Integra Lifesciences Production Corporation2024-02-04
VitalDetect (K231625)Wellvii, Inc.2024-02-02
AllPEP (K233855)Enchant Tek Co. , Ltd.2024-02-02
OIC FLEX-FIX™ System (K233531)Orthopaedic Implant Company2024-02-02
Indigo® Aspiration System - Lightning® Flash (K240030)Penumbra, Inc.2024-02-02
BD Vacutainer® K2 EDTA Blood Collection Tubes (K231373)Becton, Dickinson and Company2024-02-02
← Previous Next →

Track 2024 automatically

Every clearance here is in the API, with alerts when new ones post.