Atlas FDA

2022

3,209 FDA 510(k) clearances · Clearance year

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RecordFirmDate
SCOPE BUDDY PLUS Endoscope Flushing Aid (K213833)Medivators, Inc.2022-01-14
IPL Hair Removal (K212318)Dongguan Define Beauty Electronic Technology Co., Ltd.2022-01-14
Dermatological diode laser system (K212478)Beijing Stelle Laser Technology Co., Ltd.2022-01-14
Surgical Face Mask (K212913)Jiangxi Ganlong Pharmaceutical Co., Ltd.2022-01-14
BRM TOOL Screws (K203773)Brm Extremities Srl2022-01-14
Surgical Mask (K212997)Guangdong Zhizhen Biological Medical Co., Ltd.2022-01-14
Quantib ND (K213737)Quantib B.V.2022-01-14
Bio-Medicus Life Support Catheter and Introducer (K201057)Medtronic, Inc.2022-01-14
Medline Universal Grounding Pad (K212093)Medline Industries, Inc.2022-01-14
Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104) (K211632)Shenzhen Narig Bio-Medical Technology Co., Ltd.2022-01-14
Eclipse II with Smart Noise Cancellation (K213307)Carestream Health, Inc.2022-01-14
Precise Image (K210760)Philips Medical Systems Nederland B.V.2022-01-14
UltraPrint-Dental Temp C&B UV (K213643)Guangzhou Heygears IMC., Inc.2022-01-14
iASSIST Knee System (K213033)Orthosoft D/B/A Zimmer Cas2022-01-14
Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert (K213642)GE Healthcare2022-01-13
3N Contact Lenses Adjunct Cleaner (K211361)Suzhou 3N Biological Technology Co., Ltd.2022-01-13
Distal Humerus Plating System (K213895)Skeletal Dynamics, Inc.2022-01-13
Dental Electric Motor (K203706)Guilin Woodpecker Medical Instrument Co., Ltd.2022-01-13
Stronghold Group Nitrile Examination Glove, Powder Free (K213859)Stronghold Group, LLC2022-01-13
PRESIDENT The Original (K220097)Coltène/Whaledent AG2022-01-13
Straight Arm DDR (K214012)Konica Minolta Healthcare Americas, Inc.2022-01-12
BIB Stent Placement Catheter (K213915)NuMED, Inc.2022-01-12
andorate Suction Valve, andorate Air/Water Valve (K213095)Ga Health Company Limited2022-01-12
UNiD Spine Analyzer (K212005)Medicrea International, Inc.2022-01-12
Arm Blood Pressure Monitor (K212877)Alicn Medical Shenzhen, Inc.2022-01-12
Surgical gowns (K212718)Xiantao Dingcheng Non-Woven Product Co., Ltd.2022-01-12
Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner (K212569)Materialise NV2022-01-12
Venus BlissMAX (K213308)Venus Concept USA, Inc.2022-01-12
Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) (K212735)Xingyu Medical Tech Co., Ltd.2022-01-11
Disposable Surgical Gown (K212591)Suzhou Janee Medical Technology Co., Ltd.2022-01-11
Esteya (K213942)Nucletron B.V.2022-01-11
Cardiovascular Suite 4.2.1 (K202094)Quipu S.R.L2022-01-11
360CAS (K213380)Kico Knee Innovation Company Pty Limited2022-01-11
Medical Examination Gloves (K213168)Shandong Huiwosheng Health Technology Co.,Ltd2022-01-11
ES1 System (K213102)E-Scopics2022-01-11
High Retention Attachment System (K213391)Zest Anchors, LLC2022-01-11
i3 Foldable Mobility Scooter (K191356)Puc Perfect Union Co., Ltd.2022-01-11
Ora-Aid (K211851)Tbm Corporation2022-01-11
Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System (K213199)Stryker GmbH2022-01-11
G-Tech Wireless Patch System (WPS) (K212954)G-Tech Medical2022-01-10
Powered Wheelchair (K212854)Zhejiang Qianxi Vehicle Co., Ltd.2022-01-10
3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix (K212541)Deltamed GmbH2022-01-10
iQ 2 Nasal Mask, Phantom 2 Nasal Mask (K211274)Sleepnet Corporation2022-01-10
Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger (K212688)Qura S.R.L2022-01-10
Sheng Jing Tang Surgical Mask (K211260)Liaoning Shengjingtang Biotechnology Co., Ltd.2022-01-10
Romero Cervical Cage (K212358)Spineup, Inc.2022-01-10
MagnetOs granules (K213111)Kuros Biosciences B.V2022-01-10
Gingi-Aid Gel (K211419)Belport Company, Inc., Gingi-Pak2022-01-10
DUMI ManipulatOR (K212505)The O R Company Pty, Ltd.2022-01-10
Powder free nitrile examination glove- black, non sterile (K212801)Hong Seng Gloves Sdn Bhd2022-01-09
Powder Free Nitrile Examination Gloves, Blue Chemotest (K211666)Careglove Global Sdn. Bhd.2022-01-09
CELERITY HP Chemical Indicator (K213262)STERIS Corporation2022-01-07
Selebrek PTCA Balloon Dilatation Catheter (K211349)Kossel Medtech (Suzhou) Co., Ltd.2022-01-07
Agile Devices Angler Steerable, Deflectable Microcatheter (K211110)Agile Devices, Inc.2022-01-07
CORE1 Implant System (K210039)Cybermed, Inc.2022-01-07
Custom Stable Rigid Gas Permeable Scleral Contact Lens (K213880)Valley Contax, Inc.2022-01-07
Picocaremajesty (K212127)Wontech Co., Ltd.2022-01-07
GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 head Holes, GPC 2.4mm Variable Angle Locking Two Column Volar Distal Radius Plates, 7 Head Holes, 2.4 mm Variable Angle Locking Two Column Volar Distal Radius Plate-Narrow, 6 Head Holes, Variable Angle Locking Screw 2.4 mm, Stardrive (K210198)Gpc Medical Limited2022-01-07
Tesera-k ALIF System (K212980)Kyocera Medical Technologies, Inc.2022-01-07
Sunrise Sleep Disorder Diagnostic Aid (DEN210015)Sunrise2022-01-07
Infrared Thermometer (K210564)Alicn Medical Shenzhen, Inc.2022-01-07
Visualase MRI-Guided Laser Ablation System (SW 3.4) (K211269)Medtronic Navigation, Inc.2022-01-07
Pectus Blu Support Bar System (K212841)Biomet Micofixation2022-01-07
DropSafe Safety Pen Needles (K211716)Htl Strefa SA2022-01-07
EK Implants and Abutments System (K203360)Hiossen, Inc.2022-01-07
AIBOLIT 3D+ (K211443)Aibolit Technologies, LLC2022-01-07
Fetal Doppler (K211940)Shenzhen Taikang Medical Equipment Co., Ltd.2022-01-07
Prelude IDeal 9F Hydrophilic Sheath Introducer (K212152)Merit Medical Systems2022-01-07
ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (K212166)Inomed Medizintechnik GmbH2022-01-07
Acumed Ankle Syndesmosis Repair System (K212990)Acumed, LLC2022-01-07
Cyclops™ Anterior Cervical Plate System (K213901)Degen Medical2022-01-07
Vital Navigation System (K213720)Zimvie (Zimmer Biomet Spine, Inc.)2022-01-07
SignaSure Dual Mobility System (K211742)Signature Orthopaedics Pty, Ltd.2022-01-07
Dental Zirconia Ceramic (K213570)Aidite (Qinhuangdao) Technology Co., Ltd.2022-01-07
Tigereye CTO-Crossing Catheter (K212468)Avinger, Inc.2022-01-06
23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) (K211499)23AndMe, Inc.2022-01-06
ExactechGPS Total Shoulder Application, Equinoxe Planning Software (K213546)Blue Ortho2022-01-06
DePuy Corail AMT Hip Prosthesis (K213839)DePuy Orthopaedics, Inc.2022-01-06
Gold Anchor (K213053)Naslund Medical AB2022-01-06
ENEO TOTALE (Model: ENEOT947) (K213841)Premier North America, Inc.2022-01-06
iPrime Viscodelivery System (K212797)Glaukos2022-01-06
Penta Glove (K212847)Pentavest Holdings Sdn Bhd2022-01-06
Enlight 2100 (K211135)Timpel S.A.2022-01-06
TOMTEC-ARENA (K213544)Tomtec Imaging Systems GmbH2022-01-06
BHA100 Series Braun Clear Hearing Aid (K212609)Kaz USA, Inc., A Helen of Troy Company2022-01-05
Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor (K212115)Joytech Healthcare Co. , Ltd.2022-01-05
MPO Knee Instruments; MPO PROPHECY Knee Instruments (K213817)Microport Orthopedics, Inc.2022-01-05
MPO Hip Instruments (K213816)Microport Orthopedics, Inc.2022-01-05
Jplant (K211978)Jj Medical Co., Ltd.2022-01-05
PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Packs (K211318)Smith Nephew Medical Limited2022-01-05
FORZA XP Expandable Spacer System (K213951)Orthofix US, LLC2022-01-05
Vinyl Exam Gloves (K213019)Hebei Astro Medical Supply Co., Ltd.2022-01-05
PRO-DENSE LoVisc Bone Graft Substitute (K213342)Wrightmedicaltechnologyinc2022-01-05
PASS LP™ Spinal System, CD Horizon™ Spinal System (K213281)Medicrea International SA2022-01-05
BTL-899A (K213344)BTL Industries, Inc.2022-01-05
Urethral Warming Catheter Kit (K211149)Varian Medical Systems, Inc.2022-01-05
Self-adhesive Electrode (K213879)Bozhou Rongjian Medical Appliance Co., Ltd.2022-01-05
Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle (K213831)Gyrus Acmi, Inc.2022-01-04
InnoClip Disposable Clip Applier, InnoClip Clip Applier (K202994)Taiwan Surgical Corporation2022-01-04
T-Edge 10, T-Edge 11 (K213080)Tuttnauer , Ltd.2022-01-04
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Every clearance here is in the API, with alerts when new ones post.