Atlas FDA

2022

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

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RecordFirmDate
BeautiBond Xtreme (K213965)Shofu Dental Corporation2022-03-18
Vintage Prime Press (K212939)Shofu Dental Corporation2022-03-18
Powder Free Nitrile Examination Gloves, Blue and Violet Blue, Test For Use With Chemotherapy Drugs (K220228)Shandong Blue Sail Health Technology Co., Ltd.2022-03-18
Needle Stimulator (Model: RJNS6-1) (K220153)Bozhou Rongjian Medical Appliance Co., Ltd.2022-03-18
Merits P335 Powered Wheelchair (K220529)Merits Health Products Co., Ltd.2022-03-18
Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses (K212631)Contamac, Ltd.2022-03-17
SICtapered & SICvantage tapered (K210489)Sic Invent AG2022-03-17
OxyMinder (K213948)Bio-Med Devices, Inc.2022-03-17
Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use Hand Switch Bipolar Forceps with Smoke Evacuation, Single Use Hand Switch Monopolar Forceps, Single Use Hand Switch Bipolar Forceps (K210315)Modern Medical Equipment Manufacturing, Ltd.2022-03-17
RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm (K213444)Ureteral Stent Company2022-03-17
K Clear (K220726)Kline Europe GmbH2022-03-16
Healgen Strep A Rapid Test Strip (Throat Swab) (K212623)Healgen Scientific,, LLC2022-03-16
Customize (K213779)3D-Side S.A.2022-03-16
Fiber Dust PRO (K220426)Quanta System Spa2022-03-16
iTEAR100 Neurostimulator (K213623)Olympic Ophthalmics2022-03-16
AccuFit Lateral 2-Hole Plate (K220324)Precision Spine, Inc.2022-03-16
IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit (K210528)Millennium Medical Technologies Inc (Dba Cellmyx)2022-03-16
Intera Refill Kit (K213823)Intera Oncology, Inc.2022-03-16
EchoSK and EchoSGyn modules for EchoS Family devices (K212851)Echolight S.P.A2022-03-16
Disposable Nitrile Examination Glove (K213121)Jiangsu Cureguard Glove Co., Ltd.2022-03-15
Fit Pro Breast Pump (K212955)Hygeia II Medical Group, Inc.2022-03-15
Peridot Spinal Interbody System (K213980)Gbs Commonwealth Co., Ltd.2022-03-15
VoqX Electronic Stethoscope (K212709)Sanolla , Ltd.2022-03-15
VITEK MS PRIME (K212461)bioMerieux, Inc.2022-03-15
CerusEndo Microcatheter (027) (K213314)Cerus Endovascular, Inc.2022-03-15
CareGUARD Sterilization Wrap (K213907)Care Essentials Pty, Ltd.2022-03-14
Arterys MICA (K203744)Arterys, Inc.2022-03-14
Aluminum back folding wheelchair SYIV 100-LQXAL2482-407 (K213790)Mobility Source Medical Technology Co., Ltd.2022-03-14
Optimotion Implants Porous Metal-Backed Patella (K220049)Optimotion Implants, LLC2022-03-14
Qitexio (K203738)Medex2022-03-14
2.4mm Distal Radius System (K211324)Auxein Medical Private Limited2022-03-14
BriefCase (K214043)Aidoc Medical , Ltd.2022-03-14
DWFritz ASM2000 (K213894)Dwfritz Automation, Inc.2022-03-14
Stasis Gel (K211420)Belport Company, Inc., Gingi-Pak2022-03-14
Yadu Medical Face Mask (Level 1) (K212330)Henan Yadu Industrial Co., Ltd.2022-03-14
OPN NC PTCA Dilatation Catheter (K212393)Sis Medical AG2022-03-14
Disposable Medical Face Mask (K213806)Xiantao Zhibo Nonwoven Products Co., Ltd.2022-03-12
Intai Anatomic Locking Plate and Screw System (K201229)Intai Technology Corporation2022-03-11
Maxima Surgical Gown (K201351)Elevate Textiles2022-03-11
RI.HIP MODELER (K212040)Blue Belt Technologies, Inc.2022-03-11
CardIQ Suite (K213725)GE Medical Systems SCS2022-03-11
Pectus Support Bar System (K213712)Biomet Microfixation2022-03-11
MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty (K220315)Orthocon, Inc.2022-03-11
DEKA SMARTPERIO (K213658)El.En Electronic Engineering Spa2022-03-11
Intracept Intraosseous Nerve Ablation System (K213836)Relievant Medsystems, Inc.2022-03-11
Dental Electric Motor (K202075)Foshan Cicada Dental Instrument Co, Ltd.2022-03-11
Apollo Ankle Fracture Plating System (K213005)Glw Medical, Inc.2022-03-11
DESS Dental Smart Solutions (K212628)Terrats Medical SL2022-03-11
32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch (K213687)Neocoil, LLC2022-03-11
MAGNETOM Vida, MAGNETOM Sola (K220425)Siemens Medical Solutions USA, Inc.2022-03-11
TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst) (K213827)Smith & Nephew, Inc.2022-03-11
Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection Cables, Unify Wireless FootSwitch, Unify Cart (K213354)Conmed Corporation2022-03-11
EmbryoSlide+ ic8 dish (K213869)Vitrolife A/S2022-03-11
Minuteman G5 MIS Fusion Plate (K211880)Spinal Simplicity, LLC2022-03-11
EndoGator Endoscopy Irrigation Tubing (K220395)STERIS Corporation2022-03-11
Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use (K212920)Shandong Weigao Group Medical Polymer Co., Ltd.2022-03-11
Demetra Dermatoscope BDEM-01 (K213957)Barco N.V.2022-03-11
Dental sensors NanoPix1, NanoPix2 (K220422)Iray Technology Taicang , Ltd.2022-03-11
PHantom Trilogy (K213534)Resurgeonz, LLC2022-03-11
Shoulder Innovations Total Shoulder System (K213615)Shoulder Innovations, Inc.2022-03-11
Personal Kinetigraph (PKG) System Gen 2 Plus (K211887)Gkc Manufacturing Pty, Ltd.2022-03-11
Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy Drugs (K213910)Changzhou Universal Medical Equipment Co., Ltd.2022-03-10
SIGNUS SACRONAIL® Transsacral Stabilization System (K212755)Signus Medizintechnik GmbH2022-03-10
Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets (K211911)Coloplast Corp.2022-03-10
One Step Pregnancy Test (K210341)Spd Swiss Precision Diagnostics GmbH2022-03-10
Hexa-Temp (K214071)Spident Co., Ltd.2022-03-10
D-Laser Blue, D-Laser 16 (K210367)Guilin Woodpecker Medical Instrument Co., Ltd.2022-03-10
GLP systems Track (K213486)Abbott Laboratories2022-03-10
Smile-100 System (K212965)Niramai Health Analytix Private Limited2022-03-10
NextAR™ TKA Platform My Knee PPS (K213751)Medacta International S.A.2022-03-10
Sterilization Wraps (K220133)Weihai Hongyu Nonwoven Fabric Products Co., Ltd.2022-03-10
Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K213373)Smart Glove Corporation Sdn. Bhd.2022-03-10
Reprocessed Carto Vizigo Bi-Directional Guiding Sheath (K212165)Innovative Health, LLC2022-03-10
Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs (K212148)Ansell Healthcare Products, LLC2022-03-10
Infrared Forehead Thermometer, model: HS-9802D (K213038)Jiaxing Shangjia Intelligence Technology Co., Ltd.2022-03-10
ClearRead Xray Pneumothorax (K213566)Riverain Technologies, Inc.2022-03-10
Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide (K220361)STERIS Corporation2022-03-10
ZEN-2090 Turbo (K211780)Genoray Co., Ltd.2022-03-09
BD Insulin Syringe (0.3mL) (K212499)Becton, Dickinson and Company2022-03-09
Genesys Spine 3DP Lumbar Interbody System (K220096)Genesys Spine2022-03-09
SafeOp 2: Neural Informatix System (K213849)Alphatec Spine, Inc.2022-03-09
PathLoc Lumbar Interbody Fusion Cage System (K213441)L&K BIOMED Co., Ltd.2022-03-09
4K UHD LCD Monitor OEV321UH (K220069)Olympus Medical Systems Corp.2022-03-09
Amplatzer Steerable Delivery Sheath (K220340)ABBOTT MEDICAL2022-03-09
Disposable Medical Nitrile gloves (K213851)Guangdong Xingcan Brothers Medical Technology Co.,Ltd2022-03-09
Auto CPAP System (K211155)BMC Medical Co., Ltd.2022-03-09
Acetabular Dome Hole Plug (K220376)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2022-03-09
Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L), Reprocessed Pulse Oximeter Sensor (D-20), Reprocessed Pulse Oximeter Sensor (N-25), Reprocessed Pulse Oximeter Sensor (I-20), Reprocessed Pulse Oximeter Sensor (Max-A), Reprocessed Pulse Oximeter Sensor (Max-AL), Reprocessed Pulse Oximeter Sensor (Max-P), Reprocessed Pulse Oximeter Sensor (Max-N), Reprocessed Pulse Oximeter Sensor (Max-I) (K211138)Stryker Sustainability Solutions2022-03-08
EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws) (K220374)Medos International SARL2022-03-08
SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814) (K203637)Coloplast2022-03-08
Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2328 Infant O2 (K211140)Stryker Sustainability Solutions2022-03-08
IPL Hair Removal Device (K213558)Ulike Co., Ltd.2022-03-08
Oclet TDS 1000 (K212049)Tendonova Corporation2022-03-08
Medical Face Mask (K214087)Hubei Medlink Healthcare Co., Ltd.2022-03-08
TENS & EMS DEVICE (Model: FM-B2403A) (K213741)Shenzhen Jian Feng Electronic Technology Co., Ltd.2022-03-08
Elation Pulmonary Balloon Dilation Catheter (K213434)Merit Medical Systems, Inc.2022-03-08
SkinPen Precision System (K220506)Crown Aesthetics2022-03-07
BTL-785W (K211639)BTL Industries, Inc.2022-03-07
syngo.CT Applications (K220450)Siemens Medical Solutions USA, Inc.2022-03-07
InRoad® Dental Synthetic Bone Graft (K202675)Osteogene Tech Corp2022-03-04
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Every clearance here is in the API, with alerts when new ones post.