Atlas FDA

2022

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

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RecordFirmDate
Dia-X Bond Universal (K220804)DiaDent Group International2022-06-15
Logic Hd camera head green, System green (K212808)Richard Wolf Medical Instruments Corporation2022-06-14
Disposable Surgical Face Mask (M663BE, M663BT) (K220550)Makrite Industries, Inc.2022-06-14
Zsquare ENT-Flex Endoscope (K220004)Zsquare, Ltd.2022-06-14
ACUSON Sequoia Diagnostic Ultrasound System (K221500)Siemens Medical Solutions USA, Inc.2022-06-14
Yomi Robotic System with YomiPlan Go (K211466)Neocis, Inc.2022-06-14
EVA NEXUS Ophthalmic Surgical System (K213467)D.O.R.C. Dutch Ophthalmic Research Center (International)2022-06-14
PERF-GEN Pulsatile Perfusion Solution (K221386)Institut Georges Lopez2022-06-14
BEL-GEN Cold Storage Solution (K221387)Institut Georges Lopez2022-06-14
Digital Radiography CXDI-Elite, Digital Radiography E1 (K221620)Canon, Inc.2022-06-14
3M Filtek Supreme Flowable Restorative (K221695)3M Company Espe Dental Products2022-06-13
iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System (K221081)First Source, Inc.2022-06-13
ProdiGI (DEN220006)Covidien, LLC2022-06-13
Disposable Hemostatic Closure Clip Device (K220157)Micro-Tech (Nanjing) Co., Ltd.2022-06-13
Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (K203208)Taiwan Aulisa Medical Devices Technologies, Inc.2022-06-12
Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2 (K221384)Hivox Biotek, Inc.2022-06-11
Swoop Portable MR Imaging System (K221393)Hyperfine, Inc.2022-06-10
PAL System (K212024)Microaire Surgical Instruments, LLC2022-06-10
EasyClip® and EasyClip® Xpress (K210582)Stryker GmbH2022-06-10
Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System (K220319)Stryker GmbH2022-06-10
Extroducer Infusion Catheter System (K213442)SmartWise Sweden AB2022-06-10
MediLab (K221065)Sigma Scientific Services, LLC2022-06-10
Saffron Fixation System (K220420)Coloplast A/S2022-06-10
SmileGuard (K220894)Envisiontec GmbH2022-06-10
iFuse-TORQ® Implant System (K213667)SI-BONE, Inc.2022-06-10
Omni Foot and Ankle Plating System (K221362)Exremity Medical, LLC2022-06-10
Elecsys AMH (K203757)Roche Diagnostics2022-06-10
Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 (K221087)Medtronic Navigation, Inc.2022-06-10
Nalu Neurostimulation System (K221376)Boston Scientific Neuromodulation2022-06-10
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (K221658)Centers for Disease Control and Prevention2022-06-10
Rune Labs Tremor Transducer System (K213519)Rune Labs, Inc.2022-06-10
Surgical Isolation Cover Gown (K220528)Wuhan Dymex Healthcare Co., Ltd.2022-06-10
WesperO2 (K213515)Wesper, Inc.2022-06-10
Armory Motion (K213097)Pain Management Technologies, Inc.2022-06-10
IntellaMap Orion High Resolution Mapping Catheter (K220796)Boston Scientific Corporation2022-06-10
ALLY Adaptive Cataract Treatment System (K220259)Lensar, Inc.2022-06-09
Niti-S Biliary Slim M Stent (K221071)Taewoong Medical Co., Ltd.2022-06-09
MyCRO Band (K213587)Otto Bock Healthcare LP2022-06-09
Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection (K221339)Contego Medical, Inc.2022-06-09
Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet (K221368)Promisemed Hangzhou Meditech Co., Ltd.2022-06-09
KHEIRON® Spinal Fixation System (K211981)S.M.A.I.O2022-06-09
Cysto-Gastro-Sets (K211909)G-Flex Europe Sprl2022-06-09
Nasogastric Feeding Tubes - ENFit Port - PVC (K213258)Cair Lgl2022-06-09
EksoNR (K220988)Ekso Bionics, Inc.2022-06-09
Auryon Atherectomy System (K221077)Eximo Medical, Ltd.2022-06-09
The Luminance RED Acne Device (K220729)Luminance Medical Ventures, Inc.2022-06-09
HELIOS IV 785 (K212663)Laseroptek Co., Ltd.2022-06-09
RedPoint Medical's Better Bunion System (K220717)Redpoint Medical, LLC2022-06-09
IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System, IdentiTi™ Cervical Standalone Interbody System, IdentiTi™ NanoTec™ Cervical Standalone Interbody System (K220782)Alphatec Spine, Inc.2022-06-09
ACUTRON (K211000)Ilooda Co,., Ltd.2022-06-09
HD60 Series Ultrasound Diagnostic System (K213862)Qingdao Hisense Medical Equipment Co., Ltd.2022-06-08
Promisemed Heel Blood Lancet (K221371)Promisemed Hangzhou Meditech Co., Ltd.2022-06-08
FairFix AM Adjustable Button FairFix PSP Adjustable Button (K221389)Medacta International S.A.2022-06-08
TrabEx Pro (K213173)Microsurgical Technologies, Inc.2022-06-08
INHANCETM Hybrid Anatomic Glenoid Implant (K212933)Depuy Ireland UC2022-06-08
ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits (K213185)Coloplast Corp.2022-06-08
EarliPoint System (K213882)Earlitec Diagnostics, Inc.2022-06-08
AIR Recon DL (K213717)Ge Medical Systems,Llc (Ge Healthcare)2022-06-08
Lap-Band System Calibration Tube (K220455)Reshape Lifesciences2022-06-07
Infinity Gateway Suite (K203579)Draeger Medical Systems, Inc.2022-06-07
D²RS and D²RS 9090 (K221335)Stephanix2022-06-07
Zoupure Nitrile Powder Free Examination glove (K220693)Thai Rayong Product Glove Zoupure Co., Ltd.2022-06-07
FX V135 Shoulder Prosthesis (K213117)Fx Shoulder USA, Inc.2022-06-07
WHILL Model F (K221438)Whill, Inc.2022-06-07
Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System (K221160)Cepheid2022-06-07
Adhese Universal DC, Cention Primer (K210804)Ivoclar Vivadent, AG2022-06-07
Natural Rubber Latex Ultrasound Transducer Probe Covers (K213087)Global Protection Corp.2022-06-07
Surgical Face Mask (HNFM0304) (K221222)Shanghai Hua EN Industrial Co, Ltd.2022-06-06
Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 (K220358)GE Medical Systems Ultrasound and Primary Care Diagnostics2022-06-06
Multi-Band Ligator (K213223)Beijing Zksk Technology Co., Ltd.2022-06-06
Arthrex Knotless AC Repair Devices (K220947)Arthrex, Inc.2022-06-06
Powder Free Nitrile Gloves (K213448)St Future International Limited2022-06-06
Diacare 7000 (K211207)Globus Sport and Health Technologies, LLC2022-06-06
Drug Relief v1 (K221231)Dyansys, Inc.2022-06-06
Smart Correction System Rings and Compatible HA-Coated Half Pins (K221366)Wishbone Medical, Inc.2022-06-06
Keos Anterior Cervical Interbody Fusion Device System (K212450)Keos2022-06-06
Disposable Polypectomy Snare (K213222)Beijing Zksk Technology Co., Ltd.2022-06-06
PrimeLOC Attachment System (K220612)Innovative Product Brands, Inc.2022-06-06
Q2 Blood Administration Sets (K213846)Quest Medical, Inc.2022-06-05
BriefCase (K221314)Aidoc Medical , Ltd.2022-06-03
3D Anatomic Models (K220205)Ricoh USA, Inc.2022-06-03
MICROLET NEXT lancing device, MICROLET Lancet (K220633)Ascensia Diabetes Care U.S., Inc.2022-06-03
Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim (K220672)Riverstone Resources Sdn Bhd2022-06-03
Gastric Alimetry System (K213924)Alimetry , Ltd.2022-06-03
TrueBeam, TrueBeam STx, Edge, VitalBeam (K213977)Varian Medical Systems, Inc.2022-06-03
Portable Oxygen Concentrator, model: P2-E6 (K210371)Qingdao Kingon Medical Science and Technology Co., Ltd.2022-06-03
eCareManager 4.5 (K211046)Visicu, Inc.2022-06-03
Multifrax Laser System (K213332)Paradigm Medical Corporation2022-06-03
SILKRO (K210084)Hironic Co., Ltd.2022-06-03
BiMobile Instruments (for BiMobile Dual Mobility System) (K211567)Waldemar Link GmbH & Co. KG2022-06-03
Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris, Aptima Trichomonas Vaginalis Assay (250 test kit) Panther, Aptima Trichomonas Vaginalis Assay (250 test kit) Tigris (K220321)Hologic, Inc.2022-06-03
21HQ613D (K221061)Lg Electronics.Inc2022-06-03
KLS Martin Neuro Rongeurs (K210741)KLS-Martin L.P.2022-06-03
Atrial Fibrillation History Feature (K213971)Apple, Inc.2022-06-03
Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-Sterile (K220665)Excellent Medical Technology Group Co., Ltd.2022-06-03
CIRCUL8 Connect DVT Prevention Device (K220761)Ortho8, Inc.2022-06-03
VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL) (K213931)bioMerieux, Inc.2022-06-03
Knee 3 (K220652)Brainlab AG2022-06-03
SOFT PLUG Extended Duration 180 Tapered Canalicular Plug (K213988)Oasis Medical, Inc.2022-06-03
Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle (K214063)Guangzhou Shengwei Medical Devices Co., Ltd.2022-06-03
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Every clearance here is in the API, with alerts when new ones post.