Atlas FDA

2022

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

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RecordFirmDate
Parsortix PC1 Device (DEN200062)Angle Europe , Ltd.2022-05-24
Medline General Surgery Tray (K213481)Medline Industries, Inc.2022-05-24
MY01 Continuous Compartmental Pressure Monitor (K220952)MY01, Inc.2022-05-24
MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides (K220888)Medacta International S.A.2022-05-24
M-Vizion Monobloc (K212327)Medacta International S.A.2022-05-24
Disposable Face Mask (K220191)Jiujiang Taixin Technology Co., Ltd.2022-05-24
e-motion M25 (K221215)Alber GmbH2022-05-24
LigaPASS™ 2.0 Ligament Augmentation System (K213659)Medicrea International SA2022-05-24
ON3D (K221000)3D Ons, Inc.2022-05-23
LiquiBand XL (K211878)Advanced Medical Solutions Limited2022-05-23
Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs (K220155)Motex Healthcare (Anhui) Co., Ltd.2022-05-23
SCENARIA View (K213829)Fujifilm Healthcare Corporation2022-05-23
Assure Titanium Blood Glucose Monitoring System (K200788)Arkray, Inc.2022-05-23
Tapestry Biointegrative Implant (K220867)Embody, Inc.2022-05-23
Smart Wireless Stethoscope (K220470)Shanghai Hulu Devices Co., Ltd.2022-05-23
3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large (K220507)3M Company2022-05-23
3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam Indicator Tape 1355 (K220564)3M Company2022-05-23
Triever24, Triever20 (K213402)Inari Medical2022-05-23
Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) (K211810)Pt. Shamrock Manufacturing Corpora2022-05-23
ONO Retrieval Device (K212988)Onocor Vascular, LLC2022-05-23
CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid (K212563)Prevest Denpro Limited2022-05-23
DailyMate Orthodontic Aligner System (K212803)3D Global Biotech, Inc.2022-05-23
Disposable surgical mask (K220532)Xiamen Blue Star Enterprise Co., Ltd.2022-05-23
Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set (K213540)Qura S.R.L2022-05-20
7D Surgical System - Percutaneous Application (7D Flash Frame) (K220522)7D Surgical2022-05-20
CalcShift™ Displacement Calcaneal Osteotomy System (K212979)Nextremity Solutions, Inc.2022-05-20
Artisan Bone Plug, Universal Cement Restrictor (K220838)Howmedica Osteonics, Dba Stryker Orthopaedics2022-05-20
iovera System (K220656)Pacira Biosciences, Inc.2022-05-20
Disposable Sampler Viral Transport Media (K211256)Wuxi Nest Biotechnology Co., Ltd.2022-05-20
Med-link Pulse Oximeter (K212752)Shenzhen Med-Link Electronics Tech Co., Ltd.2022-05-20
syngo Dynamics (Version VA40E) (K220832)Siemens Medical Solutions USA, Inc.2022-05-20
Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine (K210545)Marci Beauty, Inc.2022-05-20
Diode Laser Therapy Systems (K220381)Beijing Lasertell Medical Co., Ltd.2022-05-20
X-Twist PEEK Suture Anchor (K221135)Parcus Medical, LLC2022-05-19
Artiglass NRFitTM Tip L.O.R. Glass Syringes (K213800)Artiglass Srl2022-05-19
Procedure Mask with Ear Loops and Surgical Mask with Ties (K221134)Safesource Direct, LLC2022-05-19
ARCHITECT Toxo IgG (K210596)Abbott Laboratories2022-05-19
BD Epilor Syringe (K210983)Becton, Dickinson and Company2022-05-19
SMR Reverse Liner (K220792)Lima Corporate S.P.A.2022-05-19
Medical Surgical Mask (Planar type) (K220824)Hunan Chopard Medical Devices Co., Ltd.2022-05-19
Univers Revers Humeral Cup Implant (K221232)Arthrex, Inc.2022-05-19
PAPAYA & PAPAYA Plus (K220423)Genoray Co., Ltd.2022-05-19
Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection (K213174)Cardinalhealth2022-05-19
Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC) (K220485)The Anspach Effort, Inc.2022-05-19
RevoLix HTL (K211534)Lisa Laser Products GmbH2022-05-19
PAPAYA 3D & PAPAYA 3D Plus (K220392)Genoray Co., Ltd.2022-05-19
Accu-Chek Safe-T-Pro Plus Lancing Device (K220849)Roche Diabetes Care, Inc.2022-05-19
PINE Pedicle Screw System (K220285)Tdm Co., Ltd.2022-05-19
Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI) (K220370)Tianjin Huahong Technology Co., Ltd.2022-05-19
OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement (K211869)Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE2022-05-19
CoverScan v1 (K212565)Perspectum, Ltd.2022-05-19
Alinity i STAT High Sensitivity Troponin-I (K202525)Abbott Laboratories Diagnostics Division2022-05-19
Quell-FM (DEN210046)Neurometrix, Inc.2022-05-18
WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated Blood Pressure Meter with Stethoscope, MODEL WX0201, WX0202, WX0203 (K212416)Wenzhou Xikang Medical Instruments Co., Ltd.2022-05-18
Nitrile Powder Free Examination Gloves (K220211)Hebei Kangxida Medical Technology Development Co., Ltd.2022-05-18
Siren SGT (K220218)Tools For Surgery, LLC2022-05-18
GSS610N21 Series Steam Sterilizer (K214120)Maquet GmbH2022-05-18
gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler (K220917)Gri-Alleset, Inc.2022-05-18
Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid) (K212408)Pt. Maja Agung Latexindo2022-05-18
Osteotomy Truss System (OTS) (K220463)4Web Medical, Inc.2022-05-18
Medline Orbis LVL 3 Surgical Gown (K220333)Medline Industries, LP2022-05-18
BENCOX Mirabo Cup System (K220468)Corentec Co., Ltd.2022-05-18
MolecuLight I:X (K213840)MolecuLight, Inc.2022-05-18
The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories (K220467)Lumenis Be, Ltd.2022-05-18
Heel Stick Safety Lancet (HHZ-II, HHZ-III) (K220372)Tianjin Huahong Technology Co., Ltd.2022-05-17
Medline Integrated Arterial Catheter (K210548)Centurion Medical Products2022-05-17
BriefCase (K221240)Aidoc Medical , Ltd.2022-05-17
CERAMENT G (DEN210044)Bonesupport AB2022-05-17
MULTIX Impact E (K220919)Siemens Medical Solutions USA, Inc.2022-05-17
CATALYS Precision Laser system (K220516)Amo Manufacturing USA, LLC2022-05-17
Biocore9 Acetabular Cup System (K212761)Biocore9, LLC2022-05-17
Monaco RTP System (K213787)Elekta Solutions AB2022-05-17
Skin Care Beauty Mask (Model: MJ-06) (K220168)Shenzhen Kaiyan Medical CO , Ltd.2022-05-17
Rapid PE Triage and Notification (PETN) (K220499)Ischemaview, Inc.2022-05-17
Neoss Individual Prosthetics (K211396)Neoss, Ltd.2022-05-17
Cervical Spine Truss System Plating Solution (CSTS-PS) (K212527)4Web Medical, Inc.2022-05-17
Imperative Care Radial 088 Access System (K220807)Imperative Care, Inc.2022-05-17
syngo.CT CaScoring (K221219)Siemens Medical Solutions USA, Inc.2022-05-17
SternaLock Sternal Closure System (K212782)Biomet Microfixation2022-05-17
Procedure mask/Surgical mask/Face mask (K220194)Winner Medical Co., Ltd.2022-05-17
IPL HAIR REMOVAL HANDSET, Model: IPL-666 (K220669)Shenzhen Junbobeauty Technology Co., Ltd.2022-05-16
Clicky Cross (K210516)Yomura Technologies, Inc.2022-05-16
STERRAD NX with ALLClear Technology (K220404)Advanced Sterilization Products, Inc.2022-05-16
SONON Ultrasound Imaging System, Model: SONON300C (K211665)Healcerion Co., Ltd.2022-05-16
Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems (K213583)Philips Medical Systems Nederland B.V.2022-05-16
AAMI3 Isolation Gown (K213832)Hubei Xinxin Non-Woven Co., Ltd.2022-05-16
Caas Qardia (K212376)Pie Medical Imaging BV2022-05-16
Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs (K220491)Hainan Asther Medical Equipment Co., Ltd.2022-05-14
Introcan Safety IV Catheter (K220626)B.Braun Medical, Inc.2022-05-14
Telepack + (K221174)Karl Storz Endoscopy America, Inc.2022-05-13
ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System (K220115)MiRus, LLC2022-05-13
Zone Specific AIM (K220186)Conmed Corporation2022-05-13
Argo Knotless SP Anchor (K220757)Conmed Corporation2022-05-13
Provena(TM) Midline Catheter (K213203)C.R. Bard, Inc.2022-05-13
XACT ACE Robotic System (K221116)Xact Robotics, Ltd.2022-05-13
PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG (K221144)Radisen Co., Ltd.2022-05-13
Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM) (K210615)Thompson Surgical Instruments, Inc.2022-05-13
HDF Assist Mudule, HDF Infusion Set and Substitution Filter (K210575)Nephros2022-05-13
Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) (K212475)Prevest Denpro Limited2022-05-13
Quantib Prostate (K221106)Quantib B.V.2022-05-13
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