Atlas FDA

2022

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

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RecordFirmDate
DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue) (K222442)Anhui Bytech Medical Supplies Co., Ltd.2022-09-28
SteriCUBE® Multiple Tray Sterilization Systems (K222328)Stericube, LLC2022-09-28
EndoGI S-Path Biliary Stent System (K222627)Endo GI Medical2022-09-28
Dental Air Polishing Handpiece (K221548)Guilin Woodpecker Medical Instrument Co., Ltd.2022-09-28
MitraClip G4 Steerable Guide Catheter (K221397)ABBOTT MEDICAL2022-09-28
TROJAN Fire & Ice lubricated male natural rubber latex condom (K221906)Church & Dwight Co., Inc.2022-09-28
Neteera 130H/131H Vital Sign Monitoring Sensor (K212143)Neteera Technologies , Ltd.2022-09-28
Clean Connecting Tube (K220785)Yangzhou Fartley Medical Instrument Technology Co., Ltd.2022-09-27
Digital Radiography CXDI-CS01 (K222661)Canon, Inc.2022-09-27
5000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ultrasound System 5500 CV, Ultrasound System 5300 G, Ultrasound System 5300 P, Ultrasound System 5300 W) (K222648)Philips Ultrasound, LLC2022-09-27
Medline UNITE® Medial Malleolus Peg Plate System (K221360)Medline Industries, LP2022-09-27
NanoZoomer S360MD Slide scanner system (K213883)Hamamatsu Photonics K.K.2022-09-27
Infrared thermometer (K221211)Shenzhen Yolanda Technology Co., Ltd.2022-09-27
NS-HGlio (K221738)Neosoma, Inc.2022-09-27
XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3 (K220342)Canon Medical Systems Corporation2022-09-27
MTX-C1 (K212561)Ilooda Co,., Ltd.2022-09-27
Dental Implantation Systems, Dental Electrical Motors (K220831)Foshan Coxo Medical Instrument Co., Ltd.2022-09-27
RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device (K221062)Bionime Corporation2022-09-26
QT ECG (K220795)QT Medical, Inc.2022-09-26
OtoSight Middle Ear Scope (K222655)Photonicare, Inc.2022-09-26
Auryon Atherectomy Catheters (K220116)Eximo Medical, Ltd.2022-09-26
Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V (K221631)Olympus Medical Systems Corp.2022-09-26
Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R; HD Medical Video Endoscope Image Processor: PV300) (K222602)Zhuhai Pusen Medical Technology Co., Ltd.2022-09-26
Flowart (K221473)Asset Medikal Tasarim As.2022-09-26
Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80) (K222266)Jingzhou Haixin Green Cross Medical Products Co., Ltd.2022-09-26
Palm NRG cellulite body device (model: Palm NRG body device) (K214015)Heat IN A Click, LLC2022-09-26
Resonic Rapid Acoustic Pulse Device (K222629)Zeltiq Aesthetics, Inc.2022-09-25
Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural) (K221718)Hartalega NGC Sdn. Bhd.2022-09-24
Betel Gloves Nitrile Examination Glove Powder Free (K222342)Betel Care Sdn. Bhd.2022-09-24
Black Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid (K222294)Onetexx Sdn Bhd2022-09-24
Single-use medical latex examination gloves (LG100) (K222693)Fitone Latex Products Co., Ltd. Guangdong2022-09-24
Powder Free Nitrile Examination Glove (K212751)Dainam Glove Joint Stock Company2022-09-24
Nitrile Examination Glove, Pink Color; Nitrile Examination Glove, Black Color, Nitrile Examination Glove, White Color (K221887)Guangdong Kingfa Sci. & Tech.Co., Ltd.2022-09-24
Platform® Acetabular System (K220483)Total Joint Orthopedics, Inc.2022-09-23
A.B. Dental Devices Dental Implants System (K202144)A.B. Dental Device , Ltd.2022-09-23
Wet Flavored Personal Lubricants (K221829)Trigg Laboratories, Inc.2022-09-23
OptiCross™ 18 Peripheral Imaging Catheter (K222568)Boston Scientific Corporation2022-09-23
Medical Surgical Mask (K222204)Guangzhou Zhengkang Medical Equipment Co.,Ltd2022-09-23
HotDog Temperature Management System (K220941)Augustine Temperature Management2022-09-23
Diosculpt (K222265)Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd2022-09-23
3M™ Attest™ Hydrogen Peroxide Indicator Tape 1228 (K222152)3M Company2022-09-23
Align (K222561)Acuity Surgical Devices, LLC2022-09-23
DENU Composite Resin, DENU Flow Resin (K213339)Hdi, Inc.2022-09-23
reepot Nd; YAG laser system (K222555)Ilooda Co,., Ltd.2022-09-23
ATEC IOM Accessory Instruments (K221821)Alphatec Spine, Inc.2022-09-23
XACT Robotic System, ACE Model (K213759)Xact Robotics, Ltd.2022-09-23
NeutrArt (K221481)Asset Medikal Tasarim As.2022-09-23
FREEPRINT crown (K222877)Detax GmbH2022-09-23
Esthetic Colorant (K220369)Kuraray Noritake Dental, Inc.2022-09-23
Conductive Gel (K221724)Tone-A-Matic International, Inc.2022-09-23
CellFX System (K213674)Pulse Biosciences, Inc.2022-09-22
Talee, Talee PostOP (K220681)Invent Medical USA, LLC2022-09-22
TRANBERG Thermoguide Therapy System (K214125)Clinical Laserthermia Systems, AB2022-09-22
ProGrip Self-Gripping Polypropylene Mesh (K220540)Covidien2022-09-22
SurgiLance® Safety Lancet (K222224)Medipurpose Pte. , Ltd.2022-09-22
WasherCap Fixation System (K212197)Abanza Tecnomed S.L2022-09-22
Dual Switch (K211605)Laser Engineering, Inc.2022-09-22
GlasIonomer FX ULTRA (K222253)Shofu Dental Corporation2022-09-22
Irrisept Antimicrobial Wound Lavage (K222804)Irrimax Corporation2022-09-22
Disposable Polyp Snare (K220089)Jiangsu Vedkang Medical Science and Technology Co., Ltd.2022-09-22
EQ-M (K210475)Meta Systems Co., Ltd.2022-09-21
ArcSP Suprapubic Sling System (K222293)Urocure, LLC2022-09-21
BD MAX Enteric Viral Panel (K220607)Becton, Dickinson and Company2022-09-21
MedtFine Blood Lancet (K221383)Shanghai Carelife International Trading Co. , Ltd.2022-09-21
EpiFaith CV (K212615)Flat Medical Co., Ltd.2022-09-21
MCB UNIT Model: V10GMCBUS (K222542)Lamidey Noury Medical2022-09-21
SpeediCath Flex Set (K222059)Coloplast2022-09-21
Clearblue ® Early Pregnancy Test (K213379)Spd Swiss Precision Diagnostics GmbH2022-09-21
V-Print dentbase (K220236)Voco GmbH2022-09-21
PWD Negative Pressure Wound Therapy System (K212359)Applied Tissue Technologies, LLC2022-09-21
SomnoMetry (K221179)Neumetry Medical, Inc.2022-09-21
Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200 (K221214)Shenzhen Ionka Medical Technology Co., Ltd.2022-09-21
Disposable Surgical Gown UM-148 (K221717)Unimax Medical Products Co., Ltd.2022-09-20
Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120 (K221227)Tuttnauer , Ltd.2022-09-20
Surgical Face Mask (Non-sterile) (K221976)Xiantao Junhui Plastic Products Co., Ltd.2022-09-20
DePuy Synthes 3.5mm Intrapelvic Acetabular System (K221809)DePuy Synthes2022-09-20
JO CUMPLAY Personal Lubricant (K221908)CC Wellness, LLC2022-09-20
Tandry Compression Screw System (K220359)Microware Precision Co., Ltd.2022-09-20
Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs) (K214056)Mezorrison Medical Technology (Dongying) Co., Ltd.2022-09-20
Aorta-CAD (K213353)Imagen Technologies, Inc.2022-09-20
LUOFUCON Collagen Wound Dressing (K213598)Huizhou Foryou Medical Devices Co., Ltd.2022-09-20
Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug) (K222642)Inner Mongolia Cureguard Medical Technology Co., Ltd.2022-09-20
Millipede 088 Access Catheter (K214048)Perfuze, Ltd.2022-09-20
C630G LCD monitor, JUSHA-C630G LCD monitor, C630 LCD monitor, JUSHA-C630 LCD monitor (K222121)Nanjing Jusha Display Technology Co., Ltd.2022-09-19
Pro M Class (K213897)Saeyang Microtech Co., Ltd.2022-09-19
Arthrex Compression FT Pins (K220839)Arthrex, Inc.2022-09-19
Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3 (K221638)Olympus Medical Systems Corp.2022-09-19
Lancet (K221839)Hebei Xinle Sci&Tech Co., Ltd.2022-09-19
35g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown;43g Standard SMMS Surgical Gown;43g Reinforced SMMS Surgical Gown ;50g Standard SMMS Surgical Gown; 50g Reinforced SMMS Surgical Gown;BVB Surgical Gown (K221819)Winner Medical Co., Ltd.2022-09-19
Promisemed X-Safety Pen Needle (K220129)Promisemed Hangzhou Meditech Co., Ltd.2022-09-19
LANDMARK REBOA Catheter (K214060)Zien Medical Technologies, Inc.2022-09-19
NB 1 SA Implant System (K222131)Arum Dentistry Co., Ltd.2022-09-19
Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe (K213013)Jeil Tech Co., Ltd.2022-09-19
Esthetic Abutments Nobel Biocare N1 (K220339)Nobel Biocare Services AG2022-09-16
Exsalta (K221676)Drw Medical2022-09-16
Altus Spine Pedicle Screw System (K211027)Altus Partners, LLC2022-09-16
Electric Wheelchair, Model: 9000N (K221799)Silver Fox Corporation Limited2022-09-16
Phagenyx System (DEN220025)Phagenesis Limited2022-09-16
Surgical Face Masks (Ear Loops And Tie-On) (K221534)San-M Package Co., Ltd.2022-09-16
Tempo Smart Button (K212217)Eli Lilly and Company2022-09-16
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Every clearance here is in the API, with alerts when new ones post.