| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K221885 |
10/26/2022 |
23andMe Personal Genome Service (PGS) Pharmacogenetic Reports |
23andMe, Inc. |
Marianna Frendo |
| K212168 |
10/06/2022 |
A&D Medical UM-212BLE Blood Pressure Monitor |
A&D Company, Ltd |
Chanda Melville |
| K220949 |
10/27/2022 |
Architect CMV IgG |
Abbott Laboratories |
Shannon Reibling |
| K222113 |
10/13/2022 |
Abiomed 14Fr Low Profile Introducer Set |
Abiomed Inc. |
Ken Ryder |
| K220890 |
10/31/2022 |
IO Needle Safety Sheath |
Actuated Medical, Inc |
Douglas R. Dillon |
| K222209 |
10/17/2022 |
AcQMap High Resolution Imaging and Mapping System |
Acutus Medical Inc. |
Subhadra Elango |
| K223065 |
10/26/2022 |
Adcura« Sagittae« Lateral Lumbar Interbody Fusion Devices |
Adcura, Inc. |
Andrew Rogers |
| K221994 |
10/04/2022 |
Hailie Sensor NF0107 & NF0108 |
Adherium (NZ) Ltd |
Tara Creaven-Capasso |
| K221574 |
10/16/2022 |
LUDWIG Electrosurgical Device |
Aesthetics Biomedical |
Lawrence A. Rheins |
| K220709 |
10/07/2022 |
BriefCase |
Aidoc Medical, Ltd. |
Nimrod Epstein |
| K221913 |
10/12/2022 |
Arm Blood Pressure Monitor |
Alicn Medical Shenzhen,Inc |
Fang Meisong |
| K223060 |
10/26/2022 |
DigiX FDX |
Allengers Medical Systems Limited |
Sanjeev K Marjara |
| K220730 |
10/13/2022 |
allFlex Ureteral Catheters, Krait Ureteral Catheters |
Allwin Medical Devices, Inc |
Digish Mehta |
| K222064 |
10/12/2022 |
The Alma Soprano Titanium |
Alma Lasers Inc. |
Jessica Rivera-Montejo |
| K222028 |
10/07/2022 |
IdentiTiÖ Porous Ti Interbody System, IdentiTiÖ NanoTecÖ Interbody System, TranscendÖ PEEK Interbody System, TranscendÖ NanoTecÖ Interbody System, IdentiTiÖ ALIF Standalone Interbody System, IdentiTiÖ NanoTecÖ ALIF Standalone Interbody System |
Alphatec Spine |
Neha Mohindroo |
| K220857 |
10/13/2022 |
X-CUBE 50, X-CUBE 60 |
Alpinion Medical Systems Co., Ltd. |
Boyeon Cho |
| K221093 |
10/14/2022 |
X-CUBE 70, X-CUBE 90 |
Alpinion Medical Systems Co., Ltd. |
Boyeon Cho |
| K221576 |
10/12/2022 |
Ameda Pearl Electric Breast Pump |
Ameda, Inc. |
Sean Pettibone |
| K222203 |
10/18/2022 |
DualXSLIM(R) T/PLIF |
Amplify Surgical, Inc. |
Erickson Nathan |
| K220267 |
10/07/2022 |
AMSafe NeuFlo Needleless Connector |
Amsino International, Inc. |
Jane Gao |
| K222141 |
10/21/2022 |
Safety Blood Collection Needle (Without Needle Holder) |
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. |
Bingyi Xiang |
| K222284 |
10/14/2022 |
Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214) |
Applied Medical Resources Corporation |
Blake Stacy |
| K221830 |
10/11/2022 |
Apyx One Console |
Apyx Medical Corporation |
David Ceretti |
| K211892 |
10/06/2022 |
ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) |
ARFTX Medical LLC |
Ozgen Ozfidan |
| K221218 |
10/26/2022 |
Silverlon Wound Contact, Burn Contact Dressings |
Argentum Medical, Inc. |
Kathy Herzog |
| K221175 |
10/17/2022 |
Multi-Lancet Device 2, ReliOn Premier Lancing Device |
Arkray, Inc. |
Shinjiro Sekimoto |
| K222267 |
10/03/2022 |
Arthrex 2.4 mm Volar Distal Radius Plate System |
Arthrex Inc. |
Stacy Valdez |
| K221128 |
10/05/2022 |
Arthrex ACL TightRope«, PCL TightRope«, and TightRope« II |
Arthrex Inc. |
Lai Saeteurn |
| K220880 |
10/27/2022 |
Arthrex BioSuture |
Arthrex Inc. |
Stacy Valdez |
| K221951 |
10/11/2022 |
Branchor Balloon Guide Catheter |
Asahi Intecc Co., Ltd |
Katsuhiko Fujimura |
| K203638 |
10/12/2022 |
AT-Patch ECG Analysis System |
ATsens Co., Ltd |
KeonHoon Lee |
| K221759 |
10/05/2022 |
Cornisol |
Aurolab |
Krishna Kumar |
| K221047 |
10/03/2022 |
SILO TFX MIS Sacroiliac Joint Fixation System |
Aurora Spine, Inc. |
Laszlo Garamszegi |
| K213014 |
10/03/2022 |
Varixis Elbow System |
Auxein Medical Private Limited |
Rahul Luthra |
| K222431 |
10/06/2022 |
b-ONER MOBIO Total Knee System |
b-ONE ORTHO, Corp. |
Allison Gecik |
| K213106 |
10/20/2022 |
BTI Interna Dental Implant System UnicCa - Prosthetic Components |
B.T.I. Biotechnology Institute, SL. |
Jose Ramon Rivero |
| K212262 |
10/03/2022 |
PCA Syringe Sets |
Baxter Healthcare Corporation |
Jeffrey E. Thompson |
| K221504 |
10/14/2022 |
BD SurgiphorÖ Antimicrobial Irrigation System |
BD |
Shelley Wilcox |
| K221992 |
10/21/2022 |
Electronic Pulse Stimulator |
Beijing Choice Electronic Technology Co., Ltd. |
Haiying Zhao |
| K213697 |
10/31/2022 |
ORiGO System |
Bien-Air Surgery SA |
Jonas Guerdat |
| K220870 |
10/20/2022 |
BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel |
BioFire Defense, LLC |
Cynthia Pillips |
| K222601 |
10/27/2022 |
FilmArray Pneumonia Panel plus |
BioFire Diagnostics, LLC |
Kevin Bourzac |
| K220805 |
10/13/2022 |
VITEK 2 AST-Gram Positive Cefoxitin Screen |
bioMerieux, Inc |
Debra Broyles |
| K220169 |
10/11/2022 |
SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25) |
Bionet Co., Ltd. |
ChuelWon Lee |
| K221810 |
10/31/2022 |
LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device |
Bonraybio Co., LTD. |
Clare Huang |
| DEN210027 |
10/14/2022 |
The Cooral System |
BrainCool AB |
Martin Waleij |
| K222966 |
10/27/2022 |
Cirq Arm System (2.0);Alignment System Spine |
Brainlab AG |
Sadwini Suresh |
| K222793 |
10/17/2022 |
WavelinQÖ Generator |
C.R. Bard, Inc. |
Jakob Wells |
| K220853 |
10/13/2022 |
PicoWay Laser System |
Candela Corporation |
Danielle Gibboney |
| K222662 |
10/14/2022 |
Vitrea CT Cardiac Analysis |
Canon Medical Informatics, Inc. |
Jay Vaishnav |
| K222968 |
10/25/2022 |
Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR |
Canon Medical Systems Corporation |
Janine F Reyes |
| K222855 |
10/17/2022 |
Digital Radiography CXDI-Pro, Digital Radiography D1 |
Canon, Inc. |
Mr. Akira Hirai |
| K221492 |
10/07/2022 |
SteriTite Container System with MediTray Parts |
Case Medical, Inc. |
Michael Polozani |
| K221310 |
10/07/2022 |
Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing |
Changzhou Endoclean Medical Device Co., Ltd. |
Wang Qi |
| K222031 |
10/28/2022 |
Spinal Inner Fixation System |
Changzhou Geasure Medical Apparatus and Instruments Co., Ltd |
Jing Huang |
| K221263 |
10/12/2022 |
Aqua Naina Plus Sterile Saline Solution |
Chemtex USA Inc. |
Haribabu Talasila |
| K220140 |
10/05/2022 |
ClearCorrect System |
ClearCorrect, LLC |
Christopher Klaczyk |
| K212779 |
10/05/2022 |
Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing |
CoaguSense, Inc. |
Michael Acosta |
| K220527 |
10/20/2022 |
PADnet Xpress |
Collaborative Care Diagnostics LLC, d.b.a. Biomedix |
James Hartnett |
| K223098 |
10/28/2022 |
Bakri Essential Postpartum Balloon |
Cook Incorporated |
Ian Herman |
| K223064 |
10/28/2022 |
ALLY II Uterine Positioning SystemÖ (UPS) |
CooperSurgical, Inc. |
Yin Huang |
| K220546 |
10/05/2022 |
Colibrφ System |
Copan WASP S.r.l. |
Giovanna Catalano |
| K222435 |
10/11/2022 |
Renamel« Microhybrid ;Renamel« Flowable Microhybrid |
Cosmedent, Inc |
Gary Chuven |
| K211427 |
10/13/2022 |
CREOKORREKT Aligners |
CreoDent Prosthetics LTD |
Calvin Shim |
| K213466 |
10/20/2022 |
Houdini Cross Support Catheter |
Cruzar Medsystems Inc |
Dave Tornatore |
| K211785 |
10/17/2022 |
CASSATTÖ SIJ Fixation System |
CTL Medical Corporation |
Sean Suh |
| K222698 |
10/07/2022 |
CUVIS-spine |
Curexo, Inc. |
Jungeun Park |
| K222505 |
10/27/2022 |
CurvaFix IM System |
CurvaFix, Inc. |
Steve Dimmer |
| K221322 |
10/27/2022 |
CUSTMBITE Snoring System |
Dental Choice Holdings LLC |
Danielle M Jackson |
| K212746 |
10/17/2022 |
ATTUNE Revision Cones |
Depuy Ireland UC |
Erin Combs |
| K221462 |
10/21/2022 |
DePuy Reclaim Monobloc Revision Femoral Stem |
DePuy Ireland UC |
Jennifer Hill |
| K222276 |
10/15/2022 |
CONDUIT Cages; FIBERGRAFT BG Putty |
DePuy Spine |
Philip Desjardins |
| K222515 |
10/05/2022 |
FaSet Fixation System |
Dio Medical Corporation |
Milan George |
| K222572 |
10/18/2022 |
FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUMÖ & BALTEUM-ONEÖ Lumbar Plate System |
Dio Medical Corporation |
Milan George |
| K222415 |
10/25/2022 |
Rexious Spinal Fixation System |
Dio Medical Corporation |
Milan George |
| K222448 |
10/13/2022 |
UNITY Sacroiliac Joint Fixation System |
Dio Medical Corporation |
Milan George |
| K212745 |
10/27/2022 |
ORAcollect«òDx |
DNA Genotek Inc |
Austin Udocor |
| K222424 |
10/07/2022 |
Protect-It Custom Fit Dental Guard |
DOC Brands, Inc. |
Sean Stubbs |
| K213690 |
10/26/2022 |
Eclipse Blood Collection Set |
Eclipse Medcorp LLC |
Julie Summerville |
| K221014 |
10/17/2022 |
Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile |
Effortless Oxygen. LLC |
Samir Ahmad |
| K222047 |
10/26/2022 |
Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant) |
Elekta Solutions AB |
Helena Skar |
| K213429 |
10/20/2022 |
AccuSert Needle Inserter |
Emed Technologies Corporation |
Peter Kollings |
| K222087 |
10/13/2022 |
SCIg60 Infusion System |
EMED Technologies Corporation |
Olena Whalen |
| K221936 |
10/17/2022 |
Standalone ALIF Interbody Fusion System |
Eminent Spine |
Stephen Courtney |
| K221958 |
10/21/2022 |
Flex-MI |
EMSI, Inc. |
Chad Sagnip |
| K222369 |
10/07/2022 |
PURE Laser |
Endymed Medical, Ltd. |
Ohad Fisher |
| K220992 |
10/19/2022 |
Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple |
Ever Global (Vietnam) Enterprise Corporation |
Jerry Lin |
| K222797 |
10/14/2022 |
X-Pac Expandable Lumbar Cage System |
Expanding Innovations, inc |
Robert Jaramillo |
| K222631 |
10/26/2022 |
VASSALLO GT EXT |
Filmecc Co. Ltd. |
Toshiya Osawa |
| K221712 |
10/12/2022 |
Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm) |
Fotona d.o.o. |
Marko Berdajs |
| K222081 |
10/13/2022 |
ID-510 iRestore Elite |
Freedom Laser Therapy, Inc. |
Wei-Chih Chen |
| K222952 |
10/27/2022 |
2008T BlueStar Hemodailysis Machine |
Fresenius Medical Care Renal Therapies Group, LLC |
Denise M Oppermann |
| K222318 |
10/31/2022 |
Fresenius Liberty Select Cycler |
Fresenius Medical Care Renal Therapies Group, LLC |
Denise Oppermann |
| K223070 |
10/28/2022 |
Remi Robotic Navigation System |
Fusion Robotics, LLC |
Sarah Braun |
| K220165 |
10/21/2022 |
Enteral Transition Adaptor |
GBUK Group Ltd |
Rachael Hume |
| K221321 |
10/18/2022 |
MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System |
GE Medical Systems Information Technologies, Inc. |
Honghong Yang |
| K222270 |
10/21/2022 |
HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments |
Globus Medical Inc. |
Kelly Baker |
| K213842 |
10/03/2022 |
ONVOY Acetabular System |
Globus Medical Inc. |
Jennifer Antonacci |
| K221489 |
10/27/2022 |
Artemis Proximal Femoral Nail System |
GLW, Inc. |
Arundhati Radhakrishnan |
| K222418 |
10/07/2022 |
Nuvola |
Gruppo Europeo Ortodonzia srl |
Massimiliano Bucceri |
| K222714 |
10/07/2022 |
Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs |
Guang Dong Kingfa Sci. & Tech.Co., Ltd. |
Xiaoge Yu |
| K211321 |
10/13/2022 |
Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) |
Guangzhou Sonostar Technologies Co., Ltd. |
Weizhong Cai |
| K212702 |
10/13/2022 |
IM/ST Fixture System |
Guilin FiTeeth Medical Instrument Co., Ltd. |
Jun Zhou |
| K213857 |
10/14/2022 |
HeartFlow Analysis |
HeartFlow, Inc. |
Windi Hary |
| K220227 |
10/12/2022 |
Auto Folding Scooter, S21F |
Heartway Medical Products Co., Ltd. |
Ke-Min Jen |
| K221374 |
10/26/2022 |
Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL) |
Hebei Titans Hongsen Medical Technology Co., Ltd. |
Chai Wu |
| K213396 |
10/13/2022 |
SPIFE A1AT kit |
Helena Laboratories, Corp. |
Rachel Easley |
| K220092 |
10/07/2022 |
YADU Surgical Gowns |
HeNan YADU Industrial Co., Ltd. |
Charles Shen |
| K221449 |
10/06/2022 |
Genius AI Detection 2.0 |
Hologic, Inc. |
Deborah Thomas |
| K220099 |
10/20/2022 |
eClinic Stethopod |
HomeDiagnostic LLC |
Jian Gong |
| K222282 |
10/27/2022 |
HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System |
Hospital Equipment Manufacturing Company |
Himanshu Sachdeva |
| K222632 |
10/21/2022 |
UHR Bipolar Implants, Restoration GAP II Implants |
Howmedica Osteonics Corp., dba Stryker Orthopaedics |
Margaret Klippel |
| K214116 |
10/11/2022 |
AAMI4 Isolation Gown |
Hubei Xinxin Non-woven Co.,Ltd. |
Nicole Jin |
| K222498 |
10/26/2022 |
Medical Examination Gloves (Nitrile) (XS, S, M, L, XL) |
Humanwell Healthcare Group Medical Supplies Co., Ltd. |
Aixue Yao |
| K222432 |
10/11/2022 |
IPL Hair Removal Device, Model(s): KCA423, KCA437, KCA439 |
Hunan Guangye Biotechnology Co., Ltd. |
Eileen Li |
| K220852 |
10/06/2022 |
iCare IC200 |
Icare Finland Oy |
Hannes Hyv÷nen |
| K222215 |
10/21/2022 |
IPD Dental Implant Abutments |
Implant Protesis Dental 2004 S.L |
Francesc Fumanal |
| K221764 |
10/07/2022 |
InBody Blood pressure monitor, Model BPBIO480KV |
InBody Co, Ltd. |
Kichul Cha |
| K222199 |
10/21/2022 |
Collagen P.I.N. (Percutaneous Induction Needling) |
Induction Therapies LLC |
Amelia Aslam |
| K213464 |
10/04/2022 |
HemosIL Liquid Anti-Xa |
Instrumentation Laboratory Co. |
Carol Marble |
| K221840 |
10/14/2022 |
Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves |
Integra LifeSciences Production Corporation |
Amanda Erwin |
| DEN220024 |
10/18/2022 |
ScanNav Anatomy Peripheral Nerve Block |
Intelligent Ultrasound Limited |
Nicholas Sleep |
| K221154 |
10/07/2022 |
Infant Heel WarmerTM; Heel Snuggler« |
International Biomedical |
Amy Pieper |
| K221653 |
10/06/2022 |
InfaTherm Disposable Infant Warming Mattress |
International Biomedical |
Amy Pieper |
| K221517 |
10/04/2022 |
POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lens |
Interojo Inc. |
Si-Chul Rho |
| K222827 |
10/20/2022 |
da Vinci Firefly Imaging System |
Intuitive Surgical Inc. |
Melissa Gonzalez |
| K222886 |
10/20/2022 |
Mercu 1717V |
iRay Technology Taicang Ltd. |
Junjie Qian |
| K221406 |
10/28/2022 |
Vented Vial Transfer Pin |
Jiangsu Caina Medical Co., Ltd. |
Jianwei Pan |
| K222937 |
10/01/2022 |
Disposable Nitrile Examination Glove |
Jiangsu Cureguard Glove Co., Ltd. |
Guo Hua |
| K221372 |
10/17/2022 |
YUWELL Electronic Blood Pressure Monitor |
Jiangsu Yuyue Medical Equipment & Supply CO.,LTD. |
Yinzhen Zhu |
| K223008 |
10/08/2022 |
Disposable Vinyl Examination Gloves |
Jiangxi Handspro Products Solutions CO., LTD. |
Jun Yin |
| K221308 |
10/17/2022 |
Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle |
Jiangxi Maidikang Medical Devices Co., Ltd |
Wu Huansheng |
| K222348 |
10/27/2022 |
JR MEDIC |
JR Engineering & Medical Technologies (M) SDN.BHD. |
Ganesan Subramaniam |
| K222349 |
10/21/2022 |
JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple) |
JR Engineering & Medical Technologies (M) SDN.BHD. |
Ganesan Subramaniam |
| K221169 |
10/25/2022 |
JR MEDIC Nitrile Examination Gloves Powder Free- Black |
JR Engineering & Medical Technologies (M) SDN.BHD. |
Ganesan Subramaniam |
| K213610 |
10/07/2022 |
Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps |
Katalyst Surgical, LLC |
Liz Morgan |
| K214109 |
10/28/2022 |
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
Kontour(XiÆan) Medical Technology Co., Ltd. |
Rongrong Cong |
| K221575 |
10/07/2022 |
Pre-Formed Blue |
Lake Region Medical |
Deko Hussein |
| K220138 |
10/05/2022 |
Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP |
LED SpA |
Amalia Lamberti |
| K222365 |
10/25/2022 |
Leltek Ultrasound Imaging System (Model: LU700 Series) |
Leltek Inc |
Paul Chang |
| K222205 |
10/07/2022 |
Cold Sore Device (Model: QPZ-01) |
Light Tree Ventures Europe B.V. |
Alain Dijkstra |
| K222427 |
10/06/2022 |
PRIMA TT Glenoid |
LimaCorporate S.p.A. |
Michela Zanotto |
| K222807 |
10/26/2022 |
TEMA Elbow system - Line extension |
LimaCorporate S.p.A. |
Marco Tallerico |
| K222791 |
10/16/2022 |
SafeBreak Vascular |
Lineus Medical, LLC |
Vance Clement |
| K222366 |
10/26/2022 |
EsoCheck Cell Collection Device |
Lucid Diagnostics, Inc. |
Lishan Aklog |
| K222335 |
10/11/2022 |
Surgical Mask |
Luoyang Sunmed Devices Co., Ltd. |
Tian Qian |
| K213748 |
10/14/2022 |
CoreLevee |
Lutronic Corporation |
Haewon Park |
| K212649 |
10/25/2022 |
Disposable Surgical Face Mask |
Lyncmed Medical Technology (Beijing) Co., Ltd. |
Naomi Zhou |
| K212391 |
10/21/2022 |
MCI-Neuro Fixation System |
MCI Medical Concept Innovation Inc. |
Carlos Lacerda |
| K222657 |
10/18/2022 |
MEBO Wound Dressing |
MEBO Life Science Inc. |
Sidney Hong |
| K221545 |
10/24/2022 |
MectaLIF Anterior Extension |
Medacta International S.A. |
Stefano Baj |
| K221632 |
10/18/2022 |
Spine CAMPÖ |
Medical Metrics, Inc. |
Kirk Johnson |
| K222201 |
10/21/2022 |
Biological Feedback and Stimulation System |
Medlander Medical Technology Inc. |
Wang Wang |
| K220565 |
10/25/2022 |
Hudson RCI Triflo II Incentive Deep Breathing Exerciser |
Medline Industries, Inc. |
Nicole Schaffer |
| K220365 |
10/06/2022 |
Gemini Sterilization Wrap |
Medline Industries, LP |
Jennifer Mason |
| K213978 |
10/18/2022 |
TELIGEN System |
Medos International, SARL |
Daria Bochenek |
| K222473 |
10/13/2022 |
EXPEDIUM« Spine System, EXPEDIUM VERSE« Spine System: ALTALYNEÖ Ultra Rods |
Medos-International, SARL |
Denielle Smith |
| K210414 |
10/21/2022 |
CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown |
Medtecs (Taiwan) Corp. |
William Yang |
| K221646 |
10/04/2022 |
CD HORIZONÖ ASTUTEÖ SPINAL SYSTEM; CD HORIZONÖ Growth Rod Conversion Set; CD HORIZONÖ SPINAL SYSTEM; CD HorizonÖ Fenestrated Screw Set; COLORADO 2Ö SPINAL System; GDLHÖ POSTERIOR SPINAL SYSTEM; SHILLAÖ Growth Guidance System; TENORÖ SPINAL SYSTEM |
Medtronic Sofamor Danek USA, Inc. |
Shana Foster |
| K220929 |
10/31/2022 |
Excelsior |
Merit CRO, Inc. |
Yijuan Huang |
| K222354 |
10/03/2022 |
Elastic Traction System |
Micro-Tech (Nanjing) Co., Ltd. |
Sally He |
| K220318 |
10/14/2022 |
PAL Infiltration System |
MicroAire Surgical Instruments, LLC |
Glenn Gerstenfeld |
| K220132 |
10/26/2022 |
FIREFLY« Cervical Navigation Guide |
Mighty Oak Medical Inc. |
Mark A. Wylie |
| K221498 |
10/07/2022 |
Miha Bodytec II |
Miha Bodytec GmbH |
Felix Schweigert |
| K220256 |
10/07/2022 |
MIM-Ablation |
MIM Software Inc. |
Daniel Darkow |
| K221818 |
10/07/2022 |
Rebellion; Phantom Multi-Bite Kerrison Rongeur |
Morpheus AG |
Timo Rack |
| K202953 |
10/03/2022 |
Aurolase Therapy, Laser Delivery Device (LDD) |
Nanospectra Biosciences, Inc. |
David Jorden |
| K220994 |
10/14/2022 |
Shoulder PacemakerTM |
NCS Lab Srl |
Matteo Mantovani |
| K222890 |
10/19/2022 |
RADIANCE ULTRA 32 4K ZEROWIRE DUO |
NDS Surgical Imaging, LLC. |
Jim Leng |
| K222407 |
10/14/2022 |
16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast Coil |
NeoCoil, LLC |
Katie Gonzalez |
| K221795 |
10/19/2022 |
STERN FIX Sternal Stabilization System |
Neos Surgery SL |
Eduard Garcia Puig |
| K222032 |
10/26/2022 |
NEUROMARK System |
Neurent Medical |
Karen E. Peterson |
| K222404 |
10/20/2022 |
Evo« sEEG System |
NeuroOne Medical Technologies Corp. |
Debra Kridner |
| K221563 |
10/24/2022 |
Neurosteer EEG Recorder |
Neurosteer Inc. |
Nathan Intrator |
| K213969 |
10/07/2022 |
VisionAir Patient-Specific Airway Stent |
New COS Inc. DBA VisionAir Solutions |
Keith Grafmeyer |
| K221667 |
10/28/2022 |
Non Sterile Powder Free Latex Examination Glove |
New Era Medicare Sdn. Bhd. |
Fatin Nor Irdina binti Ahmad Fauzi |
| K222157 |
10/11/2022 |
ECHO Photocoagulator |
Norlase |
Jan Forstberg |
| K203549 |
10/18/2022 |
Nova Primary Glucose Analyzer System |
Nova Biomedical Corporation |
Rachel Gilbert |
| K221783 |
10/24/2022 |
SafetiCET (SC-150);SafetiCET (SC-180);SafetiCET (SC-220);SafetiCET (SC-250);SafetiCET (SC-250B) |
NSP Tech Pte Ltd |
HC Tan |
| K221064 |
10/30/2022 |
Nuheara IQbuds 2 PRO Hearing Aid |
Nuheara Limited |
John Luna |
| K221751 |
10/21/2022 |
NuVasive Cohere ALIF System Intervertebral Body Fusion Device |
NuVasive, Incorporated |
Jessica LeBlanc |
| K221172 |
10/14/2022 |
FOCUS Interbody System |
OC Medical Devices |
Jack Mathews |
| K213061 |
10/07/2022 |
SuperCheck Pro Blood Glucose Monitoring System |
OK BioTech Co., Ltd. |
Laurie Liu |
| K213742 |
10/19/2022 |
Infinity Pro, Logic, Quality, Sprint |
Olsen Ind·stria e ComΘrcio S.A. |
Ana Clßudia Espφndola |
| K222298 |
10/18/2022 |
Violet 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 |
Onetexx SDN BHD |
Freddy Low |
| K221928 |
10/04/2022 |
ROSA« Knee System |
Orthosoft d/b/a Zimmer CAS |
Kavina Veeren |
| K221613 |
10/03/2022 |
Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets |
Owen Mumford Ltd |
Darren Mansell |
| K222303 |
10/25/2022 |
Unistik« Pro |
Owen Mumford Ltd |
Darren Mansell |
| K221892 |
10/05/2022 |
VISIONAIR |
PacificMD Biotech Llc |
Jetmir Palushi |
| K220190 |
10/24/2022 |
The GIRO Growth Modulation System |
Pega Medical, Inc. |
Ariel R. Dujovne |
| K220683 |
10/04/2022 |
INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4) |
Penumbra, Inc. |
Sindokht (Sisi) Soltanzadeh |
| K213666 |
10/06/2022 |
NuCath Wedge Pressure Catheter |
PFM Medical, Inc. |
Jessica Jho |
| K212493 |
10/24/2022 |
KODEX û EPDÖ System 1.5.0 |
Philips Medical Systems Nederland, B.V. (PMSN) |
Betina Schepers |
| K220111 |
10/07/2022 |
RespiraSense |
PMD Solutions |
Sinead O'Sullivan |
| K221435 |
10/28/2022 |
SUPERTILT PLUS (STP) |
Power Plus Mobility |
Jason Mohan |
| K220823 |
10/26/2022 |
Preat Abutments |
Preat Corporation |
Chris Bormes |
| K221420 |
10/27/2022 |
AlphaIDÖ At Home Genetic Health Risk Service |
Progenika Biopharma S.A., a Grifols company |
Diego Tejedor |
| K221889 |
10/06/2022 |
ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring |
ProSomnus Sleep Technologies |
Divya Mavalli |
| K223235 |
10/26/2022 |
Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) |
PT. Sintong Unigolden Glove |
MP Vivekanandan |
| K211409 |
10/19/2022 |
Proximerge 2 Dental Implant System |
Quadric BioMed, LLC |
Aaron Bass |
| K222068 |
10/12/2022 |
Durex Penck III Regular |
RB Health (US) LLC |
Kyle Prince |
| K222281 |
10/26/2022 |
Intracept Intraosseous Nerve Ablation System |
Relievant Medsystems, Inc. |
Thomas A. Slater |
| K222167 |
10/18/2022 |
E-Z Chek Chlorine Residual Test Strips (K100-0101B) |
Reprocessing Products Corporation (RPC) |
Dave Cox |
| K222763 |
10/13/2022 |
Responsive Arthroscopy Mustang and Mustang Knotless Suture Anchors |
Responsive Arthroscopy LLC |
Garrett Ahlborg |
| K211872 |
10/12/2022 |
PiezoImplant System |
Rex Implants, Inc. |
Giuseppe Vercellotti |
| K221510 |
10/12/2022 |
TrusFIL-Flow Flowable Composite Restorative |
Rizhao HuGe Biomaterials Company, Ltd. |
Maggie Zheng |
| K220911 |
10/12/2022 |
Elecsys CMV IgG |
Roche Diagnostics |
Bin Sun |
| K220923 |
10/12/2022 |
Elecsys HSV-1 IgG (08948844160) |
Roche Diagnostics |
Cynthia Aker |
| K220924 |
10/12/2022 |
Elecsys HSV-2 IgG (08948887160) |
Roche Diagnostics |
Cynthia Aker |
| K213804 |
10/22/2022 |
cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems |
Roche Molecular Systems, Inc. |
Rita Hoady |
| K222678 |
10/27/2022 |
Mobility+ Enteral Feeding System |
Rockfield Medical |
Orla Connaughton |
| K222743 |
10/04/2022 |
Route 92 Medical Full Length 070 Access System |
Route 92 Medical, Inc. |
Kirsten Valley |
| K222231 |
10/27/2022 |
S.I.N. Dental Implant System |
S.I.N. - Sistema de Implante Nacional S.A. |
Denise Domiciano |
| K222514 |
10/27/2022 |
S.I.N. Instrument Kits |
S.I.N. û Sistema de Implante Nacional S.A. |
Denise Domiciano |
| K222721 |
10/18/2022 |
Violet Nitrile Powder Free Patient Examination Glove, Non Sterile |
Safeskin Retailing (HK) Limited |
Alvin Ho |
| K222581 |
10/28/2022 |
Stela Automix System |
SDI Limited |
Quynh Jewell |
| K222583 |
10/28/2022 |
Stela Capsule System |
SDI Limited |
Quynh Jewell |
| K222080 |
10/06/2022 |
Garion Image-Intensified Fluoroscopic X-Ray System, Mobile |
SG Healthcare CO LTD |
Byung Ju Kang |
| K222842 |
10/20/2022 |
V-Patch Cardiac Monitor |
Shandong CoreCare Technology Limited |
Cao Cheng |
| K222376 |
10/03/2022 |
Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA) |
Shandong Lianfa Medical Plastic Products Co. Ltd. |
Charles Shen |
| K222737 |
10/05/2022 |
Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US) |
Shanghai AnQing Medical Instrument Co., Ltd. |
Shuwen Fan |
| K221770 |
10/13/2022 |
Fiber Laser Treatment System |
Shanghai Apolo Medical Technology Co., Ltd. |
Felix Li |
| K220332 |
10/27/2022 |
uMR Omega with uWS-MR-MRS |
Shanghai United Imaging Healthcare Co.,Ltd. |
Xin Gao |
| K221170 |
10/07/2022 |
Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106, AOJ-F107 |
Shenzhen AOJ Medical Technology Co., Ltd. |
Jack Wang |
| K221643 |
10/21/2022 |
Hair Removal Device (Model: IPL-D26, IPL-D19) |
Shenzhen Desida Technology Co., Ltd. |
Gong Yong |
| K221979 |
10/16/2022 |
Pulse Oximeter (Model C101A2, C101B1, C101A3) |
Shenzhen IMDK Medical Technology CO., Ltd. |
Yuan Xia |
| K222537 |
10/14/2022 |
IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi |
Shenzhen Ishine Technology Company Limited |
Chaohui An |
| K222547 |
10/20/2022 |
Electric nasal aspirator |
Shenzhen XinLianFeng Technology CO.,LTD |
Ma Qiang |
| K220057 |
10/07/2022 |
Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization |
Shinva Ande Healthcare Apparatus Co., Ltd. |
Xiaolei Tian |
| K220102 |
10/12/2022 |
MOST-T Autoclave |
Shinva Medical Instrument Co., Ltd. |
Liu Xiaolin |
| K221066 |
10/04/2022 |
Sterile Hypodermic Needles for Single Use |
Sichuan Prius Biotechnology Co., Ltd. |
Yan Liu |
| K221079 |
10/04/2022 |
Sterile Hypodermic Syringes for Single Use |
Sichuan Prius Biotechnology Co., Ltd. |
Yan Liu |
| K221068 |
10/04/2022 |
Sterile Hypodermic Syringes for Single Use with Needles |
Sichuan Prius Biotechnology Co., Ltd. |
Yan Liu |
| K221073 |
10/04/2022 |
Sterile Hypodermic Syringes for Single Use with Safety Needles |
Sichuan Prius Biotechnology Co., Ltd. |
Yan Liu |
| K221080 |
10/04/2022 |
Sterile Safety Hypodermic Needles for Single Use |
Sichuan Prius Biotechnology Co., Ltd. |
Yan Liu |
| K221501 |
10/14/2022 |
syngo.via View&GO |
Siemens Healthcare GmBH |
Frederike Jakob |
| K221305 |
10/14/2022 |
AI-Rad Companion Organs RT |
Siemens Medical Solutions USA, Inc |
Kira Kuzmenchuk |
| K222361 |
10/20/2022 |
AI-Rad Companion (Musculoskeletal) |
Siemens Medical Solutions USA, Inc. |
Kira Kuzmenchuk |
| K222380 |
10/04/2022 |
TriVerse Total Knee Replacement System |
Signature Orthopaedics Pty Ltd. |
Declan Brazil |
| K222470 |
10/25/2022 |
3Dicom MD |
Singular Health Pty Ltd |
James Hill |
| K222643 |
10/19/2022 |
Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit |
Sirius Medical Systems B.V. |
Bram Schermers |
| K213123 |
10/18/2022 |
EVOS Wrist Spanning Plate |
Smith & Nephew, Inc. |
Jyothsna Baravatula |
| K221740 |
10/20/2022 |
SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NETWORK ENABLED (72205447), SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NON-NETWORK ENABLED (72205448) |
Smith and Nephew, Inc. |
Renesha Srivastava |
| K222653 |
10/28/2022 |
JOURNEY II UKÖ and ENGAGEÖ Cementless Partial Knee System |
Smith+Nephew, Inc |
Lilian Hren |
| K222744 |
10/11/2022 |
Sol-M Luer Lock Syringe |
Sol-Millennium Medical Inc. |
Ying Zhao |
| K222856 |
10/19/2022 |
SOMAVAC 100 Sustained Vacuum System |
SOMAVAC Medical Solutions, Inc. |
Phil Ryan |
| K221447 |
10/14/2022 |
Southern Anterior Screw Fixated Cage (SASCA) |
Southern Medical (Pty) Ltd |
Dalene Styger |
| K223079 |
10/28/2022 |
Stage |
SpinTech, Inc. |
Rana El Hachem |
| K222085 |
10/31/2022 |
Standard Tapered Bougie, 38 Fr. |
Standard Bariatrics, Inc. |
Michelle Schnell |
| K221521 |
10/28/2022 |
Disposable Safety Lancet |
SteriLance Medical (Suzhou) Inc. |
Susan Sun |
| K221728 |
10/19/2022 |
Aviator« Anterior Cervical Plating (ACP) System, LITe« Plate System, DynaTranÖ Anterior Cervical Plating (ACP) System, ReflexÖ Hybrid ACP System, UniViseÖ Spinous Process Fixation Plate |
Stryker Corporation |
Katie McNeil |
| K222079 |
10/11/2022 |
Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control |
Stryker Endoscopy |
Divya Sekar |
| K222191 |
10/28/2022 |
Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40 |
SuperSonic Imagine |
Shalyna Bansropun |
| K221886 |
10/14/2022 |
Sublime Microcatheter |
Surmodics Inc. |
Holly Ramirez |
| K221778 |
10/03/2022 |
Disposable Safety Lancets |
Suzhou Kyuan Medical Apparatus Co., Ltd. |
Shi Ye |
| K221029 |
10/19/2022 |
PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch |
Synovis Life Technologies, Inc. |
Megan Sajjad |
| K221032 |
10/19/2022 |
Vascu-Guard Vascular Repair Patch |
Synovis Life Technologies, Inc. |
Sajjad Megan |
| K220305 |
10/28/2022 |
Syntheon LAA Exclusion System, Syntheon LAA Selection Guide |
Syntheon |
Sean McBryer |
| K222288 |
10/27/2022 |
DESS Dental Smart Solutions |
Terrats Medical SL |
Roger Terrats |
| K222269 |
10/26/2022 |
DESS Dental Smart Solutions |
Terrats Medical SL |
Roger Terrats |
| K220273 |
10/21/2022 |
Onetouch Non-paraben Lubricant Gel |
Thai Nippon Rubber Industry Public Company Limited. |
Tossaporn Nilkhamhang |
| K222127 |
10/24/2022 |
Soft Palate Elevator |
The TMJ Clinic, PC. |
John Summer |
| K222070 |
10/25/2022 |
EndoNaut |
Therenva SAS |
Audrey Gallois |
| K213120 |
10/12/2022 |
OW100S (model OW100S-US) |
Tissue Regeneration Technologies, LLC DBA as SoftWave TRT |
John Warlick |
| K220914 |
10/14/2022 |
Tornier Perform Humeral System û Fracture |
Tornier, Inc. |
Renee Stoffel |
| K214054 |
10/14/2022 |
TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520 |
TP Orthodontics, Inc. |
Cristiane Muller |
| K221986 |
10/18/2022 |
XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter |
Transit Scientific, LLC |
Jennifer Arnold |
| K221072 |
10/18/2022 |
TRUEdraw Lancing Device, Mini Lancing Device |
Trividia Health |
Jacqueline Davis |
| K220156 |
10/07/2022 |
Electrically Powered Wheelchair, Joy Rider |
Tung Keng Enterprise Co., Ltd. |
Jen Ke-Min |
| K221947 |
10/20/2022 |
Tyber Medical Staple Fixation System (various) |
Tyber Medical, LLC. |
Lisa Boyle |
| K222700 |
10/06/2022 |
Tibial baseplate, Tibial insert |
United Orthopedic Corporation |
Lois Ho |
| K220869 |
10/28/2022 |
Vapotherm Aerosol Adapter AAA-2 |
Vapotherm Inc. |
Michael J. Webb |
| K222686 |
10/06/2022 |
Perfit FS Dental Zirconia Fully Sintered Block |
Vatech Acucera, Inc. |
Kwon Kyung Wook |
| K223058 |
10/26/2022 |
EzRay Air 2 Wall (Model: VEX-S350W) |
Vatech Co., Ltd |
Daniel Kim |
| K201237 |
10/03/2022 |
VelanoáVascularáBloodáCollectionáAdapterá |
VelanoáVascular |
Tiffiniá Wittwer |
| K221022 |
10/21/2022 |
NextDent Ortho Flex |
Vertex-Dental BV |
Connie Peterse-van der Koppel |
| K223020 |
10/28/2022 |
VS3-Iridium System (VS3-IR) |
Visionsense Ltd. |
Guy Wroclawski |
| K223042 |
10/21/2022 |
Viz LVO ContaCT |
Viz.ai, Inc. |
Gregory Ramina |
| K214073 |
10/20/2022 |
eWave Monitor |
WearLinq, Inc. |
Konrad Morzkowski |
| K212473 |
10/28/2022 |
Welch Allyn Connex Central Station |
Welch Allyn, Inc. |
Megan Pellenz |
| K222717 |
10/31/2022 |
CL24N |
WIDE Corporation |
YeoJin Yun |
| K222722 |
10/31/2022 |
CW60N |
WIDE Corporation |
YeoJin Yun |
| K221989 |
10/13/2022 |
The Oligio |
WON TECH Co., Ltd. |
Hyun Sik Yoon |
| K222058 |
10/22/2022 |
Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant |
WRP Asia Pacific SDN. BHD. |
Siti Iylia Zarith Bt Hasan |
| K213049 |
10/16/2022 |
STIMPOD NMS450 Nerve Stimulator |
Xavant Technology (Pty) Ltd |
Roche Janse van Rensburg |
| K211060 |
10/28/2022 |
Disposable Surgical Gown Rk-3011C |
Xiantao Rhycom Non-woven Products Co., Ltd |
Liu Yang |
| K221977 |
10/20/2022 |
Disposable Surgical Gown (G4003) |
Xiantao Topmed Nonwoven Protective Products Co., Ltd. |
Vivian Zhu |
| K213128 |
10/21/2022 |
IntraOp VSP Software Device |
Xironetic, LLC |
Christian El Amm |
| K221443 |
10/21/2022 |
PureLift Pro Plus |
Xtreem Pulse LLC |
Andrew Barile |
| K202163 |
10/07/2022 |
Mico One Orthodontic Screw |
Ze Fang Technology Co., Ltd. |
Anita Chen |
| K222495 |
10/17/2022 |
Mobility Scooter, Model: W3331F |
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd |
Leo Zheng |
| K213183 |
10/14/2022 |
Safety Insulin Pen Needles |
Zhejiang Kindly Medical Devices Co. Ltd |
Yong Zhang |
| K221857 |
10/13/2022 |
Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, QL-20, Aneroid sphygmomanometer, QL-201 |
Zhejiang LuDe Technology Development Co., Ltd. |
Iris Du |
| K220220 |
10/03/2022 |
Electronic Sphygmomanometer (Model: LT-P30) |
Zhuhai Linte Medical Instrument Co., Ltd. |
Wallace Huang |
| K222074 |
10/17/2022 |
Powder Free Nitrile Examination Gloves (Blue, Black, White and/or Violet Blue), Powder Free Latex Examination Gloves |
Zibo Langu New Material Technology Co., Ltd |
Wang Qidong |
| K222566 |
10/17/2022 |
Zimmer Persona Personalized Knee System |
Zimmer, Inc. |
Lauren Ricker |
| K221858 |
10/14/2022 |
ZSFab Lumbar Interbody System |
ZS Fab Inc. |
Xuewei Ma |
