FDA device clearances in New York: 159 since Nov 2024

Name: FDA device clearances for applicants in New York
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

The full list. FDA device clearances for applicants in New York: 159 rows for $7.95, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. The list gains about 10 rows a month. The new rows come each week by email, $19 a month.

Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (pathway, device name, applicant address, contact, date received, device type and 5 more), which open on your screen as soon as the payment clears and come by email. The weekly rows run until you cancel, from the link in each delivery. The rows on this page are a sample.

For agents and scripts: this list is ordered at https://specstream.ai/data/fda-clearances/state/new-york, and every list with its row count and price is at https://specstream.ai/data/lists.json.

Updated October 30, 2026. Source: openFDA device 510(k) and PMA (U.S. Food and Drug Administration).

FDA made 159 device decisions for applicants in New York from November 15, 2024 to October 30, 2026: 107 510(k) clearances and De Novo grants and 52 PMA approvals and supplements, for 78 applicants. The newest, K263076 on October 30, 2026, is AngioVac F1885 from AngioDynamics, Inc..

The request: Every new FDA device clearance or approval for a company in New York, with its address, the device and the product code. $10 of credit on sign-up, no card.

Get new clearances like these Watch a company

SpecStream is the live web data engine for teams and agents. It reads every new FDA device clearance and approval as openFDA publishes it, and this page is that reading. Ask for the specialties, product codes or states you follow and each new decision arrives in your sheet, CRM, Slack or agent with the applicant and its address.

159Decisions
107510(k) and De Novo
52PMA
October 30, 2026Latest decision

Newest decisions

The newest 100 of 159, each linked to its FDA record. The full list adds the applicant's address, the 510(k) contact as FDA prints it, the device class and the date received.

Decision date	Number	Device	Applicant	Location	Decision	Type	Product code	Source
October 30, 2026	K263076	AngioVac F1885	AngioDynamics, Inc.	New York	Substantially Equivalent	510(k) traditional	DWF	accessdata.fda.gov
October 27, 2026	K261714	FlowXL® System: FlowXL Flowmeter and compatible Flowprobes and Flowsensors	Transonic Systems, Inc.	New York	Substantially Equivalent	510(k) traditional	DPW	accessdata.fda.gov
October 26, 2026	K261997	NeuroAlign	Medivis, Inc.	New York	Substantially Equivalent	510(k) traditional	HAW	accessdata.fda.gov
October 23, 2026	P240005/S010	enVista Envy Hydrophobic Acrylic Intraocular Lens	Bausch & Lomb, Inc.	New York	30-day notice accepted	PMA 30-day notice	MFK	accessdata.fda.gov
October 16, 2026	K262941	Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens	Bausch + Lomb, Inc.	New York	Substantially Equivalent	510(k) traditional	LPL	accessdata.fda.gov
October 14, 2026	P240005/S009	enVista Envy Hydrophobic Acrylic Intraocular Lens	Bausch & Lomb, Inc.	New York	30-day notice accepted	PMA 30-day notice	MFK	accessdata.fda.gov
October 7, 2026	K260075	eClinics	Ceiba Healthcare US, Inc.	New York	Substantially Equivalent	510(k) traditional	MSX	accessdata.fda.gov
September 30, 2026	P240005/S008	enVista Envy Hydrophobic Acrylic Intraocular Lens	Bausch & Lomb, Inc.	New York	30-day notice accepted	PMA 30-day notice	MFK	accessdata.fda.gov
September 22, 2026	P010007/S028	IMMULITE Systems AFP	Siemens Healthcare Diagnostics, Inc.	New York	30-day notice accepted	PMA 30-day notice	LOK	accessdata.fda.gov
September 14, 2026	P170035/S021	Bausch + Lomb Ultra (samfilcon A) Contact Lenses	Bausch and Lomb, Inc.,	New York	30-day notice accepted	PMA 30-day notice	LPM	accessdata.fda.gov
September 11, 2026	K262861	PureLift Pro Max	Xtreem Pulse, LLC	New York	Substantially Equivalent	510(k) special	NFO	accessdata.fda.gov
September 11, 2026	K261580	ZBPro Diagnostic (Version 2.0)	Zbeats, Inc.	New York	Substantially Equivalent	510(k) traditional	MLO	accessdata.fda.gov
September 11, 2026	K261305	MICSI-PET	Microstructure Imaging, Inc.	New York	Substantially Equivalent	510(k) traditional	KPS	accessdata.fda.gov
September 4, 2026	K253529	Peerbridge COR MDx (Cor MDx)	Peerbridge Health, Inc.	New York	Substantially Equivalent	510(k) abbreviated	MWJ	accessdata.fda.gov
September 3, 2026	P240005/S007	enVista Envy hydrophobic acrylic intraocular lens (IOL)	Bausch & Lomb, Inc.	New York	30-day notice accepted	PMA 30-day notice	MFK	accessdata.fda.gov
September 3, 2026	DEN250044	Queen of Hearts (ACS AI ECG Model)	Powerful Medical, Inc.	New York	Unknown	De Novo	SHS	accessdata.fda.gov
August 31, 2026	K261718	EZFluence (RADEZ V2)	Radformation, Inc.	New York	Substantially Equivalent	510(k) traditional	IYE	accessdata.fda.gov
August 27, 2026	K260545	CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System...	Ascensia Diabetes Care	New York	Substantially Equivalent	510(k) traditional	NBW	accessdata.fda.gov
August 26, 2026	P240021/S001	Atellica IM Total PSA II (tPSAII)	Siemens Healthcare Diagnostics, Inc.	New York	Approved	PMA 180-day supplement	MTF	accessdata.fda.gov
August 20, 2026	P010007/S027	IMMULITE Systems AFP	Siemens Healthcare Diagnostics, Inc.	New York	30-day notice accepted	PMA 30-day notice	LOK	accessdata.fda.gov
August 14, 2026	K262452	AutoContour (RADAC V6)	Radformation, Inc.	New York	Substantially Equivalent	510(k) special	QKB	accessdata.fda.gov
August 12, 2026	P240005/S005	enVista Envy hydrophobic acrylic intraocular lens (IOL), enVista Envy toric hydrophobic acrylic intraocular...	Bausch & Lomb, Inc.	New York	Approved	PMA special supplement	MFK	accessdata.fda.gov
August 10, 2026	K260165	Unimpregnated Central Venous Catheter	Spectrum Vascular	New York	Substantially Equivalent	510(k) traditional	FOZ	accessdata.fda.gov
August 10, 2026	K253528	Atellica IM CA 19-9 II	Siemens Healthcare Diagnostics, Inc.	New York	Substantially Equivalent	510(k) traditional	NIG	accessdata.fda.gov
July 30, 2026	K261448	neXus Ultrasonic Surgical Aspirator System	Misonix, LLC	New York	Substantially Equivalent	510(k) traditional	LFL	accessdata.fda.gov
July 30, 2026	K254038	Motivista (CT-155)	Click Therapeutics, Inc.	New York	Substantially Equivalent	510(k) traditional	SAP	accessdata.fda.gov
July 29, 2026	K251908	Emanate Tray	Emanate Biomedical	New York	Substantially Equivalent	510(k) traditional	OLR	accessdata.fda.gov
July 27, 2026	P010007/S026	IMMULITE 2000 AFP	Siemens Healthcare Diagnostics, Inc.	New York	30-day notice accepted	PMA 30-day notice	LOK	accessdata.fda.gov
July 24, 2026	K261364	Atellica CH Acetaminophen 2 (ACTM)	Siemens Healthcare Diagnostics, Inc.	New York	Substantially Equivalent	510(k) traditional	LDP	accessdata.fda.gov
July 22, 2026	P240005/S006	enVista Envy Hydrophobic Acrylic Intraocular Lens	Bausch & Lomb, Inc.	New York	30-day notice accepted	PMA 30-day notice	MFK	accessdata.fda.gov
July 17, 2026	K251952	Virasight	Virasoft Corporation	New York	Substantially Equivalent	510(k) traditional	PSY	accessdata.fda.gov
July 10, 2026	K261949	NYES Tuff Cuff L3 Disposable Gowns	New York Embroidery Studio	New York	Substantially Equivalent	510(k) special	FYA	accessdata.fda.gov
July 6, 2026	P150028/S007	CP Stent (Model 425), Covered CP Stent (Model 427), Mounted CP Stent (Model 426), Covered and Mounted CP...	NuMED, Inc.	New York	Approved	PMA 180-day supplement	PNF	accessdata.fda.gov
July 2, 2026	K253884	Koios DS (3.8)	Koios Medical, Inc.	New York	Substantially Equivalent	510(k) traditional	POK	accessdata.fda.gov
July 2, 2026	K253704	iPredict-DR	iHealthscreen, Inc.	New York	Substantially Equivalent	510(k) traditional	PIB	accessdata.fda.gov
July 1, 2026	K261485	Tetric plus Fill;Tetric plus Flow	Ivoclar Vivadent, Inc.	New York	Substantially Equivalent	510(k) traditional	EBF	accessdata.fda.gov
June 30, 2026	K262195	Dandy Ceramic Stain and Glaze	Zima International Inc., dba Dandy	New York	Substantially Equivalent	510(k) traditional	EIH	accessdata.fda.gov
June 26, 2026	K261455	Arterial Pressure Monitoring Set/Tray	Spectrum Vascular	New York	Substantially Equivalent	510(k) traditional	DQO	accessdata.fda.gov
June 22, 2026	K254011	Flow Water-Based Personal Lubricant	LBDO Group, Inc.	New York	Substantially Equivalent	510(k) traditional	NUC	accessdata.fda.gov
June 17, 2026	K260006	INOSS System	Inosys, Inc.	New York	Substantially Equivalent	510(k) traditional	DZE	accessdata.fda.gov
June 16, 2026	P910018/S042	LIPOSORBER® LA-15 System	Kaneka Pharma America Corp.	New York	30-day notice accepted	PMA 30-day notice	MMY	accessdata.fda.gov
June 8, 2026	K260332	EchoNext	Pathwai, Inc.	New York	Substantially Equivalent	510(k) traditional	QXO	accessdata.fda.gov
June 4, 2026	K252575	Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)	New York Embroidery Studio (NYES)	New York	Substantially Equivalent	510(k) traditional	FYA	accessdata.fda.gov
May 29, 2026	K252840	M12 Telemetry System	Global Instrumentation, LLC	New York	Substantially Equivalent	510(k) traditional	MHX	accessdata.fda.gov
May 28, 2026	K252823	Dukal Crepe Paper Sterilization Wrap	Dukal, LLC	New York	Substantially Equivalent	510(k) traditional	FRG	accessdata.fda.gov
May 21, 2026	K251920	Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask	Dcstar, Inc.	New York	Substantially Equivalent	510(k) traditional	BZD	accessdata.fda.gov
May 13, 2026	K261363	Y-Knotless Flex Anchors	CONMED Corporation	New York	Substantially Equivalent	510(k) special	MBI	accessdata.fda.gov
May 11, 2026	P250026	Atellica IM free PSA II (fPSAII)	Siemens Healthcare Diagnostics, Inc.	New York	Approved	PMA original approval	MTG	accessdata.fda.gov
May 5, 2026	K261132	Healium Intelliscan LX192LC	Healium Intelliscan Corporation	New York	Substantially Equivalent	510(k) special	IYN	accessdata.fda.gov
April 30, 2026	K250680	Bayesian Health Sepsis Flagging Device	Bayesian Health, Inc.	New York	Substantially Equivalent	510(k) traditional	SAK	accessdata.fda.gov
April 30, 2026	DEN250023	Aurie System	Cathbuddy, Inc.	New York	Unknown	De Novo	SHV	accessdata.fda.gov
April 27, 2026	K252628	CASSIE	Wesper, Inc.	New York	Substantially Equivalent	510(k) traditional	MNR	accessdata.fda.gov
April 22, 2026	K253765	VANISH PRO	Ddc Technologies, Inc.	New York	Substantially Equivalent	510(k) traditional	GEX	accessdata.fda.gov
April 21, 2026	P010007/S025	IMMULITE 2000 AFP	Siemens Healthcare Diagnostics, Inc.	New York	Approved	PMA 180-day supplement	LOK	accessdata.fda.gov
April 7, 2026	K253905	PrimeSight UltraView System	Cogentix Medical, Inc.	New York	Substantially Equivalent	510(k) traditional	FAJ	accessdata.fda.gov
April 3, 2026	K253962	ClearCheck (RADCC V2.7)	Radformation, Inc.	New York	Substantially Equivalent	510(k) traditional	IYE	accessdata.fda.gov
March 30, 2026	P910018/S041	LIPOSORBER® LA-15 System	Kaneka Pharma America Corp.	New York	Approved	PMA real-time process supplement	MMY	accessdata.fda.gov
March 25, 2026	K254278	Arterial Pressure Monitoring Set/Tray	Spectrum Vascular	New York	Substantially Equivalent	510(k) special	DQO	accessdata.fda.gov
March 19, 2026	K260509	AutoContour (RADAC V5)	Radformation, Inc.	New York	Substantially Equivalent	510(k) special	QKB	accessdata.fda.gov
March 13, 2026	P200044/S013	LungFit PH	Beyond Air, Inc.	New York	30-day notice accepted	PMA 30-day notice	QTB	accessdata.fda.gov
March 12, 2026	K253429	Genadyne ASTRA NPWT	Genadyne Biotechnologies, Inc.	New York	Substantially Equivalent	510(k) traditional	OMP	accessdata.fda.gov
March 11, 2026	K253185	Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System	Carestream Health	New York	Substantially Equivalent	510(k) traditional	IZL	accessdata.fda.gov
March 10, 2026	K253953	IPS e.max Zirconia	Ivoclar Vivadent, Inc.	New York	Substantially Equivalent	510(k) traditional	EIH	accessdata.fda.gov
March 6, 2026	K252208	JFord Speculum Sleeve	Ford Medtech, LLC	New York	Substantially Equivalent	510(k) traditional	HIB	accessdata.fda.gov
March 5, 2026	K252450	Adhese 2	Ivoclar Vivadent, Inc.	New York	Substantially Equivalent	510(k) traditional	KLE	accessdata.fda.gov
March 4, 2026	DEN250012	LifeVac	Lifevac, LLC	New York	Unknown	De Novo	QXN	accessdata.fda.gov
February 13, 2026	K253092	Argos Infinity (Rev. 1.0)	Retia Medical Systems, Inc.	New York	Substantially Equivalent	510(k) traditional	DXG	accessdata.fda.gov
February 10, 2026	K251515	Solidex® Ti-Links and Screws	CreoDent Hudson Valley	New York	Substantially Equivalent	510(k) traditional	NHA	accessdata.fda.gov
February 6, 2026	K251543	Atellica® IM TSH3-Ultra II (TSH3ULII)	Siemens Healthcare Diagnostics, Inc.	New York	Substantially Equivalent	510(k) traditional	JLW	accessdata.fda.gov
January 29, 2026	K253763	Y-Knotless Flex Anchors	Conmed Corporation	New York	Substantially Equivalent	510(k) special	MBI	accessdata.fda.gov
January 27, 2026	K254220	Reusable 3 Button Fingerswitch Wand	Soniquence, LLC	New York	Substantially Equivalent	510(k) special	GEI	accessdata.fda.gov
January 20, 2026	K250954	DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector	Carestream Health	New York	Substantially Equivalent	510(k) traditional	KPR	accessdata.fda.gov
January 5, 2026	K252988	ChartCheck (RADCH V1.6)	Radformation, Inc.	New York	Substantially Equivalent	510(k) traditional	IYE	accessdata.fda.gov
January 5, 2026	K251630	Atellica IM Total PSA II (tPSAII)	Siemens Healthcare Diagnostics, Inc.	New York	Substantially Equivalent	510(k) traditional	LTJ	accessdata.fda.gov
December 23, 2025	K252187	Aura Glide (FC40)	Aura Medical, LLC	New York	Substantially Equivalent	510(k) traditional	NFO	accessdata.fda.gov
December 22, 2025	K252361	AccurECG Analysis System (v2.0)	Accurkardia, Inc.	New York	Substantially Equivalent	510(k) traditional	DPS	accessdata.fda.gov
December 19, 2025	P200007/S002	HeartSync Multifunction Disposable Single-Use Defibrillator Pads	Graphic Controls D.B.A. Vermed	New York	30-day notice accepted	PMA 30-day notice	MKJ	accessdata.fda.gov
December 19, 2025	K252863	ClearCalc Model RADCA V2.6	Radformation, Inc.	New York	Substantially Equivalent	510(k) traditional	MUJ	accessdata.fda.gov
December 17, 2025	K252518	DuoprossTM Smart Cap (Type I)	Duopross Meditech Corporate	New York	Substantially Equivalent	510(k) traditional	FMF	accessdata.fda.gov
December 16, 2025	P860022/S061	Boston Equalens (itaflurofocon A) and Boston Equalens II (oprifocon A)	Bausch & Lomb	New York	30-day notice accepted	PMA 30-day notice	MWL	accessdata.fda.gov
December 16, 2025	P010062/S015	Boston Orthokeratology (oprifocon A)	Bausch & Lomb	New York	30-day notice accepted	PMA 30-day notice	NUU	accessdata.fda.gov
December 16, 2025	K252373	BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and...	Spectrum Vascular	New York	Substantially Equivalent	510(k) traditional	LJS	accessdata.fda.gov
December 12, 2025	K253609	TRAUMAGEL® 2.0 Hemostatic Gel	Cresilon, Inc.	New York	Substantially Equivalent	510(k) special	QSY	accessdata.fda.gov
December 5, 2025	K253868	QuietLab Pro	QuietLab, LLC	New York	Substantially Equivalent	510(k) traditional	LRK	accessdata.fda.gov
December 4, 2025	P170035/S019	Bausch + Lomb Ultra (Samfilcon A) Visibly Tinted (Soft) Contact Lenses	Bausch and Lomb, Inc.,	New York	30-day notice accepted	PMA 30-day notice	LPM	accessdata.fda.gov
December 3, 2025	P240021	Atellica IM Total PSA II (tPSAII)	Siemens Healthcare Diagnostics, Inc.	New York	Approved	PMA original approval	MTF	accessdata.fda.gov
November 24, 2025	K252509	AlphaVac Multipurpose Mechanical Aspiration System F1885	AngioDynamics, Inc.	New York	Substantially Equivalent	510(k) traditional	QEZ	accessdata.fda.gov
November 12, 2025	P200007/S001	HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads	Graphic Controls D.B.A. Vermed	New York	Approved	PMA 135-day supplement	MKJ	accessdata.fda.gov
October 31, 2025	K250306	Chex-All Sterilization Pouches and Tubes	Propper Manufacturing Co., Inc.	New York	Substantially Equivalent	510(k) abbreviated	FRG	accessdata.fda.gov
October 30, 2025	P010007/S024	IMMULITE 2000 AFP	Siemens Healthcare Diagnostics, Inc.	New York	30-day notice accepted	PMA 30-day notice	LOK	accessdata.fda.gov
October 29, 2025	K253355	Difiney Advanced Anti Snoring Device 4.0	Fissiontech, LLC	New York	Substantially Equivalent	510(k) special	LRK	accessdata.fda.gov
October 29, 2025	K252393	VITROS Immunodiagnostic Products hs Troponin I Reagent Pack	Ortho-Clinical Diagnostics, Inc.	New York	Substantially Equivalent	510(k) traditional	MMI	accessdata.fda.gov
October 24, 2025	N16895/S107	Bausch & Lomb SofLens® (polymacon) Contact Lenses	Bausch & Lomb, Inc.	New York	30-day notice accepted	PMA 30-day notice	LPM	accessdata.fda.gov
October 24, 2025	K253106	AngioVac Cannula	AngioDynamics, Inc.	New York	Substantially Equivalent	510(k) special	DWF	accessdata.fda.gov
October 22, 2025	K251628	Mandibular Advancement Device L07	Dcstar, Inc.	New York	Substantially Equivalent	510(k) traditional	LRK	accessdata.fda.gov
October 21, 2025	K231897	NeuroAlign software	Medivis, Inc.	New York	Substantially Equivalent	510(k) traditional	HAW	accessdata.fda.gov
October 17, 2025	P210019/S004	Atellica IM HBc Total 2 (HBcT2)	Siemens Healthcare Diagnostics, Inc.	New York	Approved	PMA real-time process supplement	LOM	accessdata.fda.gov
October 17, 2025	P200017/S005	Atellica IM Anti-HBe2 (aHBe2)	Siemens Healthcare Diagnostics, Inc.	New York	Approved	PMA real-time process supplement	LOM	accessdata.fda.gov
October 17, 2025	P110041/S017	Atellica IM Hepatitis B surface Antigen II (HBsII) & Atellica IM Hepatitis B surface Antigen II Confirmatory	Siemens Corp.	New York	Approved	PMA real-time process supplement	LOM	accessdata.fda.gov
October 17, 2025	P110041/S016	Atellica IM Hepatitis B surface Antigen II (HBsII)	Siemens Corp.	New York	Approved	PMA 180-day supplement	LOM	accessdata.fda.gov

Applicants with the most decisions

Applicant	Decisions	Latest
Siemens Healthcare Diagnostics, Inc.	21	September 22, 2026
Bausch & Lomb, Inc.	14	October 23, 2026
Radformation, Inc.	7	August 31, 2026
Spectrum Vascular	6	August 10, 2026
Conmed Corporation	6	January 29, 2026
Kaneka Pharma America Corp.	5	June 16, 2026
Beyond Air, Inc.	4	March 13, 2026
Siemens Corp.	4	October 17, 2025
AngioDynamics, Inc.	3	October 30, 2026
Bausch and Lomb, Inc.,	3	September 14, 2026
Ivoclar Vivadent, Inc.	3	July 1, 2026
Genadyne Biotechnologies, Inc.	3	March 12, 2026
Bausch & Lomb	3	December 16, 2025
Medivis, Inc.	2	October 26, 2026
Xtreem Pulse, LLC	2	September 11, 2026
Zbeats, Inc.	2	September 11, 2026
Click Therapeutics, Inc.	2	July 30, 2026
Koios Medical, Inc.	2	July 2, 2026
Dcstar, Inc.	2	May 21, 2026
Carestream Health	2	March 11, 2026

By panel

Panel	Decisions	Latest
Ophthalmic	24	October 23, 2026
Radiology	19	September 11, 2026
Cardiovascular	18	October 30, 2026
Immunology	13	September 22, 2026
Microbiology	11	October 17, 2025
General, Plastic Surgery	10	July 10, 2026
Dental	10	July 1, 2026
General Hospital	9	August 10, 2026
Neurology	8	October 26, 2026
Gastroenterology, Urology	8	June 16, 2026
Anesthesiology	7	May 21, 2026
Unknown	6	September 3, 2026
Orthopedic	6	May 13, 2026
Clinical Chemistry	4	August 27, 2026
Pathology	2	July 17, 2026
Obstetrics/Gynecology	2	June 22, 2026
Clinical Toxicology	1	July 24, 2026
Ear, Nose, Throat	1	March 4, 2026

By decision type

Decision type	Decisions	Latest
510(k) traditional	84	October 30, 2026
PMA 30-day notice	23	October 23, 2026
510(k) special	17	September 11, 2026
PMA 180-day supplement	13	August 26, 2026
PMA real-time process supplement	11	March 30, 2026
De Novo	4	September 3, 2026
510(k) abbreviated	2	September 4, 2026
PMA original approval	2	May 11, 2026
PMA 135-day supplement	2	November 12, 2025
PMA special supplement	1	August 12, 2026

Where FDA publishes these decisions

CC0 1.0 (openFDA). Decisions are as FDA publishes them in its 510(k) and PMA databases, read through openFDA. A PMA row is the original approval or one supplement. The panel is the FDA advisory committee that reviewed the device. FDA adds decisions to openFDA some weeks after their date, so the newest weeks fill in later. The 510(k) contact is in the full list only, as FDA prints it for the submission. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.