Data / Medical devices / United States / Solventum US LLC

Solventum US LLC: FDA-registered device maker in San Antonio, TX, United States, 97 510(k) clearances

Name: Solventum US LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Solventum US LLC is registered with the FDA (registration 3031841433) in San Antonio, TX, United States. It lists 78 device types. The FDA files 97 510(k) clearances under its listings, the newest dated November 25, 2024. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Solventum US LLC

FDA registration number: 3031841433
Address: 12930 IH 10 West, San Antonio, TX, United States, 78249
Owner or operator: Solventum US LLC (10091183)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Specification developer
First device listed: August 31, 1978
Registered through: 2026
Brand names listed: 3M, 3M BRAND REMOVER LOTION, 3M Electrosurgical Patient Plate, 3M Electrosurgical Patient Plates, 3M Littmann TeleSteth Online Auscultation System, 3M Red Dot Electrodes, 3M Remover Lotion, 3M SURGICAL CLIPPER and more

Devices it lists

Device	Product code	Class	Role	Source
A Chemical Vapor Sterilization Multivariable Chemical Indicator	QKM	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Accessories, Implant, Dental, Endosseous	NDP	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Adhesive, Bracket And Tooth Conditioner, Resin	DYH	2	Specification developer	accessdata.fda.gov
Agent, Tooth Bonding, Resin	KLE	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Antimicrobial Drapes	PLY	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Applicator, Resin	KXR	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Bag, Intestine	KGY	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Bandage, Cast	ITG	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Bandage, Elastic	FQM	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Bandage, Liquid	KMF	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Bath, Incubators/Water, All	JTQ	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Bedding, Disposable, Medical	KME	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Cabinet, Ethylene-Oxide Gas Aerator	FLI	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Cap, Device Disinfectant	QBP	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Cement, Dental	EMA	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Central Venous Catheter Dressing Change Kit	PEZ	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Continuous Measurement Thermometer	FLL	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Crown And Bridge, Temporary, Resin	EBG	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Crown, Preformed	ELZ	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Device, Intravascular Catheter Securement	KMK	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Digital Physical/Chemical Sterilization Process Sensor	SBE	2	Manufacturer, Specification developer	accessdata.fda.gov
Disk, Abrasive	EHJ	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Drape, Adhesive, Aerosol	KGT	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Drape, Surgical, Antimicrobial	KKX	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Drape, Surgical, Exempt	PUI	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Drape, Urological, Disposable	EYY	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Dressing Change Tray	OXQ	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Dressing, Wound, Drug	FRO	U	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or Biologic	NAE	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Dressing, Wound, Hydrophilic	NAC	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Dressing, Wound, Occlusive	NAD	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Electrode, Electrocardiograph	DRX	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Fiber, Medical, Absorbent	FRL	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Floss, Dental	JES	1	Complaint file establishment, Specification developer	accessdata.fda.gov
General Surgery Tray	LRO	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Guard, Instrument	LXZ	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Handpiece, Contra- And Right-Angle Attachment, Dental	EGS	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Indicator, Biological Sterilization Process	FRC	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Indicator, Physical/Chemical Sterilization Process	JOJ	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Infusor, Pressure, For I.V. Bags	KZD	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Instruments, Dental Hand	DZN	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Liner, Cavity, Calcium Hydroxide	EJK	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Mask, Surgical	FXX	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Material, Impression	ELW	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Material, Tooth Shade, Resin	EBF	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Media, Electroconductive	GYB	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Orthosis, Sacroiliac, Soft	IPW	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Pack, Hot Or Cold, Disposable	IMD	1	Complaint file establishment	accessdata.fda.gov
Pack, Hot Or Cold, Reusable	IME	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Pad, Eye	HMP	1	Manufacturer, Specification developer	accessdata.fda.gov
Phonocardiograph	DQC	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Pliers, Operative	EJY	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Powder, Porcelain	EIH	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Prism, Fresnel, Ophthalmic	HKT	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Protector, Skin Pressure	FMP	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Razor, Surgical	LWK	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Ring (Wound Protector), Drape Retention, Internal	KGW	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Scissors, Collar And Crown	EIR	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Sealant, Pit And Fissure, And Conditioner	EBC	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Securement Wound Dressing For Reduction Of Infection	SEL	U	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Solvent, Adhesive Tape	KOX	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Splint, Clavicle	IQJ	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Staple, Removable (Skin)	GDT	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Sterilizer, Ethylene-Oxide Gas	FLF	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Stethoscope, Electronic	DQD	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Stethoscope, Manual	LDE	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Syringe, Restorative And Impression Material	EID	1	Complaint file establishment, Specification developer	accessdata.fda.gov
System, Thermal Regulating	DWJ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Thermometer, Clinical Color Change	FQZ	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Transmitters And Receivers, Physiological Signal, Radiofrequency	DRG	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Tray, Impression, Preformed	EHY	1	Complaint file establishment, Contract manufacturer, Manufacturer for export, Specification developer	accessdata.fda.gov
Tube Impression And Matrix	KCQ	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Varnish, Cavity	LBH	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Warmer, Blood, Non-Electromagnetic Radiation	BSB	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Warmer, Thermal, Infusion Fluid	LGZ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Wheel, Polishing Agent	EJQ	1	Complaint file establishment, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 25, 2024	K242538	3M Attest Super Rapid Readout Biological Indicator 1493; 3M Attest Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 3M Attest Auto-reader 490; 3M Attest Auto-reader 490H; 3M Attest Mini Auto-reader 490M	FRC	Substantially Equivalent	3M Company	accessdata.fda.gov
October 18, 2024	K241959	3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD); 3M Attest Auto-reader (490); 3M Attest Auto-reader (490H); 3M Attest Mini Auto-reader (490M)	FRC	Substantially Equivalent	3M Company	accessdata.fda.gov
September 12, 2024	K241710	3M Attest Super Rapid Readout Biological Indicator 1492V; 3M Attest Auto-reader 490; 3M Attest Auto-reader 490H; 3M Attest Mini Auto-reader 490M	FRC	Substantially Equivalent	3M Company	accessdata.fda.gov
June 27, 2024	K241542	3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)	FRC	Substantially Equivalent	3M Company	accessdata.fda.gov
May 21, 2024	DEN230068	3M Attest eBowie-Dick Test Card 10135 3M Attest eBowie-Dick Card Holder 10135CH 3M Attest eBowie-Dick Auto-reader 1190	SBE	Unknown	3M Company	accessdata.fda.gov
May 18, 2023	K222578	3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)	KKX	Substantially Equivalent	3M Company	accessdata.fda.gov
May 10, 2023	K231338	3M Clinpro Clear 2.1% Sodium Fluoride Treatment	LBH	Substantially Equivalent	3M Espe Dental Products	accessdata.fda.gov
February 6, 2023	K230270	3M VitCal Liner/Base	EJK	Substantially Equivalent	3M Espe Dental Products	accessdata.fda.gov
September 23, 2022	K222152	3M Attest Hydrogen Peroxide Indicator Tape 1228	JOJ	Substantially Equivalent	3M Company	accessdata.fda.gov
June 28, 2022	K211705	3M Attest Rapid Readout Biological Indicator, 1295	FRC	Substantially Equivalent	3M Company	accessdata.fda.gov
June 24, 2022	K220942	3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES)	JOJ	Substantially Equivalent	3M Company	accessdata.fda.gov
June 13, 2022	K221695	3M Filtek Supreme Flowable Restorative	EBF	Substantially Equivalent	3M Company Espe Dental Products	accessdata.fda.gov
May 23, 2022	K220564	3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam Indicator Tape 1355	JOJ	Substantially Equivalent	3M Company	accessdata.fda.gov
April 20, 2022	K212022	3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E	QKM	Substantially Equivalent	3M Company	accessdata.fda.gov
September 5, 2021	K212081	3M(TM) Comply(TM) Hydrogen Peroxide Indicator Tape 1228	JOJ	Substantially Equivalent	3M Company	accessdata.fda.gov
April 29, 2021	K210605	3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation	DWJ	Substantially Equivalent	3M Company	accessdata.fda.gov
March 30, 2021	K210603	3M Bair Hugger Temperature Management System (Model 675)	DWJ	Substantially Equivalent	3M Company	accessdata.fda.gov
December 11, 2020	K203458	3M Comply Hydrogen Peroxide Chemical Indicator 1248	JOJ	Substantially Equivalent	3M Company	accessdata.fda.gov
October 29, 2020	K200299	Curos Jet Disinfecting Cap	QBP	Substantially Equivalent	3M Company	accessdata.fda.gov
September 4, 2020	K200835	3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad	FRO	Substantially Equivalent	3M Company	accessdata.fda.gov
July 2, 2020	K200766	3M Attest Steam Chemical Integrator Test Pack	FRC	Substantially Equivalent	3M Company	accessdata.fda.gov
June 1, 2020	K200536	3MTM AttestTM Rapid 5 Steam-Plus Test Pack	FRC	Substantially Equivalent	3M Complany	accessdata.fda.gov
April 15, 2020	K200092	3MTM AttestTM Mini Auto-reader 490M	FRC	Substantially Equivalent	3M	accessdata.fda.gov
February 7, 2020	K193154	3M Attest Super Rapid 5 Steam-Plus Challenge Pack	FRC	Substantially Equivalent	3M Company	accessdata.fda.gov
September 11, 2019	K191355	3M High Fluid-Resistant Surgical Mask and 3M High Fluid-Resistant Procedure Mask	FXX	Substantially Equivalent	3M Healthcare	accessdata.fda.gov
January 2, 2019	K183476	3M Filtek Universal Restorative	EBF	Substantially Equivalent	3M Espe Dental Products	accessdata.fda.gov
July 31, 2018	K180874	3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield	FXX	Substantially Equivalent	3M Healthcare	accessdata.fda.gov
April 23, 2018	K173519	3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5 Steam-Plus Chaallenge Pack, 3M Attest Auto-reader, 3M Attest Auto-reader	FRC	Substantially Equivalent	3M Company	accessdata.fda.gov
January 22, 2018	K173584	3M Attest Super Rapid Readout Biological Indicator, 3M Attest Auto-reader, 3M Attest Auto-reader	FRC	Substantially Equivalent	3M Company	accessdata.fda.gov
November 21, 2017	K170754	3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing	FRO	Substantially Equivalent	3M Company, 3M Healthcare	accessdata.fda.gov
July 11, 2017	K171908	3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing	SEL	Substantially Equivalent	3M Company	accessdata.fda.gov
November 28, 2016	K163207	Filtek One Bulk Fill Restorative	EBF	Substantially Equivalent	3M Company	accessdata.fda.gov
August 23, 2016	K153571	Cavilon Advanced High Endurance Skin Protectant	KMF	Substantially Equivalent	3M Healthcare	accessdata.fda.gov
January 8, 2015	K142034	3M STERI-VAC STERILIZER/AERATOR	FLF	Substantially Equivalent	3M Company	accessdata.fda.gov
December 4, 2014	K140657	CUROS RED PORT PROTECTOR	QBP	Substantially Equivalent	Ivera Medical, Inc.	accessdata.fda.gov
May 8, 2014	K141081	FILTEK BULK FILL POSTERIOR RESTROATIVE	EBF	Substantially Equivalent	3M Espe Dental Products	accessdata.fda.gov
November 1, 2013	K132109	ENAMELAST	LBH	Substantially Equivalent	Ultradent Products Inc. / Oratech, LLC	accessdata.fda.gov
March 18, 2013	K123546	3M ATTEST(TM) AUTO-READER	FRC	Substantially Equivalent	3M Company	accessdata.fda.gov
February 28, 2013	K123679	3M TEGADERM CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSING	FRO	Substantially Equivalent	3M Company	accessdata.fda.gov
November 26, 2012	K121171	CUROS TIP	QBP	Substantially Equivalent	Ivera Medical, Inc.	accessdata.fda.gov
May 30, 2012	K120412	3M SPOTON TEMPERATURE MONITORING SYSTEM	FLL	Substantially Equivalent	Arizant Healthcare, Inc.	accessdata.fda.gov
May 3, 2012	K120704	3M LITTMANN TELESTETH ONLINE AUSCULATION SYSTEM	DRG	Substantially Equivalent	3M Company	accessdata.fda.gov
March 19, 2012	K120453	FILTEK BULK FILL FLOWABLE RESTORATIVE	EBF	Substantially Equivalent	3M Espe Dental Products	accessdata.fda.gov
January 12, 2012	K111992	CUROS PORT PROTECTOR	QBP	Substantially Equivalent	Ivera Medical, Inc.	accessdata.fda.gov
May 5, 2011	K111185	RELYX LUTING PLUS AUTOMIX	EMA	Substantially Equivalent	3M Espe Dental Products	accessdata.fda.gov
January 21, 2011	K110131	LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC / E4D, LAVA ULTIMATE IMPLANT CROWN RESTORATIVE	EBF	Substantially Equivalent	3M Espe Dental Products	accessdata.fda.gov
September 8, 2010	K101249	STERIGAGE MODEL 1243RA, 1243RB, 1243RE	JOJ	Substantially Equivalent	3M Company	accessdata.fda.gov
May 12, 2010	K100235	FILTEK SUPREME ULTRA FLOWABLE RESTORATIVE	EBF	Substantially Equivalent	3M Company	accessdata.fda.gov
March 10, 2010	K092141	VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH	LBH	Substantially Equivalent	3M Espe Dental Products	accessdata.fda.gov
December 4, 2009	K093199	3M COMPLY BOWIE- DICK TYPE LEAD FREE TEST PACK	JOJ	Substantially Equivalent	3M Company	accessdata.fda.gov
April 29, 2009	K090569	MODIFICATION TO: ATTEST RAPID READOUT BIOLOGICAL INDICATOR, MODE 1292	FRC	Substantially Equivalent	3M Company	accessdata.fda.gov
February 26, 2009	K090453	SILVER ALGINATE 11 WOUND DRESSING	FRO	Substantially Equivalent	Advanced Medical Solutions Limited	accessdata.fda.gov
December 17, 2008	K083610	FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE	EBF	Substantially Equivalent	3M Company	accessdata.fda.gov
January 17, 2008	K073395	GILB-2, GLASS IONOMER PROTECTIVE COATING	EMA	Substantially Equivalent	3M Espe Dental Products	accessdata.fda.gov
June 26, 2006	K060939	RANGER IRRIGATION FLUID WARMING SYSTEM	LGZ	Substantially Equivalent	Arizant Healthcare, Inc.	accessdata.fda.gov
April 24, 2006	K060865	BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850	DWJ	Substantially Equivalent	Arizant Healthcare, Inc.	accessdata.fda.gov
September 27, 2005	K052235	LCR	EMA	Substantially Equivalent	3M Company	accessdata.fda.gov
February 22, 2005	K050159	MODIFICATION TO: 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000	DQD	Substantially Equivalent	3M Company	accessdata.fda.gov
October 16, 2003	K031012	ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO, MODEL 1294; ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO TEST PACK	FRC	Substantially Equivalent	3M Company	accessdata.fda.gov
October 7, 2003	K031263	3M LIQUID BANDAGE, MODEL 120-LB	KMF	Substantially Equivalent	3M Company	accessdata.fda.gov
August 2, 2002	K022476	RELYX RMGIP	EMA	Substantially Equivalent	3M Company	accessdata.fda.gov
June 14, 2001	K011200	GILB, MODEL 8010	EMA	Substantially Equivalent	3M Company	accessdata.fda.gov
April 13, 2001	K010781	3M ESPE HAUR	EBF	Substantially Equivalent	3M Company	accessdata.fda.gov
September 28, 2000	K002452	3M RELY X VENEER CEMENT TRY-IN PASTER	EMA	Substantially Equivalent	3M Company	accessdata.fda.gov
October 8, 1999	K992326	3M CLINPRO SEALANT	EBC	Substantially Equivalent	3M Company	accessdata.fda.gov
August 9, 1999	K991961	3M LVR SYSTEM	EBF	Substantially Equivalent	3M Company	accessdata.fda.gov
August 9, 1998	K981647	3M DENT II SYSTEM	EBF	Substantially Equivalent	3M Company	accessdata.fda.gov
April 30, 1998	K973741	BAIR HUGGER BLOOD/FLUID WARMER	BSB	Substantially Equivalent	Augustine Medical, Inc.	accessdata.fda.gov
February 3, 1998	K974553	3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT (9160) 3M UNIVERSAL ELECTROSURGICAL PAD (9130)	GEI	Substantially Equivalent	3M Healthcare	accessdata.fda.gov
January 30, 1998	K974279	3M UNIVERSAL ELECTROSURGICAL PAD, WITH CORD (CATALOG NUMBER 9135), 3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT WITH CORD (C)	GEI	Substantially Equivalent	3M Healthcare	accessdata.fda.gov
December 17, 1997	K973961	3M DENT SYSTEM II PLUS	EMA	Substantially Equivalent	3M Company	accessdata.fda.gov
October 31, 1996	K963766	3M PROPLUS SYSTEM	ELW	Substantially Equivalent	3M Company	accessdata.fda.gov
August 12, 1996	K962785	3M DENT SYSTEM	KLE	Substantially Equivalent	3M Company	accessdata.fda.gov
February 5, 1996	K955103	3M NO STING BARRIER FILM	KMF	Substantially Equivalent	3M Medical Products Group	accessdata.fda.gov
July 6, 1995	K952408	ATI DISPOSABLE TEST PACK FOR STEAM STERILIZATION	JOJ	Substantially Equivalent	Pymah Corp.	accessdata.fda.gov
August 17, 1994	K935267	B-D DIGITAL THERMOMETER	FLL	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic	accessdata.fda.gov
May 16, 1994	K941189	DISPOSABLE PROPHYLAXIS ANGLE	EGS	Substantially Equivalent	Team Technologies, Inc.	accessdata.fda.gov
February 1, 1994	K925496	ATI DISPOSABLE BIOLOGICAL-PLUS TEST PACK	FRC	Substantially Equivalent	Pymah Corp.	accessdata.fda.gov
January 5, 1994	K933139	3M VITREMER LUTING CEMENT	EMA	Substantially Equivalent	3M Company	accessdata.fda.gov
December 23, 1992	K925032	3M VITREMER TRI-CURE GLASS IONOMER SYSTEM	EMA	Substantially Equivalent	3M Company	accessdata.fda.gov
March 20, 1992	K920425	3M BRAND RESTORATIVE Z100	EBF	Substantially Equivalent	3M Company	accessdata.fda.gov
March 20, 1992	K920424	SCOTCHBOND BRAND MULTI-PURPOSE ADHESIVE SYSTEM	KLE	Substantially Equivalent	3M Company	accessdata.fda.gov
May 29, 1991	K911271	ADHESIVE PRECOATED BRACKETS	DYH	Substantially Equivalent	Unitek Corp.	accessdata.fda.gov
December 5, 1990	K904921	STERI-VAC(TM) AERATOR MODEL XL	FLI	Substantially Equivalent	3M Health Care, Ltd.	accessdata.fda.gov
July 3, 1990	K900771	ATTEST BRAND RAPID READOUT BIOLOGICAL INDICATOR	FRC	Substantially Equivalent	3M Company	accessdata.fda.gov
February 13, 1990	K900332	EM 1149 OPTIMIZE SCOTCHPLATE CONDUC ADHES DISP ELE	GEI	Substantially Equivalent	3M Company	accessdata.fda.gov
August 11, 1988	K882690	IMPRINT VINYL POLYSILOXANE IMPRESSION MATERIAL	ELW	Substantially Equivalent	3M Company	accessdata.fda.gov
November 14, 1985	K853698	SCOTCHPRIME CERAMIC PRIMER	EIH	Substantially Equivalent	3M Company	accessdata.fda.gov
November 1, 1985	K852192	DISPOSABLE STEAM BIOLOGICAL TEST PACK	FRC	Substantially Equivalent	Parke-Davis Co.	accessdata.fda.gov
January 7, 1985	K844211	CONCISE LIGHT CURED WHITE SEALANT	EBC	Substantially Equivalent	3M Company	accessdata.fda.gov
November 29, 1983	K833364	3M SCOTCHPLATE II DISPERSIVE ELECTRODE	GEI	Substantially Equivalent	3M Company	accessdata.fda.gov
January 12, 1983	K823689	3M SCOTCHPLATE 51148 SMALL CONDUCTIVE	GEI	Substantially Equivalent	3M Company	accessdata.fda.gov
January 12, 1982	K813180	SCOTCHBOND DENTAL ADHESIVE	KLE	Substantially Equivalent	3M Company	accessdata.fda.gov
December 31, 1981	K813202	THERMALOG S STEAM STERILIZATION INTEGRA	JOJ	Substantially Equivalent	Bio-Medical Sciences, Inc.	accessdata.fda.gov
September 17, 1981	K801550	3M GERMICIDAL SURGICAL INCISE DRAPE	KKX	Substantially Equivalent	3M Company	accessdata.fda.gov
March 18, 1980	K800485	VINYL POLYSILOXANE IMPRESSION MATERIAL	ELW	Substantially Equivalent	3M Company	accessdata.fda.gov
July 14, 1977	K771080	STEAM STERILIZATION INDICATOR	FRC	Substantially Equivalent	Info-Chem	accessdata.fda.gov

Compare with other makers

Updated November 25, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. 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.