Data / Medical devices / Canada / Mainline Medical Dental Supply

Mainline Medical Dental Supply: FDA-registered device maker in North York Ontario, Canada, 546 510(k) clearances and 2 PMA approvals

Name: Mainline Medical Dental Supply FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Mainline Medical Dental Supply is registered with the FDA (registration 3012421607) in North York Ontario, Canada. It lists 302 device types. The FDA files 546 510(k) clearances and 2 PMA approvals under its listings, the newest dated April 10, 2026. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number: 3012421607
Address: Rossdean Dr, North York Ontario, Canada, M9L 2S1
Owner or operator: Mainline Medical Dental Supply (10052656)
Roles: Exporter to the US
First device listed: September 2, 2016
Registered through: 2027

Devices it lists

Device	Product code	Class	Role	Source
Absorber, Saliva, Paper	KHR	1	Exporter to the US	accessdata.fda.gov
Abutment, Implant, Dental, Endosseous	NHA	2	Exporter to the US	accessdata.fda.gov
Accessories, Catheter	KGZ	1	Exporter to the US	accessdata.fda.gov
Accessories, Implant, Dental, Endosseous	NDP	1	Exporter to the US	accessdata.fda.gov
Accessories, Retractor, Dental	EIF	1	Exporter to the US	accessdata.fda.gov
Accessory, Surgical Apparel	LYU	1	Exporter to the US	accessdata.fda.gov
Activator, Ultraviolet, For Polymerization	EBZ	2	Exporter to the US	accessdata.fda.gov
Additively Manufactured, Preformed, Resin Denture Tooth	PZY	2	Exporter to the US	accessdata.fda.gov
Adhesive, Bracket And Tooth Conditioner, Resin	DYH	2	Exporter to the US	accessdata.fda.gov
Agent, Absorbable Hemostatic, Collagen Based	LMF	3	Exporter to the US	accessdata.fda.gov
Agent, Absorbable Hemostatic, Non-Collagen Based	LMG	3	Exporter to the US	accessdata.fda.gov
Agent, Polishing, Abrasive, Oral Cavity	EJR	1	Exporter to the US	accessdata.fda.gov
Agent, Tooth Bonding, Resin	KLE	2	Exporter to the US	accessdata.fda.gov
Airbrush	KOJ	2	Exporter to the US	accessdata.fda.gov
Airway, Oropharyngeal, Anesthesiology	CAE	1	Exporter to the US	accessdata.fda.gov
Aligner, Beam, X-Ray	EHA	1	Exporter to the US	accessdata.fda.gov
Alloy, Amalgam	EJJ	2	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	CCK	2	Exporter to the US	accessdata.fda.gov
Anoscope And Accessories	FER	2	Exporter to the US	accessdata.fda.gov
Applicator, Absorbent Tipped, Non-Sterile	KXF	1	Exporter to the US	accessdata.fda.gov
Applicator, Resin	KXR	1	Exporter to the US	accessdata.fda.gov
Applier, Hemostatic Clip	HBT	1	Exporter to the US	accessdata.fda.gov
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	JJB	1	Exporter to the US	accessdata.fda.gov
Bag, Urine Collecting, Ureterostomy	EXG	1	Exporter to the US	accessdata.fda.gov
Band, Elastic, Orthodontic	ECI	1	Exporter to the US	accessdata.fda.gov
Bandage, Cast	ITG	1	Exporter to the US	accessdata.fda.gov
Bandage, Elastic	FQM	1	Exporter to the US	accessdata.fda.gov
Bandage, Liquid	KMF	1	Exporter to the US	accessdata.fda.gov
Basin, Emesis	FNY	1	Exporter to the US	accessdata.fda.gov
Battery, Replacement, Rechargeable	MOQ	1	Exporter to the US	accessdata.fda.gov
Beads, Hydrophilic, For Wound Exudate Absorption	KOZ	1	Exporter to the US	accessdata.fda.gov
Blade, Scalpel	GES	1	Exporter to the US	accessdata.fda.gov
Blood Pressure Cuff	DXQ	2	Exporter to the US	accessdata.fda.gov
Blood, Occult, Colorimetric, In Urine	JIO	2	Exporter to the US	accessdata.fda.gov
Bracket, Ceramic, Orthodontic	NJM	2	Exporter to the US	accessdata.fda.gov
Bracket, Metal, Orthodontic	EJF	1	Exporter to the US	accessdata.fda.gov
Bracket, Plastic, Orthodontic	DYW	2	Exporter to the US	accessdata.fda.gov
Bulb, Inflation, For Endoscope	FCY	1	Exporter to the US	accessdata.fda.gov
Bur, Dental	EJL	1	Exporter to the US	accessdata.fda.gov
Burnisher, Operative	EKJ	1	Exporter to the US	accessdata.fda.gov
Calculator, Drug Dose	NDC	2	Exporter to the US	accessdata.fda.gov
Camera, Surgical And Accessories	KQM	1	Exporter to the US	accessdata.fda.gov
Cannula, Surgical, General & Plastic Surgery	GEA	1	Exporter to the US	accessdata.fda.gov
Capsule, Dental, Amalgam	DZS	1	Exporter to the US	accessdata.fda.gov
Carrier, Amalgam, Operative	EKI	1	Exporter to the US	accessdata.fda.gov
Carver, Dental Amalgam, Operative	EKH	1	Exporter to the US	accessdata.fda.gov
Catheter And Tip, Suction	JOL	2	Exporter to the US	accessdata.fda.gov
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	FOZ	2	Exporter to the US	accessdata.fda.gov
Catheter, Irrigation	GBX	1	Exporter to the US	accessdata.fda.gov
Catheter, Retention Type, Balloon	EZL	2	Exporter to the US	accessdata.fda.gov
Catheter, Urological	KOD	2	Exporter to the US	accessdata.fda.gov
Cement, Dental	EMA	2	Exporter to the US	accessdata.fda.gov
Clamp, Rubber Dam	EEF	1	Exporter to the US	accessdata.fda.gov
Clasp, Wire	EJW	1	Exporter to the US	accessdata.fda.gov
Cleaner, Denture, Mechanical	JER	1	Exporter to the US	accessdata.fda.gov
Cleaner, Ultrasonic, Medical Instrument	FLG	1	Exporter to the US	accessdata.fda.gov
Cleanser, Denture, Over The Counter	EFT	1	Exporter to the US	accessdata.fda.gov
Cleanser, Root Canal	KJJ	U	Exporter to the US	accessdata.fda.gov
Closure, Wound, Adhesive	MGO	1	Exporter to the US	accessdata.fda.gov
Coating, Filling Material, Resin	EBD	2	Exporter to the US	accessdata.fda.gov
Collector, Ostomy	EXB	1	Exporter to the US	accessdata.fda.gov
Collector, Urine, Powered, Non Indwelling Catheter	NZU	1	Exporter to the US	accessdata.fda.gov
Condenser, Amalgam And Foil, Operative	EKG	1	Exporter to the US	accessdata.fda.gov
Container, Liquid Medication, Graduated	KYW	1	Exporter to the US	accessdata.fda.gov
Container, Sharps	MMK	2	Exporter to the US	accessdata.fda.gov
Container, Specimen, Non-Sterile	NNI	1	Exporter to the US	accessdata.fda.gov
Container, Specimen, Sterile	FMH	1	Exporter to the US	accessdata.fda.gov
Continuous Measurement Thermometer	FLL	2	Exporter to the US	accessdata.fda.gov
Cord, Retraction	MVL	U	Exporter to the US	accessdata.fda.gov
Cotton, Roll	EFN	1	Exporter to the US	accessdata.fda.gov
Cover, Cast	KIA	1	Exporter to the US	accessdata.fda.gov
Cover, Shoe, Operating-Room	FXP	1	Exporter to the US	accessdata.fda.gov
Crown And Bridge, Temporary, Resin	EBG	2	Exporter to the US	accessdata.fda.gov
Crown, Preformed	ELZ	1	Exporter to the US	accessdata.fda.gov
Crutch	IPR	1	Exporter to the US	accessdata.fda.gov
Curette, Endodontic	EKT	1	Exporter to the US	accessdata.fda.gov
Curette, Periodontic	EMS	1	Exporter to the US	accessdata.fda.gov
Dam, Rubber	EIE	1	Exporter to the US	accessdata.fda.gov
Dental Abutment Design Software For Dental Laboratory	PNP	2	Exporter to the US	accessdata.fda.gov
Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief	MZW	2	Exporter to the US	accessdata.fda.gov
Device, Caries Detection	LFC	2	Exporter to the US	accessdata.fda.gov
Device, Intravascular Catheter Securement	KMK	1	Exporter to the US	accessdata.fda.gov
Device, Medical Examination, Ac Powered	KZF	1	Exporter to the US	accessdata.fda.gov
Device, Paste-On For Incontinence, Non-Sterile	NOA	1	Exporter to the US	accessdata.fda.gov
Device, Paste-On For Incontinence, Sterile	EXI	1	Exporter to the US	accessdata.fda.gov
Device, Pasteurization, Hot Water	LDS	2	Exporter to the US	accessdata.fda.gov
Device, Pressure Applying	KNM	1	Exporter to the US	accessdata.fda.gov
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	JMT	1	Exporter to the US	accessdata.fda.gov
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	CDM	1	Exporter to the US	accessdata.fda.gov
Disinfectant, Medical Devices	LRJ	1	Exporter to the US	accessdata.fda.gov
Disk, Abrasive	EHJ	1	Exporter to the US	accessdata.fda.gov
Drape, Surgical, Antimicrobial	KKX	2	Exporter to the US	accessdata.fda.gov
Dress, Surgical	FYE	1	Exporter to the US	accessdata.fda.gov
Dressing, Compression	MHW	1	Exporter to the US	accessdata.fda.gov
Dressing, Wound And Burn, Occlusive	MGP	U	Exporter to the US	accessdata.fda.gov
Dressing, Wound, Drug	FRO	U	Exporter to the US	accessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or Biologic	NAE	1	Exporter to the US	accessdata.fda.gov
Dressing, Wound, Hydrophilic	NAC	1	Exporter to the US	accessdata.fda.gov
Dressing, Wound, Occlusive	NAD	1	Exporter to the US	accessdata.fda.gov
Drill, Dental, Intraoral	DZA	1	Exporter to the US	accessdata.fda.gov
Drills, Burrs, Trephines & Accessories (Compound, Powered)	HBF	2	Exporter to the US	accessdata.fda.gov
Dura Substitute	GXQ	2	Exporter to the US	accessdata.fda.gov
Dye-Indicator, Ph (Urinary, Non-Quantitative)	CEN	1	Exporter to the US	accessdata.fda.gov
Elastomer, Silicone, For Scar Management	MDA	1	Exporter to the US	accessdata.fda.gov
Electrocardiograph	DPS	2	Exporter to the US	accessdata.fda.gov
Electrode, Electrocardiograph	DRX	2	Exporter to the US	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Exporter to the US	accessdata.fda.gov
Elevator, Surgical, Dental	EMJ	1	Exporter to the US	accessdata.fda.gov
Enteral Syringes With Enteral Specific Connectors	PNR	2	Exporter to the US	accessdata.fda.gov
Enzymatic Method, Creatinine	JFY	2	Exporter to the US	accessdata.fda.gov
Evacuator, Oral Cavity	EHZ	1	Exporter to the US	accessdata.fda.gov
Excavator, Dental, Operative	EKC	1	Exporter to the US	accessdata.fda.gov
Exophthalmometer	HLS	1	Exporter to the US	accessdata.fda.gov
Explorer, Operative	EKB	1	Exporter to the US	accessdata.fda.gov
External Cleaning Solution	PME	2	Exporter to the US	accessdata.fda.gov
Fentanyl And Other Opioid Protection Glove	QDO	1	Exporter to the US	accessdata.fda.gov
Fiber, Medical, Absorbent	FRL	1	Exporter to the US	accessdata.fda.gov
File, Periodontic	EMR	1	Exporter to the US	accessdata.fda.gov
File, Pulp Canal, Endodontic	EKS	1	Exporter to the US	accessdata.fda.gov
Film, Radiographic	IWZ	1	Exporter to the US	accessdata.fda.gov
Floss, Dental	JES	1	Exporter to the US	accessdata.fda.gov
Foot Examination Tool For Inflammatory Changes	OIZ	1	Exporter to the US	accessdata.fda.gov
Forceps, Dressing, Dental	EFL	1	Exporter to the US	accessdata.fda.gov
Forceps, Rongeur, Surgical	EMH	1	Exporter to the US	accessdata.fda.gov
Forceps, Tooth Extractor, Surgical	EMG	1	Exporter to the US	accessdata.fda.gov
Frame, Rubber Dam	EJE	1	Exporter to the US	accessdata.fda.gov
Garment, Protective, For Incontinence	EYQ	1	Exporter to the US	accessdata.fda.gov
Gauge, Depth, Instrument, Dental	EIL	1	Exporter to the US	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Exporter to the US	accessdata.fda.gov
General Purpose Reagent	PPM	1	Exporter to the US	accessdata.fda.gov
Glucose Dehydrogenase, Glucose	LFR	2	Exporter to the US	accessdata.fda.gov
Gown, Surgical	FYA	2	Exporter to the US	accessdata.fda.gov
Gutta-Percha	EKM	1	Exporter to the US	accessdata.fda.gov
Handle, Instrument, Dental	EJB	1	Exporter to the US	accessdata.fda.gov
Handpiece, Air-Powered, Dental	EFB	1	Exporter to the US	accessdata.fda.gov
Handpiece, Contra- And Right-Angle Attachment, Dental	EGS	1	Exporter to the US	accessdata.fda.gov
Handpiece, Direct Drive, Ac-Powered	EKX	1	Exporter to the US	accessdata.fda.gov
Headgear, Extraoral, Orthodontic	DZB	2	Exporter to the US	accessdata.fda.gov
Heat Source For Bleaching Teeth	EEG	1	Exporter to the US	accessdata.fda.gov
Hemostat	HRQ	1	Exporter to the US	accessdata.fda.gov
Hemostat, Surgical	EMD	1	Exporter to the US	accessdata.fda.gov
Heparin, Vascular Access Flush	NZW	2	Exporter to the US	accessdata.fda.gov
Holder, Film, X-Ray	EGZ	1	Exporter to the US	accessdata.fda.gov
Holder, Needle, Gastroenterologic	FHQ	1	Exporter to the US	accessdata.fda.gov
Holder, Ureteral Catheter	EYJ	1	Exporter to the US	accessdata.fda.gov
Humidifier, Respiratory Gas, (Direct Patient Interface)	BTT	2	Exporter to the US	accessdata.fda.gov
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	JIR	1	Exporter to the US	accessdata.fda.gov
Indicator, Biological Sterilization Process	FRC	2	Exporter to the US	accessdata.fda.gov
Indicator, Physical/Chemical Sterilization Process	JOJ	2	Exporter to the US	accessdata.fda.gov
Infant Heel Warmer (Chemical Heat Pack)	MPO	1	Exporter to the US	accessdata.fda.gov
Insoles, Medical	KYS	1	Exporter to the US	accessdata.fda.gov
Instrument, Diamond, Dental	DZP	1	Exporter to the US	accessdata.fda.gov
Instrument, Filling, Plastic, Dental	EIY	1	Exporter to the US	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Exporter to the US	accessdata.fda.gov
Instruments, Dental Hand	DZN	1	Exporter to the US	accessdata.fda.gov
Knife, Margin Finishing, Operative	EJZ	1	Exporter to the US	accessdata.fda.gov
Latex Patient Examination Glove	LYY	1	Exporter to the US	accessdata.fda.gov
Led Light Source	NTN	2	Exporter to the US	accessdata.fda.gov
Light, Examination, Medical, Battery Powered	KYT	1	Exporter to the US	accessdata.fda.gov
Liner, Cavity, Calcium Hydroxide	EJK	2	Exporter to the US	accessdata.fda.gov
Lubricant, Patient	KMJ	1	Exporter to the US	accessdata.fda.gov
Marker, Skin	FZZ	1	Exporter to the US	accessdata.fda.gov
Mask, Surgical	FXX	2	Exporter to the US	accessdata.fda.gov
Material, Impression	ELW	2	Exporter to the US	accessdata.fda.gov
Material, Impression Tray, Resin	EBH	1	Exporter to the US	accessdata.fda.gov
Material, Tooth Shade, Resin	EBF	2	Exporter to the US	accessdata.fda.gov
Medical Glove, Specialty	LZC	1	Exporter to the US	accessdata.fda.gov
Mercury	ELY	2	Exporter to the US	accessdata.fda.gov
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	JIL	2	Exporter to the US	accessdata.fda.gov
Mirror, Mouth	EAX	1	Exporter to the US	accessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	MWI	2	Exporter to the US	accessdata.fda.gov
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	MHX	2	Exporter to the US	accessdata.fda.gov
Mouthpiece, Saliva Ejector	DYN	1	Exporter to the US	accessdata.fda.gov
Nasal Spray, Ent Delivery	KCO	1	Exporter to the US	accessdata.fda.gov
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	CCQ	1	Exporter to the US	accessdata.fda.gov
Needle, Aspiration And Injection, Disposable	GAA	1	Exporter to the US	accessdata.fda.gov
Needle, Conduction, Anesthetic (W/Wo Introducer)	BSP	2	Exporter to the US	accessdata.fda.gov
Needle, Dental	DZM	1	Exporter to the US	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	Exporter to the US	accessdata.fda.gov
Neurosurgical Paddie	HBA	2	Exporter to the US	accessdata.fda.gov
Nitroprusside, Ketones (Urinary, Non-Quant.)	JIN	1	Exporter to the US	accessdata.fda.gov
Non-Surgical Gown	OEA	1	Exporter to the US	accessdata.fda.gov
Ophthalmoscope, Ac-Powered	HLI	2	Exporter to the US	accessdata.fda.gov
Ophthalmoscope, Battery-Powered	HLJ	2	Exporter to the US	accessdata.fda.gov
Orthosis, Corrective Shoe	KNP	1	Exporter to the US	accessdata.fda.gov
Orthosis, Limb Brace	IQI	1	Exporter to the US	accessdata.fda.gov
Orthosis, Sacroiliac, Soft	IPW	1	Exporter to the US	accessdata.fda.gov
Otoscope	ERA	1	Exporter to the US	accessdata.fda.gov
Pack, Hot Or Cold, Disposable	IMD	1	Exporter to the US	accessdata.fda.gov
Pack, Hot Or Cold, Reusable	IME	1	Exporter to the US	accessdata.fda.gov
Pad, Menstrual, Unscented	HHD	1	Exporter to the US	accessdata.fda.gov
Paper, Articulation	EFH	1	Exporter to the US	accessdata.fda.gov
Pediatric/Child Facemask	OXZ	2	Exporter to the US	accessdata.fda.gov
Pin, Retentive And Splinting, And Accessory Instruments	EBL	1	Exporter to the US	accessdata.fda.gov
Plier, Orthodontic	JEX	1	Exporter to the US	accessdata.fda.gov
Pliers, Operative	EJY	1	Exporter to the US	accessdata.fda.gov
Plugger, Root Canal, Endodontic	EKR	1	Exporter to the US	accessdata.fda.gov
Point, Abrasive	EHL	1	Exporter to the US	accessdata.fda.gov
Point, Paper, Endodontic	EKN	1	Exporter to the US	accessdata.fda.gov
Polymer Patient Examination Glove	LZA	1	Exporter to the US	accessdata.fda.gov
Post, Root Canal	ELR	1	Exporter to the US	accessdata.fda.gov
Pouch, Colostomy	EZQ	1	Exporter to the US	accessdata.fda.gov
Powder, Porcelain	EIH	2	Exporter to the US	accessdata.fda.gov
Preparer, Root Canal Endodontic	EKQ	1	Exporter to the US	accessdata.fda.gov
Probe, Periodontic	EIX	1	Exporter to the US	accessdata.fda.gov
Probe, Rectal, Non-Powered	EXX	1	Exporter to the US	accessdata.fda.gov
Prosthesis, Adhesive, External	GBJ	1	Exporter to the US	accessdata.fda.gov
Protector, Ostomy	EXE	1	Exporter to the US	accessdata.fda.gov
Pump, Infusion, Enteral	LZH	2	Exporter to the US	accessdata.fda.gov
Pump, Infusion, Insulin	LZG	2	Exporter to the US	accessdata.fda.gov
Reamer, Pulp Canal, Endodontic	EKP	1	Exporter to the US	accessdata.fda.gov
Refractometer For Clinical Use	JRE	1	Exporter to the US	accessdata.fda.gov
Remover, Crown	EIS	1	Exporter to the US	accessdata.fda.gov
Resin, Denture, Relining, Repairing, Rebasing	EBI	2	Exporter to the US	accessdata.fda.gov
Resin, Root Canal Filling	KIF	2	Exporter to the US	accessdata.fda.gov
Respirator, Surgical	MSH	2	Exporter to the US	accessdata.fda.gov
Retainer, Matrix	JEP	1	Exporter to the US	accessdata.fda.gov
Retainer, Screw Expansion, Orthodontic	DYJ	1	Exporter to the US	accessdata.fda.gov
Retractor, All Types	EIG	1	Exporter to the US	accessdata.fda.gov
Rod, Colostomy	EZP	2	Exporter to the US	accessdata.fda.gov
Saline, Vascular Access Flush	NGT	2	Exporter to the US	accessdata.fda.gov
Scaler, Periodontic	EMN	1	Exporter to the US	accessdata.fda.gov
Scaler, Ultrasonic	ELC	2	Exporter to the US	accessdata.fda.gov
Scissors, Collar And Crown	EIR	1	Exporter to the US	accessdata.fda.gov
Scissors, Surgical Tissue, Dental	EGN	1	Exporter to the US	accessdata.fda.gov
Sealant, Pit And Fissure, And Conditioner	EBC	2	Exporter to the US	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Exporter to the US	accessdata.fda.gov
Setter, Band, Orthodontic	ECR	1	Exporter to the US	accessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	HOY	1	Exporter to the US	accessdata.fda.gov
Shunt, Central Nervous System And Components	JXG	2	Exporter to the US	accessdata.fda.gov
Sigmoidoscope And Accessories, Flexible/Rigid	FAM	2	Exporter to the US	accessdata.fda.gov
Solvent, Adhesive Tape	KOX	1	Exporter to the US	accessdata.fda.gov
Specula Accessories	FXG	1	Exporter to the US	accessdata.fda.gov
Specula, Ophthalmic	HNC	1	Exporter to the US	accessdata.fda.gov
Speculum, Vaginal, Nonmetal	HIB	2	Exporter to the US	accessdata.fda.gov
Spirometer, Diagnostic	BZG	2	Exporter to the US	accessdata.fda.gov
Spreader, Pulp Canal Filling Material, Endodontic	EKK	1	Exporter to the US	accessdata.fda.gov
Spring, Orthodontic	ECO	1	Exporter to the US	accessdata.fda.gov
Staple, Removable (Skin)	GDT	1	Exporter to the US	accessdata.fda.gov
Stapler, Surgical	GAG	2	Exporter to the US	accessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	KCT	2	Exporter to the US	accessdata.fda.gov
Sterilizer, Steam	FLE	2	Exporter to the US	accessdata.fda.gov
Stethoscope, Electronic	DQD	2	Exporter to the US	accessdata.fda.gov
Stethoscope, Manual	LDE	1	Exporter to the US	accessdata.fda.gov
Strip, Polishing Agent	EHM	1	Exporter to the US	accessdata.fda.gov
Surgeon'S Gloves	KGO	1	Exporter to the US	accessdata.fda.gov
Suture, Absorbable, Natural	GAL	2	Exporter to the US	accessdata.fda.gov
Suture, Absorbable, Synthetic	GAN	2	Exporter to the US	accessdata.fda.gov
Suture, Absorbable, Synthetic, Polyglycolic Acid	GAM	2	Exporter to the US	accessdata.fda.gov
Suture, Nonabsorbable, Silk	GAP	2	Exporter to the US	accessdata.fda.gov
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	GAQ	2	Exporter to the US	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyamide	GAR	2	Exporter to the US	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyethylene	GAT	2	Exporter to the US	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polypropylene	GAW	2	Exporter to the US	accessdata.fda.gov
Suture, Surgical, Absorbable, Polydioxanone	NEW	2	Exporter to the US	accessdata.fda.gov
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene	NBY	2	Exporter to the US	accessdata.fda.gov
Syringe, Antistick	MEG	2	Exporter to the US	accessdata.fda.gov
Syringe, Cartridge	EJI	2	Exporter to the US	accessdata.fda.gov
Syringe, Irrigating (Non Dental)	KYZ	1	Exporter to the US	accessdata.fda.gov
Syringe, Periodontic, Endodontic, Irrigating	EIC	1	Exporter to the US	accessdata.fda.gov
Syringe, Piston	FMF	2	Exporter to the US	accessdata.fda.gov
Syringe, Restorative And Impression Material	EID	1	Exporter to the US	accessdata.fda.gov
System, Blood Collection, Vacuum-Assisted, Manual	KST	1	Exporter to the US	accessdata.fda.gov
System, Blood Culturing	MDB	1	Exporter to the US	accessdata.fda.gov
System, Breath Measurement	NRH	1	Exporter to the US	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Exporter to the US	accessdata.fda.gov
System, Test, Blood Glucose, Over The Counter	NBW	2	Exporter to the US	accessdata.fda.gov
System, Thermal Regulating	DWJ	2	Exporter to the US	accessdata.fda.gov
System, X-Ray, Extraoral Source, Digital	MUH	2	Exporter to the US	accessdata.fda.gov
System, X-Ray, Film Marking, Radiographic	JAC	1	Exporter to the US	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Exporter to the US	accessdata.fda.gov
Test, Urine Leukocyte	LJX	1	Exporter to the US	accessdata.fda.gov
Tester, Pulp	EAT	2	Exporter to the US	accessdata.fda.gov
Thermometer, Clinical Color Change	FQZ	1	Exporter to the US	accessdata.fda.gov
Toothbrush, Manual	EFW	1	Exporter to the US	accessdata.fda.gov
Toothbrush, Powered	JEQ	1	Exporter to the US	accessdata.fda.gov
Tourniquet, Nonpneumatic	GAX	1	Exporter to the US	accessdata.fda.gov
Tourniquet, Pneumatic	KCY	1	Exporter to the US	accessdata.fda.gov
Transformer, Endoscope	GCW	2	Exporter to the US	accessdata.fda.gov
Tray, Impression, Preformed	EHY	1	Exporter to the US	accessdata.fda.gov
Tray, Surgical	LRP	1	Exporter to the US	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Exporter to the US	accessdata.fda.gov
Tube Impression And Matrix	KCQ	1	Exporter to the US	accessdata.fda.gov
Tube Tracheostomy And Tube Cuff	JOH	2	Exporter to the US	accessdata.fda.gov
Tube, Orthodontic	DZD	1	Exporter to the US	accessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)	KNT	2	Exporter to the US	accessdata.fda.gov
Tubes, Vacuum Sample, With Anticoagulant	GIM	2	Exporter to the US	accessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood Collection	JKA	2	Exporter to the US	accessdata.fda.gov
Tubing, Noninvasive	GAZ	2	Exporter to the US	accessdata.fda.gov
Tubing, Pressure And Accessories	BYX	1	Exporter to the US	accessdata.fda.gov
Tubing/Tubing With Filter, Insufflation, Laparoscopic	NKC	1	Exporter to the US	accessdata.fda.gov
Unit, Operative Dental	EIA	1	Exporter to the US	accessdata.fda.gov
Unit, Operative Dental, Accessories	NRD	1	Exporter to the US	accessdata.fda.gov
Unit, Oral Irrigation	EFS	1	Exporter to the US	accessdata.fda.gov
Unit, Syringe, Air And/Or Water	ECB	1	Exporter to the US	accessdata.fda.gov
Varnish, Cavity	LBH	2	Exporter to the US	accessdata.fda.gov
Vinyl Patient Examination Glove	LYZ	1	Exporter to the US	accessdata.fda.gov
Warmer, Blood, Non-Electromagnetic Radiation	BSB	2	Exporter to the US	accessdata.fda.gov
Wax, Dental, Intraoral	EGD	1	Exporter to the US	accessdata.fda.gov
Wire, Orthodontic	DZC	1	Exporter to the US	accessdata.fda.gov
Wrap, Sterilization	FRG	2	Exporter to the US	accessdata.fda.gov
Zinc Oxide Eugenol	EMB	1	Exporter to the US	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. Newest 100 of 546.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 10, 2026	K252506	BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder	JKA	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
July 3, 2025	K243207	BD Vacutainer® Eclipse Blood Collection Needle	JKA	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
March 21, 2025	K243649	BD Vacutainer® Multiple Sample Luer Adapter	JKA	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
September 16, 2024	K234050	HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap	FRG	Substantially Equivalent	O&M Halyard, Inc.	accessdata.fda.gov
May 7, 2024	K234018	CEREC Cercon 4D Abutment Blocks, CEREC Cercon 4D Abutment System	NHA	Substantially Equivalent	Dentsply Sirona	accessdata.fda.gov
February 2, 2024	K231373	BD Vacutainer® K2 EDTA Blood Collection Tubes	JKA	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
January 19, 2024	K231237	BD Vacutainer® Fluoride Blood Collection Tubes	JKA	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
October 20, 2023	K231578	Lucitone Digital Print Denture System	EBI	Substantially Equivalent	Dentsply Sirona	accessdata.fda.gov
July 21, 2023	K221327	BD Alaris Pump Infusion Sets	FPA	Substantially Equivalent	Care Fusion	accessdata.fda.gov
June 21, 2023	K223376	Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)	MEG	Substantially Equivalent	Cardinal Health200, LLC	accessdata.fda.gov
March 24, 2023	K222591	BD BACTEC Plus Aerobic/F Culture Vials	MDB	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
March 24, 2023	K220212	BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder	JKA	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
December 20, 2022	K221603	Kangaroo OMNI Enteral Feeding Pump (385400 );Kangaroo OMNI Feeding Set 500ml (B5FD );Kangaroo OMNI ENtelliSet 500ml (E5FD );Kangaroo OMNI Feeding Set 1000ml (B10FD );Kangaroo OMNI ENtelliSet 1000ml (E10FD );Kangaroo OMNI ENPlus Spike Set (BSPFD );Kangaroo OMNI ENtelliSet ENPlus Spike ( ESPFD );Kangaroo OMNI Feeding Set 500ml with Flush Bag ( B5FF);Kangaroo OMNI ENtelliSet 500ml with Flush Bag (E5FF);Kangaroo OMNI Feeding Set 1000ml with Flush Bag ( E10FF );Kangaroo OMNI	LZH	Substantially Equivalent	Cardinal Health, LLC	accessdata.fda.gov
October 28, 2022	K222583	Stela Capsule System	EBF	Substantially Equivalent	Sdi Limited	accessdata.fda.gov
August 30, 2022	K214118	Riva Cem Automix	EMA	Substantially Equivalent	Sdi Limited	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
February 4, 2022	K212724	BD Vacutainer UltraTouch Push Button Blood Collection Set	JKA	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
September 26, 2021	K201592	Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove	KGO	Substantially Equivalent	Cardinal Health200, LLC	accessdata.fda.gov
December 21, 2020	K201996	Monocryl Plus Antibacterial Suture	GAM	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
September 29, 2020	K193131	BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle	BSP	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
July 12, 2020	K193627	Automatic Upper Arm Blood Pressure Monitor	DXN	Substantially Equivalent	Dongguan E-Test Technology Co., Ltd.	accessdata.fda.gov
March 6, 2020	K191915	SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated with Aloe V	KGO	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
December 2, 2019	K192374	Cardinal Health Level 3 Surgical Mask with Anti-Fog Foam Strip	FXX	Substantially Equivalent	Cardinal Health200, LLC	accessdata.fda.gov
October 8, 2019	K191133	KATANA Cleaner, KATANA Cleaner (Trial)	PME	Substantially Equivalent	Kuraray Noritake Dental, Inc.	accessdata.fda.gov
September 17, 2019	K190308	Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1)	OXZ	Substantially Equivalent	Amd Medicom, Inc.	accessdata.fda.gov
September 15, 2019	K191378	0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe	NGT	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
August 26, 2019	K191427	Halley resin system	EBI	Substantially Equivalent	Dentsply Sirona	accessdata.fda.gov
July 11, 2019	K182854	GC FujiCEM 2 (Improved)	EMA	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
July 4, 2019	K183149	Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low Dermatitis and Fentanyl Permeation Resistance Claim	LZC	Substantially Equivalent	Central Medicare Sdn Bhd	accessdata.fda.gov
June 27, 2019	K183183	VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture	GAM	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
May 23, 2019	K190018	Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs	KGO	Substantially Equivalent	Ansell Healthcare Products, LLC	accessdata.fda.gov
April 9, 2019	K181832	Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device	DXN	Substantially Equivalent	Guangdong Transtek Medical Electronics Co., Ltd.	accessdata.fda.gov
January 3, 2019	K180139	Safe Secure Sterilization Pouches and Rolls	FRG	Substantially Equivalent	Safe Secure Packing Co., Ltd.	accessdata.fda.gov
January 2, 2019	K183476	3M Filtek Universal Restorative	EBF	Substantially Equivalent	3M Espe Dental Products	accessdata.fda.gov
November 20, 2018	K182288	TPH Spectra ST Flowable Composite Restorative	EBF	Substantially Equivalent	Dentsply Sirona	accessdata.fda.gov
September 28, 2018	K181476	Prime&Bond active Universal Adhesive	KLE	Substantially Equivalent	Dentsply Sirona	accessdata.fda.gov
August 22, 2018	K181312	GrandioSO x-tra	EBF	Substantially Equivalent	Voco GmbH	accessdata.fda.gov
July 2, 2018	K173276	Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP	FRO	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
April 6, 2018	K180630	PTFE SURGICAL SUTURE	NBY	Substantially Equivalent	Omnia Spa	accessdata.fda.gov
March 8, 2018	K173500	NMF004A	EBF	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
February 27, 2018	K173275	OMNICHROMA	EBF	Substantially Equivalent	Tokuyama Dental Corporation	accessdata.fda.gov
November 15, 2017	K171873	Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs	LZA	Substantially Equivalent	Zhonghong Pulin Medical Products Co., Ltd.	accessdata.fda.gov
October 27, 2017	K170466	Automatic Blood Pressure Monitor Model LD-518 & LD-537	DXN	Substantially Equivalent	Honsun (Nantong) Co., Ltd.	accessdata.fda.gov
July 18, 2017	K171844	Inspire ICE aka Inspire ICE Clear Brackets	NJM	Substantially Equivalent	Ormco Corporation	accessdata.fda.gov
June 30, 2017	K171621	Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor	MHX	Substantially Equivalent	Welch Allyn, Inc.	accessdata.fda.gov
June 9, 2017	K170762	Cardinal Health Non-Reinforced Surgical Gown	FYA	Substantially Equivalent	Cardinal Health200, LLC	accessdata.fda.gov
May 23, 2017	K161833	LATEX EXAMINATION GLOVE POWDER FREE	LYY	Substantially Equivalent	Careglove Global Sdn. Bhd.	accessdata.fda.gov
April 21, 2017	K170869	LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated	GEI	Substantially Equivalent	Covidien	accessdata.fda.gov
February 27, 2017	K163591	BD PosiFlush Heparin Lock Flush Syringe	NZW	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
February 6, 2017	K170330	3M Protemp Cement Temporary Dental Cement	EMA	Substantially Equivalent	3M Company	accessdata.fda.gov
December 19, 2016	K162081	BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe	FMF	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
November 28, 2016	K163207	Filtek One Bulk Fill Restorative	EBF	Substantially Equivalent	3M Company	accessdata.fda.gov
November 15, 2016	K160049	Charisma	EBF	Substantially Equivalent	Heraeus Kulzer, LLC (Mitsui Chemicals Group)	accessdata.fda.gov
November 14, 2016	K162941	Ligasure Blunt Tip, Sealer/Divider, Nano-coated	GEI	Substantially Equivalent	Covidien	accessdata.fda.gov
November 7, 2016	K162257	P1145 Dental Restorative	EBF	Substantially Equivalent	Kerr Corporation	accessdata.fda.gov
October 28, 2016	K160974	Gammex Cut-Resistant Glove Liner	KGO	Substantially Equivalent	Ansell Healthcare Products, LLC	accessdata.fda.gov
October 25, 2016	K161042	CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack	KLE	Substantially Equivalent	Kuraray Noritake Dental, Inc.	accessdata.fda.gov
September 27, 2016	K162107	TPH Spectra+ Universal Composite Restorative	EBF	Substantially Equivalent	Dentsply Sirona	accessdata.fda.gov
September 27, 2016	K160825	MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology	EKX	Substantially Equivalent	Dentsply Sirona	accessdata.fda.gov
September 15, 2016	K162047	LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated	GEI	Substantially Equivalent	Covidien	accessdata.fda.gov
September 1, 2016	K161963	Monoject Enteral Syringe with ENFit Connector	PNR	Substantially Equivalent	Covidien	accessdata.fda.gov
August 23, 2016	K153571	Cavilon Advanced High Endurance Skin Protectant	KMF	Substantially Equivalent	3M Healthcare	accessdata.fda.gov
July 27, 2016	K160596	BEAUTIFIL II LS	EBF	Substantially Equivalent	Shofu Dental Corporation	accessdata.fda.gov
July 27, 2016	K153067	Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress	KIF	Substantially Equivalent	Sybron Dental Specialties	accessdata.fda.gov
April 14, 2016	K152959	Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes	KIF	Substantially Equivalent	Sybron Dental Specialties	accessdata.fda.gov
April 13, 2016	K153174	Ketac Universal Aplicap	EMA	Substantially Equivalent	3M Deutschland GmbH	accessdata.fda.gov
March 4, 2016	K152861	Aquasil Ultra + Smart Wetting Impression Material	ELW	Substantially Equivalent	Dentply International, Inc.	accessdata.fda.gov
March 1, 2016	K152748	Braun Thermoscan PRO 6000 Ear Thermometer	FLL	Substantially Equivalent	Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc)	accessdata.fda.gov
February 25, 2016	K151866	BD BACTEC Peds Plus/F Culture Vials (plastic)	MDB	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
February 12, 2016	K153309	BD Vacutainer UltraTouch Push Button Blood Collection Set	JKA	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
December 14, 2015	K151611	OneTouch Ultra Plus Flex Blood Glucose Monitoring System	NBW	Substantially Equivalent	Lifescan Europe	accessdata.fda.gov
December 9, 2015	K152243	One Coat 7 Universal	KLE	Substantially Equivalent	Coltene/Whaledent AG	accessdata.fda.gov
November 27, 2015	K150238	SensiCare Sterile Powder-Free Polymer Coated Polyisoprene Surgical glove, With Aloe Vera (Tested of Use with Chemotherapy Drugs) -Natural Color	KGO	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
October 30, 2015	K151619	Prime&Bond Elect Universal Dental Adhesive	KLE	Substantially Equivalent	Dentsply International, Inc.	accessdata.fda.gov
October 9, 2015	K151044	CLICKLINE Scissor Insert for Single Use	GEI	Substantially Equivalent	Karl Storz Endoscopy America, Inc.	accessdata.fda.gov
September 18, 2015	K151518	BRUSH&BOND PLUS	KLE	Substantially Equivalent	Parkell, Inc.	accessdata.fda.gov
August 28, 2015	K151088	DMRC Bulk Fill	EBF	Substantially Equivalent	Danville Materials, LLC	accessdata.fda.gov
August 21, 2015	K150704	PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Clear), Sample Pack (Universal (A2)), Paste (Universal (A2)), Paste (Clear), Paste (Brown (A4)), Paste (White), Paste (Opaque), Try-in Paste (Universal (A2)), Try-in Paste (Clear), Try-in Paste (Brown (A4)), Try-in Paste (White), Try-in Paste (Opaque), Tooth Primer	EMA	Substantially Equivalent	Kuraray Noritake Dental, Inc.	accessdata.fda.gov
August 17, 2015	K151332	Nexus Universal, Nexus Universal Chroma	EMA	Substantially Equivalent	Sybron Dental Specialties	accessdata.fda.gov
July 31, 2015	K151053	PSPIX 2 scanner, Imaging Plate Size 0 for PSPIX2 scanner, Imaging Plate Size 1 for PSPIX2 scanner, Imaging Plate Size 2 for PSPIX2 scanner, Imaging Plate Size 3 for PSPIX2 scanner	MUH	Substantially Equivalent	Sopro - Acteon Group	accessdata.fda.gov
July 27, 2015	K151698	BD Angiocath IV Catheter, BD Insyte IV Catheter	FOZ	Substantially Equivalent	Becton Dickinson Infusion Therapy Systems, Inc.	accessdata.fda.gov
July 7, 2015	K150933	iBond Universal & iBond Ceramic Primer	KLE	Substantially Equivalent	Heraeus Kulzer, LLC, Mitsui Chemicals Group	accessdata.fda.gov
June 23, 2015	K150218	Fill-Up!	EBF	Substantially Equivalent	Coltene/Whaledent AG	accessdata.fda.gov
June 16, 2015	K150535	Cavitron Touch Ultrasonic Scaling System	ELC	Substantially Equivalent	Dentsply International, Inc.	accessdata.fda.gov
May 29, 2015	K143263	Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets	LZH	Substantially Equivalent	Covidien	accessdata.fda.gov
February 24, 2015	K142296	Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula	JOH	Substantially Equivalent	Covidien	accessdata.fda.gov
January 22, 2015	K143247	Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and White Colored)	LZA	Substantially Equivalent	Central Medicare Sdn Bhd	accessdata.fda.gov
November 25, 2014	K142389	Variolink Esthetic	EBF	Substantially Equivalent	Ivoclar Vivadent, AG	accessdata.fda.gov
July 25, 2014	K141311	0.9% SODIUM CHLORIDE INJECTION, USP BD POSIFLUSH; SP SYRINGE, SF SYRINGE	NGT	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
July 18, 2014	K141625	POLYSYN SURGICAL SUTURE	GAM	Substantially Equivalent	Surgical Specialties Corp	accessdata.fda.gov
July 11, 2014	K141582	CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION	DPS	Substantially Equivalent	Welch Allyn	accessdata.fda.gov
July 11, 2014	K141558	QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE	GAM	Substantially Equivalent	Surgical Specialties Corp	accessdata.fda.gov
July 8, 2014	K140144	BENDA WEDGE	EJB	Substantially Equivalent	Centrix, Inc.	accessdata.fda.gov
June 9, 2014	K140539	AERO BLUE PERFORMANCE SURGICAL GOWN	FYA	Substantially Equivalent	Kimberly-Clark Corporation	accessdata.fda.gov
May 30, 2014	K130304	LMA FAMILY OF AIRWAYS	CAE	Substantially Equivalent	The Laryngeal Mask Co., Ltd.	accessdata.fda.gov
May 21, 2014	K133428	MEDIKRO NANO, MEDIKRO PRIMO AND MEDIKRO PRO	BZG	Substantially Equivalent	Medikro OY	accessdata.fda.gov
May 8, 2014	K141081	FILTEK BULK FILL POSTERIOR RESTROATIVE	EBF	Substantially Equivalent	3M Espe Dental Products	accessdata.fda.gov
March 14, 2014	K133824	CERASMART	EBF	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
March 11, 2014	K132322	NEWTRON P5 XS B.LED	ELC	Substantially Equivalent	Satelec - Acteon Group	accessdata.fda.gov
March 6, 2014	K133836	OPTIGLAZE COLOR	EBD	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
September 30, 1999	P990004	SURGIFOAM ABSORBABLE GELATIN SPONGE, USP	LMF	79	September 18, 2026	accessdata.fda.gov
October 14, 1960	N12159	SURGICEL BRAND ABSORBABLE HEMOSTAT	LMG	120	July 28, 2026	accessdata.fda.gov

Compare with other makers

Updated September 18, 2026. 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.