Data / Medical devices / United Kingdom / Ad Supply Group Limited

Ad Supply Group Limited: FDA-registered device maker in London London, City of, United Kingdom, 166 510(k) clearances and 3 PMA approvals

Name: Ad Supply Group Limited FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Ad Supply Group Limited is registered with the FDA (registration 3030733800) in London London, City of, United Kingdom. It lists 181 device types. The FDA files 166 510(k) clearances and 3 PMA approvals under its listings, the newest dated April 10, 2026. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3030733800
Address: 70-78 West Hendon Broadway, London London, City of, United Kingdom, NW9 7BT
Owner or operator: AD Supply Group Limited (10090502)
Roles: Exporter to the US
First device listed: April 5, 2024
Registered through: 2027
Brand names listed: Clamp, umbilical, Clip, implantable, GENERAL AND PLASTIC SURGERY, Shunt, central nervous system and components, System, imaging, pulsed echo, ultrasonic

Devices it lists

Device	Product code	Class	Role	Source
Absorbent, Carbon-Dioxide	CBL	1	Exporter to the US	accessdata.fda.gov
Accessories, Cleaning Brushes, For Endoscope	MNL	1	Exporter to the US	accessdata.fda.gov
Adaptor, Bulbs, Miscellaneous, For Endoscope	FFY	1	Exporter to the US	accessdata.fda.gov
Aid, Cardiopulmonary Resuscitation	LIX	2	Exporter to the US	accessdata.fda.gov
Airway, Oropharyngeal, Anesthesiology	CAE	1	Exporter to the US	accessdata.fda.gov
Amniotome	HGE	1	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	CCK	2	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	NHO	2	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	CBQ	2	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	CBS	2	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	NHQ	2	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Nitrogen, Gaseous-Phase	CCI	2	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	CBR	2	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Oxygen, Gaseous-Phase	CCL	2	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	NHP	2	Exporter to the US	accessdata.fda.gov
Anoscope And Accessories	FER	2	Exporter to the US	accessdata.fda.gov
Apparatus, Suction, Ward Use, Portable, Ac-Powered	JCX	2	Exporter to the US	accessdata.fda.gov
Applier, Hemostatic Clip	HBT	1	Exporter to the US	accessdata.fda.gov
Arthroscope	HRX	2	Exporter to the US	accessdata.fda.gov
Automated External Defibrillators (Non-Wearable)	MKJ	3	Exporter to the US	accessdata.fda.gov
Bag, Bile Collecting	EXF	2	Exporter to the US	accessdata.fda.gov
Bag, Drainage, With Adhesive, Ostomy	FON	1	Exporter to the US	accessdata.fda.gov
Bag, Urine Collection, Newborn	FOC	2	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
Bandage, Liquid, Skin Protectant	NEC	1	Exporter to the US	accessdata.fda.gov
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection	GCA	2	Exporter to the US	accessdata.fda.gov
Bilirubin (Total And Unbound) In The Neonate Test System	MQM	1	Exporter to the US	accessdata.fda.gov
Biopsy Needle	FCG	2	Exporter to the US	accessdata.fda.gov
Blade, Saw, General & Plastic Surgery, Surgical	GFA	1	Exporter to the US	accessdata.fda.gov
Blade, Saw, Surgical, Cardiovascular	DWH	1	Exporter to the US	accessdata.fda.gov
Bone Mill	LYS	1	Exporter to the US	accessdata.fda.gov
Bottle, Collection, Vacuum	KDQ	2	Exporter to the US	accessdata.fda.gov
Bur, Surgical, General & Plastic Surgery	GFF	1	Exporter to the US	accessdata.fda.gov
Cable, Transducer And Electrode, Patient, (Including Connector)	DSA	2	Exporter to the US	accessdata.fda.gov
Cannula, Nasal, Oxygen	CAT	1	Exporter to the US	accessdata.fda.gov
Cannula, Ophthalmic	HMX	1	Exporter to the US	accessdata.fda.gov
Catheter And Tip, Suction	JOL	2	Exporter to the US	accessdata.fda.gov
Catheter, Continuous Flush	KRA	2	Exporter to the US	accessdata.fda.gov
Catheter, Intravascular, Diagnostic	DQO	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, Nephrostomy	LJE	U	Exporter to the US	accessdata.fda.gov
Catheter, Nephrostomy, General & Plastic Surgery	GBO	1	Exporter to the US	accessdata.fda.gov
Catheter, Percutaneous	DQY	2	Exporter to the US	accessdata.fda.gov
Catheter, Suprapubic (And Accessories)	KOB	2	Exporter to the US	accessdata.fda.gov
Catheter, Urological	KOD	2	Exporter to the US	accessdata.fda.gov
Catheters, Suction, Tracheobronchial	BSY	1	Exporter to the US	accessdata.fda.gov
Cement, Stomal Appliance, Ostomy	EZR	1	Exporter to the US	accessdata.fda.gov
Clamp, Umbilical	HFW	2	Exporter to the US	accessdata.fda.gov
Cleaner, Ultrasonic, Medical Instrument	FLG	1	Exporter to the US	accessdata.fda.gov
Clip, Implantable	FZP	2	Exporter to the US	accessdata.fda.gov
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	ONB	2	Exporter to the US	accessdata.fda.gov
Collector, Ostomy	EXB	1	Exporter to the US	accessdata.fda.gov
Computer, Blood-Pressure	DSK	2	Exporter to the US	accessdata.fda.gov
Condenser, Heat And Moisture (Artificial Nose)	BYD	1	Exporter to the US	accessdata.fda.gov
Connector, Airway (Extension)	BZA	1	Exporter to the US	accessdata.fda.gov
Connector, Catheter	GCD	1	Exporter to the US	accessdata.fda.gov
Container, Specimen, Sterile	FMH	1	Exporter to the US	accessdata.fda.gov
Cup, Prophylaxis	EHK	1	Exporter to the US	accessdata.fda.gov
Cystotome	HNY	1	Exporter to the US	accessdata.fda.gov
Dermatome	GFD	1	Exporter to the US	accessdata.fda.gov
Device, Fixation, Tracheal Tube	CBH	1	Exporter to the US	accessdata.fda.gov
Device, Intravascular Catheter Securement	KMK	1	Exporter to the US	accessdata.fda.gov
Dilator, Catheter, Ureteral	EZN	2	Exporter to the US	accessdata.fda.gov
Dilator, Urethral	KOE	2	Exporter to the US	accessdata.fda.gov
Disinfector, Medical Devices	MEC	2	Exporter to the US	accessdata.fda.gov
Dislodger, Stone, Basket, Ureteral, Metal	FFL	2	Exporter to the US	accessdata.fda.gov
Dislodger, Stone, Biliary	LQR	2	Exporter to the US	accessdata.fda.gov
Drape, Surgical, Exempt	PUI	2	Exporter to the US	accessdata.fda.gov
Dressing, Wound And Burn, Occlusive	MGP	U	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, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	ERL	2	Exporter to the US	accessdata.fda.gov
Drills, Burrs, Trephines & Accessories (Compound, Powered)	HBF	2	Exporter to the US	accessdata.fda.gov
Drills, Burrs, Trephines & Accessories (Simple, Powered)	HBE	2	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
Electrode, Needle	GXZ	2	Exporter to the US	accessdata.fda.gov
Electrode, Needle, Diagnostic Electromyograph	IKT	2	Exporter to the US	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Exporter to the US	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed	NUJ	2	Exporter to the US	accessdata.fda.gov
Endoscopic Access Overtube, Gastroenterology-Urology	FED	2	Exporter to the US	accessdata.fda.gov
Eosin Y	HYB	1	Exporter to the US	accessdata.fda.gov
Expander, Surgical, Skin Graft	FZW	1	Exporter to the US	accessdata.fda.gov
General Purpose Reagent	PPM	1	Exporter to the US	accessdata.fda.gov
Generator, Lesion, Radiofrequency	GXD	2	Exporter to the US	accessdata.fda.gov
Giemsa Stain	HYF	1	Exporter to the US	accessdata.fda.gov
Gown, Surgical	FYA	2	Exporter to the US	accessdata.fda.gov
Hematoxylin	HYJ	1	Exporter to the US	accessdata.fda.gov
Hemocytometer	GHO	1	Exporter to the US	accessdata.fda.gov
Hemostatic Device For Endoscopic Gastrointestinal Use	QAU	2	Exporter to the US	accessdata.fda.gov
Hemostatic Metal Clip For The Gi Tract	PKL	2	Exporter to the US	accessdata.fda.gov
Holder, Head, Neurosurgical (Skull Clamp)	HBL	2	Exporter to the US	accessdata.fda.gov
Hood, Surgical	FXY	2	Exporter to the US	accessdata.fda.gov
Humidifier, Respiratory Gas, (Direct Patient Interface)	BTT	2	Exporter to the US	accessdata.fda.gov
Hysteroscope (And Accessories)	HIH	2	Exporter to the US	accessdata.fda.gov
Incubator, Neonatal	FMZ	2	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
Infusor, Pressure, For I.V. Bags	KZD	1	Exporter to the US	accessdata.fda.gov
Instrument, Biopsy	KNW	2	Exporter to the US	accessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	HWE	1	Exporter to the US	accessdata.fda.gov
Instrument, Ultrasonic Surgical	LFL	U	Exporter to the US	accessdata.fda.gov
Introducer, Catheter	DYB	2	Exporter to the US	accessdata.fda.gov
Knife, Ophthalmic	HNN	1	Exporter to the US	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Exporter to the US	accessdata.fda.gov
Laryngoscope, Rigid	CCW	1	Exporter to the US	accessdata.fda.gov
Latex Patient Examination Glove	LYY	1	Exporter to the US	accessdata.fda.gov
Lavage, Jet	FQH	2	Exporter to the US	accessdata.fda.gov
Lift, Patient, Non-Ac-Powered	FSA	1	Exporter to the US	accessdata.fda.gov
Ligator, Esophageal	MND	2	Exporter to the US	accessdata.fda.gov
Ligator, Hemorrhoidal	FHN	2	Exporter to the US	accessdata.fda.gov
Marker, Radiographic, Implantable	NEU	2	Exporter to the US	accessdata.fda.gov
Mesh, Surgical, Polymeric	FTL	2	Exporter to the US	accessdata.fda.gov
Microtome, Accessories	IDL	1	Exporter to the US	accessdata.fda.gov
Mixer, Cement, For Clinical Use	JDZ	1	Exporter to the US	accessdata.fda.gov
Monitor, Breathing Frequency	BZQ	2	Exporter to the US	accessdata.fda.gov
Monitor, St Segment With Alarm	MLD	2	Exporter to the US	accessdata.fda.gov
Nebulizer (Direct Patient Interface)	CAF	2	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, Emergency Airway	BWC	2	Exporter to the US	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	Exporter to the US	accessdata.fda.gov
Neurological Stereotaxic Instrument	HAW	2	Exporter to the US	accessdata.fda.gov
Neurosurgical Paddie	HBA	2	Exporter to the US	accessdata.fda.gov
Non-Coring (Huber) Needle	PTI	2	Exporter to the US	accessdata.fda.gov
Oximeter	DQA	2	Exporter to the US	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Exporter to the US	accessdata.fda.gov
Probe, Radiofrequency Lesion	GXI	2	Exporter to the US	accessdata.fda.gov
Protector, Ostomy	EXE	1	Exporter to the US	accessdata.fda.gov
Razor, Surgical	LWK	1	Exporter to the US	accessdata.fda.gov
Scalpel, One-Piece	GDX	1	Exporter to the US	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	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
Solvent, Adhesive Tape	KOX	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
Splint, Intranasal Septal	LYA	1	Exporter to the US	accessdata.fda.gov
Stain, Papanicolau	HZJ	1	Exporter to the US	accessdata.fda.gov
Stains, Chemical Solution	LED	1	Exporter to the US	accessdata.fda.gov
Staple, Implantable	GDW	2	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
Stents, Drains And Dilators For The Biliary Ducts	FGE	2	Exporter to the US	accessdata.fda.gov
Sterilizer, Chemical	MLR	2	Exporter to the US	accessdata.fda.gov
Stimulator, Nerve, Peripheral, Electric	KOI	2	Exporter to the US	accessdata.fda.gov
Stylet, Tracheal Tube	BSR	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, 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, Synthetic, Polyamide	GAR	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
Syringe, Antistick	MEG	2	Exporter to the US	accessdata.fda.gov
Syringe, Irrigating (Non Dental)	KYZ	1	Exporter to the US	accessdata.fda.gov
System, Dialysate Delivery, Single Pass	FIL	2	Exporter to the US	accessdata.fda.gov
System, Hemoglobin, Automated	GKR	2	Exporter to the US	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Exporter to the US	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Exporter to the US	accessdata.fda.gov
System, Irrigation, Urological	LJH	2	Exporter to the US	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Exporter to the US	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Exporter to the US	accessdata.fda.gov
Tourniquet, Pneumatic	KCY	1	Exporter to the US	accessdata.fda.gov
Transducer, Pressure, Catheter Tip	DXO	2	Exporter to the US	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Exporter to the US	accessdata.fda.gov
Trocar	DRC	2	Exporter to the US	accessdata.fda.gov
Tube Tracheostomy And Tube Cuff	JOH	2	Exporter to the US	accessdata.fda.gov
Tube, Collection, Capillary Blood	GIO	1	Exporter to the US	accessdata.fda.gov
Tube, Laryngectomy	KAC	1	Exporter to the US	accessdata.fda.gov
Tube, Tracheal (W/Wo Connector)	BTR	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, Pressure And Accessories	BYX	1	Exporter to the US	accessdata.fda.gov
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	KNS	2	Exporter to the US	accessdata.fda.gov
Ventilator, Continuous, Facility Use	CBK	2	Exporter to the US	accessdata.fda.gov
Ventilator, Emergency, Powered (Resuscitator)	BTL	2	Exporter to the US	accessdata.fda.gov
Ventilator, Non-Continuous (Respirator)	BZD	2	Exporter to the US	accessdata.fda.gov
Warmer, Infant Radiant	FMT	2	Exporter to the US	accessdata.fda.gov
Wax, Bone	MTJ	U	Exporter to the US	accessdata.fda.gov
Wire, Guide, Catheter	DQX	2	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 166.

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
June 3, 2025	K250682	BD Nexiva Diffusics Closed IV Catheter System and BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero Needle-free Connector	FOZ	Substantially Equivalent	Becton Dickinson Infusion Therapy Systems, Inc.	accessdata.fda.gov
March 11, 2025	K250374	iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC); iBur 5.0mm Coarse Diamond R	HBE	Substantially Equivalent	Stryker Instruments	accessdata.fda.gov
November 27, 2024	K241353	PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set	PTI	Substantially Equivalent	Bard Access Systems, Inc.	accessdata.fda.gov
November 1, 2024	K242320	BD Vacutainer® One Use Holder	JKA	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
January 18, 2024	K232373	Progrip Self-Gripping Polypropylene Mesh	FTL	Substantially Equivalent	Sofradim Production	accessdata.fda.gov
December 1, 2023	K233529	BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero Needle-free Connector	FOZ	Substantially Equivalent	Becton Dickinson Infusion Therapy Systems, Inc.	accessdata.fda.gov
September 11, 2023	K231283	SiteRite 9 Ultrasound System	IYO	Substantially Equivalent	Bard Access Systems, Inc. (C.R. Bard, Inc.)	accessdata.fda.gov
August 16, 2023	K231491	TA Stapler and Loading Unit with DST Series Technology	GAG	Substantially Equivalent	Covidien	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
March 10, 2023	K222478	BD Vacutainer® Luer-Lok Access Device, BD Vacutainer® Blood Transfer Device	JKA	Substantially Equivalent	Becton, Dickinson and 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
February 3, 2022	K213824	Sonopet iQ Ultrasonic Aspirator System	LFL	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
August 25, 2021	K212323	Instinct Plus Endoscopic Clipping Device	PKL	Substantially Equivalent	Wilson-Cook Medical, Inc.	accessdata.fda.gov
June 30, 2021	K210377	Stryker iBur hubs and cutting accessories	HBE	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
November 20, 2020	K193346	Codman Surgical Patties & Strips	HBA	Substantially Equivalent	Integra LifeSciences Corporation	accessdata.fda.gov
June 10, 2020	K200972	Hemospray Endoscopic Hemostat	QAU	Substantially Equivalent	Wilson-Cook Medical, Inc.	accessdata.fda.gov
April 2, 2020	K200319	HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable	FMT	Substantially Equivalent	Deroyal Industries, Inc.	accessdata.fda.gov
March 21, 2020	K200493	Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover	FXY	Substantially Equivalent	Stryker Corporation	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
January 29, 2020	K191498	Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc	LJE	Unknown	Cook Incorporated	accessdata.fda.gov
December 13, 2019	K193344	Tri-Ex Extraction Balloon with Multiple Sizing	GCA	Substantially Equivalent	Wilson-Cook Medical, Inc.	accessdata.fda.gov
July 12, 2019	K191259	Stryker CrossFlow Integrated Arthroscopy Pump	HRX	Substantially Equivalent	Stryker Corp.	accessdata.fda.gov
April 5, 2019	K190103	V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System	MLR	Substantially Equivalent	STERIS Corporation	accessdata.fda.gov
March 20, 2019	K183399	BD Nexiva Closed IV Catheter System	FOZ	Substantially Equivalent	Becton Dickinson Infusion Therapy Systems, Inc.	accessdata.fda.gov
November 30, 2018	K181221	BD PhaSeal Optima Closed System Transfer Device	ONB	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
May 24, 2018	K172665	Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords	KNS	Substantially Equivalent	Wilson-Cook Medical Inc./Cook Endoscopy	accessdata.fda.gov
May 1, 2018	K173035	Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets	FGE	Substantially Equivalent	Cook Incorporated	accessdata.fda.gov
April 30, 2018	K171678	Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m/20ft, 5/pkg, Disposable	CCK	Substantially Equivalent	Vyaire Medical, Inc.	accessdata.fda.gov
March 9, 2018	K172057	Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set	FGE	Substantially Equivalent	Cook Ireland, Ltd.	accessdata.fda.gov
March 9, 2018	K171764	Fixed Core Wire Guides	DQX	Substantially Equivalent	Cook Incorporated	accessdata.fda.gov
March 2, 2018	K173428	VERIFY Chemical Indicator for S40 Sterilant	JOJ	Substantially Equivalent	STERIS Corporation	accessdata.fda.gov
December 29, 2017	K172474	Celerity 20 HP Biological Indicator	FRC	Substantially Equivalent	STERIS Corporation	accessdata.fda.gov
November 7, 2017	K173009	NCompass Nitinol Stone Extractors	LQR	Substantially Equivalent	Cook Incorporated	accessdata.fda.gov
September 21, 2017	K161719	Salter Labs Bubble Humidifier	BTT	Substantially Equivalent	Salter Labs	accessdata.fda.gov
September 14, 2017	K171953	Bard Mission Disposable Core Biopsy Instrument	KNW	Substantially Equivalent	Bard Peripheral Vascular, Inc.	accessdata.fda.gov
August 22, 2017	K171504	VERIFY Assert VH2O2 Self-Contained Biological Indicator	FRC	Substantially Equivalent	STERIS Corporation	accessdata.fda.gov
May 25, 2017	K170242	MultiGen 2 RF Generator System	GXD	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
May 24, 2017	K163197	Cook Holmium Laser Fiber	GEX	Substantially Equivalent	Cook Incorporated	accessdata.fda.gov
February 17, 2017	K160200	Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set	BWC	Substantially Equivalent	Cook Incorporated	accessdata.fda.gov
November 22, 2016	K160884	CXI Support Catheter	KRA	Substantially Equivalent	Cook Incorporated	accessdata.fda.gov
August 23, 2016	K153571	Cavilon Advanced High Endurance Skin Protectant	KMF	Substantially Equivalent	3M Healthcare	accessdata.fda.gov
May 27, 2016	K161170	BD Eclipse Hypodermic Needle	FMI	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
March 31, 2016	K151932	Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing	HRX	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
March 10, 2016	K151421	Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines	CCK	Substantially Equivalent	Salter Labs	accessdata.fda.gov
March 1, 2016	K160230	VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm	GCJ	Substantially Equivalent	Covidien	accessdata.fda.gov
December 31, 2015	K152809	Giraffe Incubator Carestation CS1	FMZ	Substantially Equivalent	Ohmeda Medical, A Division of Datex-Ohmeda, Inc.	accessdata.fda.gov
July 2, 2015	K151548	VersaOne Bladed Trocar, VersaOne Bladeless Trocar	GCJ	Substantially Equivalent	Covidien	accessdata.fda.gov
March 18, 2015	K133788	COOK HOLMIUM LASER FIBER	GEX	Substantially Equivalent	Cook Incorporated	accessdata.fda.gov
January 18, 2015	K142749	TruWave Disposable Pressure Transducer	DXO	Substantially Equivalent	Edwards Lifesciences, LLC	accessdata.fda.gov
December 9, 2014	K142547	Bluntport Blunt Trocar with Threaded Anchor 5mm-12mm	GCJ	Substantially Equivalent	Covidien	accessdata.fda.gov
September 3, 2014	K141495	TRUWAVE DISPOSABLE PRESSURE TRANSDUCER	DXO	Substantially Equivalent	Edwards Lifesciences, LLC	accessdata.fda.gov
August 26, 2014	K141095	STRYKER STERI-SHIELD FLYTE HYBRID TOGAS	FYA	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
July 18, 2014	K141625	POLYSYN SURGICAL SUTURE	GAM	Substantially Equivalent	Surgical Specialties Corp	accessdata.fda.gov
July 11, 2014	K141558	QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE	GAM	Substantially Equivalent	Surgical Specialties Corp	accessdata.fda.gov
June 26, 2014	K140588	FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS	FXY	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
April 10, 2014	K133578	REPROCESSED LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER	NUJ	Substantially Equivalent	Stryker Sustainability Solutions	accessdata.fda.gov
February 21, 2014	K133948	BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT	KNW	Substantially Equivalent	Bard Peripheral Vascular, Inc.	accessdata.fda.gov
January 17, 2014	K132668	IOB DISPOSABLE SPECULUM	HIB	Substantially Equivalent	Iob Medical, Inc.	accessdata.fda.gov
August 23, 2013	K132268	QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN	NEW	Substantially Equivalent	Surgical Specialties Corporation Dba Angiotech	accessdata.fda.gov
August 9, 2013	K123553	ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM	KCY	Substantially Equivalent	Zimmer, Inc.	accessdata.fda.gov
March 28, 2013	K123178	STRYKER VENOM ELECTRODES AND CANNULAE	GXI	Substantially Equivalent	Stryker Instruments, Instruments Div.	accessdata.fda.gov
March 14, 2013	K130435	VERSAPORT V2 BLADELESS OPTICAL TROCAR	GCJ	Substantially Equivalent	Covidien, Formerly US Surgical A Divison of Tyco H	accessdata.fda.gov
January 10, 2013	K123911	SENOMARK ULTRA BREAST TISSUE MARKER	NEU	Substantially Equivalent	C.R. Bard, Inc.	accessdata.fda.gov
January 9, 2013	K123213	BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE	ONB	Substantially Equivalent	Becton, Dickinson & CO	accessdata.fda.gov
October 22, 2012	K122898	QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN	GAM	Substantially Equivalent	Surgical Specialties Corp. Dba Angiotech	accessdata.fda.gov
September 14, 2012	K121625	LULLABY TM WARMER	FMT	Substantially Equivalent	Wipro GE Healthcare Private, Ltd.	accessdata.fda.gov
April 3, 2012	K120065	PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES	JCX	Substantially Equivalent	Plaxtron Industrial (M) Sdn. Bhd.	accessdata.fda.gov
November 22, 2011	K112134	TRUCLEAR OPERATIVE HYSTEROSCOPE	HIH	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
September 1, 2011	K112349	VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLADELESS OPTICAL TROCAR	GCJ	Substantially Equivalent	Covidien, Formerly US Surgical A Divison of Tyco H	accessdata.fda.gov
August 12, 2011	K102120	NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202	CBK	Substantially Equivalent	Hsiner Co., Ltd.	accessdata.fda.gov
June 30, 2011	K102177	SENSICARE POWDER-FREE POLYMER COATED POLYSOPRENE SURGICAL GLOVES, STERILE	KGO	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
April 13, 2011	K110742	ONESTEP ADULT MULTI-FUNCTION ELECTRODE	MKJ	Substantially Equivalent	ZOLL Medical Corporation	accessdata.fda.gov
February 10, 2011	K103101	HI-TORQUE BALANCE MIDDLEWEIGHT ELITE	DQX	Substantially Equivalent	Abbott Vascular-Cardiac Therapies	accessdata.fda.gov
September 8, 2010	K101249	STERIGAGE MODEL 1243RA, 1243RB, 1243RE	JOJ	Substantially Equivalent	3M Company	accessdata.fda.gov
April 13, 2010	K093695	PEAK PLASMABLADE 3.OS TISSUE DISSECTION DEVICE	GEI	Substantially Equivalent	Peak Surgical, Inc.	accessdata.fda.gov
April 6, 2010	K093913	MERCURY MEDICAL T-PIECE RESUSCITATOR	BTL	Substantially Equivalent	Mercury Medical, Inc.	accessdata.fda.gov
December 9, 2009	K093750	ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBA	KRA	Substantially Equivalent	Ev3, Inc.	accessdata.fda.gov
November 2, 2009	K092359	ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A	FCG	Substantially Equivalent	Cook Ireland, Ltd.	accessdata.fda.gov
September 4, 2009	K092413	INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES	MEG	Substantially Equivalent	Inviro Medical Devices, Inc.	accessdata.fda.gov
August 25, 2009	K091292	BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771	JKA	Substantially Equivalent	Becton, Dickinson and Company (BD)	accessdata.fda.gov
March 18, 2009	K090547	ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U	NEU	Substantially Equivalent	C.R. Bard, Inc.	accessdata.fda.gov
February 23, 2009	K083641	BIVONA TRACHEOSTOMY TUBES	JOH	Substantially Equivalent	Smiths Medical Asd, Inc.	accessdata.fda.gov
April 22, 2008	K080821	MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE	BTR	Substantially Equivalent	Kimberly-Clark Corp.	accessdata.fda.gov
April 17, 2008	K080863	TRAXCESS 0.014 HYDROPHILIC GUIDEWIRE	DQX	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
November 30, 2007	K073017	STRYKER STRI-SHIELD FLYTE TOGAS	FYA	Substantially Equivalent	Stryker Instruments, Instruments Div.	accessdata.fda.gov
October 22, 2007	K071931	CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223	HBF	Substantially Equivalent	Codman & Shurtleff, Inc.	accessdata.fda.gov
October 4, 2007	K062297	VHP 136 LOW TEMPERATURE STERILIZATION SYSTEM	MLR	Substantially Equivalent	STERIS Corporation	accessdata.fda.gov
July 30, 2007	K071186	MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE	IKT	Substantially Equivalent	Ambu A/S	accessdata.fda.gov
May 30, 2007	K071185	MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE	GXZ	Substantially Equivalent	Ambu A/S	accessdata.fda.gov
March 23, 2007	K063005	STRYKER T6 HOODS AND TOGAS	FYA	Substantially Equivalent	Stryker Instruments	accessdata.fda.gov
January 30, 2007	K063238	ULTRACLIP II WING AND ULTRACLIP II COIL	NEU	Substantially Equivalent	Inrad	accessdata.fda.gov
December 14, 2006	K062380	FLOSIMPLE ARTHROSCOPY PUMP A120	HRX	Substantially Equivalent	W.O.M. World of Medicine AG	accessdata.fda.gov
September 6, 2006	K060623	SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE	FER	Substantially Equivalent	Cook Ireland, Ltd.	accessdata.fda.gov
July 12, 2006	K061363	AGILIS NXT STEERABLE INTRODUCER	DYB	Substantially Equivalent	St Jude Medical	accessdata.fda.gov
November 7, 2005	K052437	MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURE	GAM	Substantially Equivalent	Surgical Specialties Corp	accessdata.fda.gov
August 3, 2005	K050994	AIRLIFE INFANT NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM	BZD	Substantially Equivalent	Cardinalhealth	accessdata.fda.gov
May 13, 2005	K051076	ZOLL STAT*PADZ MWP MULTI-FUNCTION ELECTRODES	MKJ	Substantially Equivalent	ZOLL Medical Corporation	accessdata.fda.gov
May 12, 2005	K050600	MINILOC SAFETY INFUSION SET	FPA	Substantially Equivalent	Specialized Health Products, Intl.	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
August 7, 2020	P190007	Cardinal Health Multifunctional Defibrillation Electrode	MKJ	0	August 7, 2020	accessdata.fda.gov
July 2, 2018	P160026	LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15 MONITOR/DE	MKJ	71	September 24, 2026	accessdata.fda.gov
December 21, 2017	P160012	LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and CHARGE-PAK® Battery Charger	MKJ	6	April 18, 2023	accessdata.fda.gov

Compare with other makers

Updated April 10, 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.