Data / Medical devices / Hong Kong / Worldwide Supplies Limited

Worldwide Supplies Limited: FDA-registered device maker in Hong Kong, Hong Kong, 186 510(k) clearances

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

Worldwide Supplies Limited is registered with the FDA (registration 3014579161) in Hong Kong, Hong Kong. It lists 200 device types. The FDA files 186 510(k) clearances under its listings, the newest dated January 26, 2026. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3014579161
Address: 50 Bonham Strand NO.5, 17/F Bonham Trade Centre, Hong Kong, Hong Kong, none
Owner or operator: Worldwide Supplies Limited (10057941)
Roles: Exporter to the US
First device listed: June 14, 2018
Registered through: 2027

Devices it lists

Device	Product code	Class	Role	Source
Absorber, Carbon-Dioxide	BSF	1	Exporter to the US	accessdata.fda.gov
Accessory, Surgical Apparel	LYU	1	Exporter to the US	accessdata.fda.gov
Administration Set Securement Device	PUK	1	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
Anoscope And Accessories	FER	2	Exporter to the US	accessdata.fda.gov
Anti Fog Solution And Accessories, Endoscopy	OCT	2	Exporter to the US	accessdata.fda.gov
Apparatus, Exhaust, Surgical	FYD	2	Exporter to the US	accessdata.fda.gov
Apparatus, Suction, Operating-Room, Wall Vacuum Powered	GCX	2	Exporter to the US	accessdata.fda.gov
Arthroscope	HRX	2	Exporter to the US	accessdata.fda.gov
Audiometer	EWO	2	Exporter to the US	accessdata.fda.gov
Automated External Defibrillators (Non-Wearable)	MKJ	3	Exporter to the US	accessdata.fda.gov
Bag, Drainage, With Adhesive, Ostomy	FON	1	Exporter to the US	accessdata.fda.gov
Bag, Urinary, Ileostomy	EXH	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
Bandage, Liquid, Skin Protectant	NEC	1	Exporter to the US	accessdata.fda.gov
Basin, Emesis	FNY	1	Exporter to the US	accessdata.fda.gov
Biopsy Needle	FCG	2	Exporter to the US	accessdata.fda.gov
Blood Pressure Cuff	DXQ	2	Exporter to the US	accessdata.fda.gov
Board, Arm (With Cover), Sterile	BTX	1	Exporter to the US	accessdata.fda.gov
Bronchoscope Accessory	KTI	2	Exporter to the US	accessdata.fda.gov
Bulb, Inflation, For Endoscope	FCY	1	Exporter to the US	accessdata.fda.gov
Cable, Electrode	IKD	2	Exporter to the US	accessdata.fda.gov
Cable, Transducer And Electrode, Patient, (Including Connector)	DSA	2	Exporter to the US	accessdata.fda.gov
Cannula, Manipulator/Injector, Uterine	LKF	2	Exporter to the US	accessdata.fda.gov
Cannula, Surgical, General & Plastic Surgery	GEA	1	Exporter to the US	accessdata.fda.gov
Carrier, Ligature	GEJ	1	Exporter to the US	accessdata.fda.gov
Catheter And Tip, Suction	JOL	2	Exporter to the US	accessdata.fda.gov
Catheter, Cholangiography	GBZ	1	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, 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, Retention Type, Balloon	EZL	2	Exporter to the US	accessdata.fda.gov
Catheter, Straight	EZD	2	Exporter to the US	accessdata.fda.gov
Catheter, Ureteral, Gastro-Urology	EYB	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
Cement, Stomal Appliance, Ostomy	EZR	1	Exporter to the US	accessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)	CAI	1	Exporter to the US	accessdata.fda.gov
Clamp, Line	FKK	1	Exporter to the US	accessdata.fda.gov
Clamp, Umbilical	HFW	2	Exporter to the US	accessdata.fda.gov
Cleanser, Denture, Over The Counter	EFT	1	Exporter to the US	accessdata.fda.gov
Clinical Electronic Thermometer	SDV	2	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
Computer, Blood-Pressure	DSK	2	Exporter to the US	accessdata.fda.gov
Computer, Diagnostic, Programmable	DQK	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, I.V.	KPE	2	Exporter to the US	accessdata.fda.gov
Container, Sharps	MMK	2	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
Curette, Periodontic	EMS	1	Exporter to the US	accessdata.fda.gov
Cystotome	HNY	1	Exporter to the US	accessdata.fda.gov
Dc-Defibrillator, Low-Energy, (Including Paddles)	LDD	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
Devices Detecting Influenza A, B, And C Virus Antigens	PSZ	2	Exporter to the US	accessdata.fda.gov
Dialyzer, High Permeability With Or Without Sealed Dialysate System	KDI	2	Exporter to the US	accessdata.fda.gov
Dilator, Urethral	KOE	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
Drain, Tee (Water Trap)	BYH	1	Exporter to the US	accessdata.fda.gov
Drape, Surgical, Antimicrobial	KKX	2	Exporter to the US	accessdata.fda.gov
Drape, Surgical, Exempt	PUI	2	Exporter to the US	accessdata.fda.gov
Dressing, Compression	MHW	1	Exporter to the US	accessdata.fda.gov
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic	MGQ	U	Exporter to the US	accessdata.fda.gov
Dressing, Wound, Drug	FRO	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
Drills, Burrs, Trephines & Accessories (Compound, Powered)	HBF	2	Exporter to the US	accessdata.fda.gov
Electrocardiograph	DPS	2	Exporter to the US	accessdata.fda.gov
Electrode, Cutaneous	GXY	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
Endoscopic Grasping/Cutting Instrument, Non-Powered	OCZ	2	Exporter to the US	accessdata.fda.gov
Endoscopic Guidewire, Gastroenterology-Urology	OCY	2	Exporter to the US	accessdata.fda.gov
Endoscopic Ultrasound System, Gastroenterology-Urology	ODG	2	Exporter to the US	accessdata.fda.gov
Esthesiometer	GXB	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
Fentanyl And Other Opioid Protection Glove	QDO	1	Exporter to the US	accessdata.fda.gov
Forceps, Rubber Dam Clamp	EJG	1	Exporter to the US	accessdata.fda.gov
Forceps, Tooth Extractor, Surgical	EMG	1	Exporter to the US	accessdata.fda.gov
Formalin, Neutral Buffered	IFP	1	Exporter to the US	accessdata.fda.gov
Full-Montage Standard Electroencephalograph	GWQ	2	Exporter to the US	accessdata.fda.gov
Garment, Protective, For Incontinence	EYQ	1	Exporter to the US	accessdata.fda.gov
Gas-Machine, Anesthesia	BSZ	2	Exporter to the US	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Exporter to the US	accessdata.fda.gov
Guide, Needle, Surgical	GDF	1	Exporter to the US	accessdata.fda.gov
Handpiece, Contra- And Right-Angle Attachment, Dental	EGS	1	Exporter to the US	accessdata.fda.gov
Hemostatic Device For Endoscopic Gastrointestinal Use	QAU	2	Exporter to the US	accessdata.fda.gov
Holder, Needle, Gastroenterologic	FHQ	1	Exporter to the US	accessdata.fda.gov
Indicator, Biological Sterilization Process	FRC	2	Exporter to the US	accessdata.fda.gov
Instrument, Surgical, Disposable	KDC	1	Exporter to the US	accessdata.fda.gov
Instruments, Surgical, Cardiovascular	DWS	1	Exporter to the US	accessdata.fda.gov
Insufflator, Laparoscopic	HIF	2	Exporter to the US	accessdata.fda.gov
Joint, Knee, External Brace	ITQ	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
Lift, Patient, Non-Ac-Powered	FSA	1	Exporter to the US	accessdata.fda.gov
Ligator, Hemorrhoidal	FHN	2	Exporter to the US	accessdata.fda.gov
Light, Headband, Surgical	FSR	2	Exporter to the US	accessdata.fda.gov
Marker, Radiographic, Implantable	NEU	2	Exporter to the US	accessdata.fda.gov
Material, Impression	ELW	2	Exporter to the US	accessdata.fda.gov
Material, Tooth Shade, Resin	EBF	2	Exporter to the US	accessdata.fda.gov
Mattress, Flotation Therapy, Non-Powered	IKY	1	Exporter to the US	accessdata.fda.gov
Medical Glove, Specialty	LZC	1	Exporter to the US	accessdata.fda.gov
Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	OPJ	1	Exporter to the US	accessdata.fda.gov
Mirror, Ent	KAI	1	Exporter to the US	accessdata.fda.gov
Monitor, Breathing Frequency	BZQ	2	Exporter to the US	accessdata.fda.gov
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	DRT	2	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
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, Hypodermic, Single Lumen	FMI	2	Exporter to the US	accessdata.fda.gov
Ophthalmoscope, Battery-Powered	HLJ	2	Exporter to the US	accessdata.fda.gov
Otoscope	ERA	1	Exporter to the US	accessdata.fda.gov
Oximeter	DQA	2	Exporter to the US	accessdata.fda.gov
Oximeter, Ear	DPZ	2	Exporter to the US	accessdata.fda.gov
Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)	DRO	2	Exporter to the US	accessdata.fda.gov
Pack, Hot Or Cold, Reusable	IME	1	Exporter to the US	accessdata.fda.gov
Pad, Alcohol, Device Disinfectant	LKB	U	Exporter to the US	accessdata.fda.gov
Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling	PNG	2	Exporter to the US	accessdata.fda.gov
Pliers, Operative	EJY	1	Exporter to the US	accessdata.fda.gov
Point, Abrasive	EHL	1	Exporter to the US	accessdata.fda.gov
Polymer Patient Examination Glove	LZA	1	Exporter to the US	accessdata.fda.gov
Port & Catheter, Implanted, Subcutaneous, Intravascular	LJT	2	Exporter to the US	accessdata.fda.gov
Probe, Periodontic	EIX	1	Exporter to the US	accessdata.fda.gov
Protector, Ostomy	EXE	1	Exporter to the US	accessdata.fda.gov
Protector, Skin Pressure	FMP	1	Exporter to the US	accessdata.fda.gov
Pump, Infusion, Enteral	LZH	2	Exporter to the US	accessdata.fda.gov
Razor, Surgical	LWK	1	Exporter to the US	accessdata.fda.gov
Retinoscope, Battery-Powered	HKM	1	Exporter to the US	accessdata.fda.gov
Rod, Colostomy	EZP	2	Exporter to the US	accessdata.fda.gov
Scale, Stand-On, Patient	FRI	1	Exporter to the US	accessdata.fda.gov
Scaler, Periodontic	EMN	1	Exporter to the US	accessdata.fda.gov
Scissors, Surgical Tissue, Dental	EGN	1	Exporter to the US	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Exporter to the US	accessdata.fda.gov
Set, I.V. Fluid Transfer	LHI	2	Exporter to the US	accessdata.fda.gov
Sigmoidoscope And Accessories, Flexible/Rigid	FAM	2	Exporter to the US	accessdata.fda.gov
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	FMK	2	Exporter to the US	accessdata.fda.gov
Sleeve, Limb, Compressible	JOW	2	Exporter to the US	accessdata.fda.gov
Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide	JKS	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
Spirometer, Therapeutic (Incentive)	BWF	2	Exporter to the US	accessdata.fda.gov
Stand, Instrument, Ac-Powered, Ophthalmic	HMF	1	Exporter to the US	accessdata.fda.gov
Stand, Instrument, Ophthalmic, Battery Powered	NOI	1	Exporter to the US	accessdata.fda.gov
Stents, Drains And Dilators For The Biliary Ducts	FGE	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
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, 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, Balloon Inflation	MAV	2	Exporter to the US	accessdata.fda.gov
Syringe, Irrigating (Non Dental)	KYZ	1	Exporter to the US	accessdata.fda.gov
Syringe, Piston	FMF	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
System, Transport, Aerobic	JTW	1	Exporter to the US	accessdata.fda.gov
System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile	EYZ	1	Exporter to the US	accessdata.fda.gov
System/Device, Pharmacy Compounding	NEP	2	Exporter to the US	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Exporter to the US	accessdata.fda.gov
Tape, Measuring, Rulers And Calipers	FTY	1	Exporter to the US	accessdata.fda.gov
Toothbrush, Powered	JEQ	1	Exporter to the US	accessdata.fda.gov
Transformer, Endoscope	GCW	2	Exporter to the US	accessdata.fda.gov
Transilluminator, Battery-Powered	HJN	1	Exporter to the US	accessdata.fda.gov
Transmitters And Receivers, Electrocardiograph, Telephone	DXH	2	Exporter to the US	accessdata.fda.gov
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)	FCM	2	Exporter to the US	accessdata.fda.gov
Tray, Impression, Preformed	EHY	1	Exporter to the US	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Exporter to the US	accessdata.fda.gov
Tube Tracheostomy And Tube Cuff	JOH	2	Exporter to the US	accessdata.fda.gov
Tube, Double Lumen For Intestinal Decompression And/Or Intubation	FEG	2	Exporter to the US	accessdata.fda.gov
Tube, Tracheostomy (W/Wo Connector)	BTO	2	Exporter to the US	accessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)	KNT	2	Exporter to the US	accessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood Collection	JKA	2	Exporter to the US	accessdata.fda.gov
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	KNS	2	Exporter to the US	accessdata.fda.gov
Vaporizer, Anesthesia, Non-Heated	CAD	2	Exporter to the US	accessdata.fda.gov
Ventilator, Emergency, Manual (Resuscitator)	BTM	2	Exporter to the US	accessdata.fda.gov
Warmer, Irrigation Solution	LHC	1	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 186.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 26, 2026	K251670	MAC 7 Resting ECG Analysis System	DPS	Substantially Equivalent	Ge Medical Systems Information Technologies, Inc.	accessdata.fda.gov
December 29, 2025	K251313	Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Distal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Disposable Inner Cannula XLT	JOH	Substantially Equivalent	Covidien, LLC	accessdata.fda.gov
July 25, 2025	K243403	BD Nexiva Closed IV Catheter System	FOZ	Substantially Equivalent	Becton Dickinson Infusion Therapy Systems, Inc.	accessdata.fda.gov
December 20, 2024	K241411	Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)	MWI	Substantially Equivalent	Welch Allyn, Inc.	accessdata.fda.gov
December 6, 2024	K241946	PeritX 1L Drainage Kit (90-1010); PeritX 2L Drainage Kit (90-2010); PeritX Peritoneal Catheter Kit (50-9000C); PeritX Peritoneal Catheter and Starter Kit (50-9900C); PeritX Peritoneal Catheter Mini Kit (50-9050A); PleurX Low Profile Catheter Mini Kit (50-8050); Valve Cap (50-7235A); PeritX Valve Kit (50-7272); Catheter Access Kit (50-7280A); Lockable Drainage Line (50-7245A); Lockable Drainage Line Kit (50-7265A); PleurX Supplemental Insertion Kit (50-7262); Procedure Pack (50-	PNG	Substantially Equivalent	Bard Peripheral Vascular, Inc.	accessdata.fda.gov
November 1, 2024	K242320	BD Vacutainer® One Use Holder	JKA	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
December 5, 2023	K232434	BD Veritor System for Rapid Detection of Flu A+B CLIA Waived Kit	PSZ	Substantially Equivalent	Bd	accessdata.fda.gov
September 20, 2023	K230239	AirSeal iFS System; AirSeal dV Solution	HIF	Substantially Equivalent	Conmed Corporation	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
May 30, 2023	K230909	EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22)	FCG	Substantially Equivalent	Cook Ireland, Ltd.	accessdata.fda.gov
April 27, 2023	K230547	PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation Pencil, PlumePen Ultra Surgical Smoke Evacuation Pencils, PenAdapt Electrosurgical Pencil Adapter, SnapEvac Electrosurgical Pencil Adapter	GEI	Substantially Equivalent	Conmed Corporation	accessdata.fda.gov
April 3, 2023	K230028	Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing Assembly	JOW	Substantially Equivalent	Cardinal Health200, LLC	accessdata.fda.gov
December 2, 2022	K221401	Self-Cath and Self-Cath Plus	EZD	Substantially Equivalent	Coloplast	accessdata.fda.gov
August 16, 2022	K213937	Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution	LZA	Substantially Equivalent	O&M Halyard, Inc.	accessdata.fda.gov
August 12, 2022	K221126	Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets	FMK	Substantially Equivalent	Owen Mumford, Ltd.	accessdata.fda.gov
February 17, 2022	K220137	Lunderquist Extra Stiff Wire Guide	DQX	Substantially Equivalent	William Cook Europe Aps	accessdata.fda.gov
December 22, 2021	K210978	BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle	BSP	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
August 19, 2021	K211104	AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set	HIF	Substantially Equivalent	Conmed Corporation	accessdata.fda.gov
May 20, 2021	K210476	EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle	FCG	Substantially Equivalent	Cook Ireland, Ltd.	accessdata.fda.gov
April 30, 2021	K203786	MAC 7 - Resting ECG Analysis System	DPS	Substantially Equivalent	Ge Medical Systems Information Technologies, Inc.	accessdata.fda.gov
September 25, 2020	K200051	PUGGLE Enteral Feeding Pump and Feeding Set	LZH	Substantially Equivalent	Amsino International, Inc.	accessdata.fda.gov
July 13, 2020	K200960	Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs)	LZA	Substantially Equivalent	Medline Industires, Inc.	accessdata.fda.gov
June 10, 2020	K200972	Hemospray Endoscopic Hemostat	QAU	Substantially Equivalent	Wilson-Cook Medical, Inc.	accessdata.fda.gov
April 6, 2020	K193217	SensiCare PI and SensiCare PI Micro Surgical Gloves	KGO	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
November 26, 2019	K191502	Heraeus Peripheral Guidewire	DQX	Substantially Equivalent	Heraeus Medical Components, LLC	accessdata.fda.gov
November 6, 2019	K190268	Hydrofera Blue READY - Border	FRO	Substantially Equivalent	Hydrofera, LLC	accessdata.fda.gov
October 24, 2019	K181660	Acapella Choice Blue Vibratory PEP Device	BWF	Substantially Equivalent	Smiths Medical	accessdata.fda.gov
September 10, 2019	K191013	Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option	BZG	Substantially Equivalent	Welch Allyn, Inc.	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
March 28, 2019	K190303	AirSeal	HIF	Substantially Equivalent	Conmed Corporation	accessdata.fda.gov
March 22, 2019	K182861	Shiley Neonatal/Pediatric Tracheostomy Tube	JOH	Substantially Equivalent	Covidien	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
January 20, 2019	K183581	Codman Disposable Perforators	HBF	Substantially Equivalent	Integra Lifesciences Corp.	accessdata.fda.gov
January 2, 2019	K183476	3M Filtek Universal Restorative	EBF	Substantially Equivalent	3M Espe Dental Products	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
December 12, 2017	K170898	Wittich Nitinol Stone Basket	LQR	Substantially Equivalent	Cook Incorporated	accessdata.fda.gov
October 18, 2017	K172940	ANCHOR Tissue Retrieval System	GCJ	Substantially Equivalent	Conmed Corporation	accessdata.fda.gov
August 1, 2017	K171619	14Fr Colon Decompression Set, Macon Colon Decompression Set	FEG	Substantially Equivalent	Cook Ireland, Ltd.	accessdata.fda.gov
May 18, 2017	K171139	LaparoLight Veress Needle	HIF	Substantially Equivalent	Buffalo Filter, LLC	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 14, 2016	K162941	Ligasure Blunt Tip, Sealer/Divider, Nano-coated	GEI	Substantially Equivalent	Covidien	accessdata.fda.gov
November 2, 2016	K162095	Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)	LZA	Substantially Equivalent	Yty Industry (Manjung) Sdn Bhd	accessdata.fda.gov
August 25, 2016	K160379	Exufiber Ag+	FRO	Substantially Equivalent	Molnlycke Health Care Us, LLC	accessdata.fda.gov
May 27, 2016	K161170	BD Eclipse Hypodermic Needle	FMI	Substantially Equivalent	Becton, Dickinson and Company	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
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
September 8, 2015	K152286	LigaSure Curved, Small Jaw, Open Sealer/Divider	GEI	Substantially Equivalent	Covidien	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 14, 2015	K150844	Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula	JOH	Substantially Equivalent	Covidien	accessdata.fda.gov
June 10, 2015	K150569	LaparoVue	GCJ	Substantially Equivalent	Buffalo Filter, LLC	accessdata.fda.gov
April 24, 2015	K143530	Aespire View	BSZ	Substantially Equivalent	Datex-Ohmeda, Inc.	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
February 10, 2015	K142716	VCARE	LKF	Substantially Equivalent	Conmed Corporation	accessdata.fda.gov
December 19, 2014	K142430	LIFEPAK 15 monitor/defibrillator	MKJ	Substantially Equivalent	Physio-Control, Inc.	accessdata.fda.gov
December 19, 2014	K142356	Connex Spot Monitor,901058 Vital Signs Monitor Core	MWI	Substantially Equivalent	Welch Allyn, Inc.	accessdata.fda.gov
December 4, 2014	K143145	SafeAir Smoke Pencil	GEI	Substantially Equivalent	Lina Medical Aps	accessdata.fda.gov
September 19, 2014	K142527	Extension Set with BD Q-Syte Luer Access Split Septum	FPA	Substantially Equivalent	Acacia, Inc.	accessdata.fda.gov
August 18, 2014	K142011	SOLUTION SET/EXTENSION SET	FPA	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
July 10, 2014	K133443	MARATHON NO STING LIQUID SKIN PROTECTANT	KMF	Substantially Equivalent	Advanced Medical Solutions (Plymouth), Ltd.	accessdata.fda.gov
February 12, 2014	K132464	PTFE SURGICAL SUTURE	NBY	Substantially Equivalent	Omnia Spa	accessdata.fda.gov
February 12, 2014	K130040	MEPITEL AG	FRO	Substantially Equivalent	Molnlycke Health Care	accessdata.fda.gov
December 6, 2013	K133356	PROLENE POLYPROPYLENE NONABSORBABLE SUTURE	GAW	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
October 8, 2013	K132734	NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS	FPA	Substantially Equivalent	Baxter Healthcare Corp	accessdata.fda.gov
April 5, 2013	K123892	MEPILEX TRANSFER AG	FRO	Substantially Equivalent	Molnlycke Health Care	accessdata.fda.gov
January 10, 2013	K122687	BLOOD CULTURE HOLDER	JKA	Substantially Equivalent	Greiner Bio-One North America, Inc.	accessdata.fda.gov
October 15, 2012	K121483	REUSABLE CUTANEOUS ELECTRODE	GXY	Substantially Equivalent	Ampcare, LLC	accessdata.fda.gov
October 3, 2012	K120125	SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUF	DXQ	Substantially Equivalent	Ge Medical Systems Information Technologies, Inc.	accessdata.fda.gov
August 2, 2012	K122073	ELI 280 ELECTROCARDIOGRAPH	DPS	Substantially Equivalent	Mortara Instrument, Inc.	accessdata.fda.gov
June 29, 2012	K121092	FLOWEASE [SUBCUTANEOUS] INFUSION SET	FPA	Substantially Equivalent	Baxter Healthcare Corp	accessdata.fda.gov
April 27, 2012	K113707	STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING	KGO	Substantially Equivalent	Cardinal Health-Medical Products and Services	accessdata.fda.gov
March 19, 2012	K120453	FILTEK BULK FILL FLOWABLE RESTORATIVE	EBF	Substantially Equivalent	3M Espe Dental Products	accessdata.fda.gov
October 18, 2011	K112893	CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS	FPA	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
September 21, 2011	K111868	STERILE POLYISOPRENE POWDER-FREE BLUE SURGICAL GLOVES WITH NEU-THERA EMOLLIENT COATING	KGO	Substantially Equivalent	Cardinal Health-Medical Products and Services	accessdata.fda.gov
June 14, 2011	K111217	ADDITIVE CAP	KPE	Substantially Equivalent	Baxter Healthcare Corp	accessdata.fda.gov
May 13, 2011	K110771	BD SINGLE USE, HYPODERMIC SYRINGE	FMF	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
March 25, 2011	K103551	INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EXTENSION SET KITS,	FPA	Substantially Equivalent	Baxter Healthcare Corp	accessdata.fda.gov
July 9, 2010	K101680	WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIES	DXN	Substantially Equivalent	Welch Allyn, Inc.	accessdata.fda.gov
May 4, 2010	K100306	KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES	JOW	Substantially Equivalent	Covidien	accessdata.fda.gov
March 12, 2010	K093881	TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR	DQA	Substantially Equivalent	GE Healthcare Finland Oy	accessdata.fda.gov
January 21, 2010	K092250	MEDLINE RED RUBBER URETHRAL CATHETER	EYB	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
October 30, 2009	K093300	ESTEEM SMT POLYISOPRENE POWDER-FREE SURGICAL STERILE GLOVES	KGO	Substantially Equivalent	Cardinal Health, Inc.	accessdata.fda.gov
October 2, 2009	K090568	MEDLINE NITRILE EXAM GLOVES W/ALOE -GREEN	LZA	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
September 23, 2009	K091930	ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM, MODEL TRS100SB	GCJ	Substantially Equivalent	Anchor Products Co.	accessdata.fda.gov
April 29, 2009	K090569	MODIFICATION TO: ATTEST RAPID READOUT BIOLOGICAL INDICATOR, MODE 1292	FRC	Substantially Equivalent	3M Company	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
March 9, 2009	K082478	WELCH ALLYN CARDIOPERFECT WORKSTATION SOFTWARE (CPWS) V 1.62	BZG	Substantially Equivalent	Welch Allyn, Inc.	accessdata.fda.gov
June 13, 2008	K080519	PRISMAFLEX M150 SET	KDI	Substantially Equivalent	Gambro Renal Products, Inc.	accessdata.fda.gov
May 12, 2008	K080238	MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER, MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER	DQA	Substantially Equivalent	Masimo Corporation	accessdata.fda.gov
December 18, 2007	K070060	WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE CUFF (ONE-PIECE)	DXQ	Substantially Equivalent	Welch Allyn, Inc.	accessdata.fda.gov
September 14, 2007	K072320	GREINER VACUETTE QUICKSHIELD COMPLETE	FMI	Substantially Equivalent	Greiner Bio-One North America, Inc.	accessdata.fda.gov
August 15, 2007	K071742	BEAUTIFIL II	EBF	Substantially Equivalent	Shofu Dental Corp.	accessdata.fda.gov
May 23, 2007	K070116	POWER PORT-A-CATH AND POWER PORT-A-CATH II; IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS NEEDLE	LJT	Substantially Equivalent	Smiths Medical MD, Inc.	accessdata.fda.gov
April 20, 2007	K070247	GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM	BTM	Substantially Equivalent	Ohmeda Medical	accessdata.fda.gov
December 1, 2006	K063025	LINA POWERBLADE, MODEL 5005,5005-E,5005-C,5005-150,5000-C-150,5005-E-C-150,5005-420,5005-C-420,5005-E-420,5005-E-C-420,	GEI	Substantially Equivalent	Lina Medical Aps	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
March 7, 2006	K053442	BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE	KGO	Substantially Equivalent	Regent Medical Americas, LLC	accessdata.fda.gov
November 7, 2005	K052437	MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURE	GAM	Substantially Equivalent	Surgical Specialties Corp	accessdata.fda.gov
August 4, 2005	K051609	QUILL SYNTHETIC ABSORBABLE BARBED SUTURE	NEW	Substantially Equivalent	Quill Medical, Inc.	accessdata.fda.gov
June 20, 2005	K051367	PATIENT MONITOR, MODELS DASH 3000, 4000 AND 5000	MHX	Substantially Equivalent	Ge Medical Systems Information Technologies	accessdata.fda.gov
June 16, 2005	K051416	SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA	JOH	Substantially Equivalent	Mallinckrodt Medical	accessdata.fda.gov

Compare with other makers

Updated January 26, 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.