Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015219237

FEI Number

3015219237

Entity Name

STERIGENICS UK LIMITED

City/State/Country

Chesterfield Derbyshire, GB

Establishment Address

Unit 3a, Seymour Link Road, Chesterfield Derbyshire S43 3FG, GB

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Sotera Health LLC (Owner Number: 10029425)

Owner / Operator Contact Address

2015 Spring Road, Suite 650, Oak Brook, IL 60523, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Enspire Vacuum Tubing Cassette Enspire Vacuum and Rinse Tubing Cassette VAPR® Temperature Control End Effect Electrode 2.3 mm x 140 mm Electrosurgical cutting and coagulation device and accessories VAPR TC ELECTRODE 11 guage Bone Access Needles Homer Breast Localization Needles OnPharma OnSet Cartridge Connector MiniStop Plus BackStop Plus Monoject Bone Marrow Biopsy Tray with Safety Components PERCUCUT NEEDLES, N105, N110, N115, N710, N715, N810, N815 Turkel Safety Fluid Drainage System Curity Amniocentesis Tray Disposable Needles BONE BIOPSY NEEDLE Curity Thoracentesis Trays with Safety Components Facet Screw Instruments FNA - Fine Needle Aspiration CHIBA NEEDLE MEDTRONIC Facet Screw Instruments Turkel Thoracentesis System: 566059 Turkel Thoracentesis System: 566034 Integra; Jarit; MicroFrance; Miltex; Padgett; Xomed Anesthesia Peribulbar; Retrobulbar Needles Turkel Thoracentesis System: 566075 Monoject Sternal-lliac Aspiration Needle Turkel Safety Thoracentesis Procedural Tray Monoject Basic Bone Marrow Biopsy and Aspiration Tray with Safety Components Monoject Bone Marrow Biopsy and Aspiration Tray with Safety Components Monoject Basic Bone Marrow Biopsy Tray with Safety Components Monoject Bone Marrow Biopsy Prepping Tray with Safety Components Monoject Bone Marrow Biopsy / Aspiration Needle Cardinal blunt fill needle with filter Temporary Sharps Holder "ShortStopGrandstand Cardinal blunt fill needle wwithout filter 545050501 SmartSet GMV Gentamicin Bone Cement 40g SmartSet GMV Gentamicin Bone Cement 545050500 SmartSet GMV Endurance Gentamicin Bone Cement GMV EO US Bone Cement VAPR® 2.3 End Effect Electrode 140mm 20g SmartSet MV Bone Cement SmartSet MV Bone Cement 40g SmartSet MV Bone Cement ActiVAC, 5 Pack Hysteroscope (And Accessories) TWIZZLE ELECTRODE (5 PACK) Versapoint Bipolar Electrode - Spring Tip 5 Fr. (1.6 mm nom.) x 360 mm Versapoint Bipolar Electrode - Twizzle Tip 5 Fr. (1.6 mm nom.) x 360 mm Hysteroscope (And Accessories) SPRING ELECTRODE (5 PACK) Hysteroscope (And Accessories) BALL ELECTRODE (5 PACK) INTESTINE BAG Organ Bag 10GA EnCor 10GA EnCor MRI Blunt Tip 10GA EnCor Upright 10GA EnCor MRI Rinse Tube, VS3000 Tissue Collection Tray, 10G, 7G, MR Needle Guide Insert, 10G, Lorad Needle Guide Insert, Aurora, EnCor MRI EnCor Needle Guide Insert 7 Gauge EnCor Syringe Adapter Collection Tray Cover EnCor Needle Guide Insert 12 Gauge Needle Guide Insert, Lorad EnCor Needle Guide Insert 10 Gauge Needle Guide Insert, 12G, Fischer Tissue Collection Tray, 7G General Surgical Instrument ER2 Saturate Mixing System VORTEX & MIXOR NOZZLE UMBRELLA VORTEX ADAPTER VORTEX VACUUM MIXING SYSTEM VACUUM TUBE W/SUC BYPASS VORTEX & MIXOR NOZZLE ANGLED VORTEX VACUUM BOWL VORTEX&MIXOR NZLE STAND BRKAWY MIXOR FEMORAL PRESSURIZER-LG KYPHON® Mixer VORTEX RE-USE KIT VORTEX & MIXOR NOZZLE REVISION VORTEX&MIXOR NZLE LONG TAPERED 0206-548-000 0206-547-000 0206-556-000 0206-566-000 0206-545-000 0206-546-000 0206-509-000;0206-564-000 HiVac Bowl Bone Cement Mixing System B713 0506-482-000 0605-685-015 0606-573-000 0606-583-000 0306-564-000 0606-705-000 0506-689-015 0605-683-015 0606-595-000 0506-486-000 0606-509-000 MiniMix LV Bone Cement Mixing System SMLV 0605-687-015 0605-887-000 0506-685-015 0606-516-000 Medium Port MiniMix Bone Cement Mixing System SMMM1 RALLY Vacuum Mixing Bowl 7127-1801 0506-483-000 Mixing Bowl, Spatula B710 0606-593-000 0606-515-000 0606-517-000 0606-514-000 0707-001-000 AutoPlex M4 Cement Mixer 0506-489-000 0606-553-000S1 Kyphon Mixer 0606-705-000S1 0306-553-000S2 0506-485-000 0606-512-000 0606-593-000S1 0606-565-000 0506-686-015 0606-520-000 0506-683-015 0506-682-015 0606-518-000 0606-553-000 0606-563-000 0306-563-000 0306-573-000 0506-687-015 CellTrans Post-Operative Autotransfusion System 90 Degree Breakaway Nozzle INTRODIGITATOR CDrive Cement Dispenser CDrive Cartridge Assembly KYPHON® Directional Bone Filler Device JET-VAC CEM DISP INT TIP KYPHON® Cement Delivery System Kyphon Bone Filler Device Kyphon Cement Delivery System Kyphon Bone Filler Devices FEMORAL PRESSURIZER Cement dispenser KYPHON® Bone Filler Devices HiVac Syringe Bone Cement Mixing and Delivery System MiniMix Delivery Syringe SMDS1C ZIMMER BONE CEMENT INJECTOR ZIMMER CEMENT DISPENS ALLEVYN Complete Care 3"x4" Primapad Non-Adherent Dressing 3"x8" Primapad Non-Adherent Dressing Biatain CUD Film Wound Dressing Silflex DUODERM STERILE DRESSING, DUODERM STERILE DRESSING (SIGNAL HYDROACTIVE), BORDER, CG, EXTRA THIN, 2"x3" Reliamed Non-Adherent Dressing Episil Absorbent DUODERM CGF BDR DRS 15X15CM (1X5PK) NAI DUODERM CGF DRS15X20CM (1X5PK) NAI DUODERM SIGNAL 20X20CM (1X5PK) NAI DUODERM SIGNAL 15X18CM (1X5PK) NAI DUODERM XTHIN DRS OVAL (1X20PK) NAI DUODERM CGF BDR DRS 10X10CM (1X5PK) NAI DUODERM CGF DRS 20X20CM (1X5PK) NAI DUODERM SIGNAL 20X22.5CM (1X5PK) NAI DUODERM SIGNAL 14X14CM (1X5PK) NAI DUODERM SIGNAL 20X23CM (1X5PK) NAI DUODERM XTHIN DRS TRG (1X10PK) NAI DUODERM SIGNAL 18.5X19.5CM (1X5PK) NAI Bolin Chest Seal DUODERM XTHIN DRS 10X10CM (1X10PK) NAI DUODERM CGF BDR DRS 6X6CM (1X5PK) NAI DUODERM CGF DRS 15X15CM (1X20PK) NAI DUODERM XTHIN DRS 5X20CM (1X10PK) NAI DUODERM XTHIN DRS OVAL (1X10PK) NAI DUODERM SIGNAL 11X19CM (1X5PK) NAI DUODERM XTHIN DRS 7.5X7.5CM (1X20PK) NAI DUODERM CGF DRS 15X15CM (1X5PK) NAI DUODERM CGF BDR DRS 10X13CM (1X5PK) NAI DUODERM CGF DRS 10X10CM (1X5PK) NAI DUODERM CGF DRS 20X30CM (1X5PK) NAI DUODERM CGF DRS 10X10CM (1X20PK) NAI DUODERM CGF BDR DRS 15X18CM (1X5PK) NAI DUODERM XTHIN DRS 5X10CM (1X20PK) NAI DUODERM SIGNAL 10X10CM (1X5PK) NAI DUODERM XTHIN DRS 15X15CM (1X10PK) NAI DUODERM DRS 10X10CM (1X20PK) NAI Biatain Silicone ALLEVYN Gentle Stratamed StrataXRT Biatain Silicone Lite Stratacel Allevyn Life H-Vent StrataGRT NelDerm Hydrogel Dressings Derpixa StrataCTX Comfeel Plus Biatain Super Non-Adhesive Band-Aid Neutrogena Sensitive Skin Triangle Acne Patches Comfeel Plus Contour Biatain Super Adhesive Adhesive Bandage Coverlet Biatain Silicone Non-border Neutrogena Sensitive Skin Mini Acne Patches Comfeel Plus Transparent Foam Lite ConvaTec Neutrogena Sensitive Skin Blemish Patches Episil Biatain Adhesive CUD+ CTD Dressing wound occlusive Biatain Soft-Hold 2"x3" Primapad Non-Adherent Dressing Biatain Non-Adhesive Neutrogena Sensitive Skin Nose Patches Hydrocolloid adhesive bandages Compeed Neutrogena Stubborn Acne Ultra-Thin Blemish Patches Biatain Silicone Fit Electrosurgical cutting and coagulation device and accessories VAPRFLEX END EFFECT (FLEX END EFFECT) Electrosurgical cutting and coagulation device and accessories THERMAFLEX SIDE EFFECT (FLEX THERMAL SIDE EFFECT) Electrosurgical cutting and coagulation device and accessories ANGLED END VAPR® Angled End Effect Electrode 3.5 mm x 160 mm VAPR® Side Effect Electrode 3.5 mm x 160 mm VAPR® Flexible End Effect Electrode 3.5 mm x 160 mm VAPR® 90 Degree Hook Electrode 3.5 mm x 160 mm VAPR® Flexible Side Effect Electrode 3.5 mm x 160 mm VAPR® Angled Side Effect Electrode 3.5 mm x 160 mm VAPR® End Effect Electrode 3.5 mm x 160 mm Electrosurgical cutting and coagulation device and accessories HOOK (90 DEG HOOK) Electrosurgical cutting and coagulation device and accessories ANGLED SIDE Electrosurgical cutting and coagulation device and accessories SIDE EFFECT Electrosurgical cutting and coagulation device and accessories VAPRFLEX SIDE EFFECT (FLEX SIDE EFFECT) Electrosurgical cutting and coagulation device and accessories THERMAFLEX END EFFECT (FLEX THERMAL END EFFECT) Electrosurgical cutting and coagulation device and accessories END EFFECT VAPR® COOLPULSE® Curve XL Suction Electrode Curved Suction Electrode with Integrated Handpiece and Hand Controls 200mm VAPR® TRIPOLAR 90° Suction Electrode 90° Suction with Integrated Handpiece and Hand Controls VAPR® COOLPULSE® Curve Suction Electrode Curved Suction Electrode with Integrated Handpiece and Hand Controls 135mm Dish, Tissue Culture 17240/48 17651/100 PETRI60X15/100 Slide Permanox 384 Shallow Well, Standard Height, CC Black Italy Nunclon OmniTray Barcode Pre-Assembled CF-10 w/TS Novartis 992, 384W Plate, w/BC 384 Shallow Well, Standard Height, CC White 384 Well, White, CC Treat Skin Graft Growth Dish 1536 Shallow Well, Standard HT CC Black, w/Lid Cell Factory 1 Chamber 632 CM2 225cm2 Easy Flask, Vent 384 Well, Black, CC Treat 1536 Shallow Well, Standard HT CC White, w/Lid 1536 Shallow Well, Standard HT CC Clear, w/Lid Barcoded 384W OBP, Black, CC, GSK 384 OBP, Black, CC Treat, w/Lid Cell Fact 10 Chamber 6,320 CM2 384 OBP Coverglass, Black, CC, w/Lid 150x15mm TC Dish w/Vents 384 Shallow Well, Standard Height, CC Clear 384 OBP Coverglass, Black, CC, w/Lid Sample Cell Factory 10 Chamber 6,320 CM2 225cm2 Easy Flask, Filter 384 Well, Clear, CC Treat Omnitray, CC Treat, Ster, w/Lid EasyFill CF Adapt Port Cap, ½ 35 x 10mm Suspension Dish 96 Well OBP, TCC, Black Pre-Assembled CF-40, Novartis EasyFill CF ¼ 4 Well Dish Nunclon Strl, Lid 35 x 10mm TC Dish w/2mm Grid EasyFill, CF 3/8 Cell Factory 2 Chamber 1,264 CM2 384 Well Plate, PS, White w/o lid, CC treated CelBio, OmniTray, Nunclon,n D-BC-S1&2 384 Well Plate, Black w/o Lid Cell Factory 40 Chamber 25, 280cm Skin Graft Growth Dish with Lifter 384 OBP, Black, CC Treat, w/o Lid 384 White CC w/2 barcode labels 96 OBP Polymer Black CC w/Lid 384 Well Plate w/barcode labels 8 Well Dish Nunclon Stel, Lid 60 x 15mm TC Dish Permanox 96 OBP Polymer White CC w/Lid 60g SmartMix Cemvac prefilled with SmartSet HV Bone Cement, 80g SmartMix Cemvac prefilled with SmartSet HV Bone Cement, SmartMix Cemvac with SmartSet HV Bone Cement Medtronic Instrument Confidence High Viscosity Spinal Cement AQUACEL Foam Super absorbent woven Eclypse Adherent Sacral Foam/silicone Advazorb Silflo/Silflo Lite Foam/silicone Advazorb/Advazorb Lite (Advazorb Plus) Super absorbent woven dressing Eclypse Boot Woven Eclypse Woven Ecylpse Adherent Mepore Pro / Ultra Foam/silicone Advazorb Silfix/Silfix Lite Non woven ribbon dressing Advadraw Spiral Non woven dressing Advadraw Dressing, Wound Hydrophilie Triad Foam Wound Dressings - 004766,004781,004782,003900, 003901,003902,003903,003904, 001502,001042, 005085 Zetuvit (plus) Advazorb Fixation Advadraw Zorflex ZF20 Zorflex ZF10 Eclypse Contour Zetuvit Plus Silicone (Border) Advazorb Heel Eclypse Adherent Advazorb Sacral Zorflex ZF15 Advazorb Areola Advadraw Spiral Advazorb Eclypse Foot Advazorb Silfix Eclypse Boot Eclypse Border & Border Oval Advazorb Border Lite Eclypse Advazorb Border Eclypse Adherent Sacral ConvaFoam Border ConvaFoam Non-Adhesive AQUACEL Foam Pro ConvaFoam Silicone Exufiber SmartSet HV Bone Cement 20g SmartSet HV Bone Cement 40g SmartSet HV Bone Cement Femoral Cement Pressuriser P721 3312040 DePuy CMW 1 Bone Cement 3322020 DePuy CMW 2 Bone Cement 3312020 DePuy CMW 1 Bone Cement 3332040 DePuy CMW 3 Bone Cement 3322040 DePuy CMW 2 Bone Cement DePuy CMW 1 Bone Cement SmartSet MV Endurance Bone Cement 3332020 DePuy CMW 3 Bone Cement DePuy 3 CMW Bone Cement DePuy CMW 3 Bone Cement Electrosurgical cutting and coagulation device and accessories ELECTRODE, PK SUPERSECT (ANGLED LOOP) PLASMAKINETIC SUPERPULSE SYSTEM SuperLoop PK Front Loading Electrode PLASMAKINETIC SUPERPULSE SYSTEM SuperSect PK Front Loading Electrode Electrosurgical cutting and coagulation device and accessories ELECTRODE, PK SUPERSECT (90° LOOP) 7GA EnCor MRI 7GA EnCor 7GA EnCor Upright 12GA EnCor Probe Upright 12GA EnCor EnCor /VisilocMRI Introducer NasaMist saline Spray Granufoam Medium Dressing, 5 Pack Granufoam Medium Dressing, 10 Pack 3315020 DePuy CMW 1 Gentamicin Bone Cement DePuy CMW 1 Gentamicin Bone Cement 545031500 DePuy CMW 1 Gentamicin Bone Cement Jackson-Pratt Wound Drainage Devices TRU-CLOSE Suction Drainage System Suction Reservoir Kit 3335020 DePuy CMW 3 Gentamicin Bone Cement 545033500 DePuy CMW 3 Gentamicin Bone Cement 545032500 DePuy CMW 2 Gentamicin Bone Cement DePuy CMW 2 Gentamicin Bone Cement DePuy CMW 3 Gentamicin Bone Cement 3325040 DePuy CMW 2 Gentamicin Bone Cement

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2013-02-26
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-12-03
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2012-12-03
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2012-11-01
MBB	Bone Cement, Antibiotic	Orthopedic	Class 2	888.3027	2013-01-31
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2013-01-31
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-12-04
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2024-08-09
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2013-01-31
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2025-07-15
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2012-12-03
KGY	Bag, Intestine	General, Plastic Surgery	Class 1	878.4100	2017-06-20
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-07-01
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2013-02-26
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	Class 1	888.4210	2012-10-29
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2021-03-05
KIH	Dispenser, Cement	Orthopedic	Class 1	888.4200	2012-11-01
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2012-12-19
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2021-03-05
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-12-03
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2012-12-14
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-07-02
FEQ	Pump, Air, Non-Manual, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2021-03-05
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2019-07-01
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	Class 1	884.1730	2019-07-02
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2022-08-31
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-05-02
KIZ	Dish, Tissue Culture	Hematology	Class 1	864.2240	2012-11-01
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	Class 1	888.4210	2013-01-31
KIH	Dispenser, Cement	Orthopedic	Class 1	888.4200	2013-01-31
MBB	Bone Cement, Antibiotic	Orthopedic	Class 2	888.3027	2013-01-31
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2013-01-31
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2019-07-01
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2022-08-31
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2012-11-01
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2019-07-01
PML	Bone Cement, Posterior Screw Augmentation	Orthopedic	Class 2	888.3027	2025-06-27
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-06-27
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2013-02-04
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2019-07-02
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-07-02
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2019-07-02
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2013-01-31
HWN	Instrument, Compression	Orthopedic	Class 1	888.4540	2024-05-07
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2013-02-01
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-12-04
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2019-07-01
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2013-02-26
KCJ	Applicator, Ent	Ear, Nose, Throat	Class 1	874.5220	2012-11-06
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2025-07-15
OCT	Anti Fog Solution And Accessories, Endoscopy	Gastroenterology, Urology	Class 2	876.1500	2019-07-02
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-07-01
KCO	Nasal Spray, Ent Delivery	Ear, Nose, Throat	Class 1	874.5220	2024-05-01
MBB	Bone Cement, Antibiotic	Orthopedic	Class 2	888.3027	2013-02-01
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2013-02-01
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2012-10-23
MBB	Bone Cement, Antibiotic	Orthopedic	Class 2	888.3027	2013-02-01
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2022-08-31

Official Correspondent

Karen Whaley-Krumins

US Agent Details

Chris Eustace Email: ceustace@sterigenics.com Phone: (630) 9281700

Related Public Records

Same Entity

Sotera Health LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

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3008132411	Sterigenics Shanghai E Beam Ltd.	Shanghai, CN
9616517	Sterigenics S. de R.L. de C.V.	Tepeji del Rio de Ocampos Hidalgo, MX
3008328679	Sterigenics S. de R.L. de C.V.	Cuautitlan Izcalli Mexico, MX

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2024	Bard Peripheral Vascular Inc	2	Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
Z-0028-2013	Remington Medical Inc.	2	Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830 Meadowridge Court, Alpharetta, GA 30005. Prostate Biopsy Needles shall be single use only and are to be used by a Urologist in a healthcare setting to obtain needle biopsies of the prostate. The needles are compatible with the Bard Magnum biopsy instrument. The needles have an echogenic tip for accurate placement under ultrasound guidance and centimeter markings along the cannula to facilitate depth placement.
Z-0042-2014	Atossa Genetics, Inc.	2	Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT), MASCT System Kits, Clarity System Kits, MASCT Patient Sample Kits & Clarity Patient Sample Kits Instrument, Biopsy. The MASCT System Kit, Patient Sample Kits, or the Nipple Aspirate Fluid Laboratory Kit has the following codes: PRODUCT CODE: AG-MASCT; AG-FC5; DTG-MASCT, DTG-FC5, and NRLBH-5. PART NUMBER: 9002513; 9002513MD; 9002528; 9002528MD; 9002587; 9002614; and 9002717MD. THE MASCT SYSTEM KIT CONSISTS OF: 1. MASCT Breast Pump; 2. Instructions for Use (IFU); 3. Heating Pad; 4. Timer; 5. Saccomono's Fixative; 6. Nu Prep Gel; 7. Welcome and Training Materials Coversheet; 8. MASCT System Order Form; 9. ForeCYTE Training Video DVD; 10. MASCT System Instructions with pictures - pink; THE PATIENT SAMPLE KIT CONSISTS OF: 1. Two (2) flower assemblies (e.g., filter, filter retainer, and filter holder); 2. Instructions for Use (IFU); 3. Two (2) specimen collection devices; 4. Two (2) breast bags for transporting the specimen collection container; 5. Barcode labels; 6. Saccomono's Fixative; 7. Nu Prep Gel; 8. MASCT System package insert; 9. ForeCYTE Test Requisition Form; 10. Patient Information Sheet; 11. Atossa Patient Information; 12. FED EX Clinical PAK; 13. MASCT System Order Form; 14. FED EX Pouch; 15. FED EX Airbill; Product Usage: The MASCT Device is intended for use in the collection of nipple aspirate fluid for cytological testing. The collected fluid can be used in the determination and/or differentiation of normal versus premalignant versus malignant cells.
Z-0044-2018	Bard Peripheral Vascular Inc	2	BARD MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g x 10 cm; MC1616, 16 g x 16 cm; MC1816, 18 g x 16 cm; MC1820, 18 g x 20 cm; MC1825, 18 g x 25 cm. The core needle biopsy device is intended for use in obtaining biopsies from soft tissues.
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015219237. Last updated year: 2026. Please use registration number 3015219237 when referencing this establishment in official correspondence.