ClearanceBrief
Company · GB

ConvaTec, Inc

FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2026. Name variants (Inc, Corp, punctuation) are merged.

29510(k) clearances (2 in 12 months)
72recalls (5 in 12 months)
18recalls that name a 510(k)

Product codes

CodeDeviceRecords
BYGMask, Oxygen19
KODCatheter, Urological10
FRODressing, Wound, Drug9
KNTTubes, Gastrointestinal (And Accessories)9
EZQPouch, Colostomy8
EZDCatheter, Straight6
OMPNegative Pressure Wound Therapy Powered Suction Pump6
FONBag, Drainage, With Adhesive, Ostomy5
EXBCollector, Ostomy4
EXEProtector, Ostomy3
LNO3
NADDressing, Wound, Occlusive3
GBMCatheter, Urethral2
BYLTent, Oxygen1
DRXElectrode, Electrocardiograph1
EXGBag, Urine Collecting, Ureterostomy1
FCMTray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)1
FENDevice, Cystometric, Hydraulic1
FPDTube, Feeding1
GEIElectrosurgical, Cutting & Coagulation & Accessories1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Aug 5, 2026K260737Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Inte
Convatec, GB
EZD
Apr 1, 2026K252943GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women
Convatec Limited, GB
EZD
Jul 1, 2025K250699Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist
Convatec, GB
EZD
Jun 6, 2025K250891Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter I
Convatec Limited, GB
FCM
Mar 28, 2025K243228Flexi-Seal AIR (with ENFit Connector)
Convatec, GB
KNT
Jan 25, 2024K232665GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)
Convatec, GB
EZD
Nov 8, 2023K230400Cure Catheter Closed System; Cure Dextra Closed System
Convatec, Inc.
EZD
Nov 17, 2022K221593Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus
Convatec, Inc.
EZD
Jun 22, 2022K213283GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter
Convatec Limited, GB
GBM
Apr 30, 2019K190114Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)
Convatec Limited, GB
KNT
Oct 19, 2018K180205AVELLE Negative Pressure Wound Therapy System
Convatec Limited, GB
OMP
Aug 16, 2018K181206GentleCath Glide Intermittent Urinary Catheter
Convatec Limited, GB
GBM
Jul 20, 2018K173675AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber
Convatec Limited, GB
FRO
Nov 21, 2017K172924GentleCath Intermittent Urinary Catheter
Convatec Limited, GB
KOD
Mar 7, 2017K162906Flexi-Seal PROTECT Fecal Management System
Convatec, GB
KNT
Sep 20, 2016K161344GentleCath Glide Intermittent Catheter
Convatec Limited, GB
KOD
Jan 21, 2016K152926AQUACEL Ag Surgical SP Dressing
Convatec Limited, GB
FRO
Jul 21, 2015K150350Flexi-Seal Signal Fecal Management System
Convatec, Ltd., GB
KNT
Aug 1, 2014K140953GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETER
Convatec, Ltd., GB
KOD
Jun 6, 2013K123481AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE
Convatec, Inc.
FRO
Jul 25, 2012K121275AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER
Convatec, Inc.
FRO
Apr 26, 2012K112342FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM
Convatec, Inc.
KNT
Aug 19, 2011K111365VITALA CONTINENCE CONTROL DEVICE
Convatec, Inc.
EZQ
Dec 1, 2010K102536VITALA CONTINENCE CONTROL DEVICE
Convatec, Inc.
EZQ
Apr 2, 2010K083785VITALA CONTINENCE CONTROL DEVICE
Convatec
EZQ
Dec 16, 2009K091034AQUACEL AG SURGICAL
Convatec
FRO
Mar 7, 2008K071763AMADEUS ADAPTIVE COMPRESSION THERAPY
Convatec
JOW
Dec 23, 1997K973689DUODERM HYDROACTIVE DRESSING
Convatec, Ltd.
FRO
Dec 23, 1997K973688DUODERM CONTROL GEL FORMULA BORDER DRESSING
Convatec, Ltd.
FRO

Latest recalls

DateFirm and productCodeLinked 510(k)
Aug 19, 2026ConvaTec, Inc
Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705, 423707, 423708, 423709, 423710, 423712, 423713, 423714, 423715, 423716, 423717, 423718, 423721, 423722, 423723, 42
Open, Classified
EXGNone listed
Jul 7, 2026ConvaTec, Inc
Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
Open, Classified
FROK152926
Mar 19, 2026ConvaTec, Inc
Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm
Open, Classified
FONNone listed
Mar 19, 2026ConvaTec, Inc
Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm
Open, Classified
FONNone listed
Mar 19, 2026ConvaTec, Inc
Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
Open, Classified
FONNone listed
Oct 16, 2025ConvaTec, Inc
DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exudating wounds. DuoDERM" Extra Thin dressings are particularly suitable in areas s
Open, Classified
NADNone listed
Jan 10, 2025ConvaTec, Inc
Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an adhesive skin barrier and an adhesive pouch: ESTEEM SYN FLX WHT16/35MM PRECUT(1X10)
Open, Classified
EXENone listed
Sep 30, 2024ConvaTec, Inc
ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.
Open, Classified
FONNone listed
Apr 8, 2024ConvaTec, Inc
ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1 dressing/immediate package, 5 packages/market unit.
Open, Classified
NACNone listed
Mar 21, 2024ConvaTec, Inc
Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d) 423664, e) 423666, f) 423645, g) 423667, h) 423657, i) 423652, j) 423646, k) 423654, l) 4236
Open, Classified
FONNone listed
Dec 19, 2022ConvaTec, Inc
ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive
Open, Classified
FROK123481
Oct 24, 2022ConvaTec, Inc
ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400599. For the management of stoma output following a colostomy or ileostomy procedure.
Open, Classified
EZQNone listed
Oct 24, 2022ConvaTec, Inc
ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400598. For the management of stoma output following a colostomy or ileostomy procedure.
Open, Classified
EZQNone listed
Oct 24, 2022ConvaTec, Inc
ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/4 in., 19-64mm, REF 416975. For the management of stoma output following a colostomy or ileostomy procedure.
Open, Classified
EZQNone listed
Oct 24, 2022ConvaTec, Inc
ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 416976. For the management of stoma output following a colostomy or ileostomy procedure.
Open, Classified
EZQNone listed
Apr 22, 2022ConvaTec, Inc
SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.
Terminated
EXENone listed
Aug 20, 2021ConvaTec, Inc
DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk)
Open, Classified
NADNone listed
Aug 9, 2021ConvaTec, Inc
DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM Extra Thin Dressing 10X10CM (1X10PK) (ICC 187955)
Open, Classified
NADNone listed
Sep 6, 2019ConvaTec, Inc
Convex Two-Piece Ostomy System (Skin Barrier) marketed under the following brands: 1) Combihesive Natura Durahesive 2) SurFit Natura Durahesive 3) Natura 4) Varicare Product Usage: stoma management
Terminated
EXENone listed
Jan 9, 2019ConvaTec, Inc
FilterFlow Suction Handle CH24, 20 eaches per sales unit. Product Usage: Filter Flow is designed for orthopedic surgery and combines suctioning function with filtering. The device is intended for ort
Open, Classified
JOLNone listed
Jan 9, 2019ConvaTec, Inc
Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as: CH16/40CM and CH14/40CM Product Usage: Urinary Catheters are sterile disposable devices intended to provide an in
Open, Classified
KODK896729
Jan 9, 2019ConvaTec, Inc
Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit. Labeled as: xray CH05/40CM and xray CH08/40CM Product Usage: Duodenal and Stomach Gastroenterology Tubes are sterile disposable de
Open, Classified
FPDK896734
Jan 9, 2019ConvaTec, Inc
Forceps Blue, disposable, sterile, 100 eaches per sales unit. Product Usage: Forceps are sterile disposable devices intended for use during clinical procedures to grasp, manipulate, maneuver or assis
Open, Classified
HTDNone listed
Jul 3, 2018ConvaTec, Inc
AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient mount: a) REF ABV300, b) REF ABV301 AbViser is a sterile non-invasive disposable intra- abdominal pressure monitoring dev
Terminated
FENNone listed
Apr 25, 2018ConvaTec, Inc
Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475 Product Usage: Esteem Synergy Stomahesive with Flexible Collar 22mm Precut Skin Barrier is used together with Esteem Synergy pou
Terminated
MMHNone listed
Oct 26, 2017ConvaTec, Inc
SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar, 10 pack, 45 mm, REF 411802. Intended for use as an ostomy protector providing a protective barrier to patient skin.
Terminated
PQENone listed
May 24, 2017ConvaTec, Inc
Pediatric, High Conc. Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-ALL Oxygen Connector 50 Check Valve, One Side Valve, Product Code 9226-E
Terminated
BYGNone listed
May 24, 2017ConvaTec, Inc
Non-Rebreather Mask w 7 (2.1 m) No-Crush Tubing, Adult, Product Code 9106-E, Product Code 9108-E, Product Code ZRNRMA
Terminated
BYGNone listed
May 24, 2017ConvaTec, Inc
Non-Rebreather Oxygen Mask, Pediatric with Tubing, Product Code 86-3226E, Product Code PMD06009, Product Code PMD06106
Terminated
BYGNone listed
May 24, 2017ConvaTec, Inc
Oxygen Mask, Standard (Under the Lip) Infant, High Concentration Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector Check Valve, Two Side Valves, Product Code 3266-E
Terminated
BYGNone listed
May 24, 2017ConvaTec, Inc
Non-Rebreathing Mask, Reservoir Bag, Check Valve, Two Side Valves, with Tubing, Product Code 3230MM
Terminated
BYGNone listed
May 24, 2017ConvaTec, Inc
Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector Check Valve, One Side Valve, Product Code 3230-E
Terminated
BYGNone listed
May 24, 2017ConvaTec, Inc
Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector, Product Code 3224-E and Product Code 3226-E
Terminated
BYGNone listed
May 24, 2017ConvaTec, Inc
Non-Rebreather, Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3108-E, Product Code 3108MM, Product Code 86-106E, Product Code 86-108-E, Product Code LM-86-106, Product Code PMD06002, Product Code
Terminated
BYGNone listed
May 24, 2017ConvaTec, Inc
Oxygen Masks, Elongated (Under Chin) Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, One Side Valve, FITS-All Conn., Product Code 3106-E
Terminated
BYGNone listed
May 24, 2017ConvaTec, Inc
Rebreather Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3104MM, Product Code 9104-E, Product Code PMD06001
Terminated
BYGNone listed
May 24, 2017ConvaTec, Inc
Oxygen Masks, Elongated (Under Chin), Adult Med Concentration, No Tubing, FITS-All Conn., Product Code 3104-E
Terminated
BYGNone listed
May 24, 2017ConvaTec, Inc
Non-Rebreather Mask, Reservoir Bag, Check Valve, Two Side Valves, No Tubing, Product Code 226MM
Terminated
BYGNone listed
May 24, 2017ConvaTec, Inc
Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7) Oxygen Tubing, Product Code 108MM
Terminated
BYGNone listed
May 24, 2017ConvaTec, Inc
Oxygen Masks, Elongated (Under Chin), Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, Two Side Valve, Product Code 108-E
Terminated
BYGNone listed
May 24, 2017ConvaTec, Inc
Oxygen Mask, Adult High Concentration Non-Rebreather 2.1 m (7) Oxygen Tubing, Product Code 106MM
Terminated
BYGNone listed
May 24, 2017ConvaTec, Inc
Non-Rebreathing Mask, Reservoir Bag, Check Valve, One Side Valve, with Tubing, Product Code 106-E, Product Code 3226MM, and Product Code 9108MM
Terminated
BYGNone listed
May 24, 2017ConvaTec, Inc
Rebreathing Mask, Reservoir bag, with Tubing, Product Code 104MM
Terminated
BYGNone listed
May 24, 2017ConvaTec, Inc
Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E;
Terminated
BYGNone listed
Mar 3, 2016ConvaTec, Inc
Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered directly to a patient.
Terminated
LCQK801867
Jun 13, 2014Convatec Inc.
Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107 Product Usage:For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access
Terminated
KNTNone listed
Mar 20, 2014Convatec Inc.
SLC 3-way standard Lubricious Coated 20Ch/Fr 30 mL/cc Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which
Terminated
KODNone listed
Mar 20, 2014Convatec Inc.
'TORAY' Hydrocoat Foley Catheter 12 x10 4.00 mm Fr x mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube whic
Terminated
KODNone listed
Mar 20, 2014Convatec Inc.
JMS, Japan, 3 WAY, 20 FR 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one majo
Terminated
KODNone listed
Mar 20, 2014Convatec Inc.
SLC 2-way standard Lubricious Coated 14ch/FR 5/10ml/cc Product Usage: Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tu
Terminated
KODNone listed

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