Convatec, A Division of E.R. Squibb & Sons
Skillman, NJ, US
Convatec, A Division of E.R. Squibb & Sons appears in FDA device records in Skillman, NJ. FDA records list 84 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 84
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 84FDA records hold 84 510(k) clearances for Convatec, A Division of E.R. Squibb & Sons between 1982 and 2009. The busiest year on record is 1993, with 10. The most recent is 2009, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 2 |
| 1983 | 4 |
| 1984 | 9 |
| 1985 | 4 |
| 1986 | 6 |
| 1988 | 3 |
| 1989 | 4 |
| 1990 | 4 |
| 1991 | 5 |
| 1992 | 2 |
| 1993 | 10 |
| 1994 | 3 |
| 1995 | 7 |
| 1996 | 7 |
| 1997 | 3 |
| 1998 | 5 |
| 1999 | 2 |
| 2002 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K090254 | SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT) | FRO | Substantially Equivalent | |
| K080383 | AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING | FRO | Substantially Equivalent | |
| K063271 | AQUACEL HYDROFIBER DRESSING AND AQUACEL AG WITH HYDROFIBER SILVER IMPREGNATED ANTIMICROBIAL DRESSING | FRO | Substantially Equivalent | |
| K013814 | ABSORBENT ANTIMICROBIAL WOUND DRESSING | FRO | Substantially Equivalent | |
| K990964 | SIGNADRESS DUODERM DRESSING | KGN | Substantially Equivalent | |
| K984388 | HA ABSORBENT WOUND DRESSING | KGN | Substantially Equivalent | |
| K980720 | NONWOVEN PAD | KMF | Substantially Equivalent | |
| K980382 | NON-WOVEN COMPRESS | KMF | Substantially Equivalent for Some Indications | |
| K974823 | NONWOVEN DRESSING | KMF | Substantially Equivalent for Some Indications | |
| K974205 | KNITTED WOUND DRESSING-STANDARD, WCL AND RIBBON | KMF | Substantially Equivalent | |
| K974304 | GERMICIDAL CLOTH | LRJ | Substantially Equivalent | |
| K973632 | DUODERM CGF CONTROL GEL FORMULA DRESSING | FRO | Substantially Equivalent for Some Indications | |
| K972530 | CONVATEC ODOR CONTROL WOUND DRESSING | KMF | Substantially Equivalent | |
| K972062 | CONVATEC NON-ADHESIVE DRESSING | KMF | Substantially Equivalent | |
| K964835 | COVERAGE SPRAY HBV | LRJ | Substantially Equivalent | |
| K964749 | COVERAGE HBV | LRJ | Substantially Equivalent | |
| K963265 | PROSYS SAMEC LA | EXJ | Substantially Equivalent | |
| K962739 | T.B.Q. | LRJ | Substantially Equivalent | |
| K962590 | SIGNALDRESS | FRO | Substantially Equivalent for Some Indications | |
| K962604 | PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZING | FAQ | Substantially Equivalent | |
| K961319 | EPIVIEW | MGP | Substantially Equivalent | |
| K953767 | PROSYS BEDSIDE DRAINAGE BAG | FAQ | Substantially Equivalent | |
| K952208 | PROSYS LEG BAG | KNX | Substantially Equivalent | |
| K951022 | CIRCULON SYSTEM STEP 1 | MCY | Unknown | |
| K951021 | CIRCULON SYSTEM STEP 2 | MCY | Unknown | |
| K951945 | PROSYS LEG BAG | FAQ | Substantially Equivalent | |
| K951530 | PROSYS URIHESIVE SYSTEM LA | EXJ | Substantially Equivalent | |
| K950690 | PROSYS URIHESICE SYSTEM NL | EXJ | Substantially Equivalent | |
| K943258 | HYDROCOLLOID WOUND DRESSING | KMF | Substantially Equivalent | |
| K935948 | CONVATEC TWO PIECE ABSORBENT DRESSING SYSTEM | KGX | Substantially Equivalent | |
| K925004 | ALLKARE BARRIER WIPE | KMF | Substantially Equivalent | |
| K932101 | DUODERM IMPROVED CGF CONTROL GEL FORMULA DRESSING | MGQ | Substantially Equivalent | |
| K926230 | EPIDRESS & DERMASORB HYDROCOLLOID ALGINATE DRESSIN | KMF | Substantially Equivalent | |
| K931618 | DUODERM HYDROCOLLOID GEL | NAE | Substantially Equivalent | |
| K932143 | FLEXI-TRAK ANCHORING DEVICE | KNY | Substantially Equivalent | |
| K925993 | DUODERM HYDROACTIVE DRESSING | KMF | Substantially Equivalent for Some Indications | |
| K925991 | DUODERM CGF CONTROL GEL FORMULA DRESSING & BORDER | KMF | Substantially Equivalent | |
| K925990 | DUODERM EXTRA THIN CGF DRESSING | KMF | Substantially Equivalent for Some Indications | |
| K925992 | DUODERM TRANSPARENT HYDROCOLLOID DRESSING | KMK | Substantially Equivalent | |
| K924755 | CONVATEC LITTLE ONES PEDIATRIC URINE COLLECTION | EXI | Substantially Equivalent | |
| K924976 | ALLKARE(TM) ADHESIVE REMOVER WIPE | KOX | Substantially Equivalent | |
| K920675 | DUODERM SUSTAINED COMPRESSION BANDAGE | KGX | Substantially Equivalent | |
| K915616 | URIHESIVE STRIP | EXI | Substantially Equivalent | |
| K912667 | DUODERM HYDROACTIVE DRESSING AND CGF DRESSINGS | MGQ | Substantially Equivalent | |
| K912518 | CIRCULON(TM) ADHESIVE COMPRESSION BANDAGE | KGX | Substantially Equivalent | |
| K912550 | DUODERM(R) ADHESIVE COMPRESSION BANDAGE, MODIFIED | KGX | Substantially Equivalent | |
| K904233 | CONVATEC ABSORBENT BANDAGE | EXE | Substantially Equivalent | |
| K904852 | DUODERM DRESSINGS, CGF DRESSINGS, PASTE FULL THICK | FRO | Substantially Equivalent | |
| K905128 | FLEXI-TRAK(TM) ANCHORING DEVICE | KNY | Substantially Equivalent | |
| K903645 | DERMASORB WOUND CONTACT LAYER DRESSING | KOZ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KNYAccessories, Catheter, G-U
- FAQBag, Urine Collection, Leg, For External Use, Sterile
- KMFBandage, Liquid
- KOZBeads, Hydrophilic, For Wound Exudate Absorption
- EXBCollector, Ostomy
- KNXCollector, Urine, (And Accessories) For Indwelling Catheter
- EXJDevice, Incontinence, Urosheath Type, Sterile
- KMKDevice, Intravascular Catheter Securement
- EXIDevice, Paste-On For Incontinence, Sterile
- LRJDisinfectant, Medical Devices
- MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
- MGPDressing, Wound And Burn, Occlusive
- FRODressing, Wound, Drug
- NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic
- NADDressing, Wound, Occlusive
- EYQGarment, Protective, For Incontinence
- EXDIrrigator, Ostomy
- EXEProtector, Ostomy
- KOXSolvent, Adhesive Tape
- KGXTape And Bandage, Adhesive
- MCYWound Dressing Kit
- KGNWound Dressing With Animal-Derived Material(S)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain