Panels › Gastroenterology, Urology › Product code EZD · Class 2
Catheter, Straight
Regulation 876.5130
11510(k)s in 12 months (87 all time)
0recalls in 12 months (13 all time)
12recalls that name a 510(k)
Top companies in EZD
| Company | 510(k)s | Recalls |
|---|---|---|
| C.R. Bard, Inc. | 5 | 7 |
| Coloplast | 12 | 0 |
| Convatec | 6 | 0 |
| Cure Medical, LLC | 3 | 2 |
| Hollister Incorporated | 5 | 0 |
| Compactcath, Inc. | 3 | 0 |
| Well Lead Medical Co., Ltd. | 3 | 0 |
| Wellspect AB | 3 | 0 |
| Wellspect HealthCare (Division of DENTSPLY IH AB) | 0 | 3 |
| Adapta Medical, Inc. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 8, 2023 | C.R. Bard Inc HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b) REF 71810, c) REF 71812, d) REF 71814, e) REF 71816, f) REF 71818 Open, Classified |
EZD | K150345 |
| Jun 8, 2023 | C.R. Bard Inc Magic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 52810G Open, Classified |
EZD | K172247 |
| Jun 8, 2023 | C.R. Bard Inc Magic3 Go Intermittent Urinary Catheters, male Catalog Numbers: a) REF 50810G, b) REF 50812G, c) REF 50814G, d) REF 50816G, e) REF 50818G, f) REF 53810G, g) REF 53812G, h) REF 53814G, i) REF 53816G, j Open, Classified |
EZD | K172247 |
| Jun 8, 2023 | C.R. Bard Inc Magic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 51808, b) REF 51810, c) REF 51812, d) REF 51814, e) REF 51816, f) REF 51818 Open, Classified |
EZD | K150345 |
| Jun 17, 2020 | Wellspect HealthCare (Division of DENTSPLY IH AB) LoFric Origo, Tiemann, 16in, FR14 urinary catheters Terminated |
EZD | K122078 |
| Jun 17, 2020 | Wellspect HealthCare (Division of DENTSPLY IH AB) LoFric Origo, Tiemann, 16in, FR12 urinary catheters Terminated |
EZD | K122078 |
| Jun 17, 2020 | Wellspect HealthCare (Division of DENTSPLY IH AB) LoFric Origo, Nelaton, 16in, FR10 urinary catheters Terminated |
EZD | K122078 |
| Apr 4, 2018 | C.R. Bard, Inc. Personal Intermittent Catheters- 16" and 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch, Item Numbers: 50612, 50614, 50616, 50618, 52306, 52308, 52310, 52606, 52 Terminated |
EZD | K000723 K122785 |
| Apr 4, 2018 | C.R. Bard, Inc. Magic 3 Intermittent Catheters- 12 Male - 30 catheters per box, each catheter is packaged in an individual pouch. Urinary catheter. Terminated |
EZD | K000723 K122785 |
| Apr 4, 2018 | C.R. Bard, Inc. HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch. MGC3
Product Usage Intermittent catheters are intended for urinary blad Terminated |
EZD | K000723 K122785 |
| Dec 16, 2014 | Cure Medical LLC Pediatric, 10Fr, Intermittent Urinary Catheters
Model: P10
Pouch Label UPC (P10) *+M405P100C*
Intermediate Box Label UPC (P10) *+M405P103F*
Carton Label UPC (P10) *+M405P105H*
The product is distribu Terminated |
EZD | K110653 |
| Oct 2, 2012 | Cure Medical LLC Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialy Terminated |
EZD | K072539 |
| Jun 3, 2011 | Coloplast Manufacturing US, LLC SureCath Set with Accessories, Coloplast Corp.-MN 06093, Sterile EO., Manufacturer Coloplast -A/S 3050 Denmark.
28022S 1400 SureCath Set,acc CH8 Male,bulk
28023S 1400 Surecath Set,acc CH10 Male,bul
2 Terminated |
EZD | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.