ClearanceBrief
Panels › Gastroenterology, Urology › Product code FAD · Class 2

Stent, Ureteral

Regulation 876.4620

2510(k)s in 12 months (122 all time)
4recalls in 12 months (55 all time)
49recalls that name a 510(k)
Get daily alerts for FADSample briefCSV

Top companies in FAD

Company510(k)sRecalls
Cook Incorporated138
Vance Products Incorporated018
Boston Scientific Corp125
C.R. Bard, Inc.78
Applied Medical Resources56
Hobbs Medical, Inc.19
Surgitek90
Mentor Corp.80
Coloplast Corp.70
Cook Urological, Inc.51
DateFirm and productCodeLinked 510(k)
Sep 16, 2008Applied Medical Resources Corp
SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3857, SIZE 6F x 26cm Urological stents are disposable single-use temporary indwelling catheters that allow urine to drain th
Terminated		 FADK040760
K060673 +1
Sep 16, 2008Applied Medical Resources Corp
SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3856, SIZE 6F x 24cm Urological stents are disposable single-use temporary indwelling catheters that allow urine to drain thro
Terminated		 FADK040760
K060673 +1
Jun 29, 2007Vance Products Incorporated
Cook Urological Black Silicone Filiform Double Pigtail Ureteral Stent Set, 7.0Fr/24cm, sterile, Order Number (REF) 133724.
Terminated		 FADNone listed
Jul 13, 2006Boston Scientific Corp
Boston Scientific Contour VL Injection Stent with Hydro Plus Coating, 6 FR (2.0 mm) x 22-30 cm (220-300mm), sterile, UPN: M0061856300. Ureteral stent.
Terminated		 FADK010002
Mar 23, 2006Cook Urological, Inc.
Cook Harrison fetal bladder stent set, sterile; REF J-HFBS-503540.
Terminated		 FADNone listed

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.