3 results · 12ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Stryker 275 mL AutoFuser PainPump, single site continuous, 2 mL/hr, 1 x 5.0 in. catheter, sterile, REF 0532-200-050.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEB·May 14, 2009

Meridian Nexus, single use. Part Numbers: C4N00D001, 15867, 15880, 15880-30, 12000-1, 40000-1, 40200-1, 40301-1, 40301-1ML, 40301-1-13, 40301-1-13MM, 40301-1-24, 40301-1-30, 40302-1C24, 60000-1, 60201-1, 60300-M, 60301-1, 60301-1-24, 60302-1HM30-70, 60301-13042M, 72300-1-4-30-70, 72301-1, 72000-50-7589, 60301-1304042, and 72000-75. Manufactured for MMS Sales Corporation, 218 Highline Road, Pharr, Texas 78577, Made in Mexico.

FDA Recall
Terminated ·MMS Sales Corp·Product code CAI·February 21, 2005

Abbott brand IntraLase Femtosecond Laser System, Model 2; Catalog Numbers: 20003D/J/K, R20003D/J/K, 20005D/J/K; Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA Product Usage: Intended Use for: IntraLase Femtosecond (Model 2 and 3) and iFS Advanced Femtosecond Laser Systems. FS Laser Systems are ophthalmic surgical lasers used in certain patient populations: (1) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea; (2) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; (3) In lamellar IEK [lntraLase Enabled Keratoplasty] and corneal harvesting ; (4) In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea; (5) In the creation of a lamellar cut/resection of the cornea for lamellar IEK for the creation of a penetrating cut/incision for penetrating IEK.

FDA Recall
Terminated ·AMO Manufacturing USA, LLC·Product code HNO·October 12, 2011