15 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
1CMR Pro
FDA 510(k)
FDA Class 2
·Radiology
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613018009·K-Wire, Single Ended, Trocar Point, Diameter Si...
NA
FDA UDI
Medos International Sàrl·10886705031689·Sheath with 2 Rotating Stopcocks compatible wit...
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112557·BARRON VACUUM TREPHINE 9.0MM
PERIPHERAL VASCULAR SHEATH TUNNELER STERILIZATION CASSETTE
FDA 510(k)
FDA Class 2
·General Hospital
SPIRAL FLOW PERIPHERAL VASCULAR GRAFT
FDA 510(k)
FDA Class 2
·Cardiovascular
NA
FDA UDI
Zimmer, Inc.·00889024119611·
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·November 2, 2023
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 10, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 23, 2013
Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot 122336 Opthalmic
FDA Recall
Terminated
·Surgical Instrument Service And Savings, Inc.·Product code HRH·May 3, 2013
Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot 122336 Opthalmic
FDA Enforcement
Class II
·Terminated·Surgical Instrument Service And Savings, Inc.·July 10, 2013
Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144;
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 28, 2025
SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144;
FDA Enforcement
Class II
·Ongoing·Philips North America·August 6, 2025