14 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ENDODRAPE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489004066·PowerChem Neoprene Exam Gloves, Extra Extra Large
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108694338·Pilot Guided Sleeve Ø2mm L10mm, L20mm Drill (Br...
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180502037·LIF Distractor – 16mm x 6mm
StrykeFlow
FDA UDI
STRYKER CORPORATION·07613327051759·Reusable Suction Irrigation Tip, Pool Suction, ...
JMS A.V. FISTULA NEEDLE SET WING EATER, MODEL 14G-18G
FDA 510(k)
FDA Class 2
·General Hospital
RHINOSCAN MODEL SRE2000/ SRE2100 WITH ACOUSTIC RHINOMETRY MODULE
FDA 510(k)
FDA Class 2
·Anesthesiology
ADVISOR VITAL SIGNS MONITOR
FDA Adverse Event
Malfunction
·SMITHS MEDICAL PM, INC.·Product code CCK·December 24, 2008
ADVISOR VITAL SIGNS MONITOR
FDA Adverse Event
Malfunction
·SMITHS MEDICAL PM, INC·Product code DQK·April 28, 2010
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 22, 2013
RESERVOIR 3CC
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FRN·April 19, 2011
SCORPIO NRG INSERT TRIAL #7 12MM
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS MAHWAH·Product code LXH·June 30, 2008
MiniView 6800 Digital Mobile C-arm fluoroscopic x-ray system.
FDA Recall
Terminated
·GE OEC Medical Systems, Inc·Product code JAA·March 28, 2006
Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·November 9, 2016