15 results
·
29ms
·
Sources: EU EUDAMED, US FDA
BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647
FDA 510(k)
FDA Class 2
·Immunology
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091033036·Baltic Denture System BDLoad Sw6 PLSEbm6DFs C4 ...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0330160·Coronal Bender, Right
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0330060·Rod Bender, 5.5 mm, 3 Position
NOMOS MOTORIZED CRANE II
FDA 510(k)
FDA Class 2
·Radiology
TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025
FDA 510(k)
FDA Class 1
·Ophthalmic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Injury
·DEXCOM, INC.·Product code QBJ·April 17, 2026
HNM LATERAL ANCHOR
FDA Adverse Event
Injury
·HNM STAINLESS, LLC DBA HNM MEDICAL·Product code HWC·April 16, 2018
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 3, 2013
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·March 29, 2011
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·April 22, 2008
Zimmer Inverse/Reverse Screw system,
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·November 14, 2012
Instrument Kit for use with OsteoSponge SC grafts. The Instrument Kit is used to insert OsteoSponge SC grafts to fill bone defects in the subchondral region of articulating joints. The Instrument Kit is used to establish and maintain a port of entry for arthroscopic instruments or for an open procedure. The kit is also used to insert the OsteoSponge¿ SC graft during surgery. Such procedures include, but are not limited to, subchondral bone repair. Affected Part numbers are 6508 and 6511.
FDA Enforcement
Class II
·Terminated·Bacterin International, Inc.·April 15, 2015
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024