21 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNTHES ZERO-P
FDA 510(k)
FDA Class 2
·Orthopedic
High Density 144 Sublative iD (400 Pulse), 10-Pk
FDA UDI
SYNERON MEDICAL LTD·37290109952186·High Density 144 Sublative iD (400 Pulse), 10-Pk
ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODEL LCSC5,LCSC1,CS23C,CS231,CS14C,CS141,LCSB5,LCSK5,LCS15,LCS16,CS150
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INION CPS 2.5/2.8 SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
ULTRACISION SURG DEV, CURVED SHEARS, OPEN
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code LFL·June 7, 2006
TROCHANTERIC NAIL KIT, TI GAMMA3 10X170MM X 125
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·September 6, 2012
ULTRACISION SURG DEV, CURVED SHEARS, ENDO
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code LFL·June 7, 2006
ULTRACISION SURG DEV, CURVED SHEARS, ENDO
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.(CINCINNATI)·Product code LFL·June 2, 2006
ULTRACISION SURG DEV, CURVED SHEARS, OPEN
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code GEI·June 19, 2006
ULTRACISION SURG DEV, CURVED SHEARS, ENDO
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code LFL·June 19, 2006
ULTRACISION SURG DEV, CURVED SHEARS, ENDO
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code LFL·June 19, 2006
ULTRACISION SURG DEV, CURVED SHEARS, ENDO
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code GEI·June 19, 2006
ULTRACISION SURG DEV, CURVED SHEARS, OPEN
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code LFL·June 7, 2006
ULTRACISION SURG DEV, CURVED SHEARS, ENDO
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code GEI·June 19, 2006
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·April 23, 2013
ROTATING MULTIPLE CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·April 29, 2011
SPECTRAFLEX
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008
SYRINGE 3ML LL W/NDL 20X1 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·July 25, 2019
Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.
FDA Enforcement
Class II
·Terminated·Exactech, Inc.·October 7, 2020
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