22 results
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19ms
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Sources: EU EUDAMED, US FDA
NORDICLAB ESTRADIOL RIA TEST
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Polishers
FDA UDI
DFS - DIAMON GmbH·04057176161352·2ceram polisher flame RA
ADARA
FDA UDI
HNM TOTAL RECON LLC·00841742103099·ADARA ø4.5mm Cortical Screw, Full Thread, Self-...
Arthrex®
FDA UDI
ARTHREX, INC.·00888867042568·4 HOLE DBL COMP PLATE, SQUARE, 20MM
MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES
FDA 510(k)
FDA Class 2
·Anesthesiology
REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI-QUANTITATIVE TEST KIT
FDA 510(k)
FDA Class 2
·Immunology
4 HOLE DOUBLE COMPRESSION PLATE
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HRS·April 11, 2016
GORE SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code FTM·May 8, 2014
HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·October 18, 2012
ALLERGAN LAP BAND
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·August 9, 2010
4 HOLE DOUBLE COMPRESSION PLATE
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HRS·May 12, 2016
4 HOLE DBL COMP PLATE, SQUARE, 20MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HRS·April 23, 2015
Sedecal SP-HF 4.0 Portable X-Ray System; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) Spain
FDA Recall
Terminated
·Sedecal USA, Inc·Product code IZL--·October 27, 2003
Optima URS X-Ray System; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) SPAIN
FDA Recall
Terminated
·Sedecal USA, Inc.·Product code KPR--·September 24, 2002
Sedecal X-Ray High Voltage Generators and Controls; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) SPAIN
FDA Recall
Terminated
·Sedecal USA, Inc.·Product code IZO--·September 26, 2002
Easy Moving Motor Driven Mobile X-Ray Unit, Models SM-20HF and SM-30HF; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) SPAIN
FDA Recall
Terminated
·Sedecal USA, Inc.·Product code IZL--·September 26, 2002
Trumpf Ceiling Mounted Surgical Lighting Systems,TruLight 3000/5000, User Manual #1528403. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
FDA Enforcement
Class II
·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015
Trumpf Ceiling Mounted Surgical Lighting Systems,iLED 3/5, User Manual #1558932. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
FDA Enforcement
Class II
·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015
Trumpf Ceiling Mounted Surgical Lighting Systems,Helion/Xenion S/M/L, User Manual #1441784. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
FDA Enforcement
Class II
·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015
Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia SD, User Manual #1400191. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
FDA Enforcement
Class II
·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015