21 results
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34ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RESPIRONICS PERFORMAX TOTAL FACE MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
NA
FDA UDI
Karl Storz GmbH & Co. KG·04048551428009·Video Uretero-Renoscope FLEX-XC1
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450306611·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450291948·
CONMED
FDA UDI
Conmed Corporation·10845854033432·MICRO TAPERED FISSURE BUR, MEDIUM, 1.2 X 2.3 MM...
POWDER-FREE LATEX EXAMINATION GLOVE, BLUE COLORED
FDA 510(k)
FDA Class 1
·General Hospital
SAMARCO SPIDER PLATES
FDA 510(k)
FDA Class 2
·Orthopedic
VIDEO URETERO-RENOSCOPE FLEX-XC1
FDA Adverse Event
Malfunction
·KARL STORZ ENDOVISION·Product code FGB·March 6, 2026
OXFORD UNI FEMORAL MD
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code NRA·May 3, 2013
GRANUFLO
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 5, 2014
HEARTSTART XL
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·April 20, 2011
ANN, BLUNT TIP SCREW, 4X42MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·July 14, 2022
ANN, BLUNT TIP SCREW, 4X48MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·July 14, 2022
ANN, PROXIMAL HUMERUS, RIGHT, 11X160MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·July 14, 2022
ANN, BLUNT TIP SCREW, 4X56MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·July 14, 2022
NEB100
FDA Adverse Event
Malfunction
·SUNSET HEALTHCARE SOLUTIONS·Product code CAF·January 29, 2019
ANN, BLUNT TIP SCREW, 4X46MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·July 14, 2022
Integra Small Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Made in the USA NL 850-1121 Provides access to the lateral cerebral ventricles via hypodermic puncture. It is useful in obtaining CSF (cerebral spinal fluid_ samples for cytological and chemical studies, for monitoring ventricular fluid pressure and for ventricular drainage. The reservoir provides easy access to the lateral ventricles and to cystic tumors for the injections of chemotherapeutic agents and/or radio-isotopes. The rickham reservoir may be utilized in hydrocephalic patients as a component in systems designed to shunt CSF from the lateral ventricles into either the right atrium of the heart of the peritoneum.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·January 15, 2014
Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016
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