15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Puritan Bennett Cuff Pressure Manager
FDA 510(k)
FDA Class 2
·Anesthesiology
NA
FDA UDI
Synthes GmbH·10886982145062·2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE R...
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112595·BARRON CORNEAL PUNCH 7.0MM
SAFESTEP 22GX3/4
FDA Adverse Event
Injury
·C.R. BARD INC. (BASD)·Product code FPA·January 16, 2009
GEN-PROBE APTIMA COMBO 2 ASSAY
FDA 510(k)
FDA Class 1
·Microbiology
WELL-TENS
FDA 510(k)
FDA Class 2
·Neurology
SAFESTEP 22G X 3/4
FDA Adverse Event
Malfunction
·C. R. BARD INC. (BASD)·Product code FPA·February 6, 2009
SAFESTEP 22GX3/4
FDA Adverse Event
Malfunction
·C. R. BARD INC. (BASD)·Product code FPA·February 6, 2009
SERVO-I
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·June 15, 2023
SAIPH KNEE
FDA Adverse Event
Malfunction
·MATORTHO·Product code JWH·October 9, 2018
PERCLOSE A-T SUTURE MEDICATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·October 17, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
UNKNOWN DEPUY ASR FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·July 2, 2013
Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK, Receiver (mg/dL), Pink; MT22495-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