12 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ARTHREX BIO- COMPOSITE SUTURE ANCHORS: BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK, BIO-COMPOSITE CORKSCREW
FDA 510(k)
FDA Class 2
·Orthopedic
NA
FDA UDI
KEY SURGICAL, INC.·10849771049231·K-Wires, Single trocar, .035-inch (0.9mm) diame...
NA
FDA UDI
STERILMED, INC.·10888551020527·SAW BLADE OSCILLATING LARGE BONE
ME-92
FDA UDI
Conmed Corporation·10845854004081·OSCILLATOR BLADE, ME-92 COATED, 19.5 X 71 X 0.8...
PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI
FDA 510(k)
FDA Class 1
·Microbiology
BCI ADVISOR VITAL SIGNS MONITOR (9200)
FDA 510(k)
FDA Class 2
·Cardiovascular
SPECTRA WAVEWRITER?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 26, 2025
ENDOPATH ETS FLEX
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code KOG·December 23, 1997
VASCUTRAK PTA BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·April 8, 2013
ATTAIN ABILITY PLUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·April 27, 2011
GE OEC 2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEM INC.·Product code JAA·July 10, 2008
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