20 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ENDOSSEOUS DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
HairCheck-DT (Amphetamines)
FDA UDI
Quest Diagnostics·00868586000230·HairCheck-DT (Amphetamines) is an ELISA test ki...
Key Surgical K-Wires and Steinmann Pins
FDA UDI
KEY SURGICAL, INC.·00849771012542·K-Wires, Single trocar, .035-inch (.9mm) diamet...
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704292800·
NA
FDA UDI
KEY SURGICAL, INC.·10849771049125·K-Wires, Single trocar, .035-inch (.9mm) diamet...
Conmed/Linvatec
FDA UDI
Provision·00810041065827·
Conmed/Linvatec
FDA UDI
Provision·B504OM50711610·
Reprocessed Large Bone Knee Blade, 25 x 90 x 1.27mm
FDA UDI
SURETEK MEDICAL·B39050711611·
NA
FDA UDI
STERILMED, INC.·10888551020473·SAW BLADE OSCILLATING LARGE BONE
CONMED
FDA UDI
Conmed Corporation·10845854006382·OSCILLATOR BLADE, 25.4 X 90 X 1.27 MM (.050")
Genius Total Knee System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215021511·
MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229
FDA 510(k)
FDA Unclassified
·Unknown
ULTRAPEN REUSABLE PENCIL, MODEL 130350 THROUGH 130353, REUSABLE ACCESSORY ELECTRODE KIT (FOR USE WITH ULTRAPEN PENCIL),
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CANNULATED PARTIALLY THREADED RECONSTRUCTIVE SCREW
FDA Adverse Event
Injury
·BIOMET·Product code HSB·March 13, 2012
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·April 22, 2013
6000034-2011-00216
FDA Adverse Event
Malfunction
·COCHLEAR LTD·April 27, 2011
GE OEC 2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 10, 2008
HALL
FDA Adverse Event
Malfunction
·CONMED·Product code GFA·February 23, 2026
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000192;
FDA Enforcement
Class II
·Ongoing·Beaver Visitec International, Inc.·September 4, 2024
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