15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489125563·PowerChem Neoprene Exam Gloves, Extra Extra Large
PMMA disc
FDA UDI
Dentsply International Inc.·D00180714160·
Epimed
FDA UDI
EPIMED INTERNATIONAL, INC·00818788020352·RX-2™ Coudé® Epidural Needle 16g TW x 3.5"
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 8, 2024
MUSCLE IMAGING SYSTEM (MIS)
FDA 510(k)
FDA Class 2
·Radiology
AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL
FDA 510(k)
FDA Class 2
·Dental
SYRINGE 20ML LL S/C 50
FDA Adverse Event
Malfunction
·BECTON DICKINSON DE MEXICO·Product code FMF·August 13, 2021
PRECISION NOVI?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 14, 2026
EDWARDS ASCENDRA BALLOON CATHETER
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·April 22, 2013
ASR ACETABULAR CUPS 48
FDA Adverse Event
Injury
·DEPUY INTL. LTD.·Product code KWA·April 13, 2011
XIA LP MONOAXIAL SCREW 5.5 X 40MM
FDA Adverse Event
Injury
·STRYKER SPINE BORDEAUX·Product code KWP·July 7, 2008
RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub, Detachable Wing, Blunt Stylet, Sterile, Rx only, For Use with 19g or Smaller Catheter
FDA Enforcement
Class II
·Terminated·Epimed International·November 15, 2017
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
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024