18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Servator P SALF Solution with THAM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112878·CORNEAL TREPHINE BLADE6.5MM
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112465·BARRON VACUUM TREPHINE 6.5MM
ALPHATRAC, MODEL A 205
FDA 510(k)
FDA Class 2
·Physical Medicine
SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT AND ACM AND MIXEVACII
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 30, 2025
PRECISION SPECTRA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·June 3, 2025
COBAS C 503 ANALYTICAL UNIT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·April 2, 2026
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 8, 2011
INSPIRATION LS VENTILATOR SYSTEM
FDA Adverse Event
Malfunction
·EVENT MEDICAL LTD.·Product code CBK·August 8, 2014
S-ROM*STM STD,36NK,16X11X150
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·July 2, 2013
Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, Length 115 cm, STERILE.EO, Rx Only
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·July 10, 2024
CA090, DIRECT DRIVE LCA 3/BX
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES·Product code FZP·February 24, 2017
CA090, DIRECT DRIVE LCA 3/BX
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES·Product code FZP·February 24, 2017
CA090, DIRECT DRIVE LCA 3/BX
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES·Product code FZP·February 24, 2017
HANDPIECE MICS
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·March 4, 2019
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 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