26 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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QUANTUM SPINAL SYSTEM, QUANTUM MIS
FDA 510(k)
FDA Class 2
·Orthopedic
Aequalis™ Adjustable Reversed
FDA UDI
TORNIER, INC.·00846832068166·
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540134202·SPATULA, MALLEAB., DOUBLE-ENDED
Sklar
FDA UDI
SKLAR CORPORATION·10649111382000·STERLIZATION POUCH RACK 4 X 18
Molar Rotation2 Appliance
FDA UDI
Ortho Organizers, Inc.·00190707064525·NITANIUM® MOLAR ROTATOR2 APPLIANCE (44mm)
MICROCRUISER PLUS INTRODUCER SET
FDA 510(k)
FDA Class 2
·Cardiovascular
COULTER LIN-X LINEARITY CONTROL, MODEL A81196
FDA 510(k)
FDA Class 2
·Hematology
SMR SHOULDER SYSTEM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code PHX·May 18, 2026
HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINER
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code KWZ·September 26, 2016
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 10, 2011
DYN-LOCK-SCR Ø5 SELF-TAP L40 COCRMO
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HWC·May 9, 2013
SMART CONTROL NITINOL STENT SYSTEM
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code FGE·August 5, 2008
ACCESS ACCUTNI REAGENT
FDA Adverse Event
Injury
·BECKMAN COULTER·Product code MMI·September 15, 2016
HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006412
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·June 12, 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
Model Number L101, ESSENTIO DR SL Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·July 14, 2021
VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021