15 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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INDX DIP S TICKS
FDA 510(k)
FDA Class 1
·Microbiology
Printed Lower Crown Pack for Herbst LR6 10mm
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199015970·
NA
FDA UDI
Stryker GmbH·07613153057604·Plastic Lid
Map-iT
FDA UDI
ACCESS POINT TECHNOLOGIES, INC.·00818083014964·Fixed, 10 electrode, MPB, 5-5-5-24-4-4-4-4-4mm ...
WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CONMED TROGARD FINESSE TROCAR SYSTEM, MODEL 60-6050-XXX
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GMK IMPLANTS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 18, 2025
GMK-SPHERE PATELLA RESURFACING SIZE 1
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 23, 2021
COCR TROCH CABLE 2.0MMX750MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDQ·June 30, 2014
TALENT STENT GRAFT SYSTEM WITH XCELERANT - HYDRO
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·November 12, 2010
HS III PROXIMAL SEAL SYTEM 3.8MM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code DXC·January 4, 2013
Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60) Philips Medical Systems, Cleveland, OH
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·May 20, 2015
Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC Vertex Classic) Philips Medical System, Cleveland, OH 44143. Used to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·May 7, 2014
Nuclear gamma cameras (ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 & ADAC CARDIO C60) Nuclear gamma cameras intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·May 20, 2015
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