20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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URO-TOUCH 9 French Probe
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112823·BARRON VACUUM PUNCH 9.25MM
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113301·STAB KNIFE 45 DEGREE (BX/5)
Unicondylar Sled Prosthesis
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575359455·Tibia Plateau,all-polyethylene
NIPRO SAFETOUCH SAFETY FISTULA NEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
STEERABLE GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
PRODISC-C IMPLANT LARGE
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MJO·October 16, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·July 2, 2013
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 58MM Item Number: 15-2028/13
FDA Recall
Open, Classified
·Linkbio Corp.·Product code HSX·March 21, 2023
UNKNOWN HEAD
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·April 15, 2014
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 58MM Item Number: 15-2028/13
FDA Enforcement
Class II
·Ongoing·Linkbio Corp.·May 10, 2023
UNKNOWN LINER
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·February 12, 2014
UNKNOWN HIP FEMORAL STEM
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS INC US·Product code KXA·November 12, 2019
UNKNOWN HIP FEMORAL STEM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·November 13, 2019
UNKNOWN HIP FEMORAL AUGMENT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KXA·November 13, 2019
UNKNOWN HIP FEMORAL STEM
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS INC US·Product code KXA·November 13, 2019
Olympus Sterile Optical Laser Fiber, single use and reusable
FDA Enforcement
Class II
·Terminated·Quanta System, S.p.A.·June 16, 2021
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
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021