82 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPIC AND ELECTROSURGICAL SURGICAL INSTRUMENTS AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Safco D1amond
FDA UDI
SAFCO DENTAL SUPPLY CO.·10810063751842·Sterile Single Use Burs - ISO Code 862-014C
n/a
FDA UDI
Hager & Meisinger Gesellschaft mit beschränkter Haftung·E0HM50240111·Rotary instrument für surgical application
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193107196·HA PEEK EVOS Straight, ,11mmx10mmx 22mm , BICON...
Aztec
FDA UDI
Aztecmed/Ent LLC·B87110240110·Stevens Tenotomy Scissors, straight
IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS
FDA 510(k)
FDA Class 2
·Cardiovascular
CANVAS N-VAS-D 2.0
FDA 510(k)
FDA Class 2
·Radiology
ALPHA PLATE, LEFT, 11 HOLE
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code KTW·November 20, 2024
Giraffe Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·July 17, 2019
ALPHA PLATE, LEFT, 11 HOLE
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HRS·January 15, 2025
GALAXY INTRAVASCULAR ULTRASOUND SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - FREMONT (SUD)·Product code IYO·March 27, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·February 14, 2011
INTERLINK CATHETER EXTENSION SET/MALE LUER
FDA Adverse Event
Malfunction
·AIBONITO·Product code FPA·April 5, 2008
OMNIPOD 5 POD
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code QFG·November 7, 2024
Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coated with Silver Sulfadiazine STERILE, Box of 10 Part #7118. Indicated for use in surgical wound drainage.
FDA Enforcement
Class II
·Terminated·Bacterin International, Inc.·March 20, 2013
CN LOCK SCREW, F THREAD, Ø4.0MM X 44MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code KTW·March 6, 2025
CN LOCK SCREW, F THREAD, Ø4.0MM X 42MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code KTW·March 6, 2025
LO-PRO SCRW,TI,3.5MMX 24MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HWC·March 6, 2025
CORTICAL BONE SCREW, Ø3.5MM X 28MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code KTW·March 6, 2025
CN LOCK SCREW, F THREAD, Ø4.0MM X 44MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code KTW·March 6, 2025