22 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HydroCision SpineJet System
FDA 510(k)
FDA Class 2
·Orthopedic
MAYO STILLE SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896083851·MAYO STILLE SCISSORS STRAIGHT ROUND BLADES POWE...
Orthoquest
FDA UDI
Young Innovations, Inc.·00843471159095·Niti Thermal Tri-Force Nat Dimp 020X020 Up
BSSO TRANSORAL PLATNG DRILL RETRACTOR
FDA UDI
W.H. Holden, Inc.·D9282007290·
NLITE SYSTEM,MODEL A00-1051
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL
FDA 510(k)
FDA Class 2
·Cardiovascular
AUVON TENS & EMS DEVICE
FDA Adverse Event
Injury
·SHEN ZHEN AS TEC TECHNOLOGY CO LTD·Product code NUH·January 28, 2025
2.4MM X 8MM BONE MANIPULATION SCREW
FDA Adverse Event
Malfunction
·OSTEOMED, LLC·Product code HWC·September 22, 2025
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDI·October 24, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 1, 2013
PATIENT INTERFACE NIM4CPB1 NIM 4.0
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code GWF·October 28, 2025
AUVON TENS UNIT
FDA Adverse Event
Injury
·SHEN ZHEN AS TEC TECHNOLOGY CO LTD·Product code NUH·December 19, 2024
STIMULATOR, ELECTRICAL, EVOKED RESPONSE
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code GWF·July 31, 2023
NIM 4.0 CONSOLE
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code GWF·September 5, 2025
NIM 4.0 CONSOLE
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code GWF·August 2, 2024
NIM 4.0 CONSOLE
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code GWF·May 20, 2025
The Leica ASP6025 Tissue Processor. Pathology and Hematology Departments. The Leica ASP6025 Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration.
FDA Enforcement
Class II
·Terminated·Leica Microsystems, Inc.·September 30, 2015
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 200 MM, Silicone, Sterile, Item 431199.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024