25 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TENS and Muscle Stimulator
FDA 510(k)
FDA Class 2
·Neurology
AUVON TENS & EMS DEVICE
FDA Adverse Event
Injury
·SHEN ZHEN AS TEC TECHNOLOGY CO LTD·Product code NUH·January 28, 2025
AUVON TENS UNIT
FDA Adverse Event
Injury
·SHEN ZHEN AS TEC TECHNOLOGY CO LTD·Product code NUH·December 19, 2024
MAYO SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896055551·MAYO SCISSORS STRAIGHT BEVELED BLADES POWER CUT...
MALLET, ORTHOGNATHIC
FDA UDI
W.H. Holden, Inc.·D9282007270·
BUFFLIGHT CLT SURGICAL LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED MULTIQUAL 3, LIQUID ASSAYED MULTIQUAL MINIPAK
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ELECSYS 2010 RACK
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·July 12, 2007
VARIOUS
FDA Adverse Event
Injury
·Product code FXX·July 29, 2007
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE ? MOUNTAIN HOME·Product code FKX·August 11, 2011
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDI·October 24, 2014
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 1, 2013
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·August 13, 2018
S-ROM*SLEEVE PRX ZTT, 18F-XXL
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·February 20, 2013
FUHRMAN PLEURAL & PNEUMOPERICARDIAL DRAINAGE SET
FDA Adverse Event
Injury
·COOK, INC.·Product code DQY·March 29, 2007
UNK - ELASTIC NAILS: TITANIUM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HTY·May 5, 2021
UNK - ELASTIC NAILS: TITANIUM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HTY·May 5, 2021
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·June 25, 2018
Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
FDA Enforcement
Class II
·Completed·Hologic, Inc·December 18, 2024
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 200 MM, Silicone, Sterile, Item 431198.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020