19 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DISPOSABLE THYROID COLLAR
FDA 510(k)
FDA Class 1
·Radiology
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702597509·ELVAREX 2/KNEE HIGH/CLOSED TOE/SOFTFIT-SLIPFORM...
TALOS®-C HA
FDA UDI
MEDITECH SPINE, LLC·B167521109000·
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K1100000·Tray Lid, Universal Blank, Arcamed
TALOS®-T
FDA UDI
SpineArt SA·07640332475898·TALOS-T (HA) LORDOTIC HA PEEK IBFD 0° L28 W10...
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K1102000·Tray, 2 inch base
STS-T LITHOTRIPTER, MODEL STS-T
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MOTIVATION KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TAPERLOC COMPLETE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LZO·February 9, 2026
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·May 5, 2017
MEDSTONE LITHOTRIPTOR
FDA Adverse Event
Malfunction
·HEALTHTRONICS, INC.·Product code LNS·June 12, 2017
TPRLC 133 MP TYPE1 BM SO 9.0
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·March 27, 2018
VA-LCP-2-COLUMN DRP2.4 VOLAR R SHAFT 3HO
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HRS·May 14, 2013
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 8, 2014
ALENTI
FDA Adverse Event
Other
·ARJO HOSPITAL EQUIPMENT AB·Product code FSA·May 24, 2011
TAPERLOC COMPLETE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·December 8, 2025
OSCOR ADELANTE BREEZEWAY 8F C55¿ S61CM D66CM Catalog # AB081040 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
FDA Enforcement
Class II
·Terminated·Oscor, Inc.·December 28, 2016
Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Cranial Fixation System is indicated for use in pediatric craniotomy flap fixation.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·May 16, 2018
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024