21 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DOLPHIN IMAGING
FDA 510(k)
FDA Class 2
·Radiology
VaPro Plus Pocket
FDA UDI
HOLLISTER INCORPORATED·00610075053995·No Touch Urethral Intermittent Catheter with In...
Henschke Titanium Applicator
FDA UDI
Nucletron B.V.·08717213029910·Cervical Stopper
TRUELOK SYSTEM
FDA UDI
ORTHOFIX SRL·18033509856693·TL+ CANNULATED INLINE HINGE ASSEMBLY
Restore
FDA UDI
KEYSTONE DENTAL, INC.·D768L11043010K0·Drill
Restore
FDA UDI
KEYSTONE DENTAL, INC.·D768L11043015K0·Drill
Tecno
FDA UDI
TECNO INSTRUMENTS (PVT) LTD·08964001335474·Scoville-Greenwood 7.5” (19.1 cm), Insulated, T...
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
KENSTONE METAL·Product code ITJ·July 20, 2012
URGOTUL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER
FDA 510(k)
FDA Unclassified
·Unknown
MLS-AC DERMA SCANNER
FDA 510(k)
FDA Class 2
·Physical Medicine
OCTRODE LEAD KIT, 60CM LENGTH
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)·Product code LGW·March 22, 2024
OCTRODE LEAD KIT, 60CM LENGTH
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code LGW·May 7, 2024
TAPERLOC COMPLETE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LZO·February 9, 2026
TPRLC 133 MP TYPE1 BM SO 9.0
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·March 27, 2018
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 13, 2013
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·September 23, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 1, 2011
TAPERLOC COMPLETE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·December 8, 2025
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP30; c) NEONATAL TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP35; d) NEONATAL TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP40
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012