14 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VPAP ST
FDA 510(k)
FDA Class 2
·Anesthesiology
Leksell Gamma Knife Perfexion/Icon
FDA UDI
Elekta Solutions AB·07340048311762·Dosimetry Phantom Vantage LGK
Hillrom™
FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761976368·Trumpf Medical/Medizin Remote Control PST 300+
Control Units
FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761968028·Remote Control PST 300+
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221024688·Unitek(TM) Lingual Sheaths Slotted Tube U/L Hoo...
PHD PERSONAL HEMODIALYSIS INSTRUMENT-1M101, PHD WATER PRE-TREATMENT KIT-1W605,PHD HARD PLUMBING KIT-1W604, PHD BLOOD TUB
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9153 PAT04
FDA 510(k)
FDA Class 2
·Clinical Toxicology
UNICIRCUIT
FDA Adverse Event
Malfunction
·GE HEALTHCARE FINLAND OY·Product code BZO·September 19, 2008
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·April 26, 2013
COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL
FDA Adverse Event
Malfunction
·STAAR SURGICAL COMPANY·Product code HQL·April 7, 2011
UNKNOWN DEPUY UNI FEMORAL
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HSA·July 18, 2008
DREAMSTATION AUTO CPAP
FDA Adverse Event
Injury
·RESPIRONICS, INC.·Product code BZD·December 10, 2021
2.7 DEGREE STRAIGHT SAGITAL SAW
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·September 5, 2018
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014