71 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NORPORT CT-PC, LUCENT NON-CORING NEEDEL INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
ProSim SPOT Light
FDA UDI
FLUKE ELECTRONICS CORPORATION·00850540007102·SpO2 Pulse Oximeter Analyzer
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481118210·LOCATOR R-Tx Abutment For 3.8mm Premium, Sweden...
PH Band
FDA UDI
Medical Ingenuities, LLC·00860006401702·PH Band
Powerheart AED G3 Pro ECG Monitoring Cable
FDA UDI
Zoll Medical Corporation·00812394021338·ECG patient monitoring cable (AHA) for Powerhea...
ACON U120 URINE ANALYZER, MODEL U111-101
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TAPER OXINIUM FEMORAL HEAD
FDA 510(k)
FDA Class 2
·Orthopedic
MINI-TONG
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SCISSORS CEV104M DIA 5MM 350MM STR
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INSTRUMENTATION S.A.S. LE PAVILLON·Product code GEI·August 29, 2013
TSA W/LEC, PS80
FDA Adverse Event
Malfunction
·THERMO FISHER SCIENTIFIC·Product code LIB·May 22, 2017
UNKNOWN PATHINDER NXT OR INSTINCT JAVA IMPLANT
FDA Adverse Event
Malfunction
·ZIMMER BIOMET SPINE INC.·Product code NKB·September 24, 2022
AC TENDER I
FDA Adverse Event
Death
·UNOMEDICAL A/S·Product code FPA·May 3, 2013
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 23, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 2, 2011
GASTROINTESTINAL VIDEOSCOPE
FDA Adverse Event
Malfunction
·AIZU OLYMPUS CO., LTD.·Product code FDS·April 30, 2025
MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER W/ GEL, featuring IsoSilk(R), 5" x 98", (13cm x 249 cm), REF 3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702
FDA Enforcement
Class II
·Terminated·Ecolab Inc·February 19, 2014
TL PEDICLE SCREW DIA. 6,5 LG 50
FDA Adverse Event
Malfunction
·ZIMMER SPINE·Product code NKB·July 9, 2019
TL PEDICLE SCREW DIA. 6,5 LG 50
FDA Adverse Event
Malfunction
·ZIMMER SPINE·Product code NKB·July 9, 2019
TL PEDICLE SCREW DIA. 6,5 LG 35
FDA Adverse Event
Malfunction
·ZIMMER SPINE·Product code HWC·July 9, 2019
TL PEDICLE SCREW DIA. 6,5 LG 40
FDA Adverse Event
Malfunction
·ZIMMER SPINE·Product code NKB·July 9, 2019