17 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ZS3 Ultrasound System, z.one pro Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197078030·Deaver Retractor
25x300...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197078023·Deaver Retractor serrated
22x215...
SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS
FDA 510(k)
FDA Class 2
·Orthopedic
STATIS DENTAL HANDPIECES
FDA 510(k)
FDA Class 1
·Dental
INTELLIVUE MULTI-MEASUREMENT MODULE X3
FDA Adverse Event
Malfunction
·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code MHX·June 12, 2025
SYMBIQ SINGLE CHANNE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·June 7, 2013
FISHER & PAYKEL
FDA Adverse Event
Malfunction
·FISHER PAYKEL·Product code BZO·October 7, 2006
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 15, 2014
BELIFU
FDA Adverse Event
Injury
·HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED·Product code GZJ·February 10, 2020
APPROACH CTO MICROWIRE WIRE GUIDE
FDA Adverse Event
Injury
·Product code DQX·May 21, 2021
APPROACH CTO MICROWIRE WIRE GUIDE
FDA Adverse Event
Injury
·COOK INC·Product code DQX·December 28, 2021
APPROACH CTO MICROWIRE WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·October 17, 2023
APPROACH CTO MICROWIRE WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·October 3, 2023
APPROACH CTO MICROWIRE WIRE GUIDE
FDA Adverse Event
Injury
·COOK INC·Product code DQX·October 31, 2023
INTELLIVUE MULTI-MEASUREMENT MODULE X3
FDA Adverse Event
Malfunction
·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code MHX·February 11, 2026
Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021