17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PICOCLAMP
FDA 510(k)
FDA Class 2
·Cardiovascular
Oticon
FDA UDI
Sbo Hearing A/S·05714464029730·OTICON MORE 2 MINIRITE T C063
OAK RIDGE PRODUCTS SHARP CONTAINER
FDA 510(k)
FDA Class 2
·General Hospital
CRYOTRON 2 CRYOTHERAPY DEVICE
FDA 510(k)
FDA Unclassified
·Unknown
IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 11.5MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·April 30, 2024
IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·April 29, 2024
3DKNEE
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code HSH·November 7, 2008
UNICEL® DXC 880I SYNCHRON® ACCESS® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code CGA·September 1, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·July 16, 2013
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
FDA Enforcement
Class II
·Ongoing·Abbott Point Of Care Inc.·September 24, 2025
IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·April 30, 2024
DENTAL ABUTMENT
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code NHA·April 13, 2023
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
FDA Recall
Open, Classified
·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025
RESTYLANE DEFYNE
FDA Adverse Event
Injury
·Q-MED AB·Product code LMH·January 6, 2026
SCULPTRA
FDA Adverse Event
Injury
·Q-MED AB·Product code LMH·January 6, 2026
RESTYLANE VOLYME
FDA Adverse Event
Injury
·Q-MED AB·Product code LMH·January 5, 2026
BIOABSORBABLE INTERFERENCE SCREWS
FDA Adverse Event
Malfunction
·S.B.M. SAS·Product code MAI·February 21, 2025