17 results · 22ms · Sources: EU EUDAMED, 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