26 results · 22ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

COBRA Fusion Ablation System

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776165192·Rigid Retr prgs sharp

Integra® Jarit®

FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780181934·Integra® Jarit® Finger Rake Retractor, 6-1/2", ...

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306812125·Schamberg Comedone Extractor, Medium, with Crimp

IN-OVATION® C

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151801·IN-OVATION® C EURO 018 U5-5 CS HK

IN-OVATION® C

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151101·IN-OVATION® C Base Rx 018 UP5-5 CHK

IN-OVATION® C

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151111·IN-OVATION® C Base Rx 018 U5-5 CS-BC HK

IN-OVATION® C

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151811·IN-OVATION® C EURO 018 U5-5 CS-BC HK

IN-OVATION® C

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151001·IN-OVATION® C Base Rx 018 U5-5

MYSTIQUE® MB

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K110151101·MYSTIQUE® MB RT RX 018 U 5-5 CS HK

IN-OVATION® C

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151611·IN-OVATION® C Roncone 018 U5-5 CS BC HK

BINAXNOW COVID-19 AG SELF TEST 2CT

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·November 9, 2022

APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM), H3-828XX (OD44 TO 60MM)

FDA 510(k)
FDA Class 2 ·Orthopedic

ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T

FDA 510(k)
FDA Class 2 ·Radiology

TRILOGY 100

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code CBK·June 18, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011

PRIME CARE (R) TRANSCEND ADVANCED MATTRESS

FDA Adverse Event
Malfunction ·PRIMUS MEDICAL LLC·Product code IKY·September 18, 2014

VASERLIPO SYSTEM

FDA Adverse Event
Injury ·SOLTA MEDICAL, INC·Product code QPB·January 5, 2023

ACHIEVE MAPPING CATHETER - 15 MM

FDA Adverse Event
Injury ·MEDTRONIC CRYOCATH LP·Product code DRF·August 14, 2019

VASERLIPO SYSTEM

FDA Adverse Event
Injury ·SOLTA MEDICAL, INC·Product code QPB·January 10, 2023