15 results · 31ms · 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.

FLEXLENS(METHAFILCON A)

FDA 510(k)
FDA Class 2 ·Ophthalmic

CONNECTOR 22F - 15M

FDA UDI
Intersurgical Incorporated·05030267057344·CONNECTOR 22F - 15M

TROCHANTERIC NAIL TRAY, LONG, Ø10mm x 125°

FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665038989·

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690190660·Femoral Sizing Guide Bushing Neut/+2mm

Eye Shield

FDA UDI
KATENA PRODUCTS, INC.·00841668111123·FOX EYE SHIELD ALUMINUM

Kalitec Universal Instruments

FDA UDI
Kalitec Direct LLC·B07301K0620000·Universal Removal Set

KEYMED FLEXIBLE ESOPHAGEAL DILATORS

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANDEL AND HAND CONTROL, MODEL WAVE18S; HARMONIC DISPOSABLE TORQUE WRENCH

FDA 510(k)
FDA Unclassified ·Unknown

5CM, 33CM PEEK MONOPOLAR HANDLE 33CM

FDA Adverse Event
Malfunction ·STRYKER ENDOSCOPY SAN JOSE·Product code KOG·January 22, 2013

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 28, 2014

INTEGRATED APD SET W/CASSETTE3-PRONG

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·January 17, 2011

36MM COCR MOD HD +3MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JDI·January 19, 2018

ARCOMXL 36MM RLC LNR HW SZ25

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LPH·January 19, 2018

ARCOS CON SZ A HI 50MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JDI·January 19, 2018

Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024