20 results · 21ms · 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.

LANX ANTERIOR CERVIAL PLATE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

DeRoyal

FDA UDI
DEROYAL INDUSTRIES, INC.·00749756001960·Cervical Collar

Premier

FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·D6911040401·CUBE PESSARY W/ DRAINAGE HOLES #1

BiomarC®

FDA UDI
Carbon Medical Technologies, Inc.·00858015005103·Preloaded Carbon Tissue Marker, Needle Tip Deli...

VIDAS® T4

FDA UDI
BIOMERIEUX SA·03573026156916·The VIDAS ® T4 (T4) assay is intended for use o...

ICU Medical

FDA UDI
ICU MEDICAL, INC.·00840619045371·TriOx™ SO2 Umbilical Artery Catheter U440, 4F, ...

Hayden Medical

FDA UDI
Hayden Medical, Inc.·00840319700020·Miniature Blade Handle w/ self-locking chuck, 3...

Toilet Support Arms

FDA UDI
Ropox A/S·05707581014741·

VAPOTHERM, MODEL 2000I

FDA 510(k)
FDA Class 2 ·Anesthesiology

TRI-PLEX ADAPTER

FDA 510(k)
FDA Class 2 ·Anesthesiology

InnovaMatrix AC

FDA UDI
Triad Life Sciences, Inc.·00850002643169·4cm x 4cm Placental ECM

Phonak

FDA UDI
Sonova AG·07613275614174·Phonak Naída B90-UP (beige)

InnovaMatrix FS

FDA UDI
Triad Life Sciences, Inc.·00850002643343·4cm x 4cm Fenestrated Placental ECM

PRECICE STRYDE SYSTEM

FDA Adverse Event
Malfunction ·NUVASIVE SPECIALIZED ORTHOPEDICS, INC.·Product code PGN·August 17, 2021

CONTOUR

FDA Adverse Event
Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·April 8, 2013

MODULAR ANALYZER

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·May 7, 2008

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·April 5, 2011

VIDAS FT4 60 TEST

FDA Adverse Event
Malfunction ·BIOMERIEUX SA·Product code KLI·July 14, 2021

VIDAS T4 60 TESTS

FDA Adverse Event
Malfunction ·BIOMERIEUX, SA·Product code KLI·April 23, 2021

CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024