13 results · 20ms · 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.

VACUTAINER BRAND PRONTO NEEDLES HOLDER

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DeltaForm HD

FDA UDI
Merz Dental GmbH·D7091980098·DeltaForm HD upper posteriors, XS, C1 -MADE IN ...

Eighteeth

FDA UDI
Changzhou Sifary Medical Technology Co., Ltd.·06941877815196·The NanoPix series sensors (NanoPix1, NanoPix1....

Shur-Clens

FDA UDI
Asept Pak, Inc.·10860006476028·Case of 24 containers containing 120 mL of Hypo...

All Purpose Cuff

FDA UDI
SUNTECH MEDICAL, INC.·10840935102519·

All Purpose Cuff

FDA UDI
SUNTECH MEDICAL, INC.·10840935107682·

SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1

FDA 510(k)
FDA Class 2 ·Anesthesiology

MRJ EXTENDED

FDA 510(k)
FDA Class 2 ·Radiology

MENTOR MEMORYGEL BREAST IMPLANT

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code FTR·March 19, 2026

EMAX 2 PLUS MOTOR

FDA Adverse Event
Malfunction ·THE ANSPACH EFFORT, INC.·Product code HBC·February 21, 2013

PARADYM

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA S.R.L. - CRM FACILITY·Product code MRM·August 5, 2014

ACCU-CHEK ® COMPACT TEST DRUM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·February 7, 2011

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·September 21, 2022