13 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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