14 results
·
18ms
·
Sources: EU EUDAMED, US FDA
VECAFIX*
FDA 510(k)
FDA Class 1
·General Hospital
Keystone Industries
FDA UDI
Keystone Industries·H66818100501·Bx 809 S.S. Mesh X-Fine 6X6 (single)
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K1100500·Caddie, 4.75mm Screws
MetaSystems Probes
FDA UDI
MetaSystems Probes GmbH·04251315820968·XCE 10 orange, Centromere-Specific Probe
MetaSystems Probes
FDA UDI
MetaSystems Probes GmbH·04251315820951·XCE 10 green, Centromere-Specific Probe
FIT TEST C&B
FDA 510(k)
FDA Class 2
·Dental
ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Lenses, Soft Contact, Daily Wear
FDA Pre-Market Approval
FDA Class 2
·OPTECH FRE-FLEX SOFT CONTACT LENS
Lenses, Soft Contact, Daily Wear
FDA Pre-Market Approval
FDA Class 2
·OPTECH FRE-FLEX SOFT CONTACT LENS
SEE H10
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code NBC·April 18, 2013
R SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORP·Product code MKJ·February 4, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 31, 2012
HS ACE 14 CM SCISSOR HANDLE
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code LFL·November 12, 2007
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024