16 results
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26ms
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Sources: EU EUDAMED, US FDA
AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL III
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PULSE
FDA UDI
Nuvasive, Inc.·00195377049193·PULSE LessRay Table Array
Premier
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·D6911050186·INHALATION SET, TRACH,AIR-LON - SIZE 6
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496050186·RED WELLNESS 70 LEGGINGS, SIZE XXL, NERO, GRADU...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450142646·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450051634·
DATEX-OHMEDA INOVENT DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
WELCH ALLYN IMPACT BLOOD PRESSURE SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX)
FDA Adverse Event
Malfunction
·ANGIOSCORE, INC.·Product code NWX·April 3, 2013
ARCHITECT ANTI-HBS
FDA Adverse Event
Other
·ABBOTT LABORATORIES·Product code LOM·May 22, 2008
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 12, 2011
PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code KRR·October 15, 2025
PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code KRR·October 20, 2025
PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code KRR·October 15, 2025
Tracheostomy Tubes, Air Lon Inhalation Set (Inner Cannula with 15 mm Adapter) Nylon, item number 1050180 size 3, item number 1050182 size 4, item number 1050184 size 5, item number 1050186 size 6, item number 1050188 size 7, and item number 1050190 size 8.
FDA Recall
Terminated
·Premier Dental Products Co·Product code JOH·August 5, 2004
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012