11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RUBBER CONDOM (NON-COLORED)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756735797·CRANI PACK
VINYL PATIENT EXAMINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
BIO-STYM 250 (MUSCLE STIMULATOR)
FDA 510(k)
FDA Class 2
·Physical Medicine
THREE-PC. SYRINGES 2-30 ML, W. MOUNT. N
FDA Adverse Event
Malfunction
·B. BRAUN MELSUNGEN AG·Product code FMF·June 3, 2014
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910 ·Product code KWA·January 4, 2013
FLANGE FIXTURE AND ABUTMENT
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS·Product code LXB·November 11, 2010
GYC-1000
FDA Adverse Event
Malfunction
·NIDEK CO., LTD.·Product code HQF·June 18, 2015
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025