39 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CERAMIR CROWN & BRIDGE
FDA 510(k)
FDA Class 2
·Dental
Bone Level Implant
FDA UDI
BIO CONCEPT Co., Ltd.·06947600305231·
16PW - Heat Stress Relief
FDA UDI
Certified Safety Manufacturing, Inc.·00766588130408·Heat Stress Relief - 16 Poly White
CapSure® Spine System
FDA UDI
Spine Wave, Inc.·10840642104011·Rod Curved 5.5 x 40mm
Ø13mm Sacroiliac Falco Fusion Screw - L40mm
FDA UDI
McNicoll Chirurgical Inc.·07540161800116·Ø13mm Sacroiliac Falco Fusion Screw - L40mm
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0130400·ROD REDUCER, AXIAL
BIPAP AUTO BIFLEX
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·December 23, 2025
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
FDA 510(k)
FDA Class 2
·Orthopedic
LIGHT SABER INTRODUCER NEEDLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
GLOBAL STEPTECH
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295005704·GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE ...
GLOBAL AP
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295005667·GLOBAL AP HUMERAL HEAD SIZE 40 x 15
GLOBAL STEPTECH
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295005643·GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE ...
GLOBAL STEPTECH
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295005612·GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE ...
GLOBAL STEPTECH
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295005605·GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE ...
Portex
FDA UDI
ICU MEDICAL, INC.·15019315051326·
GLOBAL STEPTECH
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295005742·GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE ...
GLOBAL AP
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295005698·GLOBAL AP HUMERAL HEAD ECCENTRIC SIZE 40 x 18
GLOBAL AP
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295005681·GLOBAL AP HUMERAL HEAD ECCENTRIC SIZE 40 x 15
GLOBAL AP
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295005674·GLOBAL AP HUMERAL HEAD SIZE 40 x 18
GLOBAL STEPTECH
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295005629·GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE ...