53 results
·
18ms
·
Sources: EU EUDAMED, US FDA
PREGNANCY TEST KIT, DAISY 2 IN HOME
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ReLine
FDA UDI
Nuvasive, Inc.·00887517010414·RELINE-C Drill Bit
Hillrom™
FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761990296·Table top segment 130 S
BIOMET EBI BONE HEALING SYSTEM SFLX 4 COIL
FDA Adverse Event
Injury
·EBI, LLC.·Product code LOF·April 7, 2017
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690196563·AK3 4 in 1 A/P Cutting Block, size 2
Daytona® Small Stature
FDA UDI
Seaspine Orthopedics Corporation·10889981185640·CoCr Locking Cap 4.5mm, Small Stature, T25, BT
A.T.S.®
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024376588·
Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use
FDA 510(k)
FDA Class 2
·General Hospital
ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X (2.0K, 2.5CA), MODEL 5M8002A
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Stimulator, Bone Growth, Non-Invasive
FDA Pre-Market Approval
FDA Class 2
·Biomet(R) EBI BONE Healing System
Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79-0002 Software Version: N/A Product Description: Locking Cap Component: No
FDA Enforcement
Class II
·Ongoing·SEASPINE ORTHOPEDICS CORPORATION·January 1, 2025
Stimulator, Bone Growth, Non-Invasive
FDA Pre-Market Approval
FDA Class 2
·EBI BONE HEALING SYSTEM MODEL 1020
Stimulator, Bone Growth, Non-Invasive
FDA Pre-Market Approval
FDA Class 2
·BIO OSTEOGEN SYSTEM 204
Stimulator, Bone Growth, Non-Invasive
FDA Pre-Market Approval
FDA Class 2
·BIOMET EBI BONE HEALING SYSTEM
Stimulator, Bone Growth, Non-Invasive
FDA Pre-Market Approval
FDA Class 2
·EBI BONE HEALING SYSTEM - MODEL 2001
Stimulator, Bone Growth, Non-Invasive
FDA Pre-Market Approval
FDA Class 2
·BIO OSTEOGEN SYSTEM 204
Stimulator, Bone Growth, Non-Invasive
FDA Pre-Market Approval
FDA Class 2
·BIO OSTEOGEN SYSTEM 204
Stimulator, Bone Growth, Non-Invasive
FDA Pre-Market Approval
FDA Class 2
·BIO OSTEOGEN SYSTEM 204
Stimulator, Bone Growth, Non-Invasive
FDA Pre-Market Approval
FDA Class 2
·EBI BONE HEALING SYSTEM
Stimulator, Bone Growth, Non-Invasive
FDA Pre-Market Approval
FDA Class 2
·BIOMET BHS-MINI