53 results · 18ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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