37 results · 21ms · 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.

A1C-CELLULAR

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

Leksell Vantage Stereotactic System

FDA UDI
Elekta Solutions AB·07340201501351·LEKSELL VANTAGE CROSS-HAIRS

DeRoyal

FDA UDI
DEROYAL INDUSTRIES, INC.·00749756001830·Wrist/Forearm Splint

Immunalysis

FDA UDI
IMMUNALYSIS CORP·00840937110355·Ethyl Alcohol Enzyme Assay

20GA Straight Laser Probe, SMA906

FDA UDI
Peregrine Surgical, Llc·00632307001895·20GA Straight Laser Probe, SMA906

BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·March 28, 2025

Gorilla Plating System

FDA UDI
Paragon 28, Inc.·00889795009548·BOW & Arrow, Base Wedge Plate, 2.5mm Wedge

Cosmolock

FDA UDI
Kalitec Direct LLC·B07311K0100250·Caddie Lid, Fixed Cross Links 5.5mm

Intelliguides

FDA UDI
Mios Marketing, LLC·G2710310400250·Talar Osteotmy Guide, 40mm x 25mm

SPLITTABLE SHEATH INTRODUCER KIT

FDA 510(k)
FDA Class 2 ·Cardiovascular

ELECTRICATOR MODEL 26000

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Cap, Cooling (Infants)

FDA Pre-Market Approval
FDA Class 3 ·OLYMPIC COOL-CAP

Cap, Cooling (Infants)

FDA Pre-Market Approval
FDA Class 3 ·OLYMPIC COOL-CAP SYSTEM

Cap, Cooling (Infants)

FDA Pre-Market Approval
FDA Class 3 ·OLYMPIC COOL CAP

Cap, Cooling (Infants)

FDA Pre-Market Approval
FDA Class 3 ·OLYMPIC COOL-CAP SYSTEM

Cap, Cooling (Infants)

FDA Pre-Market Approval
FDA Class 3 ·OLYMPIC COOL-CAP SYSTEM

Cap, Cooling (Infants)

FDA Pre-Market Approval
FDA Class 3 ·OLYMPIC COOL-CAP SYSTEM

Cap, Cooling (Infants)

FDA Pre-Market Approval
FDA Class 3 ·OLYMPIC COOL-CAP SYSTEM

Cap, Cooling (Infants)

FDA Pre-Market Approval
FDA Class 3 ·OLYMPIC COOL-CAP SYSTEM

Cap, Cooling (Infants)

FDA Pre-Market Approval
FDA Class 3 ·OLYMPIC COOL-CAP SYSTEM