27 results · 20ms · 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.

UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea Hybrid Contact Lens

FDA 510(k)
FDA Class 2 ·Ophthalmic

LEONE SPA

FDA UDI
LEONE SPA·08033707011323·CALIBRA 1ST MOL BANDS W/G8025-02 n.UR 10

Symmetry Beebee

FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482173930·Symmetry® Scissors, Beebee Wire, Curved, Serrat...

Innomed, Inc.

FDA UDI
INNOMED, INC.·00840277101150·Cheng Large Trephine

Zinnanti Surgical

FDA UDI
Zinnanti Surgical Design Group Inc·G3731425100·6" Smoke Evac Fusion 25mm x 10mm Loop

Responsive Orthopedics Total Knee Arthroplasty System

FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973101925·Poly Insert MPCS, Size 5L, 10mm

ICRCO 3600M

FDA 510(k)
FDA Class 2 ·Radiology

DIMENSIONS HB1C KIT, MODEL DF105A

FDA 510(k)
FDA Class 2 ·Hematology

WAVEWRITER ALPHA? 16

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 15, 2025

HNM Medical

FDA UDI
HNM STAINLESS, LLC.·00842962110829·BEEBEE WIRE SCISSORS, 4", SERRATED, CVD

Ascend

FDA UDI
ALPHATEC SPINE, INC.·00190376668086·12mm CORE, NANOTEC KBN 14 x 25 mm 10°

Ascend

FDA UDI
ALPHATEC SPINE, INC.·00190376667652·12mm CORE, NANOTEC BAN 14 x 25 mm 10°

SURESCAN

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·January 16, 2018

R3 PRIMARY LINERS CO

FDA Adverse Event
Injury ·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·October 6, 2014

ETS FLEX ARTICNG LNR CUTR

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 3, 2013

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·June 28, 2011

HANDPIECE MICS

FDA Adverse Event
Malfunction ·MAKO SURGICAL CORP.·Product code OLO·May 23, 2018

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWQ·August 22, 2017

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025