23 results · 31ms · Sources: EU EUDAMED, US FDA

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SIDEKICK RAIL FIXATOR

FDA 510(k)
FDA Class 2 ·Orthopedic

SchureMed

FDA UDI
SCHUERCH CORPORATION·00810014604282·2" Armboard Pad, Deluxe

DIAMOND CARPAL

FDA UDI
Stryker GmbH·00886385006666·Drill bushing, 1.5mm Non-compressing

SchureMed

FDA UDI
SCHUERCH CORPORATION·00810014603865·2" Armboard Pad, Deluxe

Symmetry Surgical®

FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482139752·Forcep Bipolar Bayonet Angled Up Insulated 0.5m...

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450047408·

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·January 10, 2018

Disposable Cuff

FDA UDI
SUNTECH MEDICAL, INC.·10840935100799·

Cam Lock Shaft

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215043834·

VIRIDIS DERMA LASER

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

SYNTHETIC POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 22, 2019

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·February 14, 2018

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code HWC·March 17, 2016

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 5, 2018

PREFYX PPS SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - SPENCER·Product code FTL·April 26, 2013

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORP.·Product code LZG·April 6, 2011

POLYFLUX LR CAPILLARY DIALYZER

FDA Adverse Event
Malfunction ·GAMBRO DIALYSATOREN GMBH·Product code MSF·July 24, 2008

BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM

FDA Adverse Event
Malfunction ·BD (SUZHOU)·Product code FOZ·November 29, 2023

Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

FDA Enforcement
Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024