23 results · 21ms · Sources: EU EUDAMED, US FDA

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DANA DIABECARE II INSULIN PUMP & SUPERLINE-EASYRELEASE, SOFT-RELEASE-ST, & SOFT-RELEASE-R INFUSION SETS

FDA 510(k)
FDA Class 2 ·General Hospital

PORTUX CAD/CAM Disc. 98.5X 25mm A1. MN

FDA UDI
PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A·07701126710912·PORTUX CAD/CAM Disc. 98.5X 25mm A1. MN

Safco polycarbonate crowns

FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310223173·Safco polycarbonate crowns #42 5/box

2040 Ceramic Brackets

FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746005770·COSMETIC 20/40 LR 2ND BIC 018 T-17 A+2 R=0

Specials

FDA UDI
Seaspine Orthopedics Corporation·10889981157258·Cambria Trial without Depth Stop

MODEL 9000 BARIATRIC WHEELCHAIR

FDA 510(k)
FDA Class 1 ·Physical Medicine

COALESCENT SURGICAL U-CLIP

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

TRANSEND GUIDEWIRE

FDA Adverse Event
Malfunction ·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP·Product code DQX·October 27, 2009

TRANSEND GUIDEWIRE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 7, 2010

NITINOL TC ELECTRODE

FDA Adverse Event
Malfunction ·COSMAN MEDICAL·Product code GXI·August 23, 2017

TRANSEND GUIDEWIRE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 10, 2010

TRANSEND GUIDEWIRE

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·July 14, 2010

TRANSEND GUIDEWIRE

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·November 9, 2010

TRANSEND GUIDEWIRE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 10, 2010

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 27, 2013

PRECISION XTRA

FDA Adverse Event
Malfunction ·Product code NBW·March 17, 2011

VITROS CHEMISTRY PRODUCTS TOBRA REAGENT

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code LDO·March 28, 2008

TRANSEND GUIDEWIRE

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 27, 2010

TSRH SPINAL SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 24, 2016

ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM SS/SS ECHO B PG, Item Number H787065970395, Catalog No.REF 06597039, 2) 5 F Stiffened Micro-Introducer Kit, STF 5F M.I. KIT 45CM SS/SS ECHO S PG, Item Number H787065970415, Catalog No. REF 06597041 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick

FDA Enforcement
Class III ·Terminated·Angiodynamics, Inc.·December 28, 2016