23 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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