130 results
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20ms
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Sources: EU EUDAMED, US FDA
LIQUID-STAT LIQUID REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Primescan 2 Cart
FDA UDI
SIRONA Dental Systems GmbH·E27668004570·Primescan 2 Cart
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209101153·KIT, MCI WALK - BLK
VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES
FDA 510(k)
FDA Class 1
·Ophthalmic
COLOR LCD MONITOR, MODEL RADIFORCE RX211
FDA 510(k)
FDA Class 2
·Radiology
STAT DL 9.5 FR 40 CC IAB
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·April 27, 1998
8CM ANGLE ATTACHMENT
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·May 8, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 22, 2012
LCS COMPLETE POLY PATELLA STD+
FDA Adverse Event
Injury
·DEPUY (IRELAND)·Product code NJL·August 12, 2010
UltraxxTM Nephrostomy Balloon Set The Ultraxx" Nephrostomy Balloon Set consists of a radiopaque balloon catheter, radiopaque sheath, and inflation device. The Ultraxx" Nephrostomy Balloon Set is used to dilate the musculofascia, renal capsule, and parenchyma to establish and maintain a percutaneous tract.
FDA Recall
Terminated
·Cook Inc.·Product code LJE·January 27, 2016
Ascend AQ Ureteral Dilation Balloon Catheter Set The Ascend AQ Ureteral Dilation Balloon Catheter Set consists of a radiopaque balloon catheter and inflation device. The Ascend AQ Ureteral Dilation Balloon Catheter Set is used for transluminal dilation of ureteral strictures or ureteral dilation prior to ureteroscopy and stone manipulation.
FDA Recall
Terminated
·Cook Inc.·Product code LJE·January 27, 2016
Kopans Breast Lesion Localization Needle The Kopans Breast Lesion Localization Needle consists of a bevel-tip needle with centimeter markings and a hookwire. The hookwire features a burnish mark that allows the operator to ensure that the hookwire is within the needle tip during needle manipulation. The Kopans Breast Lesion Localization Needle is intended for preoperative marking of nonpalpable breast lesions.
FDA Recall
Terminated
·Cook Inc.·Product code MIJ·January 8, 2016
Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Catheter Tray Cook Spectrum Minocycline/Rifampin Impregnated Triple Lumen Central Venous Catheter Tray
FDA Recall
Terminated
·Cook Inc.·Product code FOZ·November 28, 2016
Percutaneous Gastrojejunostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
FDA Recall
Terminated
·Cook Inc.·Product code KNT·October 19, 2017
Wills-Oglesby Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
FDA Recall
Terminated
·Cook Inc.·Product code KNT·October 19, 2017
Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
FDA Recall
Terminated
·Cook Inc.·Product code KNT·October 19, 2017
Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-56-ZT, REF G48469, 16Fr ID/ 6.0 mm OD, Sterile.
FDA Recall
Terminated
·Cook, Inc.·Product code MIH·April 15, 2011
Cook Medical Zenith Flex AAA Main Body Extension, REF ESBE-30-39, REF G32183, 20 Fr. ID/ 7.7 OD, Sterile.
FDA Recall
Terminated
·Cook, Inc.·Product code MIH·April 15, 2011
Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-16-56-ZT, REF G48461, 16Fr ID/ 6.0 mm OD, Sterile.
FDA Recall
Terminated
·Cook, Inc.·Product code MIH·April 15, 2011
Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-90-ZT, REF G48471, 16Fr ID/ 6.0 mm OD, Sterile.
FDA Recall
Terminated
·Cook, Inc.·Product code MIH·April 15, 2011