20 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INTERPORE CROSS ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PULL THRU CHANNEL CLEANING BRUSH SINGLE
FDA UDI
MEDIVATORS INC.·40677964021273·PULL THRU CHANNEL CLEANING BRUSH SINGLE
RMO
FDA UDI
Rmo, Inc.·00885797099747·LING RETNR BD 3X3 6 CS WO/INST
GRADIA®
FDA UDI
Gc America Inc.·D0470025921·GRADIA® DIRECT X Unitips -20 tips 0.16 mL/0.30...
GRADIA®
FDA UDI
Gc America Inc.·14548161292160·GRADIA® DIRECT X Unitips -20 tips 0.16 mL/0.30...
UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET
FDA 510(k)
FDA Class 2
·General Hospital
ECHOCOM, IMAGECOM, DOKUCOM
FDA 510(k)
FDA Class 2
·Cardiovascular
RESOLUTE INTEGRITY RX
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·June 17, 2016
RESOLUTE INTEGRITY RX
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code NIQ·June 17, 2016
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·February 15, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·February 28, 2011
INDURA CATHETER
FDA Adverse Event
Malfunction
·RICE CREEK MANUFACTRING·Product code LKK·February 8, 2008
Gown Cool Impervious XLGE Breathable Customed, 900-2592: (1) GOWN XL SURGICAL MICROCOOL (1) WRAPPER 24" X 24" (1) TOWELS ABSORBENT 15" X 20" LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
HEARTMATE 3 SYSTEM CONTROLLER
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·December 9, 2020
Gown Cool Impervious XLGE Breathable, catalog #900-2592 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Enforcement
Class I
·Terminated·Customed, Inc·December 10, 2014
GOWN COOL IMPEV. XLGE BREATHABLE 24/CS CUSTOMED Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
FDA Enforcement
Class II
·Terminated·Customed, Inc·September 9, 2015
Gown Cool Impervious XLGE Breathable, catalog #900-2592 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code KKX·October 8, 2014
Gown Cool Impervious XLGE Breathable Customed, 900-2592: (1) GOWN XL SURGICAL MICROCOOL (1) WRAPPER 24" X 24" (1) TOWELS ABSORBENT 15" X 20" LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code LRO·May 20, 2014
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·March 27, 2013
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024