22 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY
FDA 510(k)
FDA Class 2
·General Hospital
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772813827·GENUMEDI PRO SILVER SIZE II
ArgenZ Anterior 95x14 #2
FDA UDI
ARGEN CORPORATION, THE·D818121262·Dental porcelain/ceramic restoration kit
SoloPace Fusion Sterile Pack
FDA UDI
SOLO PACE INC.·00850056280044·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450862773·
CORNEAL TREPHINE BLADE
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896012936·CORNEAL TREPHINE BLADE
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383505833·Gutta Percha Points is used to root canal filin...
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970430·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973691·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973073·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970447·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973905·
FLEXI-LITE
FDA 510(k)
FDA Class 2
·Anesthesiology
MAGNETOM SYMPHONY QUADRATURE TX/RX HEAD COIL
FDA 510(k)
FDA Class 2
·Radiology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·September 26, 2014
HEARTSTART MRX -EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·May 4, 2011
COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·August 29, 2017
UNKNOWN
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·July 10, 2017
Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).
FDA Recall
Open, Classified
·GE Medical Systems, LLC·Product code ITX·November 10, 2022