31 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SURGILANCE SAFETY LANCETS, MODELS SLN100, SLN200, SLN240, SLN300, SLB200, SLB250
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MegaBeam® Reusable Fiber Optic Delivery System
FDA UDI
Ceram Optec SIA·04049089100405·
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704508086·
DD Bio Splint P
FDA UDI
Dental Direkt GmbH·EDDIK101151·DD Bio Splint P are transparent dental milling ...
Needle Guide
FDA UDI
CIVCO MEDICAL INSTRUMENTS CO., INC.·10841436102268·Sterile endocavity needle guide with (3.5 x 20c...
S-Core™
FDA UDI
SUBCHONDRAL SOLUTIONS, INC.·00850017962415·Size 4 Cannulated Sizer
Zavation
FDA UDI
Zavation LLC·00197157009724·4.5mm TAP, CANNULATED
FacetLink System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575426607·Facet Screw
ELMED
FDA UDI
ELMED INCORPORATED·00842180163546·4MM, 45CM, NEW CATHETER PASSER, SHUNT GUIDE W/ ...
ONE TOUCH BASIC
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·December 14, 2001
MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
FDA 510(k)
FDA Class 2
·Hematology
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 26, 2019
CURRENT PLUS DR, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 9, 2013
TANDEM T: SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES CARE INC.·Product code LZG·September 17, 2014
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·May 24, 2011
UNK COIL-THERMO MECHANICAL
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·August 18, 2020
Hudson RCI Sheridan: 1) CF 6.0 mm, Product Codes: 5-10112, 5-10212 2) CF 6.5 mm, Product Codes: 5-10113, 5-10213 3) CF 7.0 mm, Product Codes: 5-10114, 5-10214 4) CF 7.5 mm, Product Codes: V5-10115, 5-10115, 5-10215 5) CF 8.0 mm, Product Codes: 5-10116, 5-10216, V5-10116 6) CF 8.5 mm, Product Codes: 5-10117, 5-10217 Product Usage: Tracheal tube/airway management
FDA Recall
Terminated
·Teleflex Medical·Product code BTR·May 24, 2019
Operations and Technical Manuals for the firm's WarmAir Model 135 Hyperthermia System (115V, 100V, and 230/240V), 510 (k) #K101148, Serial Numbers: 994-1350001 through 104-1356894. The WarmAir 135 Hyperthermia System is a patient temperature management device which provides forced air warmed by the controller to ... a blanket that is placed over or around adult, pediatric or neonatal patients in order to warm them. The heated air is blown through a connecting flexible hose to a disposable blanket to provide patient therapy by the means of warmed air. The system can be used in long-term care facilities, surgical facilities, hospitals including the Post-anesthesia Care Unit (PACU), Intensive Care Unit (ICU), Surgical Intensive Care Unit (SICU), Emergency Room (ER), Operating Room (OR), medical and surgical floors, or any other department or hospital facility requiring patient temperature management. To prevent hypothermia and/or reduce cold discomfort before, during, and after surgical procedures. Used to raise a patient's temperature and/or maintain a desired patient temperature through convective heat transfer from the controller to a warm-air heated blanket.
FDA Recall
Terminated
·Cincinnati Sub-Zero Products Inc·Product code DWJ·July 20, 2011
Hudson RCI Sheridan: 1) CF 6.0 mm, Product Codes: 5-10112, 5-10212 2) CF 6.5 mm, Product Codes: 5-10113, 5-10213 3) CF 7.0 mm, Product Codes: 5-10114, 5-10214 4) CF 7.5 mm, Product Codes: V5-10115, 5-10115, 5-10215 5) CF 8.0 mm, Product Codes: 5-10116, 5-10216, V5-10116 6) CF 8.5 mm, Product Codes: 5-10117, 5-10217 Product Usage: Tracheal tube/airway management
FDA Enforcement
Class I
·Terminated·Teleflex Medical·June 26, 2019