26 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (MOXIFLOXACIN)
FDA 510(k)
FDA Class 2
·Microbiology
PowerPICC Provena
FDA UDI
Bard Access Systems, Inc.·00801741224089·Catheter Placement Kit
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001036·artVeneer life upper anteriors, BXL, A2
AOS CAPTURED CORTICAL SCREW 5.0mm x 36mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665019131·
XCM Biologic® Tissue Matrix
FDA UDI
DSM BIOMEDICAL, INC.·00812337020367·
Medstone
FDA UDI
Stille AB·07332339232269·
Cadwell
FDA UDI
CADWELL INDUSTRIES, INC.·00840067103289·Thermocouple
BED RAIL
FDA Adverse Event
Death
·EVEREST & JENNINGS INTL., LTD.·Product code FNL·December 26, 1995
THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE
FDA 510(k)
FDA Class 2
·Radiology
ENTEC REFLEX WAND 55, MODEL E4055-00
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·February 2, 2026
CAPTURED CORTICAL SCREW, Ø5.0MM X 36MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HSB·June 18, 2025
CAPTURED CORTICAL SCREW, Ø5.0MM X 36MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HSB·August 29, 2022
AEROAUTOCAT 2 WAVE
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DSP·February 27, 2013
LEGEND XT 4CH COMBO PKG
FDA Adverse Event
Injury
·Product code IPF·February 21, 2011
HUMAPEN ERGO, TEAL/CLEAR
FDA Adverse Event
Injury
·ELI LILLY AND CO.·Product code FMF·February 20, 2008
GALILEO® TROCH NAIL, Ø11MMX20CMX125°
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HSB·August 29, 2022
GALILEO LAG SCREW, RIGHT, Ø10.5MMX100MM
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HSB·August 29, 2022
Alpha-Omega Services, Inc. Product No: SPECIAL-NFV Description: CUSTOM FLEXIGUIDE NEEDLE, SERIES 15, WITH FEMALE LUER AND STYLET WITH MALE LUER 28CM, SET OF 100 Quantity: 1/PKG Lot No: K00136 L-SPECIAL- NFV. The FlexiGuide is a flexible needle designed to provide an enclosed pathway for localized radiation therapy using a Remote High Dose Rate (HDR) Afterloader or manual Low Dose Rate (LDR) method.
FDA Recall
Terminated
·Alpha Omega Services Inc·Product code IWJ·November 15, 2007
Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 670-1670-00 Product Usage: The CardioCall event recorder is worn by the patient to record a short period of electrocardiogram which can be sent to his physician.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·November 4, 2015