21 results
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26ms
·
Sources: EU EUDAMED, US FDA
TRANS-PACE 100
FDA 510(k)
FDA Class 2
·Cardiovascular
ReLine
FDA UDI
Nuvasive, Inc.·00195377068026·RELINE Plate, Occip Adjustable Large
Instruments
FDA UDI
Nuvasive, Inc.·00887517384300·ALGI Cobb Elevator, Straight Large
Photodynamic Bone Stabilization Procedure Pack
FDA UDI
ILLUMINOSS MEDICAL, INC.·M986USSL09002200·Photodynamic Bone Stabilization Procedure Pack
Photodynamic Bone Stabilization Procedure Pack
FDA UDI
ILLUMINOSS MEDICAL, INC.·USSL0900220·
NA
FDA UDI
Stryker GmbH·00886385022314·Sigmoid Notch Screw
Pediatric Front Closing Special Procedure Apron, Medium, 12" x 29"
FDA UDI
Flow X Ray Corporation·00843696128319·Pediatric Front Closing Special Procedure Apron...
Photodynamic Bone Stabilization System
FDA UDI
ILLUMINOSS MEDICAL, INC.·M986US09002200·9mmx220mm Photodynamic Bone Stabilization LED L...
Mariner
FDA UDI
Seaspine Orthopedics Corporation·10889981129224·Screw Shank Driver
HYFRECATOR
FDA UDI
Conmed Corporation·20653405031601·HYFRECATOR 2000 220 Volts AC - 50/60 Hz Electro...
COLON VIEW, MODEL CSCV-001A
FDA 510(k)
FDA Class 2
·Radiology
MA-300 ELECTROMYOGRAPHY SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
LINER FOR METAL BACK GLENOID STANDARD
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code KWS·November 7, 2022
ALARIS PUMP MODULE ADMINISTRATION SET
FDA Adverse Event
Death
·CAREFUSION CORPORATION·Product code FPA·June 18, 2014
UNKNOWN MESH PRODUCT (EWHU)
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·November 10, 2010
ADVANTA 2 BED
FDA Adverse Event
Malfunction
·HILLROM DE MEXICO S DE RL DE CV·Product code FNL·November 15, 2012
Wallach Cryotip T-00337 Anorectal Tip, Teflon Coated, used with the Cryosurgical LL100 or LL50X Reference: 900220
FDA Recall
Terminated
·Wallach Surgical Devices, Inc.·Product code GEH·June 6, 2007
Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons , 220 VOLTS AC, REF/Catalog Number 7-900-220, Rx Only, There is no problem with the Hyfrecator 2000 Electrosurgical Units --- ASSEMBLED IN MEXICO -- CONMED CORPORATION 525 FRENCH ROAD UTICA, NY 13502 ---
FDA Recall
Terminated
·ConMed Corporation·Product code GEI·February 28, 2017
Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons , 220 VOLTS AC, REF/Catalog Number 7-900-220, Rx Only, There is no problem with the Hyfrecator 2000 Electrosurgical Units --- ASSEMBLED IN MEXICO -- CONMED CORPORATION 525 FRENCH ROAD UTICA, NY 13502 ---
FDA Enforcement
Class II
·Terminated·ConMed Corporation·April 19, 2017
Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90 degree Tip, PL17-160-090
FDA Enforcement
Class II
·Ongoing·Scientia Vascular, Inc.·March 22, 2023