18 results
·
20ms
·
Sources: EU EUDAMED, US FDA
MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM
FDA 510(k)
FDA Class 2
·Dental
CANCELLO-PURE WEDGE
FDA Adverse Event
Injury
·RTI BIOLOGICS·Product code MQV·April 16, 2010
LEONE SPA
FDA UDI
LEONE SPA·08033707001058·MEDIUM SCREWS S/STEEL 11mm
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014605746·MAQUET ALPHASTAR 1132 3" DELUXE
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450388075·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450314289·
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345024069·Paddle Shaver, 11mm
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0103110·Shaver, Closed, 11mm
LIPOMATIC; LIPOMATIC LIPOSUCTION DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PARAPOST FIBER WHITE
FDA 510(k)
FDA Class 1
·Dental
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K08-PI (Custom Fluid Management Kit), REF: K08-02042 K08-02948 K08-03026 K08-03119 An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
FDA Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·August 21, 2024
PELVISOFT ACELLULAR COLLAGEN BIOMESH
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTM·April 24, 2013
SMART CONTROL NITINOL STENT SYSTEM
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIO·May 6, 2011
POLYFLUX LR CAPILLARY DIALYZER
FDA Adverse Event
Malfunction
·GAMBRO DIALYSATOREN GMBH·Product code MSF·July 24, 2008
X3 TRIATHLON CS INSERT #5 9MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·July 1, 2013
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K08-PI (Custom Fluid Management Kit), REF: K08-02042 K08-02948 K08-03026 K08-03119 An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
FDA Recall
Open, Classified
·Merit Medical Systems, Inc.·Product code OJA·June 11, 2024
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014