19 results
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28ms
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Sources: EU EUDAMED, US FDA
ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Custom Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964023147·The ENDO CARRY-ON Procedure Kit contains all of...
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489004035·PowerChem Neoprene Exam Gloves, Medium
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489105633·PowerChem Neoprene Exam Gloves, Medium
4.0 X 34mm CANN SCREW FASTENER Ti FL THD
FDA UDI
Osteocentric Technologies, Inc.·00810074304726·4.0 X 34mm CANN SCREW FASTENER Ti FL THD
WVSM Wireless Vital Signs Monitor
FDA UDI
ATHENA GTX, INC.·B3945000034030·Wireless Patient Monitor
Spacelabs Healthcare
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522124785·4 ELECTRODE EVO RECORDER PACKED, FRENCH
SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NOVOFINE 31 DISPOSABLE NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
2.0X9MM FOSSA X-DR SCREW
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code JEY·January 28, 2016
2.7X10MM HT X-DRIVE SCREW
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HWC·January 28, 2016
6.0MM TI MATRIX SCREW
FDA Adverse Event
Malfunction
·SYNTHES (USA) BRANDYWINE·Product code NKB·February 28, 2013
SYNCHRON UNICEL DXC 600
FDA Adverse Event
BECKMAN COULTER INC.·Product code JJE·March 1, 2011
UNICEL DXI 800 ACCESS IMMUNOASSSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·February 21, 2008
TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code LZD·August 5, 2015
TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code LZD·August 5, 2015
smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·March 27, 2013
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024