17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Skeletal Dynamics Forearm Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
METZENBAUM SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896055315·METZENBAUM SCISSORS CURVED TUNGSTEN CARBIDE BLA...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694006927·Sliding Length Gauge, Lag Screw Depth Gauge
BAILEY HEMOSTATIC FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896061101·BAILEY HEMOSTATIC FORCEPS ACUTE ANGLED EXTRA FI...
ELMED
FDA UDI
ELMED INCORPORATED·00842180102705·MONOPOLAR RF-CABLE WITH DUAL STAGE MALE BANANA ...
BOEHRINGER LABORATORIES PNEUMATIC AMBULATORY COMPRESSION SYSTEM 8200 SERIES
FDA 510(k)
FDA Class 2
·General Hospital
MALLORY/HEAD LATERALIZED PRESS-FIT FEMORAL
FDA 510(k)
FDA Class 2
·Orthopedic
ATTAIN BIPOLAR OVER THE WIRE LEAD
FDA Adverse Event
Injury
·MPRI·Product code LWP·August 11, 2011
PRESTIGE CERVICAL DISC SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code MJO·October 24, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 1, 2013
PROXIMAL HUMERUS, RIGHT, ÿ 11X160MM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HRS·May 13, 2025
ANN BLUNT TIP SCREW 4X44MM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HRS·May 13, 2025
ANN BLUNT TIP SCREW 4X46MM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HRS·May 13, 2025
RATCHETING SCREWDRIVER HANDLE
FDA Adverse Event
Malfunction
·SYNTHES TUTTLINGEN·Product code HXX·February 28, 2017
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
FDA Enforcement
Class II
·Terminated·Bayer Corp·June 11, 2014
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
FDA Enforcement
Class I
·Terminated·Animas Corporation·April 10, 2013