16 results
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40ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EVOS Lumbar Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
ELMED
FDA UDI
ELMED INCORPORATED·00842180102842·RIGHT ANGLE MONOPOLAR RF-CABLE W/ FEMALE BANANA...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694007030·Double Sided Drill Guide Handle
NIHLEN FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896061156·NIHLEN FORCEPS VERY DELICATE STREAMLINED CURVED...
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100552821·IN-OVATION® C EURO 022 U 5-5/L 3-3 CS-BC HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100552811·IN-OVATION® C EURO 022 U5-5/L3-3 CS HK
RAYSTATION VERSION 1.0
FDA 510(k)
FDA Class 2
·Radiology
CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer System
FDA 510(k)
FDA Class 2
·Orthopedic
NC TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·October 24, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code FSA·July 1, 2013
PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 - (4X)
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·September 26, 2024
MECTALIF TRANSFORAMINAL CAGES TIPEEK
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code MAX·April 25, 2025
Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK, Receiver (mg/dL), Pink; MT22495-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016
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