21 results · 36ms · Sources: EU EUDAMED, US FDA

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OsteoMed Cannulated Screw System

FDA 510(k)
FDA Class 2 ·Orthopedic

HHM

FDA UDI
Oticon A/S·05707131282811·H110V2, BTE 13 WL 100 CNB HHM

AGC Tradition Knee System

FDA UDI
Biomet Orthopedics, LLC·00880304008212·

Release Module

FDA UDI
ORMCO CORPORATION·00889989059878·Release Module Heavy Force

N/A

FDA UDI
Smith & Nephew, Inc.·00817470009002·STRAIGHT PICK

VARIANT

FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030SPO1510210·Threaded Fixation Pin, ø3mm x 210mm

ANEROID SPHYGMANOMETER WITH STETHOSCOPE, MODEL HS-50A

FDA 510(k)
FDA Class 2 ·Cardiovascular

CUBESCAN / BIOCON-700

FDA 510(k)
FDA Class 2 ·Radiology

PRODIGY AUTOCODE

FDA Adverse Event
Injury ·OK BIOTECH CO., LTD.·Product code NBW·March 14, 2017

MEGA SUTURECUT NEEDLE DRIVERINSTRUMENT

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·June 6, 2013

HIP HEAD, 10/12 TAPER, 28MM, +5MM

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD·Product code KWY·June 29, 2011

PRECISION LINK

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC. USA·Product code NBW·August 29, 2008

BELLAFILL DERMAL FILLER

FDA Adverse Event
Injury ·SUNEVA MEDICAL, INC.·Product code LMH·January 11, 2024

Biograph mMR. Model Number: 10433372.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

UNIVERSA SOFT URETERAL STENT SET

FDA Adverse Event
Malfunction ·COOK INC·Product code FAD·January 29, 2019

UNIVERSA SOFT URETERAL STENT SET

FDA Adverse Event
Malfunction ·COOK UROLOGICAL INC·Product code FAD·May 13, 2016

UNIVERSA SOFT URETERAL STENT SET

FDA Adverse Event
Injury ·COOK INC·Product code FAD·September 8, 2016

UNIVERSA SOFT URETERAL STENT SET

FDA Adverse Event
Injury ·COOK UROLOGICAL INC·Product code FAD·May 13, 2016

UNKNOWN

FDA Adverse Event
Malfunction ·COOK INC·Product code FAD·July 23, 2019

Medical Linear Accelerator

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·September 14, 2016