21 results · 23ms · Sources: EU EUDAMED, US FDA

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STEELEX STERNUM SET

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

CONMED

FDA UDI
Conmed Corporation·10845854009215·GRAFT HARVESTING BLADE 11 X 20 MM

Navagio

FDA UDI
Kalitec Direct LLC·B07330K0134110·Trial, TLIF, 27L OB STR 7Deg, 11mm

True Position®

FDA UDI
ATLAS SPINE, INC.·M68112080234110·34mm x 11mm Non-Lordotic Spacer

ELECSYS TESTOSTERONE CALSET II

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

PULPDENT CAVITY PREPARATION IV

FDA 510(k)
FDA Class 2 ·Dental

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 24, 2021

TSVMWB11

FDA Adverse Event
Malfunction ·ZIMMER DENTAL-2023411·Product code DZE·October 4, 2018

ASPHERE M SPEC 11/13 40 +3

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·March 27, 2013

DEPUY ASR XL FEM IMP SIZE 45

FDA Adverse Event
Malfunction ·DEPUY INTERNATIONAL, LTD.·Product code KWA·March 2, 2011

LEEP

FDA Adverse Event
Injury ·COOPERSURGICAL, INC.·Product code HGI·April 2, 2008

SPECTRA WAVEWRITER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 2, 2019

FREEDOM SPINAL CORD STIMULATOR

FDA Adverse Event
Injury ·STIMWAVE TECHNOLOGIES INC.·Product code GZB·May 12, 2020

COMP LK SCR 3.5HEX 4.75X45 ST

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWS·October 10, 2023

COMP LK SCR 3.5HEX 4.75X40 ST

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWS·October 10, 2023

COMP LK SCR 3.5HEX 4.75X45 ST

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWS·October 10, 2023

COMPR VRS GLEN PPS MIN TPR ADR

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code PHX·October 10, 2023

COMP LK SCR 3.5HEX 4.75X45 ST

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWS·October 10, 2023

COMP LK SCR 3.5HEX 4.75X45 ST

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWS·October 10, 2023

Laparotomy Sponge with the following product description and model numbers: 1. Lap 18X18 XR (5 each/pack, 20 pack/case) - Model Number 300, 450, SM40018, V300; 2. Lap 18X18 XR (5 each/pack, 40 pack/case) - Model Number 400, 404, V400, V450; 3. Lap 18X18 XR w/ring (5 each/pack, 40 pack/case) - Model Number 402; 4. Lap 4X18 XR (5 each/pack, 40 pack/case) - Model Number 407; 5. Lap 12X12 XR (5 each/pack, 40 pack/case) - Model Number 411; 6. Lap 12X12 XR w/ring (5 each/pack, 40 pack/case) - Model Number 412; 7. Lap 8X36 XR (5 each/pack, 40 pack/case) - Model Number 419; 8. Lap 17X26 XR (5 each/pack, 20 pack/case) - Model Number 426;

FDA Enforcement
Class II ·Terminated·Medical Action Industries Inc·April 3, 2019