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ASTRALIS 7, MODEL 557545

FDA 510(k)
FDA Class 2 ·Dental

Henry Schein

FDA UDI
HENRY SCHEIN, INC.·00304040028872·Plaster & Stone Remover

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033471012·

AMS FASCIAL-ANCHORING SYSTEM

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

SURGASSIST SYSTEM WITH CIRCULAR STAPLER DISPOSABLE LOADING UNIT, MODEL CS21,CS25,CS29,CS33

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

SECURE II MED/SURG BED

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·March 20, 2013

UNK ZIMMER HUMERAL INSTRUMENT

FDA Adverse Event
Injury ·ZIMMER INC·Product code KWT·March 8, 2011

APR HIP SYSTEM ENHANCED ACETABULAR INSERT

FDA Adverse Event
Malfunction ·ZIMMER, INC.·Product code KWB·March 14, 2008

IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 11.5MM

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·April 26, 2024

PKG, SPRING HANDLE, P/N 0250080237. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

FDA Enforcement
Class II ·Terminated·Stryker Endoscopy·December 24, 2014

IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 8MM

FDA Adverse Event
Malfunction ·ZIMMER DENTAL·Product code DZE·December 19, 2019

IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 13MM

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·August 7, 2019

IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM

FDA Adverse Event
Malfunction ·ZIMVIE US CORP LLC·Product code DZE·May 29, 2026

IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·February 23, 2022

IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 8MM

FDA Adverse Event
Malfunction ·ZIMMER DENTAL·Product code DZE·October 11, 2022

IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM

FDA Adverse Event
Injury ·ZIMVIE US CORP LLC·Product code DZE·May 20, 2026

IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM

FDA Adverse Event
Injury ·ZIMVIE US CORP LLC·Product code DZE·May 12, 2026

IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM

FDA Adverse Event
Injury ·ZIMVIE US CORP LLC·Product code DZE·May 12, 2026

IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM

FDA Adverse Event
Injury ·ZIMVIE US CORP LLC·Product code DZE·March 25, 2026

IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 8MM

FDA Adverse Event
Injury ·ZIMVIE US CORP LLC·Product code DZE·April 28, 2026