19 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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STERILUCENT SELF-SEAL STERILIZATION POUCH
FDA 510(k)
FDA Class 2
·General Hospital
N/A
FDA UDI
TETRA MEDICAL SUPPLY CORP.·00614138122482·TETRA ULTRA ORTHO SHOE FEMALE MEDIUM
Health Support
FDA UDI
Carolon Company·00078301141425·
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515019164·Buie Clamp & Hemorrhoid Fcps, 8 1/4"
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221037374·Unitek(TM) Bicuspid Band General Purpose Wide L...
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167311414120·
TALOS®-A
FDA UDI
SpineArt SA·07640375237675·TALOS®-A (HA) PEEK PLANAR, SYMMETRIC IBFD D26 ...
TALOS® HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167321414120·
K2M General Instruments
FDA UDI
VB Spine LLC·10888857581074·Split Tube Retractor Ø14x40 mm
Responsive Orthopedics Total Knee Arthroplasty System
FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973101758·Poly Insert MPCS, Size 4R, 12mm
EVA TPN BAG
FDA 510(k)
FDA Class 2
·General Hospital
ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000
FDA 510(k)
FDA Class 2
·Anesthesiology
Unison™-C Anterior Cervical Fixation System
FDA UDI
Pioneer Surgical Technology, Inc.·00846468075170·Stand-Alone Cervical Interbody Fusion Device
Unison™-C Anterior Cervical Fixation System
FDA UDI
Pioneer Surgical Technology, Inc.·00846468077204·Trial
BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·October 24, 2018
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 4, 2014
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL NEUROMODULATION·Product code LGW·May 24, 2013
TRAUMA STRETCHER
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·June 1, 2011
PKG, 5MM MULTI-FUNCTION PEEK HANDLE, P/N 0250181106 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