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BLOOD PRESSURE MONITOR, MODEL KP-7000

FDA 510(k)
FDA Class 2 ·Cardiovascular

Baltic Denture System BD Load

FDA UDI
Merz Dental GmbH·D7091032492·Baltic Denture System BDLoad Mw6 PLSEbim6DFm C1...

ACE SurgicalSilk Bb 4-0 18" Dsm13

FDA UDI
Surgical Specialties México, S. de R.L. de C.V.·00848782022854·003-2492 Silk Bb 4-0 18" Dsm13

KADANCE 2000

FDA 510(k)
FDA Class 2 ·Orthopedic

SIMPLICITY SOFT INFUSION SET

FDA 510(k)
FDA Class 2 ·General Hospital

9611993-2022-032492

FDA Adverse Event
Injury ·NOBEL BIOCARE (PRODUCTION) AB·Product code DZE·January 11, 2022

GRANUFLO

FDA Adverse Event
Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·March 29, 2013

INTERSTIM II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code EZW·March 23, 2011

CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING

FDA Adverse Event
Other ·EDWARDS LIFESCIENCES·Product code KRH·April 16, 2008

Toshiba Excelart VANTAGE Model MRT-1503, Magnetic Resonance Imaging Systems, Regulation Number 21 CPR 892.1000, Regulatory Class II, Product Code 90-LNH and was cleared with K032490

FDA Recall
Terminated ·Toshiba American Med Sys Inc·Product code LNH·October 12, 2005

Torcon NB

FDA UDI
COOK INCORPORATED·00827002310704·Torcon NB, Advantage Catheter

SELEX/MAGNUM MOD HD 40MM +9

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code LZO·April 24, 2014

TI LOW PROFILE SCREW 6.5X20MM

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code LPH·April 24, 2014

UNKNOWN

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code LPH·April 24, 2014

TI LOW PROFILE SCREW 6.5X20MM

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code LPH·April 24, 2014

REGEN/RNGLC+ MULTI 64MM SZ 26

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code LPH·April 24, 2014

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016