20 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFIED SONAMET BODY COMPOSITION ANALYZER
FDA 510(k)
FDA Class 2
·Cardiovascular
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032610·Baltic Denture System BDLoad Lm6 PLSEbil2DFl D3...
Battalion
FDA UDI
ALPHATEC SPINE, INC.·00840967187846·Battalion, LLIF Trial, 10°, 26 mm Wide, 10 mm X...
Trulink
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522101779·LDWR,SET,DIN,SNAP,3-LEAD,61CM/24IN,IEC,1/ST
POD PAC-20M
FDA 510(k)
FDA Class 2
·Radiology
CLARUS STRAIGHT FIRING LASER FIBER, MODEL 1150, CLARUS SIDE FIRING LASER FIBER, MODEL 1160
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AccuSITE Needle Guide
FDA UDI
CIVCO MEDICAL INSTRUMENTS CO., INC.·10841436101667·Sterile needle guide with (14 x 147cm) telescop...
AVALUS AORTIC TISSUE VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·June 23, 2020
DEPUY ASR XL FEM IMP SIZE 53
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·April 3, 2013
1.8MM DRILL BIT WITH DEPTH
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HWE·March 23, 2011
SILICONE ADVANCED OPTIC-VIOLET SHIELD
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQL·April 22, 2008
G7 OSSEOTI MULTIHOLE 58MM G
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·September 14, 2023
BONE SCR 6.5X25 SELF-TAP
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·September 14, 2023
G7 HI-WALL ARCOMXL LNR 36MM G
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PBI·September 14, 2023
BONE SCREW SELF-TAPPING 6.5 MM DIA. 25 MM LENGTH
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·September 14, 2023
FREEDOM CONSTR HD 36MM T1 +9MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWZ·September 14, 2023
BONE SCR 6.5X25 SELF-TAP
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·September 14, 2023
BONE SCREW SELF-TAPPING 6.5 MM DIA. 25 MM LENGTH
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·September 14, 2023
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