16 results
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19ms
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Sources: EU EUDAMED, US FDA
SUPERIOR BATH, MODEL 6300
FDA 510(k)
FDA Class 2
·Physical Medicine
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040008324·Zirlux 16+ 0M2 89x17x16
ENDOPATH ETS
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code GAG·October 14, 1997
One-third tubular plates,61mm/5 holes, 3.5mm
FDA UDI
mahe medical gmbh·EMAH00200120610·One-third tubular plates,61mm/5 holes,
3.5mm
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659180796·One-third tubular plates,61mm/5 holes, _x000D_...
Integrity-SI Fusion System
FDA UDI
Lincotek Medical LLC·B57112521012061D0·12 x 60 mm SI Implant with HA Coating
DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND
FDA 510(k)
FDA Class 2
·Clinical Chemistry
A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
DENTAL IMPLANT
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·November 27, 2019
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 14, 2007
UNKNOWN DEPUY TIBIAL TRAY
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JWH·March 20, 2013
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·February 28, 2011
HUMERAL SCREW KIT 2 HUMERAL SCREWS
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDC·April 27, 2022
ULNAR COMPONENT PLASMA SPRAYED SIZE 4 75 MM LENGTH LEFT FOR CEMENTED USE ONLY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDC·April 27, 2022
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
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014