21 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MONARC SLING SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Safco CleanCare Pro Prophy Paste
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310235163·Safco CleanCare prophy paste, medium cherry, 20...
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526827943·ACHIMED ACHILLES SUPP BLACK VI
SMARTLOCK
FDA UDI
Stryker Leibinger GmbH & Co. KG·37613154184546·Locking Screws, Cross-Pin
GYROSCAN INTERA 3.0T
FDA 510(k)
FDA Class 2
·Radiology
INVACARE ELEVATING SEAT OPTION ESS6
FDA 510(k)
FDA Class 2
·Physical Medicine
PERFORMANCE TOTAL KNEE PROSTHESIS
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code HRY·October 25, 2019
PERFORMANCE DISTAL FAB LM/RL MED
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code JWH·October 18, 2016
PERFORMANCE DISTAL FAB LL/RM MED
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code JWH·October 18, 2016
VANGRD CR POR/HA FEM - RT 72.5
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·March 31, 2016
TINBN VNGRD INT CR ANAT FEMORAL R 62.5 MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·March 31, 2016
VANGUARD CR POROUS/HA FEM - RT 72.5
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·March 23, 2016
BASSINET, TRADITIONAL STYLE
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FMS·March 27, 2013
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·March 1, 2011
PROTIME MICROCOAGULATION SYSTEM
FDA Adverse Event
Other
·INTERNATIONAL TECHNIDYNE CORP.·Product code GKP·March 27, 2008
VANGUARD CEMENTLESS POROUS CR FEMORAL LT 65
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·April 20, 2017
VANGUARD CRUCIATE RETAINING POROUS HA FEMUR - RIGHT 65 MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·May 12, 2017
PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code NEW·February 11, 2026
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 Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.
FDA Enforcement
Class II
·Terminated·Welch Allyn Protocol, Inc·January 15, 2014