19 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
IMPRESS ANGIOGRAPHIC CATHETER WITH HYDROPHILIC COATING
FDA 510(k)
FDA Class 2
·Cardiovascular
LEONE SPA
FDA UDI
LEONE SPA·08033707065722·INTRAORAL ELASTICS 4,5 oz 3/8" orange
Orthopedic manual surgical instrument
FDA UDI
BAUI BIOTECH CO. LTD.·04718005153794·Anti-Rotator Wrench
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0330040·Vise Grip, Small, 5.5mm
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450384794·
Osteoboost
FDA UDI
Bone Health Technologies, Inc·00860003039748·The Osteoboost is a wearable belt with an incor...
Proximal Humeral Fracture Plate System
FDA UDI
Smith & Nephew, Inc.·00885556829691·HFP SCREW CADDY LID
Integra®
FDA UDI
Ascension Orthopedics, Inc.·10381780364856·Proximal Humeral Fracture Plate System Screw Ca...
COCAINE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
OSCAR 2, MODEL 222
FDA 510(k)
FDA Class 2
·Cardiovascular
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 14, 2019
TEMPERATURE PROBE
FDA Adverse Event
CINCINNATI SUB-ZERO PRODUCTS, INC.·Product code FLL·January 17, 2011
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 3, 2013
MALYUGIN RING SYSTEM
FDA Adverse Event
Malfunction
·MICROSURGICAL TECHNOLOGY, INC.·Product code HOC·September 5, 2014
SYNCHROMED EL
FDA Adverse Event
Malfunction
·RICE CREEK MANUFACTURING·Product code LKK·May 3, 2011
8100 ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·December 27, 2020
INNOVA 3100-IQ
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS SCS·Product code OWB·May 30, 2017
AMS Ambicor Penile Prosthesis, Penoscrotal Approach, Length: 14 cm, Diameter: 11 mm, Product Number 72401450
FDA Recall
Terminated
·American Medical Systems·Product code JCW·April 29, 2004
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