16 results
·
21ms
·
Sources: EU EUDAMED, US FDA
AMES TDA N-ACETYL-PROCAINAMIDE TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
GE Healthcare
FDA UDI
SHENZHEN LAUNCH ELECTRICAL CO., LTD·06947437900357·ECG 3 Lead Cable Undetachable, Grabber, IEC, 4....
CORONARY PERFUSION CONNECTOR PLUG
FDA 510(k)
FDA Class 2
·Cardiovascular
INTERGRO DBM
FDA 510(k)
FDA Class 2
·Orthopedic
RECEPTAL CANISTER 1000 ML CE
FDA Adverse Event
Malfunction
·AMSINO MEDICAL CO., LTD.·Product code GCX·May 25, 2012
RECEPTAL 1.5LITER PE/CE WITH (50/CASE)
FDA Adverse Event
Malfunction
·HOSPIRA LTD.·Product code GCX·August 1, 2011
NON-PVC RECEPT LINER 2000ML/CE(50/CS)
FDA Adverse Event
Malfunction
·HOSPIRA, LTD.·Product code GCX·June 21, 2011
NON-PVC RECEPT. LINER 2000ML/CE(50/CS)
FDA Adverse Event
Malfunction
·HOSPIRA, LTD.·Product code GCX·June 21, 2011
NON-PVC RECEPT LINER 2000ML/CE(50/CS)
FDA Adverse Event
Malfunction
·HOSPIRA, LTD.·Product code GCX·June 21, 2011
RECEPTAL 1.5 LITER PE/CE WITH (50/CASE)
FDA Adverse Event
Injury
·HOSPIRA LTD.·Product code GCX·November 18, 2010
RECEPTAL 1 LITER/CE WITH VALVE (50/CAS)
FDA Adverse Event
Malfunction
·HOSPIRA LTD.·Product code GCX·June 24, 2011
RECEPTAL 1 LITER/CE WITH VALVE (50/CAS)
FDA Adverse Event
Malfunction
·HOSPIRA LTD.·Product code GCX·June 24, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 24, 2014
11G BLADED MAMMOTOME ST PROBE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code KNW·December 17, 2007
LCP PROXTIBPI 3.5 LAT LE SHAFT 4HO L81 T
FDA Adverse Event
Malfunction
·SYNTHES ELMIRA·Product code HRS·October 11, 2012
Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013