15 results · 23ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Disposable sterile needle retractable safety syringe

FDA 510(k)
FDA Class 2 ·General Hospital

MSI Precision Specialty Instruments

FDA UDI
Med Saver, Inc.·00194613021238·Toynbee Infant Speculum, Oval, 2.5mm x 3.5mm Di...

LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ELECSYS SHBG CALCHECK 5

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

CABLE TENSIONER

FDA Adverse Event
Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code LXH·October 3, 2018

VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAM·July 22, 2019

PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAW·July 22, 2019

CABLE TENSIONER

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code LXH·August 18, 2014

OT VERIO PRO METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013

LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·June 1, 2011

POSTERIOR CHAMBER LENS

FDA Adverse Event
Other ·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·August 28, 2008

INTIMA-II 20GAX1.16IN PRN SLM NPVC

FDA Adverse Event
Malfunction ·BD (SUZHOU)·Product code FPA·September 16, 2019

CERVICAL PLATE VARIABLE SELF-DRILLING SCREW DIAM. 4X16MM (2X)

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code KWQ·November 10, 2016

PROXIMATE*HCS HEMORR CIR STAPL

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 23, 2019

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·September 21, 2022