17 results
·
18ms
·
Sources: EU EUDAMED, US FDA
AIRWAY, BERMAN 40, 60, 80, 90, L00MM'S
FDA 510(k)
FDA Class 1
·Anesthesiology
Actalyke XL, Dual Detection, (New Display) "CE" (110V/220V)
FDA UDI
HELENA LABORATORIES CORPORATION·M52557700010·
Site-Rite
FDA UDI
Bard Access Systems, Inc.·00801741125744·SITE-RITE 6 PROBE
Washbon
FDA UDI
ORMCO CORPORATION·00889989043303·UPPER RIGHT FIRST MOLAR WASHBON BAND SIZE 1
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690190257·IM TIBIAL ALIGNMENT GUIDE SHAFT 3, 5 DEG
CONMED
FDA UDI
Conmed Corporation·20653405008832·BIPOLAR ELECTROSURGICAL FORCEPS, 8-1/4" HARDY B...
Gonococcal Antibody Tests
FDA Pre-Market Approval
FDA Class 3
·FLUORESCENT GONORRHEA TEST-HEATED (FGT-H)
Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens
FDA 510(k)
FDA Class 2
·Ophthalmic
MASTER CLASSIC 5K LOW SPEED HANDPIECE, 20K LOW SPEED HANDPIECE, TM5 LOW SPEED HANDPIECE AND TM20 LOW SPEED HANDPIECE
FDA 510(k)
FDA Class 1
·Dental
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 14, 2011
11 GAUGE, T-GRIP ACCESS NEEDLES
FDA Adverse Event
Other
·ARTHROCARE CORP.·Product code GEA·January 29, 2008
11 GAUGE CAVITY SPINEWAND
FDA Adverse Event
Other
·ARTHROCARE CORP.·Product code GEI·January 29, 2008
EN-BLOC BIOPSY SYSTEM, MODELS 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS·Product code JAA·January 28, 2014
ARTICULEZE M HEAD 36MM+8.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·October 3, 2012
VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM
FDA Adverse Event
Death
·BOSTON SCIENTIFIC IRELAND LTD.·Product code MAF·July 25, 2010
MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715
FDA Enforcement
Class II
·Terminated·Megadyne Medical Products, Inc.·August 22, 2018