17 results · 18ms · Sources: EU EUDAMED, US FDA

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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