11 results
·
26ms
·
Sources: EU EUDAMED, US FDA
OAC (OPTICAL ASPIRATING CURETTE)
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
Shur-Clens
FDA UDI
Asept Pak, Inc.·10860006476042·Case of 24 Containers of 0.05% Chlorhexidine Gl...
DeltaForm HD
FDA UDI
Merz Dental GmbH·D7091980096·DeltaForm HD upper posteriors, S, C1 -MADE IN G...
All Purpose Cuff
FDA UDI
SUNTECH MEDICAL, INC.·10840935108016·
LDH ISOENZYME CONTROL SERUM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
GDT-1000 System
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 5, 2014
EMAX 2 PLUS MOTOR
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBC·February 21, 2013
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·February 7, 2011
Angiotech Pediatric Bone Marrow Needle. Pediatric Bone Marrow Needle. STERILE. Product Number: ION18015. 510k K980196. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended Use: Pediatric Bone Marrow Needle
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code KNW·September 1, 2009
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