22 results
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18ms
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Sources: EU EUDAMED, US FDA
VISI - STICK OPHTHALMIC SUTURE RETAINER TAPE
FDA 510(k)
FDA Class 1
·General Hospital
Alice
FDA UDI
Rmo, Inc.·00885797488909·STD EDG ALICE 3-3 018 12 BKTS
LANDANGER
FDA UDI
LANDANGER·03661219195863·
OsteoVation
FDA UDI
SKELETAL KINETICS LLC·00813845020061·OsteoVation Inject Bone Void Filler
Rampart One Lumbar Interbody Fusion System
FDA UDI
SPINEOLOGY INC.·M7404902010·Rampart One Trial, 10.5mm, M, 8°
PeritX
FDA UDI
Bard Peripheral Vascular, Inc.·00801741230608·PeritX™ 2L Drainage Kit
Symmetry Surgical
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482129449·Symmetry® Needle Holder; Straight; In Line Hand...
PC ECG, MODEL SE-1010
FDA 510(k)
FDA Class 2
·Cardiovascular
STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Truliant
FDA UDI
Exactech, Inc.·10885862525284·TRULIANT SPACER BLOCK 9 AND 11MM
OsteoVation, Inject, Bone Filler Kits 10cc (part number 390-2010, manufacturing lot 1130303) - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
FDA Enforcement
Class II
·Terminated·Skeletal Kinetics, Llc·January 27, 2021
UNKNOWN_INSTRUMENTSTIRE_PRODUCT
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code GFA·June 30, 2014
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·November 12, 2010
MICRO SAGITTAL SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·November 26, 2012
OSTEOVATION 10CC INJECT FORMULA. REF/UDI: 390-2010/00813845020061 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
FDA Enforcement
Class II
·Terminated·Osteomed, LLC·June 10, 2020
OSTEOVATION 10CC INJECT FORMULA. REF/UDI: 390-2010/00813845020061 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
FDA Recall
Terminated
·Osteomed, LLC·Product code MQV·April 2, 2020
OSTEOVATION, 10CC, INJECT FORMULA. Product Number: 390-2010, UDI: 813845020061 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
FDA Enforcement
Class II
·Terminated·Skeletal Kinetics, Llc·July 22, 2020
OsteoVation, Inject, Bone Filler Kits 10cc (part number 390-2010, manufacturing lot 1130303) - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
FDA Recall
Terminated
·Skeletal Kinetics, Llc·Product code GXP·June 6, 2019
DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
FDA Enforcement
Class II
·Ongoing·Pro-Med Instruments Gmbh·June 4, 2025
OSTEOVATION, 10CC, INJECT FORMULA. Product Number: 390-2010, UDI: 813845020061 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
FDA Recall
Terminated
·Skeletal Kinetics, Llc·Product code GXP·April 6, 2020