6,179 results
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36ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LARS ACJ
FDA 510(k)
FDA Class 2
·Orthopedic
BULLARD INTUBATING LARYNGOSCOPE LAR-A & LAR-P
FDA 510(k)
FDA Class 1
·Anesthesiology
LARS AC Band Device
FDA 510(k)
FDA Class 2
·Orthopedic
NA
FDA UDI
BHM-Tech Produktionsgesellschaft m.b.H.·09120041051067·spectacles front; AN-Evo1; contact star evo1
ROI-C
FDA Adverse Event
Injury
·LAR·Product code ODP·August 5, 2013
ALIGEL KIT TOBOGGAN STD AND LAR GE
FDA UDI
ALIMED, INC.·00733657286311·
EA/Tw Lar. chest harness,vest style
FDA UDI
Thomas Hilfen für Körperbehinderte GmbH & Co. Medico Kommanditgesellschaft·04034089089003·
Gafchromic™
FDA UDI
ASHLAND SPECIALTY INGREDIENTS G.P.·00810106410258·
Novocastra™
FDA UDI
LEICA BIOSYSTEMS NEWCASTLE LTD·05055331328403·NCL-L-AR-318 is intended for the qualitative id...
LAR-A-JECT
FDA Adverse Event
Malfunction
·SHERIDAN CATH CORP·Product code BTR·January 10, 1997
BULLARD/LARS-A ELITE
FDA Adverse Event
Injury
·ACMI CORPORATION·Product code CCW·July 14, 2006
Novocastra
FDA UDI
LEICA BIOSYSTEMS NEWCASTLE LTD·05055331333179·NCL-L-AR-318-U is intended for the qualitative ...
Sunquest Laboratory LabAccess Results Workstation (LARS)
FDA Recall
Terminated
·Sunquest Information Systems, Inc.·Product code JQP·October 5, 2010
NEU_INTERSTIM_INS
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code EZW·August 17, 2017
Sunquest Laboratory LabAccess Results Workstation (LARS)
FDA Enforcement
Class II
·Terminated·Sunquest Information Systems, Inc.·September 5, 2012
Product 41 consists of all product under product code: KTT and same usage: Item no: 119301042 LAG SCR 12.7D X 100MM STA 119301045 LAG SCR 12.7D X 105MM STA 119301047 LAG SCR 12.7D X 110MM STA 119301050 LAG SCR 12.7D X 115MM STA 119301052 LAG SCR 12.7D X 120MM STA 119301055 LAG SCR 12.7D X 125MM STA 119301057 LAG SCR 12.7D X 130MM STA 119301060 LAG SCR 12.7D X 135MM STA 119301062 LAG SCR 12.7D X 140MM STA 119301070 LAG SCR 12.7D X 155MM STA 119301020 LAG SCR 12.7D X 55MM STAN 119301022 LAG SCR 12.7D X 60MM STAN 119301025 LAG SCR 12.7D X 65MM STAN 119301027 LAG SCR 12.7D X 70MM STAN 119301030 LAG SCR 12.7D X 75MM STAN 119301032 LAG SCR 12.7D X 80MM STAN 119301035 LAG SCR 12.7D X 85MM STAN 119300537 LAG SCR 12.7D X 90MM SHOR 119301037 LAG SCR 12.7D X 90MM STAN 119301040 LAG SCR 12.7D X 95MM STAN 119301542 LAG SCR 15.8D X 100MM LAR 119301545 LAG SCR 15.8D X 105MM LAR 119301547 LAG SCR 15.8D X 110MM LAR 119301550 LAG SCR 15.8D X 115MM LAR 119301552 LAG SCR 15.8D X 120MM LAR 119301555 LAG SCR 15.8D X 125MM LAR 119301557 LAG SCR 15.8D X 130MM LAR 119301520 LAG SCR 15.8D X 55MM LARG 119301522 LAG SCR 15.8D X 60MM LARG 119301525 LAG SCR 15.8D X 65MM LARG 119301532 LAG SCR 15.8D X 80MM LARG 119301535 LAG SCR 15.8D X 85MM LARG 119301537 LAG SCR 15.8D X 90MM LARG Product Usage: Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.
FDA Recall
Terminated
·Product code KTT·January 11, 2016
BLADE EXTENDER FOR ADULT LARYNGOSCOPE
FDA Adverse Event
Malfunction
·CIRCON ACMI·Product code EQN·June 14, 2001
Product 41 consists of all product under product code: KTT and same usage: Item no: 119301042 LAG SCR 12.7D X 100MM STA 119301045 LAG SCR 12.7D X 105MM STA 119301047 LAG SCR 12.7D X 110MM STA 119301050 LAG SCR 12.7D X 115MM STA 119301052 LAG SCR 12.7D X 120MM STA 119301055 LAG SCR 12.7D X 125MM STA 119301057 LAG SCR 12.7D X 130MM STA 119301060 LAG SCR 12.7D X 135MM STA 119301062 LAG SCR 12.7D X 140MM STA 119301070 LAG SCR 12.7D X 155MM STA 119301020 LAG SCR 12.7D X 55MM STAN 119301022 LAG SCR 12.7D X 60MM STAN 119301025 LAG SCR 12.7D X 65MM STAN 119301027 LAG SCR 12.7D X 70MM STAN 119301030 LAG SCR 12.7D X 75MM STAN 119301032 LAG SCR 12.7D X 80MM STAN 119301035 LAG SCR 12.7D X 85MM STAN 119300537 LAG SCR 12.7D X 90MM SHOR 119301037 LAG SCR 12.7D X 90MM STAN 119301040 LAG SCR 12.7D X 95MM STAN 119301542 LAG SCR 15.8D X 100MM LAR 119301545 LAG SCR 15.8D X 105MM LAR 119301547 LAG SCR 15.8D X 110MM LAR 119301550 LAG SCR 15.8D X 115MM LAR 119301552 LAG SCR 15.8D X 120MM LAR 119301555 LAG SCR 15.8D X 125MM LAR 119301557 LAG SCR 15.8D X 130MM LAR 119301520 LAG SCR 15.8D X 55MM LARG 119301522 LAG SCR 15.8D X 60MM LARG 119301525 LAG SCR 15.8D X 65MM LARG 119301532 LAG SCR 15.8D X 80MM LARG 119301535 LAG SCR 15.8D X 85MM LARG 119301537 LAG SCR 15.8D X 90MM LARG Product Usage: Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.
FDA Enforcement
Class II
·Terminated·Zimmer Manufacturing B.V.·March 23, 2016
PREMIUM PLUS CEEA 31 INSTR. W/TILT-TOP
FDA Adverse Event
Injury
·PONCE-USS·Product code GAG·October 6, 2006
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·December 3, 2025