24 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Rebar Micro Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
TiWAVE L Lumbar Cage System
FDA UDI
Kalitec Direct LLC·B07323K0101140·Distractor, Smooth Paddle, Lordotic, 14mm
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0101140·Distractor, Smooth Paddle, 14mm
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197116961·Trautmann Chisel, 7mm
140mm
B-P TOTAL HIP SYSTEM
FDA UDI
ENDOTEC, INC.·00814193024817·B-P HIP MODULAR FEMORAL STEM W/O HEAD, W/ BIOCO...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197116954·Trautmann Chisel, 5mm
140mm
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197116947·Trautmann Chisel, 3mm
140mm
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197116978·Trautmann Chisel, 9mm
140mm
InterPulse
FDA UDI
STRYKER CORPORATION·04546540861764·Handpiece Set with Coaxial High Flow Tip and Su...
InterPulse
FDA UDI
STRYKER CORPORATION·07613154054084·Handpiece Set with Coaxial High Flow Tip and Du...
InterPulse
FDA UDI
STRYKER CORPORATION·04546540673565·Handpiece Set with High Flow Tip and Suction Tube
ACUVUE 2 BRAND (ETAFILCON A) CONTACT LENS, WITH UV BLOCKER TINTED (TO MASK OR ENHANCE THE NATURAL IRIS COLOR)
FDA 510(k)
FDA Class 2
·Ophthalmic
Astroglide Organix Liquid
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Widex
FDA UDI
Widex A/S·05706069914535·WIDEX MOMENT MRB2D (Honey blond ) 110, Telecoil...
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·October 17, 2008
SCD EXPRESS CONTROLLER
FDA Adverse Event
Malfunction
·COVIDIEN·Product code JOW·June 27, 2013
COULTER LH 780 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·August 5, 2011
1. InterPulse Handpiece with coaxial bone cleaning tip, Product Number: 0210-110-100, UDI: (01)4546540861641; 2. InterPulse Handpiece with Coaxial High Flow Tip, Product Number: 0210-114-100, UDI: (01)4546540861764; 3. InterPulse Handpiece with Retractable Coaxial Fan Spray Tip, Product Number: 0210-118-200, UDI: (01)4546540861818; 4. InterPulse Irrigation Only Handpiece with Fan Spray Tip, Product Number: 0210-218-000, UDI: (01)4546540144300 for orthopedic use.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·April 4, 2018
1. InterPulse Handpiece with coaxial bone cleaning tip, Product Number: 0210-110-100, UDI: (01)4546540861641; 2. InterPulse Handpiece with Coaxial High Flow Tip, Product Number: 0210-114-100, UDI: (01)4546540861764; 3. InterPulse Handpiece with Retractable Coaxial Fan Spray Tip, Product Number: 0210-118-200, UDI: (01)4546540861818; 4. InterPulse Irrigation Only Handpiece with Fan Spray Tip, Product Number: 0210-218-000, UDI: (01)4546540144300 for orthopedic use.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code FQH·November 9, 2017
ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015