19 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Terumo Circuit Tubing
FDA 510(k)
FDA Class 2
·Cardiovascular
Symmetry Surgical Ultra®
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482055540·Ultra Instruments Clamp; Bulldog Artery Clamp; ...
Handlebar Posterior Capture Size 4
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215074340·
HNM Women Care
FDA UDI
HNM STAINLESS, LLC.·00812171029144·PESSARY, RING #2, W/O SUPPORT, 2.25"
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197455367·RZ Tebbet Breast Retractor
150x36...
GM HELIX IMPLANT 6.0X10
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·March 2, 2019
TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE
FDA 510(k)
FDA Class 2
·Dental
QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962111055·BULLDOG ARTERY CLAMP, 1 1/4", SLIGTHLY CVD, TIT...
GM HELIX IMPLANT 6.0X8 MM
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·March 21, 2019
GM HELIX IMPLANT 6.0X10
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·March 20, 2019
REF.: # 703005384 CUSTOMER REF.: 15-0536
FDA Adverse Event
Death
·MAQUET CARDIOPULMONARY AG·Product code DTZ·September 21, 2015
GM HELIX ACQUA IMPLANT 6.0X10
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·March 18, 2019
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·June 6, 2013
AUTOCAT2 WAVE
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DSP·June 22, 2011
MESH - COMPOSIX KUGEL
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·September 3, 2008
GM HELIX IMPLANT 6.0X8
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·June 17, 2019
PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD, INC.·Product code JOH·December 28, 2016
Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016