10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Edge™ Diamond FP018-4.0M Football Pointed
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172003391·Diamond dental bur, reusable
Costco
FDA UDI
Bernafon AG·05711584089934·CAPTO 1 MNR, 2.4G NFM PB MAC/MSIL COSTC
PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
MAC MALE ADAPTER
FDA 510(k)
FDA Class 2
·Orthopedic
SYNCHRO2-14 SUPPORT STRAIGHT 215CM
FDA Adverse Event
Malfunction
·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code DQX·December 14, 2023
REALIZE ADJ GASTRIC BAND STR
FDA Adverse Event
Injury
·OBTECH MEDICAL SARL·Product code LTI·October 3, 2008
RECAP FEM HD COCR CEMENTED 56MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KXA·June 27, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 5, 2011
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) AIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/List Number/Item Code 750170; c) AIRE-CUF TRACHY TUBE 8.0MM MID-RANGE , Product Code/List Number/Item Code 750180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024