Atlas FDA

EQJ

18 FDA 510(k) clearances · Product code

50 daysmedian time to decision
208 days90th percentile
18clearances measured

FDA profile

Official device name
Bur, Ear, Nose And Throat
Device class
Class I (low risk)
Regulation
21 CFR 874.4140
Medical specialty
Ear, Nose, Throat
Adverse events (MAUDE)
2021: 131 · 2022: 229 · 2023: 261 · 2024: 368 · 2025: 445 · 2026: 119
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Precision Thin Reciprocating Blade, 0.010in. (K161514)Stryker Corporation2017-01-17
XPS CURVED BUR (K041985)Medtronic Xomed, Inc.2004-08-12
ESSENTIAL SHAVER SYSTEM (K974232)Gyrus Ent LLC1998-01-12
ACE SYSTEM (K960853)Xomed, Inc.1996-04-03
TREBAY MICRODEBRIDER SYSTEM (K955704)Trebay Medical Corp.1996-01-30
SOF - ABRASION BUR (K955294)Trebay Medical Corp.1995-12-22
TREBAY IRRIGATED CUTTER BLADE (MODIFICATION) (K954912)Trebay Medical Corp.1995-12-06
KARL STORZ ENT SHAVER (K953370)KARL STORZ Endoscopy-America, Inc.1995-09-06
KARL STORZ STAMMBERGER-SACHSE INTRANASAL-FRILL (K950337)KARL STORZ Endoscopy-America, Inc.1995-08-23
REDI DRILL DRILL SYSTEM (K952609)Trebay Medical Corp.1995-07-31
ESSENTIAL SHAVER SYSTEM (K953096)Smith & Nephew Richards, Inc.1995-07-28
KARL STORZ MICRO-INSTRUMENT FOR COCHLEAR IMPLANTATION (K946332)KARL STORZ Endoscopy-America, Inc.1995-06-05
TREBAY IRRGATED CUTTER BLADE (K951526)Trebay Medical Corp.1995-05-12
MEDNEXT BUR (K935584)Mednext, Inc.1994-02-22
MICROMEDICS EAR, NOSE AND THROAT BURS (K895738)Micromedics, Inc.1989-12-19
CMS FAST CUT, CMS DIAMOND AND CMS WIRE PASS (K893499)Cmsi1989-11-16
MICRO-SUGICAL POWER INSTRUMENT SYSTEM (K802503)Spire Medical, Inc.1980-10-31
OTOTOME BUR (K792028)American Sterilizer Co.1979-10-26

Track EQJ automatically

Every clearance here is in the API, with alerts when new ones post.