FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Ear, Nose, Throat ×
3,812 results
961–984 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Nov 20, 2000
SILMAX CONTOUR CARVING BLOCK IMPLANT
K002629 · JOF
Pillar Surgical, Inc.
Ear, Nose, Throat · 89d
Cleared Oct 31, 2000
SMITH & NEPHEW PISTONS
K003214 · ETB
Gyrus Ent LLC
Ear, Nose, Throat · 18d
Cleared Oct 18, 2000
KSEA UNIMAT 12
K002700 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 49d
Cleared Oct 17, 2000
XPS NITRO SYSTEM
K002828 · ERL
Xomed, Inc.
Ear, Nose, Throat · 36d
Cleared Oct 17, 2000
HEADBAND FOR BAHA
K002913 · LXB
Entific Medical Systems, Inc.
Ear, Nose, Throat · 29d
Cleared Oct 12, 2000
SMITH & NEPHEW PORPS & TORPS
K002737 · ETB
Gyrus Ent LLC
Ear, Nose, Throat · 41d
Cleared Oct 11, 2000
TITANIUM MIDDLE EAR PROSTHESES
K002897 · ETB
Xomed, Inc.
Ear, Nose, Throat · 23d
Cleared Aug 29, 2000
MODULAR PORP AND TORP MODEL TBD
K002378 · ETA
Gyrus Ent LLC
Ear, Nose, Throat · 25d
Cleared Aug 29, 2000
SMITH & NEPHEW OFF-CENTERED PORP
K002464 · ETB
Gyrus Ent LLC
Ear, Nose, Throat · 19d
Cleared Aug 25, 2000
CAPELLA
K002200 · EWO
Madsen Electronics, Inc.
Ear, Nose, Throat · 36d
Cleared Aug 09, 2000
KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170
K002221 · ETB
Heinz Kurz GmbH Medizintechnik
Ear, Nose, Throat · 16d
Cleared Aug 08, 2000
GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES,...
K001404 · ETA
Mednet Locator, Inc.
Ear, Nose, Throat · 97d
Cleared Aug 08, 2000
HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES
K001406 · ETA
Mednet Locator, Inc.
Ear, Nose, Throat · 97d
Cleared Jul 26, 2000
VOCOM SILICONE SYSTEM
K001466 · MIX
Smith & Nephew, Inc.
Ear, Nose, Throat · 77d
Cleared Jul 10, 2000
BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD
K001902 · ETA
Gyrus Ent LLC
Ear, Nose, Throat · 18d
Cleared Jun 23, 2000
AUDIO TECHNOLOGIES S:R.1
K001142 · ETB
Audio Technologies S.R.L.
Ear, Nose, Throat · 74d
Cleared Jun 19, 2000
PC COATED FLUOROPLASTIC VENT TUBES
K000801 · ETD
Gyrus Ent LLC
Ear, Nose, Throat · 98d
Cleared Jun 03, 2000
MEROGEL OTOLOGIC PACK
K001148 · KHJ
Xomed, Inc.
Ear, Nose, Throat · 54d
Cleared Jun 02, 2000
AUDIOSCREENER OAE + ABR
K001058 · EWO
Kedly, Inc.
Ear, Nose, Throat · 60d
Cleared May 23, 2000
RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL...
K000108 · EMX
Bhk Holding
Ear, Nose, Throat · 130d
Cleared Apr 21, 2000
CAVERMAP SURGICAL AID
K000507 · ETN
Uromed Corp.
Ear, Nose, Throat · 66d
Cleared Apr 12, 2000
GSI 2000 MIDDLE EAR ANALYZER
K000097 · ETY
Grason-Stadler, Inc.
Ear, Nose, Throat · 90d
Cleared Apr 03, 2000
WEHRS INCUS-STAPES
K000858 · ETB
Gyrus Ent LLC
Ear, Nose, Throat · 18d
Cleared Mar 29, 2000
ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1
K000154 · FWN
E. Benson Hood Lab, Inc.
Ear, Nose, Throat · 70d