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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
92617–92640 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 05, 1997
IMATION SE-196 LASER IMAGER
K972163 · LMC
Imation Corp.
Radiology · 88d
Cleared Sep 05, 1997
SIDEXIS DIGITAL RADIOGRAPHY SYSTEM
K972168 · EHD
Pelton & Crane Co.
Radiology · 88d
Cleared Sep 05, 1997
UNISURGE INTERFACE P
K972178 · GCJ
Unisurge Holding, Inc.
General & Plastic Surgery · 87d
Cleared Sep 05, 1997
OLYMPIX MINI-PASTEURMATIC (58210)
K972193 · LDS
Olympic Medical Corp.
General Hospital · 87d
Cleared Sep 05, 1997
ALPHA 7000 QUADRATURE WRIST COIL
K972205 · MOS
Usa Instruments, Inc.
Radiology · 85d
Cleared Sep 05, 1997
RESECTOSCOPE SAFETY SHEATH
K972210 · HIH
Conceptus, Inc.
Obstetrics & Gynecology · 86d
Cleared Sep 05, 1997
XPS STRAIGHTSHOT MICRORESECTOR
K972453 · ERL
Xomed, Inc.
Ear, Nose, Throat · 67d
Cleared Sep 05, 1997
VERA SOLDER
K972533 · EJS
Aalba Dent, Inc.
Dental · 60d
Cleared Sep 05, 1997
ALFALLOY
K972534 · EJS
Aalba Dent, Inc.
Dental · 60d
Cleared Sep 05, 1997
PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP)
K972734 · ETB
Mednet Locator, Inc.
Ear, Nose, Throat · 45d
Cleared Sep 05, 1997
TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP)
K972735 · ETA
Mednet Locator, Inc.
Ear, Nose, Throat · 45d
Cleared Sep 05, 1997
CAUSSE PISTON
K972737 · ETB
Mednet Locator, Inc.
Ear, Nose, Throat · 45d
Cleared Sep 05, 1997
HIPALLAUR 19
K972950 · EJT
Aurex Precious Metal Industries (Pty)Ltd
Dental · 77d
Cleared Sep 05, 1997
HIPALLAUR 51
K972951 · EJT
Aurex Precious Metal Industries (Pty)Ltd
Dental · 77d
Cleared Sep 05, 1997
AUREBOND 51
K972952 · EJT
Aurex Precious Metal Industries (Pty)Ltd
Dental · 77d
Cleared Sep 05, 1997
PALAUREX 76KF
K972953 · EJT
Aurex Precious Metal Industries (Pty)Ltd
Dental · 77d
Cleared Sep 05, 1997
PALAUREX 78
K972954 · EJT
Aurex Precious Metal Industries (Pty)Ltd
Dental · 77d
Cleared Sep 05, 1997
PALCERAM 56
K972955 · EJT
Aurex Precious Metal Industries (Pty)Ltd
Dental · 77d
Cleared Sep 05, 1997
PALCERAM 82SF
K972956 · EJT
Aurex Precious Metal Industries (Pty)Ltd
Dental · 77d
Cleared Sep 05, 1997
PRISMA
K972998 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 24d
Cleared Sep 04, 1997
AP-4000, AIR PULSE SENSORY STIMULATOR
K964815 · LLN
Pentax Precision Instrument Corp.
Neurology · 279d
Cleared Sep 04, 1997
E. CAM COINCIDENCE MODE (CM)
K970627 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 197d
Cleared Sep 04, 1997
SULLIVAN HUMIDAIRE HEATED HUMIDIFIER
K971260 · BTT
ResMed Corp
Anesthesiology · 153d
Cleared Sep 04, 1997
BKMI DISPOSABLE SYRINGE
K971487 · FMI
Sumi Salud C.A.
General Hospital · 134d