FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

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

Filters: Cleared only ×
175,230 results
136513–136536 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 23, 1988
IN-THE-EAR HEARING AID
K875010 · ESD
Statco Hearing Aid Laboratory
Ear, Nose, Throat · 81d
Cleared Feb 23, 1988
PERIODONTAL SCALING SOLUTION-A
K875132 · EFS
Dentsply Intl.
Dental · 70d
Cleared Feb 23, 1988
PERIDONTAL SCALING SOLUTION-B
K875149 · EFS
Dentsply Intl.
Dental · 70d
Cleared Feb 23, 1988
PERIODONTAL SCALING SOLUTION-C
K875150 · EFS
Dentsply Intl.
Dental · 70d
Cleared Feb 23, 1988
AMPLAID 309 CLINICAL AUDIOMETER
K880059 · EWO
Amplus Corp.
Ear, Nose, Throat · 47d
Cleared Feb 23, 1988
RICHARDS ITC TYPE HEARING AID MODEL IMPULSE SP
K880285 · ESD
Richards Medical Co., Inc.
Ear, Nose, Throat · 29d
Cleared Feb 23, 1988
OMNI ITC TYPE HEARING AID MODEL U-IMPULSE SP
K880286 · ESD
Richards Medical Co., Inc.
Ear, Nose, Throat · 29d
Cleared Feb 23, 1988
SERIES S515/S525 BEHIND-THE-EAR HEARING AID
K880465 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 20d
Cleared Feb 23, 1988
SERIES S415/S425 - BEHIND-THE-EAR HEARING AID
K880466 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 20d
Cleared Feb 22, 1988
RHYTHMSCAN
K871572 · DSI
Brentwood Instruments, Inc.
Cardiovascular · 306d
Cleared Feb 22, 1988
LOMA LINDA UNIV. PROTON BEAM THERAPY SYSTEM
K872369 · IWM
Loma Linda University Medical Center
Radiology · 248d
Cleared Feb 22, 1988
A.L.A.R.M. (ADJUST. LEG & ANKLE REPOSITIONING MECH
K872525 · KPR
M.C. Johnson Co., Inc.
Radiology · 242d
Cleared Feb 22, 1988
DERMATOLOGICAL PATCH
K872926 · FRO
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 210d
Cleared Feb 22, 1988
BAXTER BEDSIDE SYSTEM
K874181 · FRN
Travenol Laboratories, S.A.
General Hospital · 131d
Cleared Feb 22, 1988
S9 DISPLAY SYSTEM
K874214 · JAD
O.M.I. Oncology Microsystems, Inc.
Radiology · 129d
Cleared Feb 22, 1988
MODEL 492 SSR (TM) RECORDER
K874313 · DSH
Del Mar Avionics
Cardiovascular · 125d
Cleared Feb 22, 1988
MODIFIED MANUFACTURING PROCESS FOR OMIDERM(TM)
K874480 · NAD
Omikron Scientific, Ltd.
General & Plastic Surgery · 112d
Cleared Feb 22, 1988
AUDIOTONE MODEL A2000 BEHIND-THE-EAR HEARING AID
K874831 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 90d
Cleared Feb 22, 1988
PEGASUS AIRWAVE SYST/SPEC MATTRESS DECUBITUS ULCER
K874877 · FNM
Pegasus Airwave, Inc.
General Hospital · 101d
Cleared Feb 22, 1988
SEIKO PLAX DIACOAT II & SEIKO PLAX S.V.P.
K875063 · HQG
Epson EL Paso, Inc.
Ophthalmic · 75d
Cleared Feb 22, 1988
VACUMATE INTERMITTENT/CONTINUOUS CONTROLLER,VM2000
K875074 · KDP
Timeter Instrument Corp.
General Hospital · 75d
Cleared Feb 22, 1988
HERACURE LS 500
K875078 · HHR
W.C. Heraeus GmbH
Obstetrics & Gynecology · 55d
Cleared Feb 22, 1988
PB-A LEAD-ACID BATTERY CONVERSION KIT
K875106 · IZL
Diagnostic Imaging Specialists Corp.
Radiology · 70d
Cleared Feb 22, 1988
VICOR PACER, MODEL 410A
K880432 · DXY
Tpl-Cordis, Inc.
Cardiovascular · 25d