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
136153–136176 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 22, 1988
MODEL 303D AND 403D ADULT HEART RATE & RESPIRATOR
K880066 · DRT
Ivy Biomedical Systems, Inc.
Cardiovascular · 71d
Cleared Mar 22, 1988
SURGI-LIGHT ND:YAG LASER FOR UROLOGICAL USE
K880071 · FCS
Laserguide
Gastroenterology & Urology · 71d
Cleared Mar 22, 1988
CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPUL.
K880103 · DWF
Research Medical, Inc.
Cardiovascular · 70d
Cleared Mar 22, 1988
ANGIOPLASTY BALLOON INFLATION DEVICE
K880158 · LIT
L.O.N. Research, Inc.
Cardiovascular · 69d
Cleared Mar 22, 1988
STATFLO
K880180 · DWF
Imodex, Inc.
Cardiovascular · 69d
Cleared Mar 22, 1988
ELECTRODE CABLE
K880320 · DSA
Vital Connections, Inc.
Cardiovascular · 56d
Cleared Mar 22, 1988
MEDTRONIC MODEL 5411 SURGICAL CABLE ADAPTOR
K880323 · DSA
Medtronic Vascular
Cardiovascular · 56d
Cleared Mar 22, 1988
VITAL SYSTEM
K880351 · DXN
Pace Tech, Inc.
Cardiovascular · 56d
Cleared Mar 22, 1988
MODIFIED NICOLET VIKING SYSTEM
K880573 · IKN
Nicolet Biomedical Instruments
Neurology · 41d
Cleared Mar 22, 1988
MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE
K880740 · DQF
Spectramed, Inc.
General Hospital · 27d
Cleared Mar 22, 1988
PLAYTEX PORTABLE NON-DEOD. & DEOD REGULAR & SUPER
K881057 · HIL
Playtex, Inc.
Obstetrics & Gynecology · 11d
Cleared Mar 21, 1988
LASE EVACUATOR/ASPIRATOR
K874157 · BTA
Lase, Inc.
General & Plastic Surgery · 160d
Cleared Mar 21, 1988
MICROSHEV MODEL 2000
K874193 · GWJ
Micro-Shev , Ltd.
Neurology · 159d
Cleared Mar 21, 1988
SARA DIGICAP
K874754 · CCK
Ppg/Applied Resources, Inc.
Anesthesiology · 124d
Cleared Mar 21, 1988
CM 3000 THE MONITOR
K874898 · BZQ
Lifeline Medical Systems, Inc.
Anesthesiology · 111d
Cleared Mar 21, 1988
HEALTH CARE EYE PROTECTION
K875107 · HOY
Surgikos, Inc.
Ophthalmic · 98d
Cleared Mar 21, 1988
MEDICAL EYE DISPOSABLE SHIELD
K875302 · HOY
Bfd, Inc.
Ophthalmic · 83d
Cleared Mar 21, 1988
VISION(R) CRP
K875345 · DCK
Abbott Laboratories
Immunology · 82d
Cleared Mar 21, 1988
PLEUR-EVAC--A-5002 CHEST DRAINAGE SYSTEM W/AUTO
K880162 · CAC
Deknatel, Inc.
Anesthesiology · 68d
Cleared Mar 21, 1988
ROVENSTEIN FORCEPS
K880318 · BWB
Eastmed Enterprises, Inc.
Anesthesiology · 55d
Cleared Mar 21, 1988
MAGILL FORCEPS
K880319 · BWB
Eastmed Enterprises, Inc.
Anesthesiology · 55d
Cleared Mar 21, 1988
CERION OXY THRESHOLD ALARM
K880448 · CCL
Ceramatec, Inc.
Anesthesiology · 48d
Cleared Mar 21, 1988
3M XP515 X-RAY FILM PROCESSOR
K880563 · IXW
3M Company
Radiology · 40d
Cleared Mar 21, 1988
3M XP 505 X-RAY FILM PROCESSOR
K880564 · IXW
3M Company
Radiology · 40d