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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
117577–117600 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 30, 1992
DAVOL LAPAROSCOPIC CHOLANGIOGRAM CATHETER & KIT
K914755 · GCA
Davol, Inc.
Gastroenterology & Urology · 160d
Cleared Mar 30, 1992
MYOGLOBIN RIA TEST KIT
K915233 · DDR
Pro Diagnostics, Inc.
Immunology · 129d
Cleared Mar 30, 1992
MENTOR HORIZON LOW VISION MAGNIFIER
K915340 · HJG
Mentor O & O, Inc.
Ophthalmic · 158d
Cleared Mar 30, 1992
KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA KIT
K915428 · JZO
Kronus
Immunology · 119d
Cleared Mar 30, 1992
KRONUS KALIBRE THYROID PEROXIDASE ANTIBODY EIA KIT
K915429 · JZO
Kronus
Immunology · 119d
Cleared Mar 30, 1992
MEGA AMNIOCENTESIS KIT
K915863 · HIO
Mega Medical, Inc.
Obstetrics & Gynecology · 90d
Cleared Mar 30, 1992
ADAC XL-PLAN-PC
K920041 · IYE
Adac Laboratories
Radiology · 84d
Cleared Mar 30, 1992
HEMOMETRIX CONTINUOUS BLOOD GAS MONITORING SYSTEM
K920061 · CBZ
Abbott Laboratories
Anesthesiology · 83d
Cleared Mar 30, 1992
MEDISCINT
K920115 · IZD
Oakfield Instruments, Ltd.
Radiology · 77d
Cleared Mar 30, 1992
CORDIS BIPAL 7 BIOPSY FORCEPS
K920289 · DWZ
Cordis Corp.
Cardiovascular · 68d
Cleared Mar 30, 1992
SIENET ARCHIVE SERVER, ISA I, ISA II STORAGE SERVE
K920310 · LMD
Siemens Gammasonics, Inc.
Radiology · 67d
Cleared Mar 30, 1992
ANTI-ENA ANTIBODY TEST [SS-A (RO)]
K920383 · LLL
Immco Diagnostics, Inc.
Immunology · 60d
Cleared Mar 30, 1992
ANIT-ENA ANTIBODY TEST [SS-B (LA)]
K920384 · LLL
Immco Diagnostics, Inc.
Immunology · 60d
Cleared Mar 30, 1992
ANTI-ENA ANTIBODY TEST (SM)
K920385 · LLL
Immco Diagnostics, Inc.
Immunology · 60d
Cleared Mar 30, 1992
ANTI-ENA ANTIBODY TEST KIT
K920386 · LLL
Immco Diagnostics, Inc.
Immunology · 60d
Cleared Mar 30, 1992
RF STAT IGM TEST KIT
K920753 · DHR
Biowhittaker Molecular Applications,...
Immunology · 40d
Cleared Mar 30, 1992
GIKTER ECG CASSETTE TAPE RECORDER MODEL XR 300
K921068 · DSH
Datrix
Cardiovascular · 24d
Cleared Mar 30, 1992
STERILE/SINGLE USE EYE SPHERE IMPLANTS
K921106 · HPZ
Storz Instrument Co.
Ophthalmic · 21d
Cleared Mar 30, 1992
SOUNDCHOICE BTE
K921122 · ESD
Bausch & Lomb, Inc.
Ear, Nose, Throat · 21d
Cleared Mar 27, 1992
SPORVIEW
K905425 · FRC
Spsmedical Supply Corp.
General Hospital · 479d
Cleared Mar 27, 1992
MDT/CASTLE MODELS S-8 TABLE TOP STEAM STERILIZER
K910777 · FLE
Mdt Biologic Co.
General Hospital · 399d
Cleared Mar 27, 1992
SCALE-TRONIX PLATFORM SCALE
K912662 · FRW
Scale-Tronix, Inc.
General Hospital · 283d
Cleared Mar 27, 1992
DS-240 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM
K913595 · DXN
Koven and Assoc., Inc.
Cardiovascular · 227d
Cleared Mar 27, 1992
SHARPLAN MODEL ULTRA ULTRASONIC SURG ASPIRATOR
K913848 · MGI
Sharplan Lasers, Inc.
Obstetrics & Gynecology · 213d