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
142897–142920 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 06, 1986
MODEL MB-500 & MB-600 BLOOD PRESSURE MONITORS
K861375 · DXN
Sharp Electronics Corp.
Cardiovascular · 191d
Cleared Aug 06, 1986
COULTER COUNTER MODEL S PLUS JUNIOR
K861780 · GKL
Coulter Electronics, Inc.
Hematology · 90d
Cleared Aug 06, 1986
MINI-TRACH KIT
K862167 · BTO
Portex, Inc.
Anesthesiology · 58d
Cleared Aug 06, 1986
TIMOTHY ALLERGEN DISC
K862174 · DGC
Immuno Nuclear Corp.
Immunology · 58d
Cleared Aug 06, 1986
KALLESTAD SM/RNP TEST REAGENT
K862313 · LKJ
Kallestad Laboratories, Inc.
Immunology · 49d
Cleared Aug 06, 1986
GOULD XCALIBER
K862344 · DRS
Bio-Tek Instruments, Inc.
Cardiovascular · 47d
Cleared Aug 06, 1986
UNI-JET CONNECTOR
K862433 · BZA
Acutronic Medical Systems AG
Anesthesiology · 41d
Cleared Aug 06, 1986
KENZ-ECG-102 SINGLE CHANNEL ELECTROCARDIOGRAPH
K862544 · DPS
Suzuken Co., Ltd.
Cardiovascular · 34d
Cleared Aug 06, 1986
TRU-TRAC 3-DIMENSIONAL CERVICAL TRACTION-TD-9000
K862579 · ITH
Tru-Trac
Physical Medicine · 30d
Cleared Aug 06, 1986
SPERTILITE PHOTOTHERAPY LAMP
K862608 · FTC
Cooper-Hewitt Electric Co.
General & Plastic Surgery · 29d
Cleared Aug 06, 1986
SIGNA II RESTING ECG ELECTRODE
K862655 · DRX
Kone Instruments, Inc.
Cardiovascular · 23d
Cleared Aug 06, 1986
FLOSS CARD
K862694 · JES
Floss Card Co.
Dental · 22d
Cleared Aug 06, 1986
EM DIAGNOSTIC ECG ELECTRODE
K862746 · DRX
Electromed Intl., Ltd.
Cardiovascular · 16d
Cleared Aug 06, 1986
PREGELLED INFANT DISPOSABLE ECG ELECTRODE
K862756 · DXN
Labeltape Meditect, Inc.
Cardiovascular · 15d
Cleared Aug 06, 1986
EUROMED S-601
K862765 · DRX
Lectec Corp.
Cardiovascular · 15d
Cleared Aug 06, 1986
MEDCOMP C.A.V.H. CATHETER
K862771 · LFK
Medical Components, Inc.
Gastroenterology & Urology · 15d
Cleared Aug 06, 1986
SYRINGE INJECTION GUN
K862853
Gastrotech, Inc.
General & Plastic Surgery · 8d
Cleared Aug 05, 1986
CORDIS ANCOR ACTIVE FIXATION LEAD
K832422 · DTB
Cordis Corp.
Cardiovascular · 1110d
Cleared Aug 05, 1986
CORDIS HI-FLEX PERVENOUS ACTIVE FIXATION UNIPOLAR
K851064 · DTB
Cordis Corp.
Cardiovascular · 508d
Cleared Aug 05, 1986
UMI CATH-SEAL, 13+14F & TRANSSEPTAL CATHETER INTRO
K861984 · DYB
Universal Medical Instrument Corp.
Cardiovascular · 75d
Cleared Aug 05, 1986
6000 ND:YAG LASER FOR BENIGN/MALIGNANT OBSTRUCTION
K862698 · LLO
Cooper Lasersonics, Inc.
Anesthesiology · 21d
Cleared Aug 04, 1986
DIAGEM 300 BG REAGENT STRIPS
K854329 · CGA
Seton Products, Inc.
Chemistry · 280d
Cleared Aug 04, 1986
DIATRON BLOOD GLUCOSE METER
K855178 · CGA
Dextron, Inc.
Chemistry · 221d
Cleared Aug 04, 1986
AMPU-PAK
K860511 · LPZ
Ammerman Medical Enterprises, Inc.
General Hospital · 174d