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
174457–174480 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 19, 1976
RACESTYPTINE RINGS
K761024 · EIG
Septodont, Inc.
Dental · 65d
Cleared Nov 18, 1976
DECUBITUS MATTRESS
K760963 · IKY
Arco Medical Products Co.
General Hospital · 14d
Cleared Nov 16, 1976
SULFACYTINE 0.25 MG.
K760701 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 55d
Cleared Nov 16, 1976
ACA DATA MATE ACCESSORY
K760739 · JQP
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 48d
Cleared Nov 16, 1976
DOUBLE-ENDED NEEDLE
K760780 · FMI
Travenol Laboratories, S.A.
General Hospital · 42d
Cleared Nov 16, 1976
PH METER-125 (.01 PH)
K760788 · JQY
Corning Medical & Scientific
Chemistry · 67d
Cleared Nov 16, 1976
PH METER-130 (.001 PH)
K760789 · JQY
Corning Medical & Scientific
Chemistry · 67d
Cleared Nov 16, 1976
FUNGAL IMMUNODIFFUSION KIT
K760825
I M, Inc.
Immunology · 34d
Cleared Nov 16, 1976
POTASSIUM HYDROXIDE W/GLYCEROL MTG FL.
K760837
I M, Inc.
Immunology · 34d
Cleared Nov 16, 1976
LACTO-PHENOL COTTON BLUE MOUNTING FL.
K760838 · LEB
I M, Inc.
Immunology · 34d
Cleared Nov 16, 1976
VASPAR, SEALANT FOR FERMENTATIONS
K760839
I M, Inc.
Immunology · 34d
Cleared Nov 16, 1976
TEST FOR DETECTION OF ANTIRUBELLA ANTIB
K760889 · GOL
Abbott Laboratories
Immunology · 21d
Cleared Nov 16, 1976
GAMMA SCINTILLATION COUNTER
K760900 · JJJ
Beckman Instruments, Inc.
Immunology · 21d
Cleared Nov 16, 1976
LAS-R HUMAN ALPHA, ANTITRYPSIN TEST
K760916 · DEM
Hyland Therapeutic Div., Travenol...
Immunology · 19d
Cleared Nov 16, 1976
MODEL 2106 FETA SONDE FETAL MONITOR
K760919 · HGM
Roche Medical Electronics, Inc.
Obstetrics & Gynecology · 19d
Cleared Nov 16, 1976
CORTISOL REAGENT SYSTEM
K760939 · CGR
Beckman Instruments, Inc.
Chemistry · 15d
Cleared Nov 16, 1976
DEEP FREEZE SYSTEM (DFS-30)
K760953 · GEH
Spembly Medical , Ltd.
General & Plastic Surgery · 14d
Cleared Nov 16, 1976
SURGICAL OSCILLATING SAW
K760958 · DZH
American Safety Equipment Corp.
Dental · 15d
Cleared Nov 16, 1976
CHARNLEY FEMORAL COMPONENT
K760974 · JDG
Codman & Shurtleff, Inc.
Orthopedic · 13d
Cleared Nov 16, 1976
CHARNLEY REVISION SET
K760976 · JDG
Codman & Shurtleff, Inc.
Orthopedic · 13d
Cleared Nov 16, 1976
CHARNLEY FEMUR DRILL #1 AND #2
K760977 · HWE
Codman & Shurtleff, Inc.
Orthopedic · 13d
Cleared Nov 16, 1976
INORGANIC PHOSPHOROUS REAGENT
K760990 · CEO
Worthington Biochemical Corp.
Chemistry · 11d
Cleared Nov 16, 1976
SURGINE FACE MASK
K760991 · FXX
Surgikos, Inc.
General Hospital · 11d
Cleared Nov 16, 1976
HEARING AID (MODEL 695D, 905 & 960P)
K760996 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 8d