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
115369–115392 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 16, 1992
BIOFEEDBACK SYSTEM/3
K914920 · HCC
Davicon, Inc.
Neurology · 378d
Cleared Nov 16, 1992
CLARUS MODELS 1230 AND 1231 LAPARO-NEEDLE
K915725 · FHO
Clarus Medical Systems, Inc.
Gastroenterology & Urology · 332d
Cleared Nov 16, 1992
TROKEL /3 GONIO LASER LENS
K921414 · LQJ
Ocular Instruments, Inc.
Ophthalmic · 237d
Cleared Nov 16, 1992
ULTRASONIC PACHYMETER
K921705 · IYO
Precision Corneal Instruments
Radiology · 220d
Cleared Nov 16, 1992
BERTHOLD LB 954
K922329 · JJQ
Eg&G Berthold Analytical Instruments,...
Chemistry · 188d
Cleared Nov 16, 1992
GERSON ISOLAIR APR PARTICULATE SURGICAL MASK
K922507 · FXX
Louis M. Gerson Co., Inc.
General Hospital · 173d
Cleared Nov 16, 1992
MODIFIED TSRH CENTRAL POST HOOKS
K922520 · KWP
Sofamor Danek Mfg., Inc.
Orthopedic · 178d
Cleared Nov 16, 1992
POWERED MUSCLE STIMULATOR
K922529 · LIH
M.S.P. , Ltd.
Neurology · 172d
Cleared Nov 16, 1992
MULTIDRAW SYSTEM
K922858 · GIM
Cambridge Multi-Draw, Inc.
Chemistry · 154d
Cleared Nov 16, 1992
CLARUS MODELS 1100, 1101, 1102, 1103 LASER DISC
K922881 · GEX
Clarus Medical Systems, Inc.
General & Plastic Surgery · 153d
Cleared Nov 16, 1992
ENZYGNOST F 1+2
K922934 · MIF
Behring Diagnostics, Inc.
Hematology · 151d
Cleared Nov 16, 1992
LB 9502- CLINILUMAT, LB 953 - AUTO-CLIMILUMAT
K922976 · JJQ
Eg&G Berthold Analytical Instruments,...
Chemistry · 171d
Cleared Nov 16, 1992
AST (GOT) - ASPARTATE AMINOTRANSFERASE
K923505 · CIT
Randox Laboratories, Ltd.
Chemistry · 124d
Cleared Nov 16, 1992
ALT (GPT) - ALANINE AMINOTRANSFERASE
K923510 · CKA
Randox Laboratories, Ltd.
Chemistry · 124d
Cleared Nov 16, 1992
VISTA FREE THYROXINE ASSAY
K923572 · CEC
Syva Co.
Chemistry · 122d
Cleared Nov 16, 1992
ACCULITE SSL
K923619 · IWE
Medical Alignment Systems
Radiology · 118d
Cleared Nov 16, 1992
BYRNE EXPULSIVE LENS
K923670 · HJI
Ocular Instruments, Inc.
Ophthalmic · 117d
Cleared Nov 16, 1992
QC-CHEX
K923971 · JPK
Streck Laboratories, Inc.
Hematology · 102d
Cleared Nov 16, 1992
CLEANING BRUSH
K924103 · FEB
United States Endoscopy Group, Inc.
General Hospital · 95d
Cleared Nov 16, 1992
SIDESTREAM DISPOSABLE
K924123 · CAF
Medic-Aid , Ltd.
Anesthesiology · 91d
Cleared Nov 16, 1992
ECLIPSE 2100(TM) MODEL 32
K924214 · GEX
Cardiogenes
General & Plastic Surgery · 111d
Cleared Nov 16, 1992
HEARING AID (ALL-IN-THE-EAR)
K924350 · ESD
Ear Masters, Inc.
Ear, Nose, Throat · 81d
Cleared Nov 16, 1992
STANDARD HUMAN PLASMA
K924393 · JPA
Behring Diagnostics, Inc.
Hematology · 77d
Cleared Nov 16, 1992
GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT
K924496 · JPD
Drew Scientific , Ltd.
Hematology · 73d