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
153145–153168 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 13, 1984
HDL EZ-TZ3 CHOLESTEROL REAGENT KIT
K840677 · LBS
Preventive Diagnostics Corp.
Chemistry · 58d
Cleared Apr 13, 1984
2U PENICILLIN DISC
K840686 · JTO
Remel Co.
Microbiology · 58d
Cleared Apr 13, 1984
COLISTIN DISC
K840708 · JTO
Remel Co.
Microbiology · 56d
Cleared Apr 13, 1984
PENTRA-FIL II
K840727 · EBF
Pentron Corp.
Dental · 52d
Cleared Apr 13, 1984
URETERAL DILATOR
K840746 · KOE
American Edwards Laboratories
Gastroenterology & Urology · 85d
Cleared Apr 13, 1984
HYDROXYLAPATITE COATED ENDOSSEOUS DENT
K840750 · DZE
Calcitek, Inc.
Dental · 50d
Cleared Apr 13, 1984
AMBEZE DISPOSABLE INCONTINENCE PANTS
K840753 · EYQ
Ipco Corp.
Gastroenterology & Urology · 50d
Cleared Apr 13, 1984
MAXISHIELD INCONTINENCE CARE SYSTEM
K840754 · EYQ
Ipco Corp.
Gastroenterology & Urology · 50d
Cleared Apr 13, 1984
MINIGARD DISPOSABLE LINERS
K840755 · EYQ
Ipco Corp.
Gastroenterology & Urology · 50d
Cleared Apr 13, 1984
PARAMAX ALCOHOL REAGENT
K840769 · DML
American Dade
Chemistry · 65d
Cleared Apr 13, 1984
ALCOHOL & AMMONIA CALIBRATOR I
K840771 · JIT
American Dade
Chemistry · 65d
Cleared Apr 13, 1984
ALCOHOL & AMMONIA CALIBRATOR II
K840772 · JIT
American Dade
Chemistry · 65d
Cleared Apr 13, 1984
LACTATE REAGENT
K840778 · KHP
American Dade
Chemistry · 65d
Cleared Apr 13, 1984
NEONATAL BILIRUBIN REAGENT
K840779 · CIG
American Dade
Chemistry · 65d
Cleared Apr 13, 1984
URIC ACID REAGENT
K840781 · KNK
American Dade
Chemistry · 65d
Cleared Apr 13, 1984
ALBUMIN REAGENT
K840782 · CIX
American Dade
Chemistry · 58d
Cleared Apr 13, 1984
PARAMAX MAGNESIUM REAGENT
K840784 · JGJ
American Dade
Chemistry · 58d
Cleared Apr 13, 1984
CK/MB IMMUNO-ISOENZYME CONTROL SERUM
K840793 · JJT
Seragen Diagnostics, Inc.
Chemistry · 50d
Cleared Apr 13, 1984
BIOPSY FORCEPS
K840818 · FCL
American Endoscopy, Inc.
Gastroenterology & Urology · 49d
Cleared Apr 13, 1984
TDX ETHANOL
K840826 · DIC
Abbott Laboratories
Chemistry · 49d
Cleared Apr 13, 1984
INFUSION NEEDLE IIPN
K840944 · FMI
Medi Tex, Inc.
General Hospital · 39d
Cleared Apr 13, 1984
CULTURE MEDIA FOR ANTIMICROBIAL SUSCEP
K840969 · JTZ
Chatham Biological
Microbiology · 38d
Cleared Apr 13, 1984
CULTURE MEDIUM FOR PATHOGENIC NEISSER
K840970 · JTY
Chatham Biological
Microbiology · 38d
Cleared Apr 13, 1984
SELECTIVE CULTURE MEDIUM
K840971 · JSD
Chatham Biological
Microbiology · 38d