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
153913–153936 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 13, 1984
CHLAMYDIAE ISOLATION MEDIUM W/CYCLOHEX
K834122 · KIT
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 76d
Cleared Feb 13, 1984
CHLAMYDIAL TRANSPORT MEDIUM
K834125 · JSM
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 76d
Cleared Feb 13, 1984
CARDIOVASCULAR SPRING GUIDE WIRE
K834223 · DQX
Mallinckrodt Critical Care
Cardiovascular · 69d
Cleared Feb 13, 1984
RAAF DUAL LUMEN CATH. REPAIR KIT 2.2
K834225 · LJS
Quinton, Inc.
General Hospital · 69d
Cleared Feb 13, 1984
HDL CHOLESTEROL PRETREATMENT
K834251 · LBR
American Monitor Corp.
Chemistry · 68d
Cleared Feb 13, 1984
REFLOCHECK & GLUCOSE TEST STRIP SYS
K834271 · CGA
Boehringer Mannheim Corp.
Chemistry · 67d
Cleared Feb 13, 1984
UNICONDYLAR FIBER METAL KNEE
K834298 · HRY
Zimmer, Inc.
Orthopedic · 67d
Cleared Feb 13, 1984
MEDAID DUAL CHANNEL TENS
K834334 · GZJ
Par Medex , Ltd.
Neurology · 63d
Cleared Feb 13, 1984
DESERET NEONATAL CATHETER SET
K834393 · FOZ
Parke-Davis Co.
General Hospital · 61d
Cleared Feb 13, 1984
MODEL 1888 ALPHA COS/RESPIRATION CAR
K834460 · LLK
Spacelabs, Inc.
General Hospital · 56d
Cleared Feb 13, 1984
ENTERNAL FEEDING TUBE
K834562 · KNT
Sheridan Catheter Corp.
Gastroenterology & Urology · 47d
Cleared Feb 13, 1984
DIFFERENTIATION DISKS HIPPURATE
K834581 · JTO
Difco Laboratories, Inc.
Microbiology · 46d
Cleared Feb 13, 1984
ARTERIAL CANNULA STRAIGHT BEVELED TIP
K840001 · DWF
Dlp, Inc.
Cardiovascular · 41d
Cleared Feb 13, 1984
ARTERIAL CANNULA CURVED BEVELED TIP
K840002 · DWF
Dlp, Inc.
Cardiovascular · 41d
Cleared Feb 13, 1984
NABI RF-Q.S. TEST
K840005 · DHR
Intl. Diagnostic, Inc.
Immunology · 40d
Cleared Feb 13, 1984
CARDIOPLEGIA HEAT EXCHANGER HE-100
K840045 · DTR
American Bentley
Cardiovascular · 38d
Cleared Feb 13, 1984
CHOCOLATE AGAR GC BASE PLATE
K840065 · JTY
Otisville Biotech, Inc.
Microbiology · 35d
Cleared Feb 13, 1984
CHOCOLATE AGAR MUELLERH-HINTON BASE
K840066 · JTZ
Otisville Biotech, Inc.
Microbiology · 35d
Cleared Feb 13, 1984
THAYER-MARTIN AGAR PLATE
K840067 · JTY
Otisville Biotech, Inc.
Microbiology · 35d
Cleared Feb 13, 1984
KV BLOOD AGAR PLATE
K840074 · JSJ
Otisville Biotech, Inc.
Microbiology · 35d
Cleared Feb 13, 1984
GN BROTH TUBE
K840076 · JSJ
Otisville Biotech, Inc.
Microbiology · 35d
Cleared Feb 10, 1984
OCUMAP 100 AUTOPERIMETER
K832555 · HPT
Shorashim
Ophthalmic · 193d
Cleared Feb 10, 1984
PAP SMEAR BRUSH
K832986 · HHT
Donald G. Zeller
Obstetrics & Gynecology · 162d
Cleared Feb 10, 1984
MUCOSAL ADJUSTMENT PASTE LIQUID SPRAY
K833132 · EFH
Myo-Tronics Research, Inc.
Dental · 150d