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
136681–136704 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 11, 1988
DUAL-CURE RADIOPAQUE
K874189 · EBF
Pentron Corp.
Dental · 120d
Cleared Feb 11, 1988
OMNIPLANE 200 FILM CHANGER SYSTEM
K874451 · IZP
Medrad, Inc.
Radiology · 106d
Cleared Feb 11, 1988
P-S MEDICAL VENTRICULAR ACCESS PORT
K874468 · LKG
Pudenz-Schulte Medical Research Corp.
General Hospital · 101d
Cleared Feb 11, 1988
CALCIUM ASSAY KIT, NUMBER 120-19
K874496 · CIC
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 101d
Cleared Feb 11, 1988
CSF-VENTRICULOSTOMY RESERVOIR
K874498 · LKG
Pudenz-Schulte Medical Research Corp.
General Hospital · 101d
Cleared Feb 11, 1988
MINIMED III INFUSION PUMP & UNI-SET ADMIN SET
K874564 · FRN
Medtronic Minimed
General Hospital · 99d
Cleared Feb 11, 1988
PULSOR, THERAPEUTIC VIBRATOR
K874716 · ISA
Gmg Enterprises, Inc.
Physical Medicine · 86d
Cleared Feb 11, 1988
COAT-A-COUNT NEONATAL 17-ALPHA HYDROXPROG RIA KIT
K874782 · JLX
Diagnostic Products Corp.
Chemistry · 84d
Cleared Feb 11, 1988
OXYGEN SUPPLY CONTROL REGULATOR (OSCR)
K874804 · NFB
Transamerica Products, Inc.
Anesthesiology · 80d
Cleared Feb 11, 1988
HEALTHDYNE RATE METER
K874814 · BZQ
Healthdyne, Inc.
Anesthesiology · 79d
Cleared Feb 11, 1988
NOVA STAT PROFILE 5 ANALYZER + QUALITY CONTROL
K874832 · JGS
Nova Biomedical Corp.
Chemistry · 79d
Cleared Feb 11, 1988
T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE
K874866 · KLI
Serono Diagnostics, Inc.
Chemistry · 76d
Cleared Feb 11, 1988
MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT)
K874903 · JPZ
Simmler, Inc.
Chemistry · 72d
Cleared Feb 11, 1988
IRON PROCEDURE
K874918 · JIY
Data Medical Associates, Inc.
Chemistry · 70d
Cleared Feb 11, 1988
STRYKER 1990 LIBERTY ELECTRIC CRITICAL CARE BED
K875037 · FNL
Stryker Corp.
General Hospital · 66d
Cleared Feb 11, 1988
EASY-TEST PROTHROMBIN TIME PT ITEM NO. 16628
K875062 · GJS
Em Diagnostic Systems, Inc.
Hematology · 64d
Cleared Feb 11, 1988
IMMPULSE T4 ASSAY REAGENTS
K875081 · CDX
Sclavo, Inc.
Toxicology · 64d
Cleared Feb 11, 1988
MEDICRAT, HYPODERMIC SYRINGES & NEEDLES
K875148 · FMF
Knowltech Ind., Inc.
General Hospital · 58d
Cleared Feb 11, 1988
DISPOSABLE CORONARY CONTROL SYRINGE 12CC
K875196 · DXT
Merit Medical Systems, Inc.
Cardiovascular · 56d
Cleared Feb 11, 1988
REVISED LABELING FOR ADX OPIATES
K880010 · DJG
Abbott Laboratories
Toxicology · 38d
Cleared Feb 11, 1988
REVISED LABELING FOR ADX PHENCYCLIDINE
K880011 · LCL
Abbott Laboratories
Toxicology · 38d
Cleared Feb 11, 1988
REVISIED LABELING FOR ADX BENZODIAZEPINES
K880014 · JXM
Abbott Laboratories
Toxicology · 38d
Cleared Feb 11, 1988
MEDEX MACHINE
K880032 · ISD
Medex, Inc.
Physical Medicine · 37d
Cleared Feb 11, 1988
LEECO PREGNASTICK (EIA) CATALOG #003
K880069 · LCX
Leeco Diagnostics, Inc.
Chemistry · 31d