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
133417–133440 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 31, 1988
DIRECTIGEN RESPIRATORY SYNCYTIAL VIRUS TEST KIT
K882629 · GQG
Bd Becton Dickinson Vacutainer...
Microbiology · 126d
Cleared Oct 31, 1988
ONE-STEP HCG
K882896 · DHA
Wampole Laboratories
Chemistry · 112d
Cleared Oct 31, 1988
PISTON SYRINGE WITH NEEDLE
K883033 · FMF
Select Sources, Inc.
General Hospital · 104d
Cleared Oct 31, 1988
INSULIN SYRINGE
K883078 · FMF
Select Sources, Inc.
General Hospital · 104d
Cleared Oct 31, 1988
FIAGEN RUBELLA IGG
K883182 · LFX
Cyberfluor, Inc.
Microbiology · 95d
Cleared Oct 31, 1988
BIO THERAPY (TM) ADVANCED PRESSURE RELIEF SYSTEM
K883256 · FNM
Bio Clinic Co.
General Hospital · 90d
Cleared Oct 31, 1988
IRMA-COUNT (TM) SHBG (SEX HORMORNE BIND GLOBULIN)
K883267 · CDZ
Diagnostic Products Corp.
Chemistry · 89d
Cleared Oct 31, 1988
PL 20/20 INFANT VISION TESTER
K883337 · HOX
Optimed Technologies, Inc.
Ophthalmic · 83d
Cleared Oct 31, 1988
NATURALYTE MIXER
K883408 · FIN
National Medical Care, Medical...
Gastroenterology & Urology · 81d
Cleared Oct 31, 1988
IMMUNOCCULT-LXI
K883432 · KHE
Intl. Immunoassay Laboratories, Inc.
Hematology · 77d
Cleared Oct 31, 1988
SR1 SYSTEM AUTOMATED PHOTOMETRIC ANALYZER
K883539 · JJE
Serono-Baker Diagnostics, Inc.
Chemistry · 76d
Cleared Oct 31, 1988
KD 0.1 M SODIUM CITRATE SOLUTION
K883635 · JPA
King Diagnostics, Inc.
Hematology · 67d
Cleared Oct 31, 1988
KD 0.02 M CALCIUM CHLORIDE SOLUTION
K883637 · JPA
King Diagnostics, Inc.
Hematology · 67d
Cleared Oct 31, 1988
KD ONE-STAGE PROTHROMBIN TIME TEST
K883640 · JPA
King Diagnostics, Inc.
Hematology · 67d
Cleared Oct 31, 1988
BEHRING TURBITIMER
K883646 · JJQ
Behring Diagnostics, Inc.
Chemistry · 67d
Cleared Oct 31, 1988
B3000/B3000M MAGNETIC RESONANCE IMAGING SCANNER
K883699 · LNH
Fonar Corp.
Radiology · 62d
Cleared Oct 31, 1988
TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINE
K883765 · KHQ
Biotecx Laboratories, Inc.
Chemistry · 55d
Cleared Oct 31, 1988
ROCKET INTRAUTERINE SOUND
K883806 · HHM
A & A Medical, Inc.
Obstetrics & Gynecology · 54d
Cleared Oct 31, 1988
HI CHEM KINETIC CHOLESTEROL REAGENT #88218
K883844 · CHH
Hichem Diagnostics
Chemistry · 49d
Cleared Oct 31, 1988
DERATA MEDI-JECTOR V
K883847 · KZE
Derata Corp.
General Hospital · 49d
Cleared Oct 31, 1988
UNIMAX(TM) HEARING AID BTE MODELS:100S, 110C, PPS4
K883961 · ESD
Unimax Hearing Instruments
Ear, Nose, Throat · 41d
Cleared Oct 31, 1988
ANALYST THEOPHYLLINE ROTOR
K884002 · KLS
The DU Pont Co.
Toxicology · 40d
Cleared Oct 31, 1988
PRN PLUS + INFUSION SET
K884053 · FPA
Prn Services, Inc.
General Hospital · 35d
Cleared Oct 28, 1988
PERMANENT PACING LEADS PYBJ SERIES
K882345 · DTB
Oscor Medical Corp.
Cardiovascular · 143d