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
154705–154728 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 16, 1983
N-ACETYLPROCAINAMIDE CALIBRATOR
K833385 · DLG
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 78d
Cleared Dec 16, 1983
HUMPHREY A.D.E. SYSTEM
K833478 · CAI
Anaesthetic Breathing System
Anesthesiology · 53d
Cleared Dec 16, 1983
WILLIAM HARVEY H-71-5-F CARDIOTOMY
K833479 · DTN
C.R. Bard, Inc.
Cardiovascular · 70d
Cleared Dec 16, 1983
OXYGEN MONITOR/CONTROLLER
K833496 · CCL
Oxequip Health Ind.
Anesthesiology · 70d
Cleared Dec 16, 1983
PACEMAKER SYS ANALYZER #384
K833647 · KRE
Pacesetter Systems
Cardiovascular · 60d
Cleared Dec 16, 1983
CD-102 CARBON DIOXIDE ANALYZER/RECOR
K833739 · CCJ
Instrumentarium Corp.
Anesthesiology · 52d
Cleared Dec 16, 1983
GROUP STREP BROTH T3472 LIM
K833759 · JSD
Gibco Laboratories Life Technologies,...
Microbiology · 51d
Cleared Dec 16, 1983
CLOSTRIDIUM DIFFICILE EY AGAR P2787
K833760 · JSJ
Gibco Laboratories Life Technologies,...
Microbiology · 51d
Cleared Dec 16, 1983
TROJAN PLUS II
K833765 · HIS
Youngs Rubber Corp.
Obstetrics & Gynecology · 50d
Cleared Dec 16, 1983
PROCESS 100 ST
K833846 · IZO
Cgr Medical Corp.
Radiology · 92d
Cleared Dec 16, 1983
8 FRENCH DILATOR 15CM, W/LUER LOCK
K833965 · DRE
Quinton, Inc.
Cardiovascular · 30d
Cleared Dec 16, 1983
AQUAPAK 020 HUMIDIFIER ADAPTER
K833974 · BTT
Respiratory Care, Inc.
Anesthesiology · 30d
Cleared Dec 16, 1983
FACTOR II DEFICIENT SUBSTRATE PLASMA
K834031 · GGP
Helena Laboratories
Hematology · 24d
Cleared Dec 16, 1983
DRAGER PEEP SYSTEM D
K834085 · BYE
Draeger Medical, Inc.
Anesthesiology · 17d
Cleared Dec 16, 1983
IMPLANTABLE PULSE GENERATOR
K834096 · DXY
Intermedics, Inc.
Cardiovascular · 18d
Cleared Dec 15, 1983
GEL-SCAN DIAGNOSTIC ULTRASOUND COUPLING
K834088 · HEM
Whs Products, Inc.
Obstetrics & Gynecology · 92d
Cleared Dec 14, 1983
STERILE DISP. INSTRUMENT TRAYS
K831841 · KDD
E.M. Adams
General & Plastic Surgery · 190d
Cleared Dec 14, 1983
ERIKA DI-ALA-KIT-SINGLE DIALYSIS ON/OF
K833252 · KOC
Erika, Inc.
Gastroenterology & Urology · 85d
Cleared Dec 14, 1983
PADGETT SUCTION CANNULA
K833717 · GEA
Advanced Biosearch Assn.
General & Plastic Surgery · 54d
Cleared Dec 13, 1983
MORTARA INSTRUMENT #101
K832050 · DPS
Mortara Instrument, Inc.
Cardiovascular · 172d
Cleared Dec 13, 1983
SPINAL NEEDLES & ACCESSORY
K834164 · FPK
Elfa Trading Co.
General Hospital · 12d
Cleared Dec 13, 1983
SYRINGE
K834165 · FMF
Elfa Trading Co.
General Hospital · 12d
Cleared Dec 12, 1983
SURGICAL TUBE HOLDER
K831489 · GEI
The Urology Group
General & Plastic Surgery · 216d
Cleared Dec 12, 1983
PHOTOMETER LP 300
K832531 · JJQ
Dr. Bruno Lange GmbH
Chemistry · 136d