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
157633–157656 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 18, 1983
DAC-CEL DIAGNATAL HCG STANDARDS RD49
K830204 · JJX
Wellcome Diagnostics
Chemistry · 29d
Cleared Feb 18, 1983
TDX N-ACETYLPROCAINAMIDE
K830206 · LAN
Abbott Laboratories
Chemistry · 28d
Cleared Feb 18, 1983
REAGENTS CORNING CHLORIDE METER FOR
K830217 · JFS
Fisher Scientific Co., LLC
Chemistry · 25d
Cleared Feb 18, 1983
THE TOOTHPIK
K830225 · JES
Fred M. Davis
Dental · 25d
Cleared Feb 18, 1983
CONTOX HEAVYMETALS CONTROL
K830234 · DIF
Kaulson Laboratories, Inc.
Toxicology · 24d
Cleared Feb 18, 1983
TRANSLUCENT POLY. CATH. CONNECTOR AND
K830237 · DQO
Vertex Medical Corp.
Cardiovascular · 24d
Cleared Feb 18, 1983
ULTRA CHEM CRESOLCAVERSACHEM #65082
K830238 · CIC
Emd Chemicals, Inc.
Chemistry · 24d
Cleared Feb 18, 1983
ULTRAZYME PLUS GAMMA GT-MCA #65055-65056
K830240 · JQB
Emd Chemicals, Inc.
Chemistry · 24d
Cleared Feb 18, 1983
CAST SHOE, CAST BOOT
K830246 · JQB
Warm & Form, Orthopedic Materials
Chemistry · 24d
Cleared Feb 17, 1983
EXPANDED PTFE PROSTHESIS BLOOD ACCES
K823748
C.R. Bard, Inc.
Gastroenterology & Urology · 66d
Cleared Feb 17, 1983
DE VO/44 OXYGEN CONCENTRATOR #444
K830174 · CAW
The Devilbiss Co.
Anesthesiology · 30d
Cleared Feb 16, 1983
KF-101-07 DIALYZER
K822337 · KOC
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 196d
Cleared Feb 16, 1983
KF-101-10 DIALYZER
K822338 · KOC
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 196d
Cleared Feb 16, 1983
KF-101-13 DIALYZER
K822339 · KOC
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 196d
Cleared Feb 16, 1983
DIRECT FA CONJUGATE FOR LEGIONELLA SPP
K822859 · LHL
Zeus Technologies
Microbiology · 142d
Cleared Feb 16, 1983
MICROELISA MINIREADER II
K830200 · LBI
Dynatech Corp.
Chemistry · 27d
Cleared Feb 15, 1983
CETUS CMV IHA
K822965 · LJO
Cetus Corp.
Immunology · 131d
Cleared Feb 15, 1983
BIOSELF 101
K823209 · LHD
Bioself, Inc.
Obstetrics & Gynecology · 110d
Cleared Feb 15, 1983
MOTILITY CATHETERS
K823701 · FFX
Mui Scientific
Gastroenterology & Urology · 69d
Cleared Feb 15, 1983
MF 360B ELECTROSURGICAL UNIT
K823923 · GEI
Aspen Laboratories, Inc.
General & Plastic Surgery · 49d
Cleared Feb 15, 1983
HIPUSH HANDHELD MASSAGER
K823927 · ISA
New Age Corp.
Physical Medicine · 48d
Cleared Feb 15, 1983
LITH A TEST TM
K830091 · CEN
Lenal Creative Approaches, Inc.
Hematology · 35d
Cleared Feb 15, 1983
MS-2 BACTERIAL IDENTI. SYS
K830099 · JTO
Abbott Laboratories
Microbiology · 35d
Cleared Feb 15, 1983
QUIK-DIP BLOOD STAIN
K830127 · IAF
Mercedes Scientific Co., Inc.
Pathology · 34d