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
157081–157104 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 12, 1983
DISPOSABLE SKIN STAPLER
K830768 · FZQ
Surgeons Choice, Inc.
General & Plastic Surgery · 32d
Cleared Apr 12, 1983
CADWELL 8400
K830771 · GWF
Cadwell Laboratories, Inc.
Neurology · 32d
Cleared Apr 12, 1983
AMES TDA VALPROIC ACID TEST
K830789 · LEG
Miles Laboratories, Inc.
Chemistry · 29d
Cleared Apr 12, 1983
INDUCTIVELY-COUPLED PLASMA SPECTROMETER
K830799 · JXR
The Perkin-Elmer Corp.
Toxicology · 29d
Cleared Apr 12, 1983
DSL 1900
K830816 · CGI
Diagnostic Systems
Chemistry · 28d
Cleared Apr 12, 1983
ASAHI BLOOD/PLASMA PUMP #ABP-01A &
K830818 · FIR
Parker Hannifin Corp.
Gastroenterology & Urology · 28d
Cleared Apr 12, 1983
NEGATIVE URINE CONTROL
K830834 · JJW
Helena Laboratories
Chemistry · 27d
Cleared Apr 12, 1983
REFLEX ONE STAPLE EXTRACTOR
K830867
Richard-Allan Medical Ind., Inc.
General & Plastic Surgery · 25d
Cleared Apr 12, 1983
TITAN GEL LDH ISO-ENZYME CONTROL
K830872 · CFE
Helena Laboratories
Chemistry · 25d
Cleared Apr 12, 1983
THREE CHANNEL MONITOR SERIES 6700
K830899 · DXJ
Marquette Electronics, Inc.
Cardiovascular · 22d
Cleared Apr 12, 1983
TDX T-UPTAKE
K830912 · KHQ
Abbott Laboratories
Chemistry · 22d
Cleared Apr 12, 1983
SURGITEK SIZER FOR PENILE PROSTHESIS
K830917 · FAE
Medical Engineering Corp.
Gastroenterology & Urology · 21d
Cleared Apr 12, 1983
TREONIC IP5
K830936 · FRN
Vickers America Medical Corp.
General Hospital · 19d
Cleared Apr 12, 1983
SUR-FIT FLEXIBLE
K830945 · EXB
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 19d
Cleared Apr 12, 1983
SYRINGE/NEEDLE DISPOS-BOX-CUTTER/CRIMPER
K830947
Post Medical, Inc.
General & Plastic Surgery · 19d
Cleared Apr 12, 1983
POLYETHYLENE MEDULLARY PLUG - STIIHMER/
K830949 · LZN
Allo Pro Corp.
Orthopedic · 19d
Cleared Apr 12, 1983
EASY BREATHER HEADER BAGS
K830961 · KCT
Medical Industries Packaging, Inc.
General Hospital · 18d
Cleared Apr 12, 1983
DOUBLE LUMEN TRANSFER DEVICE
K830970 · LHI
Codan Trading Co.
General Hospital · 15d
Cleared Apr 12, 1983
SUTTER CPM 5000
K830974 · JFA
Sutter Biomedical, Inc.
Physical Medicine · 15d
Cleared Apr 11, 1983
NATURAL LOCK ACETABULAR COMPONENT
K830662 · JDL
Advanced Biosearch Assn.
Orthopedic · 39d
Cleared Apr 11, 1983
KODAK LANEX FAST SCREENS SO-470
K837201
Eastman Kodak Company
Radiology · 45d
Cleared Apr 11, 1983
KODAK ORTHO C FILM SO-344
K837202
Eastman Kodak Company
Radiology · 45d
Cleared Apr 11, 1983
DIGITAL SUBTRACTION ANGIOGRPAHY
K837252
Aster Medical, Inc.
Radiology · 47d
Cleared Apr 08, 1983
STERILE HD CVP TRAY
K823521 · FMF
Bill Dude Hospital Disposables, Inc.
General Hospital · 130d