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
155929–155952 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 12, 1983
CHIN (MENTOPLASTY) IMPLANTS
K831724 · FWP
S. Jackson, Inc.
General & Plastic Surgery · 73d
Cleared Aug 12, 1983
QUARTER GLOBE CAPS
K831727 · FTM
S. Jackson, Inc.
General & Plastic Surgery · 73d
Cleared Aug 12, 1983
INTRACARDIA SUCKERS
K831759 · DWF
Research Industries Corp.
Cardiovascular · 72d
Cleared Aug 12, 1983
SIMPLICITY PLUS
K831761 · FRN
Critikon Company, LLC
General Hospital · 72d
Cleared Aug 12, 1983
VARIOUS CARDIOVASCULAR SURGICAL DEVICE
K831769 · DWF
Research Industries Corp.
Cardiovascular · 72d
Cleared Aug 12, 1983
AQUALIZER MOUTHPIECE
K831793 · KMY
Martin D. Lerman
Dental · 70d
Cleared Aug 12, 1983
AXIOM FEEDING GASTRO TUBE
K831823 · KNT
Axiom Medical, Inc.
Gastroenterology & Urology · 66d
Cleared Aug 12, 1983
FEEDING TUBE PLACEMENT STYLET
K831840 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 66d
Cleared Aug 12, 1983
PRESSURE MONITORING IV BOTTLE CAP
K831867 · DRS
Alto Development Corp.
Cardiovascular · 63d
Cleared Aug 12, 1983
ALLERGENETICS FLUORO-FAST READER
K831870 · JZT
Axonics, Inc.
Chemistry · 63d
Cleared Aug 12, 1983
BONE SCREW
K831873 · HWC
W.L. Gore & Associates, Inc.
Orthopedic · 60d
Cleared Aug 12, 1983
LIPASE REAGENT SET
K831874 · JGX
Sterling Biochemical, Inc.
Chemistry · 60d
Cleared Aug 12, 1983
HEARING AID UNITRON #UE8-D
K831883 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 60d
Cleared Aug 12, 1983
BETA I PROGRAMMABLE INFUSION PUMP
K831897 · FRN
Orange Medical Instruments, Inc.
General Hospital · 59d
Cleared Aug 12, 1983
ELECATH BALTHERM TLC THERMAL DILUTION
K831945 · DYG
Electro-Catheter Corp.
Cardiovascular · 57d
Cleared Aug 12, 1983
CRYOMEDICS NEUROSTAT
K831963 · GXH
Spembly Medical , Ltd.
Neurology · 56d
Cleared Aug 12, 1983
POWER OPTIC
K831976 · EAY
Ritter Co.
Dental · 53d
Cleared Aug 12, 1983
INFUTROL 7000 INFUSION PUMP
K832008 · FRN
Valleylab, Inc.
General Hospital · 50d
Cleared Aug 12, 1983
AMERI CLEAR
K832011 · KEM
Stephens Scientific
Hematology · 50d
Cleared Aug 12, 1983
LME TEMP. MONITOR
K832042 · FLL
Litton Medical Electronics
General Hospital · 49d
Cleared Aug 12, 1983
RIM-HAEMOPHILUS 1 & 2
K832051 · JST
Austin Biological Laboratories
Microbiology · 49d
Cleared Aug 12, 1983
AMRESCO NA/K REAGENT SET
K832070 · JGS
American Research Products Co.
Chemistry · 46d
Cleared Aug 12, 1983
ELECTRIC INSTRUMENT TABLE
K832073 · HMF
CooperVision, Inc.
Ophthalmic · 45d
Cleared Aug 12, 1983
ELECTRONIC BLOOD PRESS. METER-ZH-820P
K832075 · DXN
Panasonic Co. Div. Matsu Elec. Corp....
Cardiovascular · 45d