Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
150337–150360 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 01, 1985
CARDIO DATA MK4 HOLTER ANALYSIS SYSTEM
K850136 · DSI
Cardio Data
Cardiovascular · 18d
Cleared Feb 01, 1985
ECONO MATE -OXYGEN CONCENTRATOR
K850253 · CAW
Mountain Medical Equipment, Inc.
Anesthesiology · 10d
Cleared Jan 31, 1985
COLOR DOPPLER 880
K843643 · DXK
Irex Corp.
Cardiovascular · 136d
Cleared Jan 31, 1985
UMI AMNIOCENTESIS KIT W/SPINAL NEEDLE
K844558 · HIO
Universal Medical Instrument Corp.
Obstetrics & Gynecology · 71d
Cleared Jan 30, 1985
TITANIUM MITTELMEIER TYPE ACETABULAR
K842466 · KWA
American Ortomed Corp.
Orthopedic · 219d
Cleared Jan 30, 1985
UNILOC-CEMENTLESS & SELF TAP ACETABULAR
K842518 · KWA
American Ortomed Corp.
Orthopedic · 204d
Cleared Jan 30, 1985
MEDSENTRY SOFTOUCH SYSTEM
K844499 · FNM
Medsentry Corp.
General Hospital · 71d
Cleared Jan 30, 1985
BIO-STAT III PLATE WASHER
K844552 · JTC
Whittaker Bioproducts, Inc.
Microbiology · 70d
Cleared Jan 30, 1985
TITERTEK DULUTER/DISPENSER 78-640-00
K844568 · JTC
Flow Laboratories, Inc.
Microbiology · 68d
Cleared Jan 30, 1985
CAMPYPAK PLUS W/PALLADIUM CATALYST DISPOS. HYDROGE
K844571 · KZJ
Bd Becton Dickinson Vacutainer...
Microbiology · 68d
Cleared Jan 30, 1985
PDC 104 & PDC 304 STYLE CULTURE COLLECTION & TRANS
K844634 · JSM
Precision Dynamics Corp.
Microbiology · 64d
Cleared Jan 30, 1985
POLYSTAT, BIOLOGICAL STAIN
K844640 · IAB
Surgipath Medical Industries, Inc.
Pathology · 63d
Cleared Jan 29, 1985
ARGON DUAL LUMEN HEMODIALYSIS, CATHETER
K842039 · KNZ
Argon Medical Corp.
Gastroenterology & Urology · 253d
Cleared Jan 29, 1985
CULTURESET HSV ISOLATION & ID SYS
K842216 · GQL
Ortho Diagnostic Systems, Inc.
Microbiology · 239d
Cleared Jan 29, 1985
CMV TEST
K843138 · LIN
Microbiological Research Corp.
Microbiology · 173d
Cleared Jan 29, 1985
JCM LABS CUSTOM PRESCRIPTION & ACCENT IN-THE-EAR
K844093 · ESD
Jcm Labs, Inc.
Ear, Nose, Throat · 99d
Cleared Jan 29, 1985
PERRY SUTURING SET W/ANESTHETIC
K844610
Perry, Div.
Cardiovascular · 63d
Cleared Jan 29, 1985
WETS & DRIES
K844832
Abco Dealers, Inc.
General & Plastic Surgery · 48d
Cleared Jan 29, 1985
VISION -FORMERLY PDA- ALKALINE PHOSPHATASE
K850110 · CJE
Abbott Laboratories
Chemistry · 15d
Cleared Jan 28, 1985
KINAIR, LOW AIR LOSS BED
K843781 · FNL
Kinetic Concepts, Inc.
General Hospital · 124d
Cleared Jan 28, 1985
GRC-WT, GRC-W
K843899 · HKI
Olympus Corp.
Ophthalmic · 117d
Cleared Jan 28, 1985
STRATOFUSE SYRINGE PIGGYBACK PUMP
K844627 · FRN
Strato Medical Corp.
General Hospital · 62d
Cleared Jan 28, 1985
MODEL 1001
K844718 · FRN
A0kfusion Systems, Inc.
General Hospital · 55d
Cleared Jan 28, 1985
360 INFUSER
K844719 · FRN
Bd Becton Dickinson Vacutainer...
General Hospital · 55d