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

Filters: Cleared only ×
175,820 results
149929–149952 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 05, 1985
MAYO ELBOW II
K843778
Zimmer, Inc.
Orthopedic · 161d
Cleared Mar 05, 1985
ACCESS C
K843911 · JOP
Advanced Technology Laboratories, Inc.
Cardiovascular · 153d
Cleared Mar 05, 1985
PLASMA CYCLIC ADENOSINE MONOPHOSPHATE BY RADIOIMMU
K844135 · CHO
Immuno Nuclear Corp.
Chemistry · 133d
Cleared Mar 05, 1985
ELECTRONIC MUSCLE STIMULATOR
K844489 · IPF
Beverly Hills Exercise Equipment
Physical Medicine · 106d
Cleared Mar 05, 1985
ABSORBABLE GAUZE PRODUCTS
K844573 · EFQ
Medicon, Inc.
General & Plastic Surgery · 102d
Cleared Mar 05, 1985
TSH-STAT
K844583 · JLW
Nuclear Medical Laboratories, Inc.
Chemistry · 102d
Cleared Mar 05, 1985
EXCEL TECH MST-7 ISOELECTRONIC THERAPY DEVICE
K844617 · IPF
Excel Tech. , Ltd.
Physical Medicine · 98d
Cleared Mar 05, 1985
QBC CENTRIFUGAL HEMATOLOGY ANALYZER
K844645 · GKZ
Bd Becton Dickinson Vacutainer...
Hematology · 96d
Cleared Mar 05, 1985
ECHO TYPE 4 CF ANTIGEN
K844695 · GNL
Hillcrest Biologicals
Microbiology · 92d
Cleared Mar 05, 1985
TRI-COUNT CALIBRATOR
K844708 · KSA
Hematology Marketing Assoc.
Hematology · 92d
Cleared Mar 05, 1985
MODELS 134, 135 & 136 TRANSFER CART/TABLE
K844711 · INK
Tri W-G, Inc.
Physical Medicine · 92d
Cleared Mar 05, 1985
MODELS 841,842,843,851,852 & 853 ELEVATING TRACTIO
K844712 · INQ
Tri W-G, Inc.
Physical Medicine · 92d
Cleared Mar 05, 1985
NSI ELT-D DILUTING FLUID 4000ML
K844782 · GIF
Nobel Scientific Industries, Inc.
Hematology · 85d
Cleared Mar 05, 1985
ARTISAN FOLDING WHEELCHAIRS
K844799 · IOR
Artisan Wheel Chair Manufacturers
Physical Medicine · 84d
Cleared Mar 05, 1985
CHLAMYDIA GROUP CF ANTIGEN
K844868 · GPW
Hillcrest Biologicals
Microbiology · 81d
Cleared Mar 05, 1985
THREADED TITANIUM METAL BACKED ACETABULAR CUP
K844906 · LZO
Depuy, Inc.
Orthopedic · 78d
Cleared Mar 05, 1985
CFE ACETABULAR CUP
K844941 · JDI
Biomet, Inc.
Orthopedic · 75d
Cleared Mar 05, 1985
LEUCINE AMINOPEPTIDASE REAGENT
K844965 · JGG
Alladin Diagnostic, Inc.
Chemistry · 71d
Cleared Mar 05, 1985
ECHO TYPE 9 CF ANTIGEN
K844967 · GNL
Hillcrest Biologicals
Microbiology · 71d
Cleared Mar 05, 1985
BIO-BAG ENVIRONMENTAL CHAMBER -TYPE A-MULTI-PLATE
K845008 · KZJ
Marion Laboratories, Inc.
Microbiology · 69d
Cleared Mar 05, 1985
OPERAID DISPOS. IRRIGATING KNIFE
K845039 · KYG
Jedmed Instrument Co.
Ophthalmic · 67d
Cleared Mar 05, 1985
COXSACKIE B SERIES CF ANTIGENS
K850003 · GNG
Hillcrest Biologicals
Microbiology · 62d
Cleared Mar 05, 1985
PRECINORM H & PRECIPATH H
K850017 · JJY
Boehringer Mannheim Corp.
Chemistry · 62d
Cleared Mar 05, 1985
SANYO ELECTRONIC MUSCLE STIMULATORS
K850047 · IPF
General Physiotherapy, Inc.
Physical Medicine · 56d