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
149353–149376 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 18, 1985
PATIENT MONITOR MODEL RM-300
K850794 · DTR
Honeywell, Inc.
Cardiovascular · 51d
Cleared Apr 18, 1985
SUN BEDS
K851255 · FTC
Tannhut
General & Plastic Surgery · 21d
Cleared Apr 17, 1985
SILICONE SPLINTING MATERIAL
K840113 · MDA
General Dental Products, Inc.
General & Plastic Surgery · 462d
Cleared Apr 17, 1985
H-H TENDEON IMPLANT
K843013
Holter-Hausner Intl.
Orthopedic · 260d
Cleared Apr 17, 1985
ARROW-GEISS PERCUTANEOUS TPN KIT
K844080 · LJS
Arrow Intl., Inc.
General Hospital · 180d
Cleared Apr 17, 1985
ETHICON - CHOLANGIOCLIP
K850273 · FZP
Ethicon, Inc.
General & Plastic Surgery · 84d
Cleared Apr 17, 1985
ESCHWEILER SYSTEM 2000 - GLOOD GAS ANALYZERS
K850360 · CHL
Text Tech Corp.
Chemistry · 77d
Cleared Apr 17, 1985
FLOWMETER, BACKPRESSURE COMPENSATED, THORPE TUBE
K850560 · CAX
Precision Medical, Inc.
Anesthesiology · 64d
Cleared Apr 17, 1985
ALBA DRY BURN PAD
K850881
Alba Health Care
General & Plastic Surgery · 44d
Cleared Apr 17, 1985
ALBA DRY BURN DRESSING
K850904 · NAD
Alba Health Care
General & Plastic Surgery · 43d
Cleared Apr 17, 1985
V-MUELLER INVERTED LINEAR ANASTOMOSIS INSTRUMENTS
K850947 · GAG
American V. Mueller
General & Plastic Surgery · 41d
Cleared Apr 17, 1985
SINGLE LEG MAYFIELD TABLE
K851022
Ohio Medical Instrument Co., Inc.
General & Plastic Surgery · 36d
Cleared Apr 17, 1985
ACETAZYME, STANBIO ACETAMINOPHEN PROC/TEST 0870
K851278 · LDP
Stanbio Laboratory
Toxicology · 16d
Cleared Apr 17, 1985
ANALYTES ALBUMIN, TOTAL BILIRUBIN, AST, ALT GEN2 S
K851308 · CIX
Technicon Instruments Corp.
Chemistry · 16d
Cleared Apr 16, 1985
ADAC DPS-4070 DIGITAL RADIOGRAPHY SYS
K843708 · LLZ
Adac Laboratories
Radiology · 207d
Cleared Apr 16, 1985
ND1100 BONE DENSITY SCANNER
K844766 · KGI
Nuclear Data, Inc.
Radiology · 130d
Cleared Apr 16, 1985
HEAD-SPINE STABILIZER HSS-1
K844926 · JAK
Imaging Accessories, Inc.
Radiology · 118d
Cleared Apr 16, 1985
BIOLOGICAL TELEMETRY SYSTEM
K850087
Chattanooga Group, Inc.
Physical Medicine · 95d
Cleared Apr 16, 1985
ELEKIBAN MAGNETO-THERAPEUTIC DEVICE
K850172
Mns, Ltd.
Physical Medicine · 90d
Cleared Apr 16, 1985
AUSONICS-ALPHA I DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT
K850173 · IZH
Ausonics Pty , Ltd.
Radiology · 90d
Cleared Apr 16, 1985
UNISONIC ELECTRONIC DIGITAL BP MONITOR EBM-1050
K850315 · DXN
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 81d
Cleared Apr 16, 1985
UNISONIC ELECTRONIC DIGITAL BP MONITOR EBM-2050
K850316 · DXN
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 81d
Cleared Apr 16, 1985
UNISONIC ELECTRONIC DIGITAL BP MONITOR EBM-3050
K850317 · DXN
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 81d
Cleared Apr 16, 1985
ULTRAFIL-LT (GUTTA PERCHA)
K850863 · EKM
The Hygenic Corp.
Dental · 46d