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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
158449–158472 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 24, 1983
SEMINAL COLLECTION DEVICE
K823937 · HIS
Health Development Corp.
Obstetrics & Gynecology · 57d
Cleared Feb 24, 1983
NON-STERILE PERITONEAL ACCESS CATHET-
K830257 · FKX
Evermed, Inc.
Microbiology · 30d
Cleared Feb 24, 1983
FREEMAN/SAMUELSON TOTAL KNEE
K830408 · MBV
Depuy, Inc.
Orthopedic · 17d
Cleared Feb 23, 1983
NON-PRESSURE AUTOCLAVE FOR STERILIZATION
K823457 · FLE
Interdent, Inc.
General Hospital · 97d
Cleared Feb 23, 1983
MODEL ICPM & ACCESSORIES
K823681 · JFC
Electromedics, Inc.
Physical Medicine · 78d
Cleared Feb 23, 1983
CENTRAL VEIN CATHERIZATION KIT
K823758 · DQO
Access Devices, Inc.
Cardiovascular · 71d
Cleared Feb 23, 1983
ESA ARTHROSCOPY CANNULA TRAY
K823832 · HRX
Concept, Inc.
Orthopedic · 64d
Cleared Feb 23, 1983
SDC RECTAL TEMP. PROBE PRODUCT #1020
K830039 · FLL
Science Development Corp.
General Hospital · 47d
Cleared Feb 23, 1983
POLYESTER X-RAY DETECTABLE STRUNG-SPONGE
K830201 · GDY
American Medical Disposable, Inc.
General & Plastic Surgery · 34d
Cleared Feb 23, 1983
COTTON BALLS, X-RAY OPAQUED STRUNG & NON
K830202 · GDY
American Medical Disposable, Inc.
General & Plastic Surgery · 34d
Cleared Feb 23, 1983
FRANZEN NEEDLE GUIDE
K830235 · GDM
Precision Dynamics Corp.
General & Plastic Surgery · 29d
Cleared Feb 19, 1983
SOLUTION TRANSFER CONTAINER
K830299 · KPE
The Healthcare Group Laboratories, Inc.
General Hospital · 22d
Cleared Feb 18, 1983
AFP SYSTEM PULSE GENERATOR MODEL 261/262
K822639 · DXY
Pacesetter Systems
Cardiovascular · 170d
Cleared Feb 18, 1983
SUTURE NEEDLES
K823229
Feuerstein Produktions
General & Plastic Surgery · 112d
Cleared Feb 18, 1983
AFP PULSE GENERATOR
K823559 · DXY
Pacesetter Systems
Cardiovascular · 78d
Cleared Feb 18, 1983
INTRA-AORTIC BALLOON SYSTEM
K823739 · DSP
Smec, Inc.
Cardiovascular · 67d
Cleared Feb 18, 1983
BLOOD GAS INCUBATOR #260650
K823766 · JRG
Boekel Industries, Inc.
Chemistry · 66d
Cleared Feb 18, 1983
COEURLOCK STERILE DISPOS. ANGIOGRAPHIC
K823920 · DXT
Coeur Laboratories, Inc.
Cardiovascular · 52d
Cleared Feb 18, 1983
USCI TEMP. ATRIO-VENTRICULAR ELECTRODE
K830094 · LDF
C.R. Bard, Inc.
Cardiovascular · 38d
Cleared Feb 18, 1983
SELFAST
K830107 · EMA
North Pacific Dental, Inc.
Dental · 38d
Cleared Feb 18, 1983
HYDROL
K830112 · EJK
North Pacific Dental, Inc.
Dental · 38d
Cleared Feb 18, 1983
SULCARINGS
K830116 · EIF
North Pacific Dental, Inc.
Dental · 38d
Cleared Feb 18, 1983
EXTERNAL INFUSION PUMP
K830151 · FRN
Intermedics, Inc.
General Hospital · 32d
Cleared Feb 18, 1983
IBM 588 DIGITAL ECG ACQUISITION/ANALYSIS
K830163 · DSI
Intl. Business Machines
Cardiovascular · 31d