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

Filters: Cleared only ×
176,076 results
162169–162192 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 25, 1982
PETAL SOFT PLASTIC APPLICATOR TAMPAX
K813642 · HEB
Tampax, Inc.
Obstetrics & Gynecology · 26d
Cleared Jan 25, 1982
PBC SYRINGE
K813647 · FMF
Philadelphia Biologics Center
General Hospital · 25d
Cleared Jan 25, 1982
SPINOCAN SPINAL NEEDLE
K820047 · BSP
Burron Medical Products, Inc.
Anesthesiology · 17d
Cleared Jan 25, 1982
OPEN LOOP AMBULATORY INSULIN INFUSION
K820073 · FRN
Cardiac Pacemakers, Inc.
General Hospital · 13d
Cleared Jan 25, 1982
ESKA JONAS SILICONE-SILVER PENILE PROST
K820081 · FAE
Dacomed Corp.
Gastroenterology & Urology · 13d
Cleared Jan 22, 1982
SPIROX H
K812956 · BZK
Cairco , Ltd.
Anesthesiology · 93d
Cleared Jan 22, 1982
SPIROX A
K812959 · BZK
Cairco , Ltd.
Anesthesiology · 93d
Cleared Jan 22, 1982
AGGLUTEX AMPHETAMINE TEST KIT
K812986 · DJP
Hoffmann-La Roche, Inc.
Toxicology · 88d
Cleared Jan 22, 1982
DISPOSABLE ARTHROSCOPY CANNULA SET
K813000 · LXH
Clinical Technology Corp.
Orthopedic · 88d
Cleared Jan 22, 1982
SODIUM & POTASSIUM PRODUCTS
K813127 · JIX
Alko Diagnostic Corp.
Chemistry · 78d
Cleared Jan 22, 1982
BRADYCARDIA ALARM
K813174 · DRT
Douglas Scientific Products
Cardiovascular · 77d
Cleared Jan 22, 1982
REGU-VAC OXYGENATING SUCTION CATHETER
K813220
Bd Becton Dickinson Vacutainer...
Cardiovascular · 74d
Cleared Jan 22, 1982
NEOCARE BABY-CONTROLLED INCUBATOR
K813238 · FMZ
Vickers America Medical Corp.
General Hospital · 66d
Cleared Jan 22, 1982
PRE-PACK TENS
K813286 · GDY
Cunningham Woodland, Inc.
General & Plastic Surgery · 60d
Cleared Jan 22, 1982
CONPHAR LARYNGOSCOPE
K813297 · EQN
Conphar, Inc.
Ear, Nose, Throat · 60d
Cleared Jan 22, 1982
CONPHAR PALM ANEROID SPHYGMOMANOMETER
K813302 · DXQ
Conphar, Inc.
Cardiovascular · 60d
Cleared Jan 22, 1982
CONPHAR, WALL ANEROID SPHYGMOMANOMETER
K813303 · DXQ
Conphar, Inc.
Cardiovascular · 60d
Cleared Jan 22, 1982
RADIONUCLIDE DOSE CALIBRATOR
K813379 · KPT
Medi Nuclear Corp., Inc.
Radiology · 52d
Cleared Jan 22, 1982
DISPOSABLE ADULT ANES. CIRCUIT
K813382 · CAI
Intec.
Anesthesiology · 51d
Cleared Jan 22, 1982
DS-7 CLOSED WOUND SUCTION DRAIN SYSTEM
K813394 · GCX
Cox-Uphuff Intl.
General Hospital · 49d
Cleared Jan 22, 1982
ERG-JET ELECTRODE
K813399 · HLZ
Nicolet Biomedical Instruments
Ophthalmic · 49d
Cleared Jan 22, 1982
COMFORT CUSHION DRY BURN PAD III
K813419 · NAB
American Convertors Div., American...
General & Plastic Surgery · 46d
Cleared Jan 22, 1982
LASER PHOTOCOAGULATOR ARGON MED. LASER
K813429 · HPJ
American Laser Corp.
Hematology · 45d
Cleared Jan 22, 1982
RTP-5000
K813439 · JAD
Adac Laboratories
Radiology · 45d