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
162193–162216 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 22, 1982
BOUNDARY SINGLE-USE DRAPES
K813450 · KKX
The Buckeye Cellulose Corp.
General Hospital · 43d
Cleared Jan 22, 1982
5B SLAVE MODULE SYRINGE PUMP
K813473 · FRN
Baxter Healthcare Corp
General Hospital · 39d
Cleared Jan 22, 1982
OMS INFUSION CANNULA ASSEMBLE
K813481 · HMX
Optical Micro Systems, Inc.
Ophthalmic · 52d
Cleared Jan 22, 1982
OMS ANTERIOR CHAMBER INFUSION NEEDLE
K813483
Optical Micro Systems, Inc.
Ophthalmic · 52d
Cleared Jan 22, 1982
BRITT KRYPTON LASERS 150K & 152K
K813492 · HQF
Britt Corp., Inc.
Ophthalmic · 42d
Cleared Jan 22, 1982
COMMAND P5
K813534 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 36d
Cleared Jan 22, 1982
MOD. 587 BLOOD PRESSURE & PULSE MONITOR
K813556 · DXN
Bio Mega Diagnostic, Inc.
Cardiovascular · 31d
Cleared Jan 22, 1982
RADIATION STERILIZED SURGEON'S GLOVES
K813565 · KGO
Travenol Laboratories, S.A.
General Hospital · 31d
Cleared Jan 22, 1982
SIEMENS-ELEMA PULSE GENERATOR 659
K813576 · DXY
Siemens Elema AB
Cardiovascular · 30d
Cleared Jan 22, 1982
TDX PRIMIDONE
K813597 · DJD
Abbott Laboratories
Chemistry · 25d
Cleared Jan 22, 1982
101-32 FEMORAL COMPONENT
K813599 · JDL
Intermedics Orthopedics
Orthopedic · 25d
Cleared Jan 22, 1982
AUFRANC-TURNER TYPE ACETABULAR COMPON
K813600 · JDI
Intermedics Orthopedics
Orthopedic · 25d
Cleared Jan 22, 1982
POTASSIUM REAGENT SET
K813608 · CEJ
Diagnostic Specialties
Chemistry · 24d
Cleared Jan 22, 1982
TEKNA MED MYRINGOTOMY DISPOS-OTO KIT
K813616 · ETD
Humboldt Products
Ear, Nose, Throat · 24d
Cleared Jan 22, 1982
INDEFLATOR
K813622 · DQO
Advanced Catheter Systems
Cardiovascular · 24d
Cleared Jan 22, 1982
SIMPSON-ROBERT CORONARY GUIDING CATHET
K813623 · DQO
Advanced Catheter Systems
Cardiovascular · 24d
Cleared Jan 22, 1982
ADVANCED CATHETER SYSTEMS CORONARY GUID
K813624 · DQO
Advanced Catheter Systems
Cardiovascular · 24d
Cleared Jan 22, 1982
SERIES 400 DISPOSABLE TEMPERATURE PROBE
K813639 · FLL
Yellow Springs Instrument Co., Inc.
General Hospital · 22d
Cleared Jan 22, 1982
MICROMEDIC HTSH RIA KIT
K813645 · JLW
Micromedic Systems
Chemistry · 22d
Cleared Jan 22, 1982
TOTAL HEMOLYTIC COMPLEMENT TEST KIT
K820005
Meloy Laboratories, Inc.
Immunology · 18d
Cleared Jan 22, 1982
ZEON COMPOSITE RESIN SYSTEM
K820006 · EBF
National Patent Development Corp.
Dental · 18d
Cleared Jan 22, 1982
ARROW JUGULAR PUNCTURE KIT 16 GA.
K820009 · DQY
Arrow Intl., Inc.
Cardiovascular · 17d
Cleared Jan 22, 1982
CARDIOSTRESS
K820011 · DPS
Instruments For Cardiac Research
Cardiovascular · 17d
Cleared Jan 22, 1982
SPRYCE, DENTURE CLEANSER
K820020 · EFT
Richardson-Vicks, Inc.
Dental · 17d