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
159601–159624 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 18, 1982
AHBD
K822739 · JMK
Gilford Diagnostics
Chemistry · 39d
Cleared Oct 18, 1982
PILLING LACRIMAL INTUBATION SYSTEM(STER.
K822747
Narco Scientific
General & Plastic Surgery · 38d
Cleared Oct 18, 1982
SYSMEX PDA-410 (PARTICLE DISTRIB. ANALY
K822758 · GKL
Toa Medical Electronics USA, Inc.
Hematology · 34d
Cleared Oct 18, 1982
NEGATIVE PRESSURE ARTERIAL BLOOD LINE
K822796 · KOC
Erika, Inc.
Gastroenterology & Urology · 32d
Cleared Oct 18, 1982
GAS-FLOW METER GFL 10
K822820 · DTX
Gambro, Inc.
Cardiovascular · 28d
Cleared Oct 18, 1982
GAMBRO BLOOD LEVEL DETECTOR LCS 10
K822821 · DTW
Gambro, Inc.
Cardiovascular · 28d
Cleared Oct 18, 1982
GAMBRO PRESSURE MONITOR PRM 10
K822822 · DXS
Gambro, Inc.
Cardiovascular · 28d
Cleared Oct 18, 1982
HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT
K822823 · LKM
Eko Scann AB
Hematology · 27d
Cleared Oct 18, 1982
TICARCILLIN 75MCG. SENSI-DISC
K822832 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 27d
Cleared Oct 18, 1982
MODEL 200 SQUID
K822853 · HPT
Synemed, Inc.
Ophthalmic · 21d
Cleared Oct 18, 1982
COAT-A-COUNT TOBRAMYCIN RIA KIT
K822858 · KLB
Diagnostic Products Corp.
Chemistry · 21d
Cleared Oct 18, 1982
BRACHIAL CORONARY GUIDING CATHETER
K822862 · DQO
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 21d
Cleared Oct 18, 1982
SURGI-SCRUB V
K822865 · GEC
Acme United Corp.
General & Plastic Surgery · 21d
Cleared Oct 18, 1982
THERMOSTATIC WATER MIXING VALVE TWV10
K822874 · DWC
Gambro, Inc.
Cardiovascular · 21d
Cleared Oct 18, 1982
MODEL 78534A PATIENT MONITOR
K822876 · DRT
Hewlett-Packard Co.
Cardiovascular · 21d
Cleared Oct 18, 1982
MODEL 78554A DATA MGMT. PLUG-IN MODULE
K822877 · DXG
Hewlett-Packard Co.
Cardiovascular · 21d
Cleared Oct 18, 1982
MODEL 78553A PRESSURE PLUG-IN MODULE
K822878 · DSK
Hewlett-Packard Co.
Cardiovascular · 21d
Cleared Oct 18, 1982
ARTERIO VENOUS SHUNT CANNULA & ADAPTORS
K822880 · FIQ
Renal Systems, Inc.
Gastroenterology & Urology · 27d
Cleared Oct 18, 1982
DIABRITE
K822894 · EJR
Antraco, Inc.
Dental · 20d
Cleared Oct 18, 1982
LATEST RF KIT FOR RHEUMATOID FACTOR
K822905 · DHR
Fisher Scientific Co., LLC
Immunology · 19d
Cleared Oct 15, 1982
BIPOLAR TEMP. PACING CATHETER W/STYLETET
K822002 · LDF
Ziehm International, Inc.
Cardiovascular · 99d
Cleared Oct 15, 1982
BALLOON TEMP. PACING CATHETER
K822003 · LDF
Ziehm International, Inc.
Cardiovascular · 99d
Cleared Oct 15, 1982
ADHESIVE WOUND COVER FILM
K822080 · NAD
Hollister, Inc.
General & Plastic Surgery · 92d
Cleared Oct 15, 1982
VYGON EPIDURAL ANAESTHESIA TRAY
K822691 · CAZ
Exco, Inc.
Anesthesiology · 42d