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
165721–165744 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 22, 1980
HYPERALIMENTATION DRESSING CHANGE TRAY
K803114 · FRO
American Medical Disposable, Inc.
General & Plastic Surgery · 12d
Cleared Dec 22, 1980
SIMPLE DRESSING TRAY #82028
K803118 · KDD
American Medical Disposable, Inc.
General & Plastic Surgery · 12d
Cleared Dec 20, 1980
DRAGER AV2 ANESTHESIA VENTILATOR
K802168 · CBK
Draeger Medical, Inc.
Anesthesiology · 103d
Cleared Dec 19, 1980
ACCU-COUNTER SURGICAL SPONGE COUNTING SY
K802868
Surgical Systems, Inc.
General & Plastic Surgery · 35d
Cleared Dec 19, 1980
SHEA LOCKING BAIL PROSTHESIS
K802873 · ETB
Richard'S Medical Equip., Inc.
Ear, Nose, Throat · 35d
Cleared Dec 19, 1980
AMIKACIN RIA KIT
K802877 · KLQ
Antibodies, Inc.
Chemistry · 32d
Cleared Dec 19, 1980
BUCKBERG-SHILEY BLOOD CARDIOPLEGIC SPL.
K802879 · DTR
Shiley, Inc.
Cardiovascular · 32d
Cleared Dec 19, 1980
ABSELE* ABSORBABLE BONE SEALANT
K802881
Ethicon, Inc.
Ophthalmic · 32d
Cleared Dec 19, 1980
T3-SQUIBB RIA KIT
K802883 · CDP
E. R. Squibb & Sons, Inc.
Chemistry · 32d
Cleared Dec 19, 1980
ARGYLE DOUBLE SEAL CHEST DRAINAGE UNIT
K802891 · CCJ
Sherwood Medical Co.
Anesthesiology · 32d
Cleared Dec 19, 1980
CERAMIBOND
K802899 · DYW
Zulauf, Inc.
Dental · 32d
Cleared Dec 19, 1980
CYBREX CARBAMAZEPINE
K802902 · KLT
Abbott Laboratories
Immunology · 32d
Cleared Dec 19, 1980
6-435 FILTER PAD, 5/PKG.
K802914 · CAH
Lifecare Services, Inc.
General Hospital · 31d
Cleared Dec 19, 1980
MONTG. TRACHEAL TREPHINE FENE STRATOR
K802915 · KBF
Boston Medical Products, Inc.
Ear, Nose, Throat · 30d
Cleared Dec 19, 1980
MONTG. TRACHEAL CANNULA
K802916 · BTO
Boston Medical Products, Inc.
Anesthesiology · 30d
Cleared Dec 19, 1980
BECKMAN ASTRA SYSTEMS CALCIUM CHEMISTRY
K802923 · CIC
Beckman Instruments, Inc.
Chemistry · 31d
Cleared Dec 19, 1980
6-415 FILTER, ELEMENT, 170-C
K802925 · DSK
Lifecare Services, Inc.
Cardiovascular · 30d
Cleared Dec 19, 1980
SCI-PHARM UNIVERSAL CAVITY VARNISH
K802926 · LBH
Scientific Pharmaceuticals, Inc.
Dental · 30d
Cleared Dec 19, 1980
PRESSURE MONITORING SET
K802945 · DQO
Norton Performance Plastics Corp.
Cardiovascular · 30d
Cleared Dec 19, 1980
MONITOR, AIRWAY PRESSURE
K802955 · CAP
Novametrix Medical Systems, Inc.
Anesthesiology · 29d
Cleared Dec 19, 1980
NIKON URINE REFRACTOMER SG-1
K802959 · JRE
Nippon Kogaku, Inc.
Chemistry · 29d
Cleared Dec 19, 1980
101, 151, 161 PORTABLE AUDIOMETERS
K802963 · EWO
Amplaid USA, Inc.
Ear, Nose, Throat · 28d
Cleared Dec 19, 1980
ISPVAC TM
K802973 · GCY
Innovative Surgical Products, Inc.
General & Plastic Surgery · 31d
Cleared Dec 19, 1980
RAPI-DOT
K802974 · JHJ
Organon, Inc.
Chemistry · 28d