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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
138793–138816 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 25, 1987
ARIES
K873170 · BYE
Mountain Medical Equipment, Inc.
Anesthesiology · 45d
Cleared Sep 25, 1987
PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA
K873400 · CFT
Serono Diagnostics, Inc.
Chemistry · 32d
Cleared Sep 25, 1987
FAC GE1/HI PERF FAC UPR BODY TE2/FULL BODY GA 8-12
K873430 · FTC
Klafs Sunlight Corp.
General & Plastic Surgery · 30d
Cleared Sep 25, 1987
VAN DELLEN ASPIRATOR
K873462 · BTA
Van Dellen, Ltd.
General & Plastic Surgery · 28d
Cleared Sep 24, 1987
VARIOUS TYPES OF: KEELER MAGNATONE 2 STETHOSCOPES:
K871369 · LDE
Keeler Instruments, Inc.
Cardiovascular · 170d
Cleared Sep 24, 1987
INTELECT MODEL 575
K872654 · IPF
Chattanooga Group, Inc.
Physical Medicine · 79d
Cleared Sep 24, 1987
MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROAT
K872710 · EWG
Directed Energy, Inc.
Ear, Nose, Throat · 79d
Cleared Sep 24, 1987
TORAY ANTHRON AORTA BYPASS TUBES
K872762 · DWF
Toray Industries (America), Inc.
Cardiovascular · 73d
Cleared Sep 24, 1987
CYBEX 340
K872911 · IKK
Cybex
Physical Medicine · 62d
Cleared Sep 24, 1987
97-D EMERSON DIMMER CONTROL
K872936 · IQA
J. H. Emerson Co.
Physical Medicine · 59d
Cleared Sep 24, 1987
97-TD EMERSON TIMER/DIMMER CONTROL
K872937 · IQA
J. H. Emerson Co.
Physical Medicine · 59d
Cleared Sep 24, 1987
LACERATION AND INSTRUMENT TRAYS
K873290 · LRP
Advantage Medical Systems, Inc.
General & Plastic Surgery · 38d
Cleared Sep 24, 1987
SKYTRON MODEL 130 SURGICAL TABLE
K873478 · FWY
Skytron, Div. the Kmw Group, Inc.
General & Plastic Surgery · 31d
Cleared Sep 24, 1987
NINJA SCALPEL
K873493 · GES
Primrose Medical, Inc.
General & Plastic Surgery · 24d
Cleared Sep 24, 1987
JOHNSON & JOHNSON BIPOLAR ENDOPROTHESIS
K873514 · KWY
Johnson & Johnson Professionals, Inc.
Orthopedic · 24d
Cleared Sep 23, 1987
CT PACE CATALOG NUMBER B7950A
K872526 · JAK
General Electric Co.
Radiology · 90d
Cleared Sep 23, 1987
IMATRON C-100 ULTRAFAST CT SCANNER
K872615 · JAK
Imatron, Inc.
Radiology · 79d
Cleared Sep 23, 1987
SHILEY PTS CHEST DRAINAGE AUTOTRANSFUSION SET
K872720 · DTN
Shiley, Inc.
Cardiovascular · 75d
Cleared Sep 23, 1987
EXPANDED USE FOR SHILEY 3L CARDIOTOMY RESERVOIR
K872721 · DTN
Shiley, Inc.
Cardiovascular · 75d
Cleared Sep 23, 1987
EXPANDED USE FOR SHILEY 3L CARDF PLUS
K872722 · DTN
Shiley, Inc.
Cardiovascular · 75d
Cleared Sep 23, 1987
MEDIX BIOTECH APOLIPOPROTEIN A-I TEST KIT
K872794 · MSJ
Medix Biotech, Inc.
Immunology · 71d
Cleared Sep 23, 1987
NOVAMETRIX MODEL 505 PULSE OXIMETER
K873078 · DQA
Novametrix Medical Systems, Inc.
Anesthesiology · 49d
Cleared Sep 23, 1987
BRAIN HEART INFUS AGAR SLANT W/10% SHEEP BLOOD C&C
K873216 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 40d
Cleared Sep 23, 1987
BRAIN HEART INFUSION BROTH 10 ML - PRODUCT #T3006
K873217 · JSG
Lakewood Biochemical Co., Inc.
Microbiology · 40d