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
157897–157920 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 13, 1983
THYMINE/THYMIDINE DISCS DDG
K830939 · JTO
Oxoid U.S.A., Inc.
Microbiology · 20d
Cleared Apr 13, 1983
ISOLATION MASK I.C.S.
K831062 · LGM
American Threshold Industries, Inc.
General Hospital · 5d
Cleared Apr 13, 1983
CEILEX LS-15/ALLMEC ARGOSTAT
K837352
Elscint, Inc.
Radiology · 9d
Cleared Apr 13, 1983
FLOATEX LS-22
K837353
Elscint, Inc.
Radiology · 9d
Cleared Apr 12, 1983
CHEMOTHERAPY INFUSION CATHETER
K822096 · JCY
American Heyer Schulte
General & Plastic Surgery · 270d
Cleared Apr 12, 1983
CONVERTORS PRIMARY WOUND DRESSING II
K822990 · FRO
American Hospital Supply Corp.
General & Plastic Surgery · 182d
Cleared Apr 12, 1983
FREEDOM
K823849 · IOR
Carbonite Corp.
Physical Medicine · 112d
Cleared Apr 12, 1983
DEFIGARD M(OR DEFISCOPE M
K823931 · LDD
Odam
Cardiovascular · 104d
Cleared Apr 12, 1983
MINIDEF (OR DEFIPORT
K823933 · LDD
Odam
Cardiovascular · 104d
Cleared Apr 12, 1983
ULTRASONIC MEDICAL DEVICE MODEL 3 LO 4
K827708
Sterisson
Radiology · 274d
Cleared Apr 12, 1983
INFLATABLE PENILE PROSTH. - CYLINDER
K830048 · FAE
American Medical Systems, Inc.
Gastroenterology & Urology · 92d
Cleared Apr 12, 1983
BEAR JET 150 VENTILATOR
K830165 · FLI
Bear Medical Systems, Inc.
General Hospital · 84d
Cleared Apr 12, 1983
SPHYGMOLOG II MODEL D
K830184 · DXN
Cardiodyne General, Inc.
Cardiovascular · 89d
Cleared Apr 12, 1983
AUTO SUTURE TA DISPOS-STAPLE CART
K830199 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 82d
Cleared Apr 12, 1983
VARIOUS INSTRUMENTS & INSTRUMENT TRAYS
K830219 · FSM
Ascep, Inc.
General & Plastic Surgery · 78d
Cleared Apr 12, 1983
IMSI/METRIPOND HAND OPERATING TABLE
K830339 · FSE
Intl. Management Services, Inc.
General & Plastic Surgery · 70d
Cleared Apr 12, 1983
PEM-C
K830397 · JSF
Health Development Corp.
Microbiology · 64d
Cleared Apr 12, 1983
DISPOSABLE INTRA-ARTICULAR BLADE
K830434 · GFA
Concept, Inc.
General & Plastic Surgery · 62d
Cleared Apr 12, 1983
MODEL 200
K830468 · FTZ
Western Laboratories Corp.
Ophthalmic · 56d
Cleared Apr 12, 1983
SURGITEK ULTRA-LO CUFF
K830504 · BTR
Mec/Surgitek Products
Anesthesiology · 55d
Cleared Apr 12, 1983
CHALLENGER #450
K830519 · DSH
Transmed, Inc.
Cardiovascular · 54d
Cleared Apr 12, 1983
N.E.W. NEB
K830527
San Diego Plastics, Inc.
Gastroenterology & Urology
Cleared Apr 12, 1983
ELECTROSURGICAL GROUND PAD-DISPERSIVE
K830613 · GEI
Con Med Equipment, Inc.
General & Plastic Surgery · 43d
Cleared Apr 12, 1983
BLOOD LINE SETS FOR HEMOFILTRATION
K830677 · FJK
Gambro, Inc.
Gastroenterology & Urology · 39d