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
154393–154416 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 19, 1984
SYS MACRODUCT SWEAT COLLECTION SYS 3600
K840472 · KTB
Wescor, Inc.
Physical Medicine · 45d
Cleared Mar 19, 1984
E-Z OPEN DUST COVERS
K840595 · FRG
Plasti-Products, Inc.
General Hospital · 39d
Cleared Mar 19, 1984
VERIFY PREGNANCY TEST KIT
K840602 · LCX
O.T.C. Diagnostics, Inc.
Chemistry · 38d
Cleared Mar 19, 1984
BERNIER ARM SUPPORT
K840653 · FNJ
T.C. Toll Corp.
General Hospital · 33d
Cleared Mar 19, 1984
ECU 1218
K840808 · IQA
Rehab Technology, Inc.
Physical Medicine · 24d
Cleared Mar 19, 1984
ANESTHESIA VENTILATOR CIRCUIT
K840850 · CAI
The Kendal Co.
Anesthesiology · 24d
Cleared Mar 19, 1984
DESERET CENTRAL VENOUS CATHETER
K840862 · FOZ
Parke-Davis Co.
General Hospital · 24d
Cleared Mar 19, 1984
PORTASCOOT POWER SEAT
K840866 · INI
E.F. Brewer Co.
Physical Medicine · 21d
Cleared Mar 19, 1984
KEYMED MOBILE ENDOSCOPY PATIENT COUCH
K840920 · FPO
Keymed, Inc.
General Hospital · 18d
Cleared Mar 19, 1984
PLAYTEX SLENDER REGULAR TAMPONS
K841154 · HIL
Playtex, Inc.
Obstetrics & Gynecology
Cleared Mar 19, 1984
DEODORANT SLENDER REG. TAMPONS
K841155 · HIL
Playtex, Inc.
Obstetrics & Gynecology
Cleared Mar 19, 1984
SUCTION TIPS
K841159
Morwel Corp.
General Hospital
Cleared Mar 16, 1984
SATELEC SUPRASSON PIEZOMATIC P2
K832664 · ELC
Spelna, Inc.
Dental · 220d
Cleared Mar 16, 1984
SATELEC PROPHY UNIT PU 2000S
K832674 · ELC
Spelna, Inc.
Dental · 220d
Cleared Mar 16, 1984
ERGO DIAGNOSTIC CARD
K834145 · HOX
American Ergo Systems
Ophthalmic · 106d
Cleared Mar 16, 1984
PLASTIC OPTICAL LENS M-110
K834261 · HQC
U-Molde Systems, Inc.
Ophthalmic · 99d
Cleared Mar 16, 1984
DENTSPLY G-106 CAVITRON ULTRASONIC
K834283 · ELC
Coopercare, Inc.
Dental · 112d
Cleared Mar 16, 1984
ARGON/KRYPTON ION LASER PHOTOCOAGULA
K834305 · HQF
Nidek, Inc.
Ophthalmic · 109d
Cleared Mar 16, 1984
MICRO FORCEPS
K834355 · HNR
Jedmed Instrument Co.
Ophthalmic · 94d
Cleared Mar 16, 1984
EYE SPONGE OR SPEAR
K834356 · HOZ
Jedmed Instrument Co.
Ophthalmic · 94d
Cleared Mar 16, 1984
ROTAVIRUS BIO-ENZABEAD SCREEN KIT
K834443 · LIQ
Litton Bionetics
Immunology · 91d
Cleared Mar 16, 1984
PHACO FRAGMENTOR GT-1
K834453 · HQC
Fibra Sonics, Inc.
Ophthalmic · 88d
Cleared Mar 16, 1984
CORNING 4000 MULTI-WELL GAMMA COUNTER
K834508 · JJJ
Corning Medical & Scientific
Toxicology · 86d
Cleared Mar 16, 1984
MICRO VIT FRAGMENTATION SYSTEM
K834537 · HQC
Medical Instrument Development...
Ophthalmic · 98d