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

Filters: Cleared only ×
175,820 results
145369–145392 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 11, 1986
DIFFERENTIATION DISKS PENICILLIN G 2 UNITS
K860561 · JTO
Difco Laboratories, Inc.
Microbiology · 25d
Cleared Mar 11, 1986
DIFFERENTIATION DISKS COLISTIN 10 MCG
K860562 · JTO
Difco Laboratories, Inc.
Microbiology · 25d
Cleared Mar 11, 1986
DIFFERENTIATION DISKS VANCOMYCIN 5 MCG
K860563 · JTO
Difco Laboratories, Inc.
Microbiology · 25d
Cleared Mar 11, 1986
DIFFERENTIATION DISKS ERYTHROMYCIN 60 MCG
K860564 · JTO
Difco Laboratories, Inc.
Microbiology · 25d
Cleared Mar 11, 1986
DIFFERENTIATION DISKS KANAMYCIN 1000 MCG
K860565 · JTO
Difco Laboratories, Inc.
Microbiology · 25d
Cleared Mar 11, 1986
ETHOX LAVAGE TUBE
K860599 · KDH
Ethox Corp.
Gastroenterology & Urology · 20d
Cleared Mar 11, 1986
OFPBL
K860707 · JSI
Remel Co.
Microbiology · 13d
Cleared Mar 10, 1986
XISCAN MODEL 1000
K852346 · JAA
Xi Tech
Radiology · 283d
Cleared Mar 10, 1986
SONOLINE CD
K852686 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 258d
Cleared Mar 10, 1986
SONOLINE SX ULTRASOUND SCANNER
K852739 · DXK
Siemens Medical Solutions USA, Inc.
Cardiovascular · 256d
Cleared Mar 10, 1986
DIMENSION TOTAL HIP PROSTHESIS POROUS COATED
K854107 · JDL
Kirschner Medical Corp.
Orthopedic · 153d
Cleared Mar 10, 1986
DIGIRAD REUSABLE IMAGE MEDIA
K854407 · LQA
Digirad Corp.
Radiology · 129d
Cleared Mar 10, 1986
INLAY WAX REGULAR
K854529 · EGD
The Hygenic Corp.
Dental · 117d
Cleared Mar 10, 1986
SOLAR F
K854641 · EIA
Alpine Dental Equipment Co.
Dental · 111d
Cleared Mar 10, 1986
NEMECTRODYN MODEL 2 & ENDOVAC 2 POWER MUSCLE STIM.
K854720 · IPF
Nemectron Medical, Inc.
Physical Medicine · 108d
Cleared Mar 10, 1986
MAXIMUS CUSHION
K855072 · KIC
Jay Medical, Ltd.
Physical Medicine · 81d
Cleared Mar 10, 1986
OCULAB BIOMETRICPEN
K860061 · IYO
Oculab, Inc.
Radiology · 63d
Cleared Mar 10, 1986
OCULAB PACHPEN
K860062 · IYO
Oculab, Inc.
Radiology · 63d
Cleared Mar 10, 1986
MODIFIED SYNATOMIC VARIABLE FIT TIBIAL PLATEAU
K860133 · HRY
Depuy, Inc.
Orthopedic · 55d
Cleared Mar 10, 1986
CELLMATICS CHLAMYDIA MONOCLONAL DFA REAGENT
K860179 · LJP
Difco Laboratories, Inc.
Microbiology · 52d
Cleared Mar 10, 1986
C ARM SURGICAL TABLE
K860446 · FWZ
Medi-Mech, Inc.
General & Plastic Surgery · 34d
Cleared Mar 10, 1986
HARBOR MEDICAL RESPIRATORY TRAY
K860506
Harbor Medical, Inc.
General & Plastic Surgery · 27d
Cleared Mar 10, 1986
HARBOR MEDICAL DRESSING TRAY
K860507
Harbor Medical, Inc.
General & Plastic Surgery · 27d
Cleared Mar 10, 1986
STANDARD WHEELCHAIRS
K860521 · IOR
Formotion, Inc.
Physical Medicine · 27d