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
76081–76104 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 05, 2002
U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM USI-2000
K013902 · IYN
U-Systems, Inc.
Radiology · 191d
Cleared Jun 05, 2002
OMEGA II SYSTEM
K020772 · KTT
Howmedica Osteonics Corp.
Orthopedic · 89d
Cleared Jun 05, 2002
PROXIMATE AND ENDOPATH LINEAR CUTTERS AND STAPLERS
K020779 · GDW
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 86d
Cleared Jun 05, 2002
ENDOSCOPIC LIGHT SOURCE XL202/L3
K020889 · GCT
World of Medicine Lemke GmbH
Gastroenterology & Urology · 78d
Cleared Jun 05, 2002
VACURECT VACUUM CONSTRICTION DEVICE
K020969 · LKY
Vacurect Manufacturing (Pty) , Ltd.
Gastroenterology & Urology · 71d
Cleared Jun 05, 2002
REDUCED SIZE ONCOLOGY SALVAGE SYSTEM
K021260 · KRO
Biomet, Inc.
Orthopedic · 47d
Cleared Jun 05, 2002
ASCENT ALL-POLY PS TIBIAL BEARINGS
K021559 · JWH
Biomet, Inc.
Orthopedic · 23d
Cleared Jun 05, 2002
REPLACE SCALLOPED MARGIN IMPLANT SYSTEM
K021584 · DZE
Nobel Biocare Uas, Inc.
Dental · 22d
Cleared Jun 05, 2002
FIXED BEARING UNI COMPONENT
K021621 · HRY
Biomet, Inc.
Orthopedic · 20d
Cleared Jun 05, 2002
PHYSICIAN'S DESKTOP REVIEW
K021669 · LLZ
Adac Laboratories
Radiology · 15d
Cleared Jun 04, 2002
KLOCKNER DENTAL IMPLANTS, MODELS SK, NK, IK, S3, AND S4
K010132 · DZE
SOADCO, S.L.
Dental · 504d
Cleared Jun 04, 2002
PHYSIOLOG, SERIES 95000
K013032 · DQK
Camtronics, Ltd.
Cardiovascular · 267d
Cleared Jun 04, 2002
HYPERION VISIQUANT ANA TEST KIT
K013213 · DHN
Hyperion, Inc.
Immunology · 251d
Cleared Jun 04, 2002
SILICONE TRACHEAL T-TUBES
K013321 · BTR
Technical Products, Inc.
Anesthesiology · 242d
Cleared Jun 04, 2002
PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS
K020364 · JGS
Phoenix Diagnostics, Inc.
Chemistry · 120d
Cleared Jun 04, 2002
OPIATE ENZYME IMMUNOASSAY, CATALOG # 0020 (500 TESTS KIT)
K020368 · DJG
Lin-Zhi International, Inc.
Toxicology · 120d
Cleared Jun 04, 2002
BIOMEDICS 52 (OCUFILCON B) UV BLOCKING DAILY WEAR SOFT CONTACT LENS
K020389 · MVN
Ocular Sciences
Ophthalmic · 119d
Cleared Jun 04, 2002
AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041...
K020395 · DKZ
Lin-Zhi International, Inc.
Toxicology · 118d
Cleared Jun 04, 2002
CARESIDE ALT
K020487 · CKA
Careside, Inc.
Chemistry · 111d
Cleared Jun 04, 2002
NLITE SYSTEM,MODEL A00-1051
K020729 · GEX
Icn Photonics , Ltd.
General & Plastic Surgery · 90d
Cleared Jun 04, 2002
UNICONDYLAR KNEE
K020741 · HRY
Encore Orthopedics, Inc.
Orthopedic · 90d
Cleared Jun 04, 2002
IGEL 55UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IGEL...
K020855 · LPL
Igel Vision Care Pte , Ltd.
Ophthalmic · 81d
Cleared Jun 04, 2002
SAVIEW TORIC 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR
K021295 · LPL
St. shine Optical Co., Ltd.
Ophthalmic · 41d
Cleared Jun 04, 2002
PARACON II/FECAL CONCENTRATOR II
K021420 · LKS
Para Scientific Co.
Microbiology · 32d