FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
120049–120072 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 28, 1991
PROACT CHOLESTEROL SYSTEMS
K912212 · CHH
Boehringer Mannheim Corp.
Chemistry · 100d
Cleared Aug 28, 1991
ANGIOGRAPHIC OR FLUOROSCOPIC X-RAY SYSTEM
K912416 · IZI
Xre Corp.
Radiology · 89d
Cleared Aug 28, 1991
DENTAL CONNECTOR PRECISION ATTACHMENT
K912435 · EGG
Metalor Dental USA Corp.
Dental · 86d
Cleared Aug 28, 1991
TANDEM-E TSH CALIBRATION VERIFICATION CONTROL SET
K912439 · JJX
Hybritech, Inc.
Chemistry · 86d
Cleared Aug 28, 1991
CSP
K912448 · OWB
Fischer Imaging Corp.
Radiology · 86d
Cleared Aug 28, 1991
MICRO-X 15 HF
K912449 · IZO
Fischer Imaging Corp.
Radiology · 86d
Cleared Aug 28, 1991
TRACETS SME 5000
K912450 · DRX
Lectec Corp.
Cardiovascular · 86d
Cleared Aug 28, 1991
SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USE
K912739 · HQC
Site Microsurgical Systems, Inc.
Ophthalmic · 68d
Cleared Aug 28, 1991
CANNULA AND TROCAR
K912836 · GCJ
Oceanside Biomedics
General & Plastic Surgery · 63d
Cleared Aug 28, 1991
INTRAVASCULAR ADMINISTRATION SETS
K912860 · FPA
Pacific Device, Inc.
General Hospital · 62d
Cleared Aug 28, 1991
FRAMES (EYE GLASSES)
K913046 · HQZ
Jiuh Chyi Ent. Co., Ltd.
Ophthalmic · 50d
Cleared Aug 28, 1991
MCS 50MO X-RAY TUBE INSERT/MXS 50MO TUBE HOU ASSEM
K913301 · ITY
Comet North America, Inc.
Radiology · 34d
Cleared Aug 28, 1991
SOLITENS MODIFIED
K913522 · GZJ
Innovative Designer Products, Inc.
Neurology · 33d
Cleared Aug 27, 1991
ELECTRONIC ULTRASOUND SCAN MODELS EUP-U12/012T/TC3
K912363 · ITX
Hitachi Medical Corp. of America
Radiology · 90d
Cleared Aug 26, 1991
KAVOKLAVE STEAM AUTOCLAVE
K910789 · FLE
Kavo America
General Hospital · 182d
Cleared Aug 26, 1991
AUTO SUTURE SURGIPORT TISSUE GRIP DISPOSABLE SLEEV
K910921 · HET
United States Surgical, A Division of...
Obstetrics & Gynecology · 174d
Cleared Aug 26, 1991
P.F.C. UNICONDYLAR KNEE SYSTEM
K910968 · HRY
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 173d
Cleared Aug 26, 1991
INNERVISION IRRIGATION PUMP
K910982 · HEI
M.D. Engineering, Inc.
Obstetrics & Gynecology · 172d
Cleared Aug 26, 1991
OXICOMPLUS
K911207 · DQA
Waters Instruments, Inc.
Anesthesiology · 160d
Cleared Aug 26, 1991
MODEL #M9 ULTRACLAVE STEAM STERILIZER
K911322 · FLE
Midmark Corp.
General Hospital · 153d
Cleared Aug 26, 1991
AUTOCOMP
K911340 · KPQ
Victoreen, Inc.
Radiology · 153d
Cleared Aug 26, 1991
BREATHING FILTERS
K911427 · CAH
Intersurgical, Inc.
General Hospital · 202d
Cleared Aug 26, 1991
GARDNER PINS (ADULT & CHILD)
K911772 · HBL
Codman & Shurtleff, Inc.
Neurology · 129d
Cleared Aug 26, 1991
NEW-VENT
K911809 · JKA
Concord/Portex
Chemistry · 125d