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
82153–82176 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 04, 2000
MEDI-CULT SPERM PREPARATION - MEDIUM
K991332 · MQL
Medicult A/S
Obstetrics & Gynecology · 381d
Cleared May 04, 2000
A-MINIATURE CENTRIFUGAL BLOOD PUMP SYSTEM, MODEL CPB 2000
K992592 · KFM
A-Med Systems, Inc.
Cardiovascular · 276d
Cleared May 04, 2000
BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD...
K993816 · MCW
Baxter Edwards
Cardiovascular · 176d
Cleared May 04, 2000
CEMSTOP CEMENT RESTRICTOR
K993841 · LZN
Encore Orthopedics, Inc.
Orthopedic · 174d
Cleared May 04, 2000
MODULAR-PLUS REVISION STEM
K994126 · LWJ
Plus Orthopedics
Orthopedic · 149d
Cleared May 03, 2000
CLINI-DENT
K000140 · MAU
The Precident Group
Dental · 106d
Cleared May 03, 2000
STANDARD & EXTENDED BLADE, STANDARD & EXTENDED NEEDLE, STANDARD & EXTENDED...
K000333 · JOS
Triad Surgical Technologies, Inc.
General & Plastic Surgery · 90d
Cleared May 03, 2000
COLORADO MICRODISSECTION NEEDLE
K000348 · GEI
Stryker Leibinger
General & Plastic Surgery · 90d
Cleared May 03, 2000
MOTORIZED MICRO MULTILEAF COLLIMATOR
K000349 · IXI
Stryker Leibinger
Radiology · 90d
Cleared May 03, 2000
FOTOMASTER
K000380 · LLZ
Hamilton Thorne Research
Radiology · 86d
Cleared May 03, 2000
EINSTEIN PROCESSING AND REVIEW WORKSTATION
K000395 · LLZ
Ge Medical Systems F.I. Haifa
Radiology · 86d
Cleared May 03, 2000
MULTI LUMEN SUCTION SYRINGE SPRAY DISPENSER
K000438 · FMF
Biosurgical Corp.
General Hospital · 83d
Cleared May 03, 2000
ATR TECNIKA
K000547 · EFB
Advanced Technology Research (A.T.R.)...
Dental · 75d
Cleared May 03, 2000
TEMPO AQUA ANGIOGRAPHIC CATHETER
K000579 · DQO
Cordis Corp.
Cardiovascular · 71d
Cleared May 03, 2000
AU5, AU6
K000681 · IYO
Biosound Esaote, Inc.
Radiology · 65d
Cleared May 03, 2000
SENSI GRIP LATEX EXAMINATION GLOVE, POWDERED CONTAINS 200 MCGM OR LESS OF...
K000745 · LYY
Tillotson Healthcare Corp.
General Hospital · 56d
Cleared May 03, 2000
DIMAX 2
K000771 · EHD
Planmeca Oy
Radiology · 55d
Cleared May 03, 2000
ENTEC REFLEX WAND 55, MODEL E4055-01, E4045-01
K000778 · GEI
Arthrocare Corp.
General & Plastic Surgery · 54d
Cleared May 03, 2000
POWDERFREE LATEX SURGEON'S GLOVES WITH PROTIEN LABELING CLAIM (50 MOCROGRAMS...
K000896 · KGO
Fitco Dipped Products Pvt., Ltd.
General Hospital · 44d
Cleared May 03, 2000
4631 DUO DELIVERY SYSTEM
K000966 · EIA
A-Dec, Inc.
Dental · 37d
Cleared May 03, 2000
4635 ASSISTANT'S INSTRUMENTATION
K000967 · EIA
A-Dec, Inc.
Dental · 37d
Cleared May 03, 2000
3181 DUO DELIVERY SYSTEM
K000968 · EIA
A-Dec, Inc.
Dental · 37d
Cleared May 03, 2000
AGILENT INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A AND AGILENT...
K001057 · DSI
Agilent Technologies, Inc.
Cardiovascular · 30d
Cleared May 03, 2000
GUGLIELMI DETACHABLE COIL AND POWER SUPPLY, MODELS POWER SUPPLY : 451006-4
K001083 · HCG
Boston Scientific, Target
Neurology · 29d