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
83425–83448 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 07, 2000
ASCENT KNEE SYSTEM
K994326 · KWH
Biomet Manufacturing, Inc.
Orthopedic · 16d
Cleared Jan 06, 2000
BELMONT MODEL NGPBP INTRA-AORTIC BALLOON PUMP
K983866 · DSP
Belmont Instrument Corp.
Cardiovascular · 430d
Cleared Jan 06, 2000
MEDISYSTEMS BUTTONHOLE NEEDLE SETS
K990803 · FIE
Medisystems Corp.
Gastroenterology & Urology · 302d
Cleared Jan 06, 2000
PSI TITANIUM ANEURYSM CLIP
K991959 · HCH
V. Mueller Neuro/Spine
Neurology · 210d
Cleared Jan 06, 2000
CRITERION 40 OR PM 40
K992101 · CAP
Caradyne, Ltd.
Anesthesiology · 198d
Cleared Jan 06, 2000
BARD MEMOTHERM FLEXX BILIARY STENT
K993392 · FGE
C.R. Bard, Inc.
Gastroenterology & Urology · 90d
Cleared Jan 06, 2000
HDR CONTOUR TP TEMPLATE AND IMPLANT ACCESSORIES
K993400 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 90d
Cleared Jan 06, 2000
DISPOS-A-SCOPE
K993738 · FER
Dispos-A-Scope
Gastroenterology & Urology · 63d
Cleared Jan 06, 2000
HYDROTOWER MANAGEMENT SYSTEM, MODEL 4-750-00
K993778 · OCX
Northgate Technologies, Inc.
Gastroenterology & Urology · 59d
Cleared Jan 06, 2000
DURAGLIDE STONE REMOVAL BALLOON, MODEL 000635-38, 000646-47, DURAGLIDE STONE...
K993892 · FGE
C.R. Bard, Inc.
Gastroenterology & Urology · 51d
Cleared Jan 06, 2000
SIS WOUND DRESSING II
K993948 · KGN
Cook Biotech, Inc.
General & Plastic Surgery · 45d
Cleared Jan 05, 2000
ACCESS HYBRITECH FREE PSA QC, MODEL 37219
K993210 · JJX
Beckman Coulter, Inc.
Immunology · 103d
Cleared Jan 05, 2000
ENSTYLET MODELS EC0010, EC0020
K993376 · DRB
Endocardial Solutions, Inc.
Cardiovascular · 90d
Cleared Jan 05, 2000
OHMEDA MEDICAL OMNIBED
K993407 · FMZ
Ohmeda Medical
General Hospital · 89d
Cleared Jan 05, 2000
VARELISA TPO ANTIBODIES, MODEL 12348/12396
K993585 · JZO
Pharmacia & Upjohn Co.
Immunology · 75d
Cleared Jan 05, 2000
SOLO-CARE BRAND HARD SOLUTION
K993949 · MRC
Ciba Vision Corporation
Ophthalmic · 44d
Cleared Jan 05, 2000
VACLOK SYRINGE
K994253 · FMF
Merit Medical Systems, Inc.
General Hospital · 19d
Cleared Jan 04, 2000
TFX MEDICAL INTRODUCER KIT
K991647 · DYB
Tfx Medical Group
Cardiovascular · 236d
Cleared Jan 04, 2000
TUBING EXTENSION SET
K993361 · MSR
Hurricane Medical
Ophthalmic · 90d
Cleared Jan 04, 2000
INTRAVASCULAR ADMINISTRATION SET
K993463 · FPA
Custom Assemblies, Inc.
General Hospital · 83d
Cleared Jan 04, 2000
REBAR MICRO CATHETER, MODELS 105-5080, 105-5086
K993672 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 64d
Cleared Jan 04, 2000
INTRODUCER SHEATHS, VESSEL DILATOR, GUIDEWIRE
K994252 · DYB
Boston Scientific Corp
Cardiovascular · 18d
Cleared Jan 03, 2000
QUEST INTERSEGMENTAL ROLLER TRACTION TABLE
K993461 · JFB
Icon Intl., LLC
Physical Medicine · 82d
Cleared Jan 03, 2000
LIQUIBAND DENTAL
K993556 · EMA
Medlogic Global Corp.
Dental · 75d