FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
74353–74376 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 23, 2002
TUBING, DIALYSATE (AND CONNECTOR)
K022068 · FID
Molded Products, Inc.
Gastroenterology & Urology · 90d
Cleared Sep 23, 2002
SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-028
K022138 · DQY
Spectranetics Corp.
Cardiovascular · 83d
Cleared Sep 23, 2002
HIP TOOL IMPLANT
K022139 · HRS
Orthopedic Sciences, Inc.
Orthopedic · 83d
Cleared Sep 23, 2002
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIMS, GREEN COLOR
K022220 · LYY
Shen Wei (Usa), Inc.
General Hospital · 76d
Cleared Sep 23, 2002
PLUS PIVOT LINK UNIVERSAL SYSTEM
K022271 · MNI
Spine Vision, Inc.
Orthopedic · 72d
Cleared Sep 23, 2002
3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS
K022287 · EZL
3t Medical Systems, LLC
Gastroenterology & Urology · 70d
Cleared Sep 23, 2002
RESTORATION MODULAR SYSTEM
K022549 · LZO
Howmedica Osteonics Corp.
Orthopedic · 53d
Cleared Sep 23, 2002
SIGN IM NAIL
K022632 · HSB
Surgical Implant Generation Network...
Orthopedic · 47d
Cleared Sep 23, 2002
ORTHOGUARD AB ANTIMICROBIAL SLEEVE
K022676 · JEC
Smith & Nephew, Inc.
Orthopedic · 42d
Cleared Sep 23, 2002
CRPEX CRP CONTROLS LEVEL L, M, H
K022725 · JJX
Good Biotech Corp.
Immunology · 38d
Cleared Sep 23, 2002
TWIN FIX
K022771 · KTT
Fixano SA
Orthopedic · 33d
Cleared Sep 23, 2002
MODIFICATION TO SANARUS CENTRICA CORE TISSUE BIOPSY
K022879 · KNW
Sanarus Medical, Inc.
Gastroenterology & Urology · 24d
Cleared Sep 20, 2002
QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA
K021648 · NJF
Inova Diagnostics, Inc.
Immunology · 123d
Cleared Sep 20, 2002
SQA V, SPERM QUALITY ANALYZER
K021746 · POV
Medical Electronic Systems, LLC
Hematology · 115d
Cleared Sep 20, 2002
CVSI PERIPHERAL BALLOON CATHETER
K022061 · DQY
Cryo Vascular Systems, Inc.
Cardiovascular · 87d
Cleared Sep 20, 2002
CHASE CARDIOVASCULAR PATCH KIT
K022093 · DXZ
Chase Medical, Inc.
Cardiovascular · 85d
Cleared Sep 20, 2002
SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S,...
K022099 · FOZ
Hdc Corp.
General Hospital · 85d
Cleared Sep 20, 2002
PRECISEPLAN 2.0
K022411 · MUJ
Precision Therapy Intl., Inc.
Radiology · 58d
Cleared Sep 20, 2002
SOAKER CATHETER
K022869 · FRN
I-Flow Corp.
General Hospital · 22d
Cleared Sep 20, 2002
POST AND CORE - THIN FOR THE BASIC DENTAL IMPLANT SYSTEM
K022912 · DZE
Basic Dental Implant Systems, Inc.
Dental · 17d
Cleared Sep 19, 2002
BINAX NOW FLU B TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN...
K021646 · PSZ
Binax, Inc.
Microbiology · 122d
Cleared Sep 19, 2002
BINAX NOW FLU A TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN...
K021649 · PSZ
Binax, Inc.
Microbiology · 122d
Cleared Sep 19, 2002
MY ALLERGY TEST
K021698 · JKA
Immunetech Corporation
Immunology · 120d
Cleared Sep 19, 2002
DISPOSABLE TEMPORARY PACING CABLE,MODELS...
K022075 · DSA
Cp Medical
Cardiovascular · 85d