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
73849–73872 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 19, 2002
3I DENTAL IMPLANT ACCESSORIES
K022113 · DZE
Implant Innovations, Inc.
Dental · 83d
Cleared Sep 19, 2002
SERVO VENTILATOR SYSTEM, MODEL 64 87 800 E407E
K022132 · CBK
Siemens Medical Solutions USA, Inc.
Anesthesiology · 80d
Cleared Sep 19, 2002
NATUS BLUE LIGHT PHOTOTHERAPY UNIT
K022196 · LBI
Natus Medical, Inc.
General Hospital · 76d
Cleared Sep 19, 2002
STERNGOLD 1, MODEL 1127781
K022252 · EJS
Sterngold
Dental · 69d
Cleared Sep 19, 2002
VOMED ENDOSCOPIC AND UROLOGICAL ACCESSORIES
K022318 · HIF
Vomed Volzer Medizintechnik GmbH & Co.
Obstetrics & Gynecology · 73d
Cleared Sep 19, 2002
SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND)
K022363 · KRH
St. Jude Medical, Inc.
Cardiovascular · 59d
Cleared Sep 19, 2002
CRAFTMATIC ADJUSTABLE BEDS WITH OPTIONAL HEAT & MASSAGE, MODELS CRAFTMATIC...
K022387 · LLI
Craftmatic Organization, Inc.
General Hospital · 58d
Cleared Sep 19, 2002
DVT60
K022786 · JOW
Huntleigh Healthcare, Inc.
Cardiovascular · 28d
Cleared Sep 19, 2002
DUOPRO SAFETY SYRINGE (DUOPROSS)
K022806 · MEG
M.K. Meditech Co. , Ltd.
General Hospital · 27d