Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
71305–71328 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 07, 2003
CSS
K031564 · GEI
Medical Scientific, Inc.
General & Plastic Surgery · 141d
Cleared Oct 07, 2003
I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3
K031873 · JJX
I-Stat Corporation
Chemistry · 112d
Cleared Oct 07, 2003
BETEC RETRACTABLE SAFETY SYRINGE (5ML)
K031909 · MEG
Betec Medical Science Co., Ltd.
General Hospital · 109d
Cleared Oct 07, 2003
ARTHREX BIO-COMPRESSION SCREW, SMALL, ARTHREX BIO-COMPRESSION SCREW, LARGE,...
K032098 · HWC
Arthrex, Inc.
Orthopedic · 91d
Cleared Oct 07, 2003
NUVASIVE CEMENT RESTRICTOR
K032180 · JDK
Nuvasive, Inc.
Orthopedic · 82d
Cleared Oct 07, 2003
DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT
K032195 · DYH
Dentaurum
Dental · 81d
Cleared Oct 07, 2003
BROTHERS POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW
K032323 · LYZ
Long First (Xiamen) Plastics Co., Ltd.
General Hospital · 71d
Cleared Oct 07, 2003
JS VASCULAR GUIDE WIRE VISE/TORQUE DEVICE
K032411 · DQX
Js Vascular, Inc.
Cardiovascular · 63d
Cleared Oct 07, 2003
METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING
K032603 · KIF
Meta Biomed Co., Ltd.
Dental · 43d
Cleared Oct 07, 2003
MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KITS
K033039 · MEB
Mckinley, Inc.
General Hospital · 8d
Cleared Oct 06, 2003
DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM
K024072 · MSS
Duckworth & Kent, Ltd.
Ophthalmic · 300d
Cleared Oct 06, 2003
CSF400 AND CSF600
K030081 · JXG
Inmed Ltda.
Neurology · 270d
Cleared Oct 06, 2003
COACH 777-3
K030756 · INI
Wheelchair & Scooter Express
Physical Medicine · 209d
Cleared Oct 06, 2003
COACH 777-4
K030757 · INI
Wheelchair & Scooter Express
Physical Medicine · 209d
Cleared Oct 06, 2003
LALAN GLOVES (PVT) LTD GLOVE, PATIENT EXAMINATION, LATEX
K031386 · LYY
Lalan Gloves (Pvt) , Ltd.
General Hospital · 158d
Cleared Oct 06, 2003
OPTIBAND LC
K032407 · DYH
Sybron Dental Specialties, Inc.
Dental · 63d
Cleared Oct 06, 2003
F-10 FOLDING POWER CHAIR
K032441 · ITI
Wheelchair & Scooter Express
Physical Medicine · 60d
Cleared Oct 06, 2003
ABBOTT ARCHITECT ESTRADIOL CALIBRATORS
K032458 · JIT
Abbott Laboratories
Chemistry · 56d
Cleared Oct 06, 2003
DIMENSION DRUG CALIBRATOR II, MODEL DC49C
K032574 · DKB
Dade Behring, Inc.
Toxicology · 47d
Cleared Oct 06, 2003
NORMED COMPRESSION BONE SCREW SYSTEM
K032634 · JDS
Noviace Corporation
Orthopedic · 41d
Cleared Oct 06, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFTRIAXONE 0.5-64 UG/ML
K032655 · LON
Becton, Dickinson & CO
Microbiology · 39d
Cleared Oct 06, 2003
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES
K032668 · LYZ
Kingswell International, Inc.
General Hospital · 39d
Cleared Oct 06, 2003
ACE NANCY NAIL
K032687 · HTY
DePuy Orthopaedics, Inc.
Orthopedic · 38d
Cleared Oct 06, 2003
MODIFICATION TO: STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230)
K032721 · GEI
Stellartech Research Corp.
General & Plastic Surgery · 33d