FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
128641–128664 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 08, 1989
VENTREZYME VAST SPECIFIC IGE ASSAY
K896694 · DHB
Ventrex Laboratories, Inc.
Immunology · 10d
Cleared Dec 07, 1989
CATHETER, CARDIOVASCULAR, BALLOON TYPE
K883852 · DXE
Wb Intl., Inc.
Cardiovascular · 450d
Cleared Dec 07, 1989
RMI CARDIOPLEGIA DELIVERY SETS
K892368 · DTL
Research Medical, Inc.
Cardiovascular · 245d
Cleared Dec 07, 1989
RMI AORTIC ROOT/CORONARY SINUS MONIT./INFUSION SET
K892377 · DTL
Research Medical, Inc.
Cardiovascular · 245d
Cleared Dec 07, 1989
CORTISOL TEST SYSTEM
K895421 · JFT
Baxter Healthcare Corp
Chemistry · 97d
Cleared Dec 07, 1989
RELY-A-BOND W/FLUORIDE (NO MIX ADHESIVE)
K895521 · DYH
Reliance Orthodontic Products, Inc.
Dental · 86d
Cleared Dec 07, 1989
LIGHT BOND PASTE W/FLUORIDE
K895522 · DYH
Reliance Orthodontic Products, Inc.
Dental · 86d
Cleared Dec 07, 1989
K-1 INFANT TRANSPORT SYSTEM
K895550 · FMZ
K-1 Medical Products, Inc.
General Hospital · 85d
Cleared Dec 07, 1989
GLYCOTEST II GLYHB ASSAY KIT
K895661 · LCP
Pierce Chemical Co.
Hematology · 78d
Cleared Dec 07, 1989
DIATEK MODEL 700 THERMOMETER
K895703 · FLL
Diatek, Inc.
General Hospital · 76d
Cleared Dec 07, 1989
MILLAR MIKRO-TIP PULSE TRANSDUCER
K895721 · DXO
Millar Instruments, Inc.
Cardiovascular · 73d
Cleared Dec 07, 1989
MODIFIED PERMCATH TRAY (2ND SUBMISSION)
K895779 · CBK
Quinton, Inc.
Anesthesiology · 91d
Cleared Dec 07, 1989
NEONATAL INCUBATOR (ACCESSORY)
K895782 · FMZ
Air-Shields Vickers, Inc.
General Hospital · 71d
Cleared Dec 07, 1989
UNIPOLAR TEMP. MYOCARDIAL HEART WIRE, MODEL 6490
K895789 · LDF
Medtronic Vascular
Cardiovascular · 70d
Cleared Dec 07, 1989
BIO-RAD BLIND PERFOR. SPECIMEN SET FOR NIDA REG.
K895816 · DIF
Bio-Rad
Toxicology · 69d
Cleared Dec 06, 1989
MODEL 600 SYRINGE PUMP
K891237 · FRN
3M Company
General Hospital · 274d
Cleared Dec 06, 1989
VOLUMETRIC PUMP SOLUTION SET W/INTEGRAL AIRWAY
K893646 · FPA
Baxter Healthcare Corp
General Hospital · 205d
Cleared Dec 06, 1989
CODMAN RF-12 DISPOSABLE SCALP CLIP APPLIER
K894778 · HBO
Codman & Shurtleff, Inc.
Neurology · 132d
Cleared Dec 06, 1989
A-PORT IMPLANT. VASCULAR ACCESS SYSTEM - A2PORT
K896093 · LJT
Therex Corp.
General Hospital · 48d
Cleared Dec 06, 1989
COMPASS(TM) STEREOTACTIC RETRACTOR SYSTEM
K896156 · GZT
Stereotactic Medical Systems, Inc.
Neurology · 43d
Cleared Dec 06, 1989
DISPOSABLE EXTERNAL CLAMPS
K896383 · GDI
Galenica Enterprises, Inc.
General & Plastic Surgery · 30d
Cleared Dec 06, 1989
DISPOSABLE 45 DEGREE SHAVER
K896538 · HRX
Bowen & Company, Inc.
Orthopedic · 20d
Cleared Dec 06, 1989
EXACTECH BONE SCREW
K896601 · HWC
Exactech, Inc.
Orthopedic · 15d
Cleared Dec 05, 1989
MEDI-TECH AMPLATZ INTRODUCER SHEALTH SYSTEM
K891121 · DYB
Boston Scientific Corp
Cardiovascular · 278d