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
72193–72216 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 14, 2003
BACT/ALERT MP CULTURE BOTTLES (PLASTIC)
K031737 · MDB
bioMerieux, Inc.
Microbiology · 40d
Cleared Jul 14, 2003
ACON STREP A RAPID TEST DEVICE
K031784 · GTY
ACON Laboratories, Inc.
Microbiology · 34d
Cleared Jul 14, 2003
VAXCEL WITH PASV PORT, MODEL 45-213
K032008 · LJT
Boston Scientific Corp
General Hospital · 14d
Cleared Jul 12, 2003
KAMAR ANNULUS DILATOR + SIZER
K030788 · DWP
Geister Medizin Technik GmbH
Cardiovascular · 122d
Cleared Jul 12, 2003
SPINAL CONCEPTS, INC. CADENCE AND FORTITUDE
K031914 · MQP
Spinal Concepts, Inc.
Orthopedic · 22d
Cleared Jul 11, 2003
BUTLER GUM PROPHY PASTE WITH NOVAMIN
K024343 · EJR
Usbiomaterials Corp.
Dental · 196d
Cleared Jul 11, 2003
VASC-ALERT
K030456 · KOC
Vasc-Alert, LLC
Gastroenterology & Urology · 150d
Cleared Jul 11, 2003
MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE
K030547 · DRL
Guardian Angel Products, Inc.
Cardiovascular · 141d
Cleared Jul 11, 2003
AUTION JET AJ-4270 URINE ANALYZER
K030600 · KQO
International Remote Imaging Systems
Chemistry · 136d
Cleared Jul 11, 2003
TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD...
K030703 · NBW
Home Diagnostics, Inc.
Chemistry · 127d
Cleared Jul 11, 2003
A/C ENZYMATIC HOMOCYSTEINE ASSAY
K030754 · LPS
Anticancer, Inc.
Toxicology · 123d
Cleared Jul 11, 2003
COOK GASTRIC SIZING BALLOON CATHETER
K030841 · KNT
Cook, Inc.
Gastroenterology & Urology · 116d
Cleared Jul 11, 2003
C. DIFF CHEK - 30
K030991 · LLH
Techlab, Inc.
Microbiology · 105d
Cleared Jul 11, 2003
C. DIFF CHEK - 60
K030992 · LLH
Techlab, Inc.
Microbiology · 105d
Cleared Jul 11, 2003
NANO TECH AND SUPER NANO ACUPUNCTURE NEEDLES
K031060 · MQX
Lhasa Medical, Inc.
General Hospital · 99d
Cleared Jul 11, 2003
TEMPORARY RESIN CEMENT
K031212 · EMA
Parkell, Inc.
Dental · 85d
Cleared Jul 11, 2003
OPTIBOLUS
K031339 · DXT
Mallinckrodt Inc., Liebel-Flarsheim...
Cardiovascular · 74d
Cleared Jul 11, 2003
PREMIER 9000 8 CHANNEL PHASED ARRAY CTL SPINE COIL
K031366 · MOS
Usa Instruments, Inc.
Radiology · 72d
Cleared Jul 11, 2003
ILT SAFE CROSS 0.035 SUPPORT CATHETER, MODEL C135SN1
K031417 · DQY
Intra Luminal Therapeutics, Inc.
Cardiovascular · 67d
Cleared Jul 11, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN GRAM POSITIVE
K031589 · LON
Becton, Dickinson & CO
Microbiology · 51d
Cleared Jul 11, 2003
MODIFICATION TO HERMES O.R. CONTROL CENTER
K031720 · GCJ
Computer Motion, Inc.
General & Plastic Surgery · 38d
Cleared Jul 11, 2003
MEDRAD SWABBABLE VALVE TRANSFER SET
K031808 · FPK
Medrad, Inc.
General Hospital · 29d
Cleared Jul 11, 2003
HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1
K031823 · MQP
Implex Corp.
Orthopedic · 28d
Cleared Jul 11, 2003
GEMINI 16
K032036 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 10d