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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
133585–133608 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 14, 1988
SHARPLAN 4300 & 4310 ULTRASONIC SURGICAL APIRATORS
K883091 · LFL
Sharplan Lasers, Inc.
General & Plastic Surgery · 84d
Cleared Oct 14, 1988
MULTI-MED INFUSION CATHETER AND KIT DOUBLE/TRIPLE
K883174 · DQY
Baxter Healthcare Corp
Cardiovascular · 79d
Cleared Oct 14, 1988
MODEL 329-701 BIPOLAR ACTIVE-FIXATION LEAD
K883265 · DTB
Telectronics and Cordis Pacing Systems
Cardiovascular · 74d
Cleared Oct 14, 1988
ACS INDEFLATOR P/T 20
K883452 · DXT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 63d
Cleared Oct 14, 1988
PORTABLE II DENTAL DELIVERY SYSTEM
K883775 · EIA
Dntl Corp.
Dental · 38d
Cleared Oct 14, 1988
POLYSAFE(TM) IMPLANTABLE PACING LEAD
K884024 · DTB
Cardiac Control Systems, Inc.
Cardiovascular · 22d
Cleared Oct 13, 1988
INTER TRON 4000
K880924 · LIH
Diversified Chiropractic Systems
Neurology · 223d
Cleared Oct 13, 1988
MEDTRONIC MODEL 4951P
K881810 · DTB
Medtronic Vascular
Cardiovascular · 168d
Cleared Oct 13, 1988
THERMO-BODY-WRAP SYSTEM
K881862 · IRT
Thermo Body Wrap Systems, Inc.
Physical Medicine · 163d
Cleared Oct 13, 1988
CIBA CORNING MAGIC LITE INTACT PTH IMMUNOASSAY
K882560 · CEW
Ciba Corning Diagnostics Corp.
Chemistry · 114d
Cleared Oct 13, 1988
RUBBER BAND, STERILE
K882695 · ECI
Bioseal
Dental · 108d
Cleared Oct 13, 1988
CENTRIFUGAL PUMP SYSTEM LX/DX VERSION
K882758 · KFM
3M Health Care, Sarns
Cardiovascular · 100d
Cleared Oct 13, 1988
CASF CANCELLOUS BONE SCREW, BT650
K882934 · HWC
Terray Manufacturing, Inc.
Orthopedic · 92d
Cleared Oct 13, 1988
ALLOPREP SYSTEM
K883065 · KIT
Osteotech, Inc.
Pathology · 85d
Cleared Oct 13, 1988
PLEUR-EVAC(R)-A-7020-INFANT CHEST DRAIN SYSTEM
K883082 · CAC
Deknatel, Inc.
Anesthesiology · 84d
Cleared Oct 13, 1988
BENNETT BCA-6 &BCA-9 MOBILE C-ARM UNIT/RADIO/FLOUR
K883092 · IZL
Bennett X-Ray Corp.
Radiology · 83d
Cleared Oct 13, 1988
EP-STAT
K883152 · DQK
Coherent Systems, Inc.
Cardiovascular · 79d
Cleared Oct 13, 1988
PTI INTRA-ART INTER MAMM ARTERY PAPAVER INFUS KIT
K883221 · DWF
Pioneering Technologies, Inc.
Cardiovascular · 76d
Cleared Oct 13, 1988
IRIS ND:YAG OPTHALMIC LASER
K883270 · LQJ
California Laboratories, Inc.
Ophthalmic · 71d
Cleared Oct 13, 1988
LARYNGOSCOPE
K883296 · CCW
Lothar Scharras
Anesthesiology · 70d
Cleared Oct 13, 1988
TECHNICON RA(TM) SYSTEMS - MAGNESIUM
K883326 · JGJ
Technicon Instruments Corp.
Chemistry · 66d
Cleared Oct 13, 1988
TELESCAN INSTANT MEMORY ECG RECORDER MODEL T-35CM
K883358 · DXH
Telescan Medical Systems
Cardiovascular · 65d
Cleared Oct 13, 1988
ARTHRO-TRAC(TM)
K883361 · HRX
Rudolph Beaver, Inc.
Orthopedic · 65d
Cleared Oct 13, 1988
ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD)
K883387 · CKD
Tech-Co, Inc.
Chemistry · 64d