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

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176,076 results
155497–155520 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 22, 1983
TRANSCUTANEOUS ELECTRONIC NERVE STIMU
K831938 · GZJ
Joseph M. Piocentile
Neurology · 189d
Cleared Dec 22, 1983
AMEDA NEONATAL RESUSCITATION UNIT-
K832637 · FMT
Egnell, Inc.
General Hospital · 140d
Cleared Dec 22, 1983
OXY MONITOR 5-RANGE DUAL-THERMISTOR
K832652 · KLK
Litton Medical Electronics
Anesthesiology · 136d
Cleared Dec 22, 1983
IRI SPEC URINALYSIS CONTROL
K832713 · JJW
Intl. Remote Imaging Systems
Chemistry · 132d
Cleared Dec 22, 1983
ACTIMETER UB-103
K832724 · DRT
Copal, Inc.
Cardiovascular · 132d
Cleared Dec 22, 1983
STEDIFLO INFUSION SET
K832739 · LDR
Dravon Medical, Inc.
General Hospital · 129d
Cleared Dec 22, 1983
MONITORING SYSTEM AS100-AS115 RECORD
K832754 · DSF
Air-Shields, Inc.
Cardiovascular · 128d
Cleared Dec 22, 1983
PRE-GELLED DISPOS ELECTRODE
K832877 · DRX
Advance Tech Intl.
Cardiovascular · 118d
Cleared Dec 22, 1983
ACUTE HEMODIALYSIS TRAYS
K833139 · KNZ
Intermed, Inc.
Gastroenterology & Urology · 99d
Cleared Dec 22, 1983
BIOMET BIPOLAR PROSTHESIS
K833175 · KWY
Biomet, Inc.
Orthopedic · 94d
Cleared Dec 22, 1983
LOW PROFILE STEERABLE-INTRAOPERATIVE
K833248 · LIT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 98d
Cleared Dec 22, 1983
RX IV PENTRON IV
K833285 · EIS
Genesis Industries, Inc.
Dental · 91d
Cleared Dec 22, 1983
ACLAIM-QAP IBM PERSONAL COMPUTER EDT
K833353 · JQP
American Dade
Chemistry · 85d
Cleared Dec 22, 1983
KNEE PROSTHESIS-PATELLA COMPONENT
K833411 · JWH
Johnson & Johnson Professionals, Inc.
Orthopedic · 83d
Cleared Dec 22, 1983
PERI MIRROR/SALIVA EJECTOR
K833429 · EAX
Dentec, Inc.
Dental · 78d
Cleared Dec 22, 1983
EPOS CHEMISTRY ANALYZER 5060 & 6410
K833448 · JJE
Emd Chemicals, Inc.
Chemistry · 78d
Cleared Dec 22, 1983
RATEMINDER II SPECIALTY CARE
K833520 · LDR
Anatros Corp.
General Hospital · 72d
Cleared Dec 22, 1983
EMIT & METHOFREXATE ASSAY
K833634 · LAO
Syva Co.
Toxicology · 66d
Cleared Dec 22, 1983
KLEIN WIRE TIGHTENER/BIONIC WIRE
K833726 · HXS
Bionic Instrument Corp.
Orthopedic · 59d
Cleared Dec 22, 1983
VENOSET MULTI MED DUAL RATE PIGGYBACK
K833741 · FPA
Abbott Laboratories
General Hospital · 57d
Cleared Dec 22, 1983
EMERGENCY ASPIRATOR
K833785 · BTA
Vitalograph , Ltd.
General & Plastic Surgery · 55d
Cleared Dec 22, 1983
MICROPROCESSOR VENTILATOR 7200
K833786 · CBK
Puritan Bennett Corp.
Anesthesiology · 55d
Cleared Dec 22, 1983
HEMASTICK 1-1.5 & 2-DISPOS. BLOOD
K833816 · FMK
Medprobe Laboratories
General & Plastic Surgery · 50d
Cleared Dec 22, 1983
BACTROL TB SLIDE
K833900
Difco Laboratories, Inc.
Pathology · 38d